ABILIFY

Most Common Side Effects: increased cholesterol; weight gain; having a sense of inner restlessness or feeling like you cannot sit still; headache; constipation; nausea; dizziness; increased glucose; rash; anxiety; fatigue; tremor; vomiting.

Less Common Side Effects: bloating or swelling of face, arms, hands, lower legs, or feet; blurry vision; body aches or pain; airway congestion; coughing; difficulty with movement; fever; increased salivation- drooling (children); joint pain; muscle aching or cramping; muscle stiffness; stuffy nose (children); swollen joints; trouble swallowing; unusual weight gain or loss; acid or sour stomach; belching; dry mouth; fear; irregular heartbeat; irritability; loss of strength; lightheadedness; nervousness; sleepiness or unusual drowsiness; difficulty falling asleep or staying asleep; stomach discomfort, upset, or pain; back pain; increased risk of upper respiratory tract infections; bloody nose; loss of

bladder control; orthostatic hypotension (dizziness or lightheadedness when standing from a seated or lying position).

Rare Side Effects: Although rare, please call your doctor as soon as possible if any of the following side effects occur: difficulty speaking; loss of balance control; muscle trembling, jerking, or stiffness; shuffling walk; severe muscle stiffness; twisting movements of body; uncontrolled movements, especially of face, neck, and back; worsening of behavior; increased need to urinate; seizures or convulsions; difficulty in breathing; fast heartbeat; high fever; high or low blood pressure; excessive sweating; lip smacking or puckering; puffing of cheeks; rapid or worm-like movements of tongue; sudden loss of consciousness; extreme fatigue; uncontrolled chewing movements; uncontrolled movements of arms and legs; unusually pale skin; changes to menstruation; swelling of face, tongue, or throat; difficulty achieving erection; hair loss; blood coagulation disorders; generalized skin itch; loss of sexual desire or function; chest pain; heart fluttering; double vision; suicidal thoughts or actions (if you do experience this, please call your doctor immediately); yellowing of the skin or eyes.

Caution

• Extrapyramidal symptoms (EPS)

Patients have reported muscle spasms of the neck and back; shuffling walk; tic-like (jerky) movements of the head, face and neck; trembling and shaking of the hands and fingers; inability to move eyes; mask-like face; loss of balance control; blurred vision; difficulty speaking or swallowing. Additionally, though not common, Tardive Dyskinesia has been reported.

• Tardive Dyskinesia

presents with lip smacking or puckering, puffing of cheeks, rapid or fine worm-like movement of tongue, uncontrolled chewing movement, or uncontrolled movements of arms and legs may occur and may not go away after stopping use of the medication.

• Neuroleptic Malignant Syndrome (NMS)

Use may be associated with NMS. Monitor for changes in thinking, fever, muscle stiffness, and/ or autonomic instability (unable to exercise, abnormal sweating, loss of appetite, loss of bladder control, difficulty with ejaculation, burry vision). Call your doctor as soon as possible if you believe you may have NMS.

• Driving and operating heavy machinery

Aripiprazole may cause drowsiness or dizziness, which could make driving, operating heavy machinery, or participating in other activities requiring alertness dangerous. Be sure you know how this medication affects you before participating in these activities.

• Blood disorder

Check with your doctor immediately if you develop fever, chills, sore throat, or sores in the mouth. These may be signs of a very serious blood problem that has occurred rarely in patients taking aripiprazole. This medication also has the potential to increase bleeding.

• Orthostatic hypotension

Orthostatic hypotension is when one feels dizzy while standing up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

• Fall risk

This medication increases the risk of experiencing a fall due to drowsiness and dizziness. Caution should be exercised by those who have a history of falls.

• Weight gain

This medication has been associated with increased appetite and weight gain.

• Seizure

This medication may, in rare cases, cause a seizure. Caution should be exercised in those who have a history of seizures.

• Withdrawal

This medication should not be suddenly stopped as doing so may cause an individual to experience symptoms of withdrawal. Please speak with your physician before stopping this medication.

Warning: [Black Box Warning]: Increased Mortality in Elderly Patients with Dementia Related Psychosis:

Elderly patients with dementia related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of 17 placebo controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipyschotic drugs, revealed a risk of death in the drug treated patients of between 1.6 to 1.7 times that seen in placebo treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug treated patients was about 4.5% compared to a rate of about 2.6% in the placebo

group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis.

Warning: [Black Box Warning]: Suicidality and Antidepressant Drugs:

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of adjunctive Abilify or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Abilify is not approved for use in pediatric patients with depression.

See PDR for an all-inclusive list of side effects.

ARICEPT

Most Common Side Effects: diarrhea; loss of appetite; nausea; vomiting; muscle cramps; insomnia (unable to fall asleep or stay asleep); fatigue. Adverse effects may be more frequent at dose escalation (increase) and tend to resolve with continued use. Check with your doctor as soon as possible if you experience any of these adverse effects.

Less Common Side Effects: abnormal dreams; constipation; dizziness; drowsiness; fainting; frequent urination; headache; joint pain, stiffness, or swelling; mental depression; pain; unusual bleeding or bruising; weight loss. Check with your doctor as soon as possible if these or other bothersome side effects occur.

Rare Side Effects: Although rare, check with you physician as soon as possible if any of the following side effects occur: black, tarry stools; bloating; bloody or cloudy urine; blurred vision; burning, prickling, or tingling sensations; cataract; chills; clumsiness or unsteadiness; excessive abnormal muscle movements; confusion; cough; decreased urination; difficult or painful urination; dryness of mouth; eye irritation; fever; flushing of skin; frequent urge to urinate; high or low blood pressure; hives; hot flashes; increased heart rate and breathing; increase in sexual desire or performance; increased sweating; increased urge to urinate during the night; irregular heartbeat; itching; loss of bladder or bowel control; mood or mental changes (abnormal crying, aggression, agitation, delusions, irritability, nervousness, or restlessness); nasal congestion; pain in chest, upper stomach, or throat; problems with speech; runny nose; severe thirst; shortness of breath or wheezing; sneezing; sore throat; sunken eyes; tightness in chest; tremor; wrinkled skin.

Caution:

• Before you have any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. Taking donepezil together with certain medicines that are used during surgery or dental or emergency treatments may increase the effects of those medicines and cause unwanted effects.

• QT prolongation - abnormal heart rhythm leading to fainting spells or sudden death, use in caution with risk factors (congenital long QT syndrome, history of prolonged QT, family history of prolonged QT or sudden cardiac death; concomitant use with other agent that prolong QT interval).

See PDR for an all-inclusive list of side effects.

ATIVAN

Most Common Side Effects: dizziness; drowsiness; unsteadiness; headache; tiredness or weakness.

Less Common Side Effects: anxiety; confusion (may be more common in the elderly); fast, pounding, or irregular heartbeat; mental depression; abdominal or stomach cramps or pain; blurred vision or other changes in vision; changes in sexual desire or ability; constipation; diarrhea; dryness of mouth or increased thirst; false sense of well-being; headache; muscle spasm; nausea or vomiting; problems with urination; trembling or shaking; unusual tiredness or weakness.

Rare Side Effects: Check with your doctor immediately if any of the following side effect occur: abnormal thinking, including disorientation, delusions, or loss of sense of reality; agitation; behavior changes including aggressive behavior, bizarre behavior, decreased inhibition, or outbursts of anger; seizures; hallucinations (seeing, hearing, or feeling things that are not there); low blood pressure; muscle weakness; skin rash or itching; sore throat, fever, and chills; trouble in sleeping; uncontrolled movements of body including the eyes; unusual bleeding or bruising; unusual excitement, nervousness, or irritability; unusual tiredness or weakness (severe); yellow eyes or skin.

Caution

• Withdrawal

Abrupt termination of treatment may be accompanied by withdrawal symptoms such as headache, anxiety, tension, depression, insomnia, restlessness, confusion, irritability, seziures, and sweating. Seizures may be more common in patients with pre-existing seizure disorders or who are taking other drugs that lower the convulsive threshold such as antidepressants. Abrupt discontinuation of product should be avoided and a gradual dosage-tapering schedule followed after extended therapy.

• Respiratory Depression

Use of benzodiazepines, including lorazepam, both used alone and in combination with other CNS depressants, may lead to potentially fatal respiratory depression

• Driving and Operating Heavy Machinery

This medication may cause you to feel dizzy or drowsy. It is recommended to avoid driving, operating heavy machinery, or performing any other task that may be dangerous if not fully alert until you know how this medication affects you

• Pre-Existing Depression

Pre-existing depression may emerge or worsen during use of benzodiazepines including lorazepam. Lorazepam is not recommended for use in patients with a primary depressive disorder or psychosis

• Physical and Psychological Dependence

Use of benzodiazepines, including lorazepam, may lead to physical and psychological dependence.

Warning: [Black Box Warning]: Risk from concomitant use with opioids.

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.

Warning: [Black Box Warning]: Abuse, misuse, and addition.

The use of benzodiazepines, including Ativan, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing Ativan and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction.

Warning: [Black Box Warning]: Dependence and withdrawal reactions.

The continued use of benzodiazepines, including Ativan may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of Ativan after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue Ativan or reduce the dosage. Seek medical attention immediately if it is suspected that an overdose of medication has been taken.

See PDR for an all-inclusive list of side effects.

BUSPAR

Most Common Side Effects: dizziness or lightheadedness (especially when getting up from a sitting or lying position); drowsiness; headache; nausea; nervousness or unusual excitement; trouble sleeping.

Less Common Side Effects: blurred vision; clamminess or sweating; decreased concentration; diarrhea; dryness of mouth; muscle pain, spasms, cramps, or stiffness; unusual tiredness or weakness.

Rare Side Effects: Check with your doctor immediately if any of the following rare side effects occur: chest pain; sudden confusion; fast or pounding heartbeat; fever; incoordination; mental depression; muscle weakness; numbness, tingling, pain, or weakness in hands or feet; skin rash or hives; stiffness of arms or legs; sore throat; uncontrolled movements of the body.

Caution

• No Antipsychotic Activity

Because buspirone has no established antipsychotic activity, it should not be used in lieu of appropriate antipsychotic treatment.

• Serotonin Syndrome

Potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, and other serotonergic drugs, including buspirone, alone but particularly with concomitant use of other serotonergic drugs (including triptans), with drugs that impair metabolism of serotonin (in particular, MAOIs, including reversible MAOIs such as linezolid and intravenous methylene blue), or with antipsychotics or other dopamine antagonists. The use of buspirone with MAOIs intended to treat depression is contraindicated. Discontinue treatment (and any concomitant serotonergic agent) immediately if signs/symptoms arise.

See PDR for an all-inclusive list of side effects.

CATAPRESS/KAPVAY

Most Common Side Effects: hypotension, skin rash, dry mouth, drowsiness, dizziness, headache, constipation, and fatigue. Check with your doctor immediately if any of the following side effects occur: Signs and symptoms of overdose: Difficulty in breathing; dizziness (extreme) or faintness; feeling cold; pinpoint pupils of eyes; slow heartbeat; unusual tiredness or weakness (extreme).

Less Common Side Effects: decreased sexual ability; dizziness, lightheadedness, or fainting, especially when getting up from a lying or sitting position; dry, itching, or burning eyes; loss of appetite; nausea or vomiting; nervousness; mental depression; swelling of feet and lower legs.

Rare Side Effects: paleness or cold feeling in fingertips and toes; vivid dreams or nightmares. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the listed side effects continue or are bothersome.

Caution:

• Do not suddenly stop taking this medication. This medication should be tapered (stopped slowly). Please consult your physician before stopping this medication.

• When first starting this medication, it can make you dizzy while standing up. Take extra caution by standing slowly from a seated or lying position.

• This medication can impair physical or mental abilities; use caution about performing tasks which require mental alertness, such as driving, operating machinery, or anything else that could be dangerous if you are not alert.

Warning

Withdrawal: Do not discontinue therapy without consulting your physician. Sudden cessation of clonidine treatment has, in some cases, resulted in symptoms such as nervousness, agitation, headache, and tremor accompanied or followed by a rapid rise in blood pressure and elevated catecholamine concentrations in the plasma. The likelihood of such reactions appears to be greater after administration of higher doses or taking this medication with beta-blocker treatment and special caution is therefore advised in these situations. Rare instances of hypertensive encephalopathy (symptoms of headache, vomiting, confusion, or balance issues), cerebrovascular accidents (stroke), and

death have been reported after clonidine withdrawal. Because children commonly have gastrointestinal illnesses that lead to vomiting, they may be particularly susceptible to hypertensive episodes resulting from abrupt inability to take medication.

See PDR for an all-inclusive list of side effects

CYMBALTA

Most Common Side Effects: Nausea, diarrhea, dry mouth, drowsiness, stomach pain, insomnia, dizziness, constipation, and headache.

Less Common Side Effects: Increased blood pressure, erectile dysfunction, abnormal orgasm or discharge of semen (ejaculation), decreased interest in sex, dizziness, anxiety, tremor or muscle spasms, weight gain, and abnormal dreams.

Rare Side Effects: Although rare; check with your physician immediately if the following occur: passing out, change in eyesight, chest pain or pressure, feeling confused, change in balance, yellow skin or eyes, enlarged breasts, nipple discharge, change in urination, signs of bleeding such as coughing up blood, or thoughts of self-harm.

Caution:

• Do not drive or do anything that could be dangerous until you know how this medication affects you

• Stand up slowly to avoid becoming dizzy

• Do not stop using this medicine suddenly, the doctor will need to slowly decrease your dose before stopping

• Avoid Alcohol while on this medication

BLACK BOX WARNING

Suicidality and Antidepressant Drugs: Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in short term studies in children, adolescents, and young adults with major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of this drug or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. This drug is not approved for use in pediatric patients.

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA—Close observation for suicidal thinking or unusual changes in behavior.

See PDR for an all-inclusive list of side effects

GEODON

Most Common Side Effects: drowsiness; orthostatic hypotension (feeling faint upon standing from a seated or lying position); inability to move eyes; increasing blinking or spasms of eyelid; unintentionally sticking out tongue; uncontrolled twisting movements of neck, trunk, arms, or legs; unusual facial expressions; loss of balance control; muscle trembling, jerking or stiffness; shuffling walk; stiffness of limbs; nausea; stomach discomfort; uncontrollable movements of body parts; anxiety; slurred speech; difficulty speaking.

Less Common Side Effects: high or low blood pressure; fast or slow heartbeat; swelling of the face, throat, or tongue; chest pain; swelling of the feet or ankles; personality changes; confusion; delirium; chills; vertigo; inability to achieve orgasm; fluttering of the heart; loss of sexual desire or function; paralysis; insomnia (inability to fall asleep or stay asleep); pain in the lower back or sides; skin rash; fungal rash; excessive sweating; sensitivity of the skin to the sun; hair loss; eczema; hives; weight gain; menstrual changes; increased gucose levels; increased thrist; constipation; heart burn; dehydration; vomiting; dry mouth; excessive saliva production; abdominal pain; difficulty

swallowing; loss of bladder control; lactation (females); muscle weakness; muscle pain; tingling of the skin in the hands or feet; slowed or rigid movement; tremor; ringing in the ears; changes in vision; increased sensitivity of the eyes to light; fever; more frequently needing to urinate; increased risk of respiratory tract infections; stuffy nose; cough; chest congestion; flu-like symptoms.

Rare Side Effects: Although rare, please contact your doctor as soon as possible if any of the following are to occur: severe muscle or joint pain; yellowing of the skin or eyes; seizures or convulsions; drooping face; loss of sexual desire or function; fever; severe rash; swollen lymph nodes; severe bleeding from the gums of the mouth or any other part of the body; bloody stool; increased need to urinate at night; difficulty breathing (gasping for air).

Caution:

• Extrapyramidal symptoms (EPS)

Patients have reported muscle spasms of the neck and back; shuffling walk; tic-like (jerky) movements of the head, face and neck; trembling and shaking of the hands and fingers; inability to move eyes; mask-like face; loss of balance control; blurred vision; difficulty speaking or swallowing. Additionally, though not common, Tardive Dyskinesia has been reported. Tardive Dyskinesia presents with lip smacking or puckering, puffing of cheeks, rapid or fine worm-like movement of tongue, uncontrolled chewing movement, or uncontrolled movements of arms and legs may occur and may not go away after stopping use of the medication.

• Neuroleptic Malignant Syndrome (NMS)

Use may be associated with NMS. Monitor for changes in thinking, fever, muscle stiffness, and/ autonomic instability (unable to exercise, abnormal sweating, loss of appetite, loss of bladder control, difficulty with ejaculation, burry vision). Call your doctor as soon as possible if you believe you may have NMS.

• QT prolongation

This drug has the potential to prolong the QT interval of the heart. Caution should be exercised by those who have a history of QT prolongation, heart syndromes such as Congenital Long QT Syndrome (CLQTS), or by those who have multiple risk factors for QT prolongation.

• Driving and operating heavy machinery

Ziprasidone may cause drowsiness or dizziness, which could make driving, operating heavy machinery, or participating in other activities requiring alertness dangerous. Be sure you know how this medication affects you before participating in these activities.

• Blood disorder

Check with your doctor immediately if you develop fever, chills, sore throat, or sores in the mouth. These may be signs of a very serious blood problem that has occurred rarely in patients taking ziprasidone. This medication also has the potential to increase bleeding/

• Orthostatic hypotension

Orthostatic hypotension is when one feels dizzy while getting up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

• Fall risk

This medication increases the risk of experiencing a fall due to drowsiness and dizziness. Caution should be exercised by those who have a history of falls.

• Rash

Cases of dermatologic reactions (including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms [DRESS]) have been reported and may be fatal. Symptoms of DRESS include a combination of three or more of the following: Severe skin eruption (rash), fever, swollen lymph nodes, itching, difficulty breathing AND at least one systemic complication.

• Weight gain

This medication has been associated with increased appetite and weight gain.

• Seizure

This medication may, in rare cases, cause individuals to experience a seizure. Caution should be exercised in those who have a history of seizures.

• Suicide

• This medication has the potential to cause new or worsening thoughts of suicide. If you experience these, immediately call your doctor.

• Withdrawal

This medication should not be suddenly stopped as it may cause an individual to experience symptoms of withdrawal. Please speak with your physician before stopping this medication.

Warning: [Black Box Warning]: Increased Mortality in Elderly Patients with Dementia Related Psychosis:

Elderly patients with dementia related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of 17 placebo controlled trials (modal duration of 10 weeks, largely in patients taking atypical antipyschotic drugs, revealed a risk of death in the drug treated patients of between 1.6 to 1.7 times that seen in placebo treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug treated patients was about 4.5% compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death)

or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. This drug is not approved for the treatment of patients with dementia-related psychosis.

See PDR for an all-inclusive list of side effects.

INVEGA

Most Common Side Effects: difficulty with speaking; drooling; fast, pounding, or irregular heartbeat or pulse; loss of balance control; muscle trembling, jerking, or stiffness; restlessness; shuffling walk; stiffness of limbs; uncontrolled movements, especially of face, neck, and back; fear or nervousness; headache; nausea; sleepiness or unusual drowsiness; weight gain; increased HDL cholesterol; increased LDL cholesterol.

Less Common Side Effects: chest pain; cold sweats; confusion; cough; difficulty with swallowing; dizziness; excessive muscle tone; fainting; inability to move eyes; increased blinking or spasms of eyelid; increased blood pressure; mask-like face; muscle tension or tightness; pain in arms or legs; slow heartbeat; slowed movements; slurred speech; sticking out tongue when not meaning to; tic-like (jerky) movements of the head, face, mouth, or neck; trembling and shaking of fingers and hands; tremors; trouble with breathing or speaking; uncontrolled twisting movements of neck, trunk, arms, or legs; unusual facial expressions; unusual weakness; acid or sour stomach; back

pain; belching; blurred vision; faintness or lightheadedness when getting up from a lying or sitting position; dry mouth; fever; heartburn; indigestion; lack or loss of strength; stomach discomfort, upset, or pain; decreased sexual drive or function.

Rare Side Effects: Although rare, please call your doctor as soon as possible if any of the following occur: face, tongue, or throat swelling; increased upper respiratory tract infections; heart attack; severely low blood pressure; rash; pneumonia; breast swelling; intestinal obstruction; seizures; abnormal or fluttering heartbeat.

Caution

• Blood sugar levels

For patients with diabetes: This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests, please contact your doctor.

• Driving and operating heavy machinery

This medicine may make you dizzy or drowsy. Avoid driving, using heavy machinery, or doing anything else that could be dangerous while you are not fully alert.

• Orthostatic hypotension

You may feel lightheaded when getting up suddenly from a sitting or lying position. Take caution by standing slowly from a seated or lying position.

• Extrapyramidal symptoms (EPS)

Extrapyramidal symptoms involve excessive normal and abnormal movements that may be uncontrollable. Symptoms to look out for include: loss of balance control; mask-like face; restlessness or need to keep moving; shuffling walk; stiffness of arms or legs; trembling and shaking of hands and fingers; inability to move eyes; increased blinking or spasms of eyelid; lip smacking or puckering; muscle spasms of face, neck, body, arms, or legs causing unusual postures or unusual expressions on face; puffing of cheeks; rapid or worm-like movements of tongue; sticking out of tongue; tic-like or twitching movements; trouble in breathing, speaking, or swallowing; uncontrolled chewing movements; uncontrolled movements of arms or legs; uncontrolled twisting movements of neck, trunk, arms, or leg.

• QT prolongation

This medication has been known to prolong the QT interval. This medication should not be used by those who have congenital long QT syndrome, as well as those with other QT risk factors.

• Seizures

This medication has the potential to lower the seizure threshold. Individuals with a history of seizures should be cautious when taking this medication and report any adverse events to their doctor.

• Fall risk

This medication may make individuals drowsy and dizzy, which can lead to falls. Older individuals and people with a history of falls should be cautious when taking this medication.

• Neuroleptic Malignant Syndrome (NMS)

Use may be associated with neuroleptic malignant syndrome; monitor for mental status changes, fever, muscle rigidity, and/or trouble with movement.

• Weight gain

This medication has been known to cause significant weight gain. If this becomes bothersome for you, please let your doctor know.

• Suicide

This medication, in rare cases, has caused new or worsening suicidal thoughts. If you experience this, please call your doctor right away.

• Withdrawal

Do not suddenly stop taking this medication as it could cause you to experience withdrawal symptoms. Please speak with your doctor before stopping this medication.

Warning: [Black Box Warning]: Increased Mortality in Elderly Patients with Dementia Related Psychosis

Elderly patients with dementia related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of 17 placebo controlled trials (modal duration of 10 weeks, largely in patients taking atypical antipyschotic drugs, revealed a risk of death in the drug treated patients of between 1.6 to 1.7 times that seen in placebo treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug treated patients was about 4.5% compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g. heart failure, sudden death) or infectious (e.g. pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. This drug is not approved for the treatment of patients with dementia-related psychosis.

See PDR for an all-inclusive list of side effects.

LATUDA

Most Common Side Effects: Increased cholesterol; increased blood glucose; increased blood triglycerides; nausea; increased risk of viral infection; drowsiness; difficulty controlling movements; jerk-like movements of the limbs or body; shuffling walk; difficulty walking; feeling restless or not able to sit still; feeling the urge to move; tic-like motions of the face; tremor; impaired speech; muscle stiffness; insomnia (unable to fall asleep or stay asleep).

Less Common Side Effects: Rapid heartbeat; dizziness when standing from a seated or lying; hypertension (high blood pressure); itchy skin; skin rash; weight gain; increased prolactin levels; regurgitation of stomach acid or acidic taste in the mouth; vomiting; dry mouth; diarrhea; decreased appetite; increased salivation; stomach pain; urinary tract infections; increased risk of influenza; agitation; anxiety; dizziness; fatigue; blurred vision; runny nose; stuffy nose.

Rare Side Effects: Increased risk of suicide; abnormal dreams; loss of menstrual period; anemia; chest pain; swelling of the face, lips, throat; or tongue; slow heartbeat; swelling of the breasts; difficulty breathing; difficulty with urination; unable to obtain or maintain erection; panic attack; muscle pain; fainting; vertigo; hives or severe rash.

Caution:

Neuroleptic Malignant Syndrome (NMS):

Patients and caregivers should be counseled that a potentially fatal symptom complex sometimes referred to as NMS has been reported in association with administration of antipsychotic drugs. Signs and symptoms of NMS include a very high fever, muscle rigidity or stiffness, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, fast heartbeat, excessive sweating, and abnormal heartbeat).

Hyperglycemia and Diabetes Mellitus:

Patients should be aware of the symptoms of hyperglycemia (high blood sugar) and diabetes mellitus. Patients who are diagnosed with diabetes, those with risk factors for diabetes, or those that develop these symptoms during treatment should have their blood glucose monitored at the beginning of and periodically during treatment.

Weight Gain:

Weight gain has been reported in patients taking medicines like Lurasidone. You and your healthcare provider should check your weight regularly. Talk to your doctor about ways to control weight gain, such as eating a healthy, balanced diet, and exercising.

Orthostatic Hypotension:

Patients should be advised of the risk of orthostatic hypotension (dizziness when standing from a seated or lying position), particularly at the time of initiating treatment, re-initiating treatment, or increasing the dose.

Leukopenia/Neutropenia:

Patients with a pre-existing low white blood cell count or a history of drug-induced leukopenia/neutropenia should be advised that they should have their CBC monitored while taking lurasidone.

Driving and operating heavy machinery:

Patients should be cautioned about performing activities requiring mental alertness, such as operating hazardous machinery or operating a motor vehicle, until they are reasonably certain that lurasidone therapy does not affect them adversely.

Pregnancy and Nursing:

Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy with lurasidone.

Concomitant Medication and Alcohol:

Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for interactions. Patients should be advised to avoid alcohol while taking lurasidone.

Heat Exposure and Dehydration:

Patients should be advised regarding appropriate care in avoiding overheating and dehydration.

Cerebrovascular Adverse Reactions:

An increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack) has been seen in elderly patients with dementia-related psychoses treated with atypical antipsychotic drugs. Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring. Tardive Dyskinesia: Discontinue if clinically appropriate. Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain. Hyperglycemia and Diabetes Mellitus: Monitor patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Monitor glucose regularly in patients with diabetes or at risk for diabetes. Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics. Weight Gain: Gain in body weight has been observed; clinical monitoring of weight is recommended. Hyperprolactinemia: Prolactin elevations may occur. Leukopenia, Neutropenia, and Agranulocytosis have been reported with antipsychotics. Patients with a pre-existing low white blood cell count (WBC) or a history of leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and lurasidone should be discontinued at the first sign of a decline in WBC in the absence of other causative factors. Orthostatic Hypotension and Syncope: Dizziness, tachycardia or bradycardia, and syncope may occur, especially early in treatment. Use with caution in patients with known cardiovascular or cerebrovascular disease, and in antipsychotic-naïve patients. Seizures: Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold. Potential for Cognitive and Motor Impairment: Use caution when operating machinery. Suicide: The possibility of a suicide attempt is inherent in schizophrenia. Closely supervise high-risk patients.

Warning: [Black Box Warning]: Suicidality and Antidepressant Drugs: Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies; consider risk prior to prescribing. Closely monitor all antidepressant treated patients for clinical worsening and for emergence of suicidal thoughts and behaviors, particularly during the initial 1 to 2 months of therapy or during periods of dosage adjustments (increases or decreases); the patient's family or caregiver should be instructed to closely observe the patient and communicate condition with health care provider. A medication guide concerning the use of antidepressants should be dispensed with each prescription.

Warning: [Black Box Warning]: Increased Mortality in Elderly Patients with Dementia-Related Psychosis: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of

the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Lurasidone is not approved for the treatment of patients with dementia-related psychosis.

See PDR for an all-inclusive list of side effects.

LEXAPRO

Most Common Side Effects: headache; insomnia; drowsiness; dizziness; nausea; diarrhea; excessive sweating; ejaculation disorder.

Less Common Side Effects: fatigue; paresthesia (tingling or prickling sensation); yawning; dry mouth; stomach pain; heartburn; constipation; inability to fall asleep; abnormal dreams; decreased sexual desire; inability to have or keep an erection, inability to achieve orgasm; nasal congestion; neck, shoulder, or back pain; indigestion; vomiting, decreased appetite.

Rare Side Effects: Although rare, check with you physician immediately if any of the following side effects occur: confusion; convulsions; fast or irregular heartbeat/ rhythm; decreased urine output; muscle pain or cramps; shortness of breath; swelling of face, ankles, or hands; diplopia (double vision); hallucinations; aggressive behavior; chest pain; skin rash or hives; weight gain; lack of concentration; jaw tightness or grinding of teeth.

Caution:

• Driving and Operating Heavy Machinery

This medication may decrease motor function, take caution operating machinery, driving, or anything else that that could be dangerous if you are not alert or well-coordinated.

• Bleeding

Increased risk of bleeding events particularly if used with aspirin, NSAIDs (ibuprofen, naproxen), warfarin, or other anticoagulants.

• QT prolongation

Abnormal heart rhythm leading to fainting spells or sudden death. Use in caution with risk factors (congenital long QT syndrome, history of prolonged QT, family history of prolonged QT or sudden cardia death, concomitant use with other agents that prolong QT interval).

• Withdrawal

Do not abruptly stop taking this medication. Abrupt discontinuation or interruption may cause withdrawal symptoms. Please talk with your doctor before stopping this medication.

• Serotonin Syndrome

Serotonin syndrome (SS) is a potentially life-threatening syndrome that has occurred with serotonergic agents (eg, SSRIs, SNRIs), particularly when used in combination with other serotonergic agents (eg, triptans, TCAs, fentanyl, lithium, tramadol, buspirone, St John's wort, tryptophan) or agents that impair metabolism of serotonin (eg, MAO inhibitors intended to treat psychiatric disorders, other MAO inhibitors [ie, linezolid and intravenous methylene blue]). Monitor patients closely for signs of SS such as mental status changes (eg, agitation, hallucinations, delirium, coma); autonomic instability (eg, tachycardia, labile blood pressure, diaphoresis); neuromuscular changes (eg, tremor, rigidity, myoclonus); GI symptoms (eg, nausea, vomiting, diarrhea); and/or seizures.

Discontinue treatment (and any concomitant serotonergic agent) immediately if signs/symptoms arise.

• Sexual Function

Antidepressants may cause or worsen sexual function or desire. If this becomes bothersome, please speak with your doctor to discuss these concerns.

Warning: [Black Box Warning] Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults with major depressive disorder (MDD) and other psychiatric disorders in short-term studies. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared with placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared with placebo in adults aged 65 or older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients less than 12 years of age.

See PDR for an all-inclusive list of side effects.

LUVOX

Most Common Side Effects: Headache, trouble sleeping, drowsiness, dizziness, nervousness/anxious, nausea, diarrhea, dry mouth, stomach upset, lower appetite, and sexual issues (erectile dysfunction)

Less Common Side Effects: Sweating, decreased libido, abnormal ejaculation, constipation, decreased appetite, frequent urination, heartburn, chest pain, upset stomach, or changes in taste.

Check with your doctor immediately if the following less common side effects occur: Behavior, mood, or mental changes; trouble in breathing; trouble in urinating; twitching.

Rare Side Effects: Check with your doctor immediately if any of the following rare side effects occur: agitation; blurred vision; clumsiness or unsteadiness; confusion; convulsions (seizures); fever; inability to move eyes; increase in body movements; menstrual changes; nose bleeds; overactive reflexes; poor coordination; red or irritated eyes; redness, tenderness, itching, burning or peeling of skin; restlessness; shivering; skin rash; sore throat, fever, and chills; sweating; talking or acting with excitement you cannot control; trembling or shaking; unusual bruising; unusual,

incomplete, or sudden body or facial movements; unusual secretion of milk, in females; weakness.

Caution

• Avoid Drinking alcohol while taking fluvoxamine

• May cause blurred vision or drowsiness, caution driving or other tasks until you know how you react

• Do not stop taking this medication suddenly, your doctor will slowly decrease the dose until you can discontinue medication

• Tell your doctor if you have any thoughts of self-harm

Warning

BLACK BOX WARNING

Antidepressant and Suicidality: Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in short term studies in children, adolescents, and young adults with major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of this drug or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. This drug is not approved for use in pediatric patients except for patients with obsessive-compulsive disorder (OCD).

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA—Close observation for suicidal thinking or unusual changes in behavior.

See PDR for an all-inclusive list of side effects.

MINIPRESS

Most Common Side Effects

Most common side effects include dizziness, drowsiness, headache, decreased energy, nausea, weakness, and a noticeably strong or irregular heartbeat.

Less Common Side Effects

Less common side effects include fainting, fluid buildup in extremities, nervousness, depression, skin rash, constipation, diarrhea, vomiting, dry mouth, frequent urination, blurred vision, shortness of breath, nasal congestion, and nosebleeds.

Rare Side Effects

Rare side effects include hair loss, changes in heartbeat, sweating, eye pain, fever, flushing, pancreatitis, urinary incontinence.

Caution

Cardiovascular: Fainting with sudden loss of consciousness may occur. Risk may be minimized by limiting initial dose, increasing dose slowly, and cautiously initiating additional antihypertensive drugs. Severe increases in heartbeat (120 to 160 beats/min) have been reported prior to fainting episodes. Low blood pressure may occur with additional antihypertensive medications.

Neurologic: Dizziness and drowsiness may occur, especially with first dose and after a dose increase. Use caution when performing tasks that require mental alertness. Stand or sit up slowly if you feel lightheaded or dizzy. Alcohol may make this problem worse.

Ophthalmic: Intraoperative floppy iris syndrome has been reported during cataract surgery. Modification to surgical technique may be necessary.

Reproductive: Priapism and prolonged erections have been reported. Seek immediate medical assistance for erections lasting longer than 4 hours.

See PDR for an all-inclusive list of side effects.

NAMENDA

Most Common Side Effects: confusion, dizziness, headache, constipation, or diarrhea.

Less Common Side Effects: hypertension or hypotension (high or low blood pressure); weight gain; abdominal or stomach pain; vomiting; inability to control bladder; aggressive behavior; anxiety; depression; drowsiness; fatigue; hallucinations; back pain; cough; difficulty breathing.

Rare Side Effects: Although rare, call your doctor as soon as possible if you experience any of the following side effects: slow heartbeat; heart failure; prolonged QT interval; severe rash or lesions on the skin, especially accompanied by a fever; pancreatitis (symptoms of: upper abdominal pain; pain that radiates to the back; pain that worsens with eating; fever; fast, rapid heartbeat; vomiting); yellowing of the eyes or skin; agitation; delusions; seizure; fainting or loss of consciousness; mania; changes in vision; acute kidney failure; allergic reaction

(symptoms of: swelling of the face, tongue, lips, or throat; hives or rash shortly after taking the medication).

Caution:

• Skin hypersensitivity:

Rare skin hypersensitivity reactions (eg, Stevens Johnson syndrome, erythema multiforme) have been reported; advise patients to report skin reactions immediately. Discontinue use with signs of hypersensitivity reaction, such as new or worsening rashes/ lesions. It is very important that your healthcare professional check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

• Seizures:

Use with caution in patients with a history of seizure disorder; may increase risk of seizures. Tell your doctor if you have a history of seizures.

See PDR for an all-inclusive list of side effects.

PROZAC

Most Common Side Effects: insomnia; dizziness; headache; drowsiness; anxiety; nervousness; yawning; tremor; decreased sexual interest or desire; nausea, indigestion; stomach pain; diarrhea; loss of appetite; dry mouth; muscle weakness; sore throat; stuffy nose; flu-like symptoms.

Less Common Side Effects: decrease or increase in blood pressure; palpitations; abnormal dreams; agitation; abnormal thoughts; excessive sweating; skin rash; itching; increased thirst; constipation; gas; altered/impaired sense of taste; ejaculation disorder; inability to have or maintain an erection; urinary frequency (having to urinate more often).

Rare Side Effects: Although rare, check with you physician as soon as possible if any of the following side effects occur: amnesia (forgetfulness), confusion; symptoms of low blood sugar (anxiety, nervousness, chills, cold sweats, confusion, fast/irregular heartbeat, shakiness); heavy or prolonged vaginal bleeding with menstrual cycle; excessive abnormal movements or excessive normal movements, or a combination of both; visual disturbances; heavy nose bleeds; acne; angle-closure glaucoma; cardiac arrhythmias or failure; yellowing of the eyes or skin; hallucinations; suicidal thoughts; black stool.

Caution:

• Driving and Operating Heavy Machinery

This medication, in some cases, may impair cognitive/motor performance, use caution operating machinery, driving, or anything else that could be dangerous if you are not alert and well able to control your movements.

• Bleed Risk

Increased risk of bleeding particularly if used with aspirin, NSAIDs (naproxen, ibuprofen), warfarin. or other anticoagulants.

• QT prolongation

Abnormal heart rhythm leading to fainting spells or sudden death, use in caution with risk factors (congenital long QT syndrome, history of prolonged QT, family history of prolonged QT or sudden cardia death; concomitant use with other agents that prolong QT interval).

• Psychosis/ Mania

May worsen psychosis in some patients or precipitate shift to mania or hypomania in patient with bipolar disorder.

• Weight Loss

May cause anorexia and/or weight loss

• Withdrawal

Abrupt discontinuation or interruption may cause withdrawal symptoms. Please speak with your doctor before stopping this medication.

• Serotonin Syndrome

Serotonin syndrome (SS) is a potentially life-threatening syndrome that has occurred with serotonergic agents (eg, SSRIs, SNRIs), particularly when used in combination with other serotonergic agents (eg, triptans, TCAs, fentanyl, lithium, tramadol, buspirone, St John's wort, tryptophan) or agents that impair metabolism of serotonin (eg, MAO inhibitors intended to treat psychiatric disorders, other MAO inhibitors [ie, linezolid and intravenous methylene blue]). Monitor patients closely for signs of SS such as mental status changes (eg, agitation, hallucinations, delirium, coma); autonomic instability (eg, tachycardia, labile blood pressure, diaphoresis); neuromuscular changes (eg, tremor, rigidity, myoclonus); GI symptoms (eg, nausea, vomiting, diarrhea); and/or seizures. Discontinue treatment (and any concomitant serotonergic agent) immediately if signs/symptoms arise.

• Decreased Sexual Function

This medication may cause or worsen sexual desire or function. If this becomes bothersome, please speak with your doctor about your concerns.

Warning: [Black Box Warning] Antidepressants increase the risk of suicidal thinking and behavior in children, adolescents, and young adults (18 to 24 years of age) with major depressive disorder (MDD) and other psychiatric disorders; consider risk prior to prescribing. Short-term studies did not show an increased risk in patients >24 years of age and showed a decreased risk in patients ≥65 years. Closely monitor all patients for clinical worsening, suicidality, or unusual changes in behavior, particularly during the initial 1 to 2 months of therapy or during periods of dosage adjustments (increases or decreases); the patient’s family or caregiver should be instructed to closely observe the patient and communicate condition with health care provider. A medication guide concerning the use of antidepressants should be dispensed with each prescription. Fluoxetine is FDA approved for the treatment of OCD in children ≥7 years of age and MDD in children ≥8 years of age.

See PDR for an all-inclusive list of side effects

REMERON

Most Common Side Effects: constipation; dizziness; drowsiness; dry mouth; increased appetite; weight gain.

Less Common Side Effects: twitching or abnormal movement; mood or mental changes, including abnormal thinking, agitation, anxiety, confusion, and feelings of hoplessness; shortness of breath; skin rash; swelling, especially of the ankles/feet; abdominal pain; abnormal dreams; back pain; dizziness or fainting when getting up suddenly from a lying or sitting position; more frequent need to urinate; increased sensitivity to touch; increased thirst; low or high blood pressure; muscle pain; nausea; vertigo (feeling of moving when not); trembling or shaking; restlessness or feeling the need to constantly move; vomiting; weakness.

Rare Side Effects: Although rare, check with your physician as soon as possible if you experience the following: convulsions (seizures); mouth sores; sore throat, chills, or fever; decreased sexual ability; menstrual pain; missing periods; mood or mental changes, including anger, feelings of being outside the body, hallucinations (seeing, hearing, or feeling things that are not there), mood swings, and unusual excitement; anxiety; breast enlargement in both males and females; hair loss; inappropriate secretion of milk--in females; increased sensitivity to sunlight; irritability; muscle twitching; red or brownish spots on skin; ringing, buzzing, or other unexplained sounds in the ears; swelling of face and tongue; swelling of testicles (more common with amoxapine); trouble with teeth or gums (more common with

clomipramine); weakness; yellow eyes or skin.

Caution

• Driving and operating heavy machinery

Mirtazapine may cause drowsiness or dizziness, which could make driving, operating heavy machinery, or participating in other activities requiring alertness dangerous. Be sure to know how this medication affects you before participating in these activities.

• Blood disorder

Check with your doctor immediately if you develop fever, chills, sore throat, or sores in the mouth. These may be signs of a very serious blood problem that has occurred rarely in patients taking mirtazapine.

• Orthostatic hypotension

Orthostatic hypotension is when one feels dizzy while getting up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

• QT prolongation

This drug has the potential to affect the QT interval of the heart, which, in rare cases, can lead to a fatal arrhythmia. This medication should be used with caution in those have a history of QT prolongation, as well as those who have multiple QT prolonging risk factors.

• Fractures

Bone fractures have been associated with antidepressant treatment.

• Anticholinergic effects

May cause anticholinergic effects (constipation, dry mouth, blurred vision, urinary retention).

• Weight gain

This medication has been associated with increased appetite and weight gain.

• Serotonin syndrome

Potentially life-threatening serotonin syndrome (SS) has occurred with serotonergic agents (eg, SSRIs, SNRIs), particularly when used in combination with other serotonergic agents (eg, triptans, TCAs, fentanyl, lithium, tramadol, buspirone, St John's wort, tryptophan) or agents that impair metabolism of serotonin (eg, MAO inhibitors intended to treat psychiatric disorders, other MAO inhibitors [ie, linezolid and intravenous methylene blue]).

• Seizures

This medication has the potential, in rare cases, cause individuals to experience a seizure. Caution should be exercised in those who have a history of seizures.

• Withdrawal

This medication should not be suddenly stopped, as this could cause an individual to experience symptoms of withdrawal. Please speak with your physician before stopping this medication.

Before having any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist that you are using this medicine.

Warning: [BLACK BOX WARNING]: Antidepressants and Suicidality:

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in short term studies in children, adolescents, and young adults with major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of this drug or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves

associated with increases in the risk of suicide. Patients of all ages who are started on therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. This drug is not approved for use in pediatric patients.

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA—Close observation for suicidal thinking or unusual changes in behavior.

See PDR for an all-inclusive list of side effects.

RISPERDAL

Most Common Side Effects: constipation; coughing; drowsiness; headache; increased dream activity; nausea; increased appetite; upper abdominal pain; sleepiness or unusual drowsiness; sore throat; stuffy or runny nose; unusual tiredness or weakness; weight gain; muscle spasms of face, neck, and back; twisting movements of body; anxiety or nervousness; changes in vision, including blurred vision loss of balance control; mask-like face; problems in urination or increase in amount of urine; restlessness or need to keep moving (severe); shuffling walk; stiffness or weakness of arms or legs; tic-like or twitching movements; trembling and shaking of fingers and hands; trouble in sleeping.

Less Common Side Effects: diarrhea; dry mouth; heartburn; mood or mental changes, including aggressive behavior, agitation, difficulty in concentration, and memory problems; skin rash or itching; sudden weakness or numbness in the face, arms or legs; unusual secretion of milk/elevated prolactin levels; decreased sexual desire or performance; inability to move eyes; back pain; body aches or pain; chills; menstrual changes; dandruff; darkening of skin color; dry skin; ear congestion; fever; increase in controllable and uncontrollable body movements; increased sensitivity of the skin to sun; increased watering of mouth; joint pain; loss of voice; oily skin; pain or tenderness

around eyes and cheekbones; shortness of breath or troubled breathing; sneezing; stomach pain; toothache; tightness of chest or wheezing; vomiting; weight loss; difficulty walking; falling; eye infection; increased risk of upper respiratory tract infections; development of breasts in males; increased blood sugars; incresed thirst; pounding or abnormal heartbeat.

Rare Side Effects: Although rare, contact you doctor as soon as possible if any of the following side effects occur: convulsions (seizures); difficult or fast breathing; fast heartbeat or irregular pulse; fever (high); high or low blood pressure; greatly increased sweating; loss of bladder control; muscle stiffness (severe); unusually pale skin; unusual tiredness or weakness (severe); difficulty in speaking or swallowing; high body temperature (dizziness; fast, shallow breathing; fast, weak heartbeat; headache; muscle cramps; pale, clammy skin; increased thirst); lip smacking or puckering; low body temperature (confusion, drowsiness, poor coordination, shivering); prolonged, painful, inappropriate erection of the penis; puffing of cheeks; rapid or worm-like movements of tongue; uncontrolled chewing movements; uncontrolled movements of arms and legs; extreme thirst; increased blinking or spasms of eyelid; loss of appetite; talking, feeling, and acting with excitement and activity that cannot be controlled; uncontrolled twisting movements of neck, trunk, arms, or legs; unusual bleeding or bruising; unusual facial expressions or body positions.

Caution

• Extrapyramidal symptoms (EPS)

Patients have reported muscle spasms of the neck and back; shuffling walk; tic-like (jerky) movements of the head, face and neck; trembling and shaking of the hands and fingers; inability to move eyes; mask-like face; loss of balance control; blurred vision; difficulty speaking or swallowing. Additionally, though not common, Tardive Dyskinesia has been reported.

• Tardive Dyskinesia

presents with lip smacking or puckering, puffing of cheeks, rapid or fine worm-like movement of tongue, uncontrolled chewing movement, or uncontrolled movements of arms and legs may occur and may not go away after stopping use of the medication.

• Neuroleptic Malignant Syndrome (NMS)

Use may be associated with NMS. Monitor for changes in thinking, fever, muscle stiffness, and/ autonomic instability (unable to exercise, abnormal sweating, loss of appetite, loss of bladder control, difficulty with ejaculation, burry vision). Call your doctor as soon as possible if you believe you may have NMS.

• QT prolongation

This drug has the potential to prolong the QT interval of the heart. Caution should be exercised by those who have a history of QT prolongation, heart syndromes such as Congenital Long QT Syndrome (CLQTS), or by those who have multiple risk factors for QT prolongation.

• Driving and operating heavy machinery

Risperidone may cause drowsiness or dizziness, which could make driving, operating heavy machinery, or participating in other activities requiring alertness dangerous. Be sure you know how this medication affects you before participating in these activities.

• Blood disorder

Check with your doctor immediately if you develop fever, chills, sore throat, or sores in the mouth. These may be signs of a very serious blood problem that has occurred rarely in patients taking risperidone. This medication also has the potential to increase bleeding/

• Orthostatic hypotension

Orthostatic hypotension is when one feels dizzy while getting up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

• Fall risk

This medication increases the risk of experiencing a fall due to drowsiness and dizziness. Caution should be exercised by those who have a history of falls.

• Weight gain

This medication has been associated with increased appetite and weight gain.

• Seizure

This medication may, in rare cases, cause individuals to experience a seizure. Caution should be exercised in those who have a history of seizures.

• Suicide

This medication has the potential to cause new or worsening thoughts of suicide. If you experience these, immediately call your doctor.

• Withdrawal

This medication should not be suddenly stopped as it may cause an individual to experience symptoms of withdrawal. Please speak with your physician before stopping this medication.

• Anticholinergic effects

May cause symptoms such as confusion, agitation, constipation, dry mouth, blurred vision, or difficultly urinating.

Warning: [Black Box Warning]: Increased Mortality in Elderly Patients with Dementia Related Psychosis: Elderly patients with dementia related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of 17 placebo controlled trials (modal duration of 10 weeks, largely in patients taking atypical antipsychotic drugs, revealed a risk of death in the drug treated patients of between 1.6 to 1.7 times that seen in placebo treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug treated patients was about 4.5% compared to a rate of about 2.6% in the placebo group. Although the causes of

death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. This drug is not approved for the treatment of patients with dementia-related psychosis.

See PDR for an all-inclusive list of side effects.

SEROQUEL

Most Common Side Effects: constipation; drowsiness; dry mouth; indigestion; headache; agitation; weight gain; elevated cholesterol; elevated triglycerides; hypertension (high blood pressure); tachycardia (rapid, pulsating heart); increased appetite; fatigue.

Less Common Side Effects: pain; decreased strength and energy; increased muscle tone; EPS side effects (symptoms such as: muscle rigidity, muscle spasms, uncontrollable abnormal movements, excessive normal movements, shuffling of feet); increased sweating; stuffy or runny nose; orthostatic hypotension (dizzy upon standing from a sitting or lying position); swelling in the feet or ankles from fluid accumulation; acne; decreased appetite; diarrhea; increased incidence of urinary tract infections; abnormal dreams. Children on this medication may be more likely to have nausea or vomiting; dizziness, lightheadedness, or fainting, especially when getting up from a lying

or sitting position; fever, chills, muscle aches, or sore throat; loss of balance control; mask-like face; shuffling walk; skin rash; slowed movements; stiffness of arms or legs; swelling of feet or lower legs; trembling and shaking of hands and fingers; trouble in breathing, speaking, or swallowing.

Rare Side Effects: Although rare, contact your doctor as soon as possible if any of the following occur: fainting; fast, pounding, or irregular heartbeat; QT prolongation of the heart rhythm; menstrual changes; unusual secretion of milk (in females); aggressive behavior; unable to focus or keep attention; migraines; restlessness, twitching, changes in vision; severe cough; difficulty breathing; excessive nose bleeds; increased incidence of upper respirator tract infections; suicidal thoughts; hypertensive emergency (extremely elevated blood pressure); Stevens-Johnson syndrome (rash); rhabdomyolysis (symptoms of: generalized, severe muscle pain; muscle weakness; dark or decreased urine).

Caution:

• Avoid alcohol

This medicine may add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Check with your doctor before taking any other medications.

• Fall risk

This medication may cause dizziness and drowsiness which could increase the risk of falling. This is especially a caution in elderly patients and those with a history of falls.

• Hyperglycemia

Atypical antipsychotics, like Seroquel (quetiapine), have been associated with the development of hyperglycemia (high blood sugar), and, in extreme cases, may be associated with ketoacidosis, coma, or death. Monitor for symptoms of hyperglycemia such as: increased thirst, increased urination, feeling weak, and/ or feeling extreme hunger that does not go away with eating. If you believe you are having these symptoms, contact your doctor as soon as possible.

• Driving and operating heavy machinery

Quetiapine may cause drowsiness, especially during the first week of use. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

• Orthostatic hypotension

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.

• QT prolongation

Abnormal heart rhythm leading to fainting spells or sudden death, use in caution with risk factors (congenital long QT syndrome, history of prolonged QT, family history of prolonged QT or sudden cardia death; concomitant use with other agents that prolong QT interval).

• Do not crush extended release tablets

Do not chew or crush the extended release tablets. The extended release tablets should be swallowed whole.

• Seizures (convulsions)

This medication increases the risk of experiencing a seizure in those at risk of seizures or in those with other conditions that lower the seizure threshold.

• Tardive dyskinesia

A syndrome of potentially irreversible, involuntary, abnormal movements can develop in patients treated with antipsychotic drugs. The prevalence of the syndrome appears to be highest among the elderly, especially elderly women. There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.

• Withdrawal

Do not suddenly stop taking this medication as it could lead to symptoms of withdrawal. Talk with your doctor before stopping this medication.

Warning: [Black Box Warning] Increased Mortality in Elderly Patients with Dementia Related Psychosis: Elderly patients with dementia related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of 17 placebo controlled trials (modal duration of 10 weeks, largely in patients taking atypical antipsychotic drugs, revealed a risk of death in the drug treated patients of between 1.6 to 1.7 times that seen in placebo treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug treated patients was about 4.5% compared to a rate of about 2.6% in the placebo group. Although the causes of

death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. This drug is not approved for the treatment of patients with dementia-related psychosis.

[Black Box Warning] Suicidal Ideation in Children, Adolescents, and Young Adults: Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in short term studies in children, adolescents, and young adults with major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of this drug or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber.

Quetiapine is not FDA approved for use in pediatric patients under ten years of age.

See PDR for an all-inclusive list of side effects.

STRATTERA

Most Common Side Effects

More common side effects include headache, insomnia, drowsiness, dry mouth, nausea, vomiting, decreased appetite, constipation, erectile dysfunction.

Less Common Side Effects

Less common side effects include increased blood pressure, palpitations, cold extremities, syncope, flushing, dizziness, depression, irritability, decreased sex drive or ability, dyspepsia.

Rare Side Effects

Rare side effects include aggressive behavior, alopecia, angioedema, delusions, liver toxicity, panic attack.

BLACK BOX WARNING

Suicidal ideation in children and adolescents: Atomoxetine increased the risk of suicidal ideation in short-term studies in children or adolescents with attention deficit hyperactivity disorder (ADHD). Anyone considering the use of atomoxetine in a child or adolescent must balance this risk with the clinical need. Comorbidities occurring with ADHD may be associated with an increase in the risk of suicidal ideation and/or behavior. Closely monitor patients who are started on therapy for suicidality (suicidal thinking and behavior), clinical worsening, or unusual changes in behavior. Advise families and caregivers of the need for close observation and communication with the prescribing health care provider.

Pooled Study Data: Pooled analyses of short-term (6- to 18-week), placebo-controlled trials of atomoxetine in children and adolescents (12 trials involving more than 2,200 patients, including 11 trials in ADHD and 1 trial in enuresis) have revealed a greater risk of suicidal ideation early during treatment in those receiving atomoxetine compared with placebo. The average risk of suicidal ideation in patients receiving atomoxetine was 0.4% compared with none in placebo-treated patients. No suicides occurred in these trials.

WARNINGS:

Hepatotoxicity – Use may be associated with rare but severe hepatotoxicity, including hepatic failure: discontinue and do not restart if signs

or symptoms of hepatotoxic reaction (ie jaundice, pruritus, flu-like symptoms, dark urine, right upper quadrant tenderness) or laboratory

evidence of liver injury are noted. Majority of reported cases occurred within 120 days of initiation of therapy.

Emergence of New Psychotic or Manic Symptoms – Treatment-emergent psychotic or manic symptoms (hallucinations, delusional thinking, mania) may occur in children and adolescents without a prior history of psychotic illness or mania. Consider discontinuation of treatment if symptoms occur.

Screening for bipolar disorder – Therapy may induced mixed/manic episodes. Use caution in patients with comorbid bipolar disorder.

Aggressive behavior or hostility – New or worsening symptoms of hostility or aggressive behaviors have been associated with use, particularly with initiation of therapy.

Serious Cardiovascular Events – Use has been associated with serious cardiovascular events including sudden death in patients with preexisting structural cardiac abnormalities or other serious heart problems. Avoid use in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities. Patients should be carefully evaluated for cardiac disease prior to initiation of therapy. Monitor for symptoms of exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during treatment.

Priapism – Prolonged and painful erections have been reported (rarely) with methylphenidate and atomoxetine use in pediatric and adult patients.

See PDR for an all-inclusive list of side effects.

TENEX

Most Common Side Effects: Drowsiness; headache; fatigue; dizziness; insomnia (not able to fall asleep or stay asleep); abdominal pain; decreased appetite.

Less Common Side Effects: low blood pressure; feeling light-headed or faint, especially when standing from a seated position; slow or fast heartbeat; irregular heartbeat; irritability; feeling tired or sluggish; anxiety; nightmares; unable to control emotions; agitation; depression; high blood pressure; loss of consciousness; skin rash; itchy skin; weight gain; dry mouth; nausea; vomiting; diarrhea; constipation; regurgitation of

stomach acid or taste of acid in the mouth; urinary incontinence; worsening asthma; fever.

Rare Side Effects: Although rare, contact your doctor as soon as possible if any of the following occur: chest pain; extremely elevated blood pressure; pale skin or lips; seizures; increased need to urinate; muscle weakness; hair loss; changes to vision; tingling of the hands, feet, or face; unable to obtain or maintain an erection; leg pain or cramps; hallucinations; swelling of the hand, legs, or feet; difficulty breathing; swelling of the face, lips, or tongue; severe rash or hives.

Caution

• Withdrawal

There is a risk of symptoms of nervousness and anxiety and, less commonly, rebound hypertension, if guanfacine is stopped abruptly. Before stopping this medication, please speak with your doctor, who can help find a plan that is right for you.

• Driving and operating heavy machinery

Exercise caution when operating heavy machinery, driving a car, or participating in any other activity that could be dangerous if not fully alert. Wait to know how this medication affects you before participating in these activities.

• Rash

Skin rash with exfoliation and pruritus have been reported; discontinue guanfacine and call your doctor if you develop a rash.

See PDR for an all-inclusive list of side effects.

ULTRAM

Warning

For all patients taking this medicine:

This medicine is a strong pain drug that can put you at risk for addiction, abuse, and misuse. Misuse or abuse of this medicine (tramadol tablets) can lead to overdose and death. Talk with your doctor.
You will be watched closely to make sure you do not misuse, abuse, or become addicted to this medicine (tramadol tablets).
This medicine may cause very bad and sometimes deadly breathing problems. Call your doctor right away if you have slow, shallow, or trouble breathing.
The chance of very bad and sometimes deadly breathing problems may be greater when you first start this medicine (tramadol tablets) or anytime your dose is raised.
Even one dose of this medicine (tramadol tablets) may be deadly if it is taken by someone else or by accident, especially in children. If this medicine (tramadol tablets) is taken by someone else or by accident, get medical help right away.
Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
Using this medicine (tramadol tablets) for a long time during pregnancy may lead to withdrawal in the newborn baby. This can be life-threatening. Talk with the doctor.
This medicine has an opioid drug in it. Severe side effects have happened when opioid drugs were used with benzodiazepines or other drugs that may make you drowsy or slow your actions. This includes slow or troubled breathing and death. Benzodiazepines include drugs like alprazolam, diazepam, and lorazepam. Benzodiazepines may be used to treat many health problems like anxiety, trouble sleeping, or seizures. If you have questions, talk with your doctor.
Many drugs interact with this medicine (tramadol tablets) and can raise the chance of side effects like deadly breathing problems. Talk with your doctor and pharmacist to make sure it is safe to use this medicine (tramadol tablets) with all of your drugs.
Do not take with alcohol or products that have alcohol. Unsafe and sometimes deadly effects may happen.
Get medical help right away if you feel very sleepy, very dizzy, or if you pass out. Caregivers or others need to get medical help right away if the patient does not respond, does not answer or react like normal, or will not wake up.

Children:

This medicine is not approved for use in children. Do not give to a child younger than 12 years of age. Children between 12 and 18 years of age who are very overweight or have certain other health problems like sleep apnea or other lung or breathing problems must not use this drug. If your child has been given this medicine (tramadol tablets), ask the doctor for information about the benefits and risks.
Some children have had very bad and sometimes deadly breathing problems when using tramadol after surgery to remove tonsils or adenoids. Do not give to a child younger than 18 years of age who has had surgery to remove tonsils or adenoids. Talk with your child's doctor.

Uses of Tramadol Tablets:

It is used to ease pain.

What do I need to tell my doctor BEFORE I take Tramadol Tablets?

If you have an allergy to tramadol or any other part of this medicine (tramadol tablets).
If you are allergic to this medicine (tramadol tablets); any part of this medicine (tramadol tablets); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
If you have any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood; or stomach or bowel block or narrowing.
If you have any of these health problems: Kidney disease or liver disease.
If you have thoughts of suicide or if you have ever had alcohol or other drug abuse or dependence.
If you have been told by your doctor that you are a rapid metabolizer of some drugs.
If you have recently drunk a lot of alcohol or taken a big amount of drugs that may slow your actions like phenobarbital or some pain drugs like oxycodone.
If you are taking carbamazepine.
If you are taking another drug that has the same drug in it.
If you are taking any of these drugs: Buprenorphine, butorphanol, nalbuphine, or pentazocine.
If you have taken certain drugs for depression or Parkinson's disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen.
If you are taking any of these drugs: Linezolid or methylene blue.
If you are breast-feeding. Do not breast-feed while you take this medicine (tramadol tablets).

This is not a list of all drugs or health problems that interact with this medicine (tramadol tablets).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (tramadol tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Tramadol Tablets?

Tell all of your health care providers that you take this medicine (tramadol tablets). This includes your doctors, nurses, pharmacists, and dentists.
Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine (tramadol tablets) affects you.
To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
Very bad and sometimes deadly allergic side effects have rarely happened. Talk with your doctor.
Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
Do not take this medicine (tramadol tablets) with other strong pain drugs or if you are using a pain patch without talking to your doctor first.
This medicine may raise the chance of seizures. The chance may be higher in people who have certain health problems, use certain other drugs, or drink a lot of alcohol. Talk to your doctor to see if you have a greater chance of seizures while taking this medicine (tramadol tablets).
If you have been taking this medicine (tramadol tablets) for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if this medicine (tramadol tablets) stops working well. Do not take more than ordered.
Long-term or regular use of opioid drugs like this medicine (tramadol tablets) may lead to dependence. Lowering the dose or stopping this medicine (tramadol tablets) all of a sudden may cause a greater risk of withdrawal or other severe problems. Talk to your doctor before you lower the dose or stop this medicine (tramadol tablets). You will need to follow your doctor’s instructions. Tell your doctor if you have more pain, mood changes, thoughts of suicide, or any other bad effects.
Long-term use of an opioid drug may lead to lower sex hormone levels. Call your doctor if you have a lowered interest in sex, fertility problems, no menstrual period (women), or change in sex ability (men).
Taking an opioid drug like this medicine (tramadol tablets) may lead to a rare but very bad adrenal gland problem. Call your doctor right away if you have very bad dizziness or passing out, very bad upset stomach or throwing up, or if you feel less hungry, very tired, or very weak.
If you are 65 or older, use this medicine (tramadol tablets) with care. You could have more side effects.
This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this medicine (tramadol tablets), call your doctor right away.

How is this medicine (Tramadol Tablets) best taken?

Use this medicine (tramadol tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

Take by mouth only.
Do not inject or snort this medicine (tramadol tablets). Doing any of these things can cause very bad side effects like trouble breathing and death from overdose.
Take with or without food. Take with food if it causes an upset stomach.

What do I do if I miss a dose?

If you take this medicine (tramadol tablets) on a regular basis, take a missed dose as soon as you think about it.
If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
Do not take 2 doses at the same time or extra doses.
Many times this medicine (tramadol tablets) is taken on an as needed basis. Do not take more often than told by the doctor.

Detailed Tramadol dosage information

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Signs or symptoms of depression, suicidal thoughts, emotional ups and downs, abnormal thinking, anxiety, or lack of interest in life.
Very bad dizziness or passing out.
Feeling confused.
Seizures.
Chest pain or pressure or a fast heartbeat.
Trouble passing urine.
Passing urine more often.
Noisy breathing.
Change in eyesight.
Severe constipation or stomach pain. These may be signs of a severe bowel problem.
A severe and sometimes deadly problem called serotonin syndrome may happen. The risk may be greater if you also take certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; severe diarrhea, upset stomach, or throwing up; or very bad headache.
A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

Tramadol side effects (more detail)

What are some other side effects of Tramadol Tablets?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

Feeling dizzy, sleepy, tired, or weak.
Diarrhea or constipation.
Dry mouth.
Headache.
Itching.
Upset stomach or throwing up.
Trouble sleeping.
Flushing.
Sweating a lot.

VISTARIL

Most Common Side Effects: Drowsiness, dry mouth, nose, or throat; stomach upset or pain, nausea, and headache.

Less Common Side Effects: Blurred vision/vision changes, body aches, confusion, skin rash or skin reaction, constipation, diarrhea,

difficulty urinating, fast heartbeat, increased sensitivity to the sun, loss of appetite, involuntary movements, fainting, or hives

Rare Side Effects

Check with your doctor immediately if any of the following rare side effects occur: abdominal or stomach pain; burning; chills; clay-colored stools or dark urine; cough; diarrhea; difficulty swallowing; dizziness; fast or irregular heartbeat; fever; headache; hives; itching; prickly sensations; puffiness or swelling of the eyelids or around the eyes, face, lips or tongue; redness of skin; seizures; shortness of breath; skin rash; swelling; tightness in chest; tingling; unusual tiredness or weakness; wheezing.

Caution

• Can add to the depressive (sedating) effects of other depressants (medicines that slow down the nervous system, causing

drowsiness): Examples are sedatives, sleeping medications, pain medication or narcotics, seizure medications, muscle relaxants,

anesthetics, and alcohol.

• This medication may cause you to be more drowsy or dizzy; use caution when operating machinery or driving. Make sure to know how you react to the medication before doing these activities.

• Caution if you have narrow-angle glaucoma

See PDR for an all-inclusive list of side effects.

VRAYLAR

Most Common Side Effects: indigestion; nausea; vomiting; constipation; diarrhea; headache; akathisia (feeling that you cannot sit still/need to move); extrapyramidal movements (spasms, muscle contractions/ rigidity, jerk-like movements, shuffling of the feet, or abnormally slowed movements); somnolence; restlessness; weight gain; excessive sweating.

Less Common Side Effects: hypertension (high blood pressure); tachycardia (rapid heartbeat); toothache; decreased appetite; fatigue; muscle rigidity; back, limb, or joint pain; changes in vision or blurred vision; orthostatic hypotension (dizziness when standing up from a lying or sitting position); diabetes mellitus; dyslipidemia; hyperglycemia (high blood sugar).

Rare Side Effects: Although rare, check with you doctor as soon as possible if any of the following occur: new or worsening thoughts of suicide; impaired judgment; pulmonary aspiration (entry of fluid or food into the lungs); impaired body temperature regulation: neuroleptic malignant syndrome (NMS): a rare and serious condition that can lead to death. Symptoms of NMS include high fever, stiff muscles, confusion, sweating, changes in pulse, heart rate, and/or an abnormally high or low blood pressure; leukopenia (low white blood cell count); neutropenia (low neutrophil count; a type of white blood cell); fatal agranulocytosis (severely low white blood cells); tardive dyskinesia:

Abnormal movements that you cannot control in your face, tongue or other body parts. Tardive dyskinesia may not go away, even if you stop taking VRAYLAR, and may start after you stop taking the medication.; seizures; stevens-johnson syndrome (rash); acid reflux; cerebrovascular accident (stroke).

Caution

• Orthostatic hypotension (dizziness when standing)

This medication may cause dizziness when standing from a lying or seated position. Take caution by standing up slowly. Fainting

may occur, especially during initial dose titration, dosage increases, and in patients with known cardiovascular disease (e.g., history of myocardial infarction, ischemic heart disease, heart failure, or conduction abnormalities), cerebrovascular disease, or at risk for hypotension (e.g., elderly, dehydration, hypovolemia, and antihypertensive therapy); monitoring recommended for at risk patients.

• Hyperglycemia (high blood sugar)

Some cases can be extreme and is associated with ketoacidosis, hyperosmolar coma, or death. Close monitoring of blood sugar

levels, especially for people with diabetes, is recommended.

• Temperature regulation

Disruption of body temperature regulation has been reported with atypical antipsychotic use; caution advised in patients with

conditions that may contribute to elevated body temperature (e.g., strenuous exercise, extreme heat exposure, dehydration,

concomitant anticholinergic use).

• Hypersensitivity reactions

These reactions have been reported, including rash, pruritus, urticaria (hives), and events suggestive of angioedema (e.g., swollen

tongue, lip, or face).

• Neuroleptic malignant syndrome

Has been reported in association with antipsychotics and may be life-threatening; Symptoms of NMS include high fever, stiff

muscles, confusion, sweating, changes in pulse, heart rate, and/or an abnormally high or low blood pressure; discontinue

immediately if suspected and monitor closely.

• Tardive Dyskinesia

Abnormal movements that you cannot control in your face, tongue or other body parts. Tardive dyskinesia may not go away, even if you stop taking VRAYLAR, and may start after you stop taking the medication. This may occur, with increased risk among elderly, especially elderly women, and patients treated with higher cumulative doses or longer treatment duration; discontinuation may be required.

• Seizures

Although rare, this may occur; use caution in patients with a history of seizures, the elderly, or with conditions that lower seizure

threshold.

• Driving and operating heavy machinery

Potential cognitive and motor impairment may affect how patients operate machinery or motor vehicles; caution advised until drug effects are known.

• Respiratory aspiration (fluid or food accumulation in the lungs)

This may occur in at-risk patients, as esophageal dysmotility and aspiration have been reported with antipsychotic drug use.

Warning: [Black Box Warning]:

INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. VRAYLAR (cariprazine) is not approved for the treatment of patients with dementia-related psychosis.

See PDR for an all-inclusive list of side effects.

WELLBUTRIN

Most Common Side Effects

Seizures: There is a chance of having a seizure (convulsion, fit) with WELLBUTRIN, especially in people:

with certain medical problems or who take certain medicines. Do not take any other medicines while you are taking WELLBUTRIN unless your healthcare provider has said it is okay to take them. If you have a seizure while taking WELLBUTRIN, stop taking the tablets and call your healthcare provider right away. Do not take WELLBUTRIN again if you have a seizure.

High blood pressure (hypertension). Some people get high blood pressure that can be severe, while taking WELLBUTRIN. The chance of high blood pressure may be higher if you also use nicotine replacement therapy (such as a nicotine patch) to help you stop smoking.

Manic episodes. Some people may have periods of mania while taking WELLBUTRIN, including: Greatly increased energy, severe trouble sleeping, racing thoughts, reckless behavior, unusually grand ideas, excessive happiness or irritability, talking more or faster than usual. If you have any of the above symptoms of mania, call your healthcare provider.

Unusual thoughts or behaviors. Some patients have unusual thoughts or behaviors while taking WELLBUTRIN, including delusions (believe you are someone else), hallucinations (seeing or hearing things that are not there), paranoia (feeling that people are against you), or feeling confused. If this happens to you, call your healthcare provider.

Visual problems. Eye pain, changes in vision, swelling or redness in or around the eye. Only some people are at risk for these problems.

You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

Severe allergic reactions. Some people can have severe allergic reactions to WELLBUTRIN. Stop taking WELLBUTRIN and call your healthcare provider right away if you get a rash, itching, hives, fever, swollen lymph glands, painful sores in the mouth or around the eyes, swelling of the lips or tongue, chest pain, or have trouble breathing. These could be signs of a serious allergic reaction.

Less Common Side Effects

Other side effects include: Dry mouth; nervousness; confusion; dizziness; agitation; amblyopia “lazy eye”; blurred vision; constipation; headache; tremor; nausea; vomiting; insomnia; fast heartbeat; sweating.

Warning

BLACK BOX WARNING

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS; AND NEUROPSYCHIATRIC REACTIONS SUICIDALITY AND ANTIDEPRESSANT DRUGS

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects over age 24; there was a reduction in risk with antidepressant use in subjects aged 65 and older. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber.

NEUROPSYCHIATRIC REACTIONS IN PATIENTS TAKING BUPROPION FOR SMOKING CESSATION

Serious neuropsychiatric reactions have occurred in patients taking bupropion for smoking cessation. The majority of these reactions occurred during bupropion treatment, but some occurred in the context of discontinuing treatment. In many cases, a causal relationship to bupropion treatment is not certain, because depressed mood may be a symptom of nicotine withdrawal. However, some of the cases occurred in patients taking bupropion who continued to smoke. Although WELLBUTRIN® is not approved for smoking cessation, observe all patients for neuropsychiatric reactions. Instruct the patient to contact a healthcare provider if such reactions occur.

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA—close observation for suicidal thinking or unusual changes in

behavior.

See PDR for an all-inclusive list of side effects.

XANAX

Less Common Side Effects

Other Less common side effects include: Accidental injury; bladder pain; bloody or cloudy urine; blurred vision; changes in sexual desire or decreased sexual ability; constipation; cramps; diarrhea; difficult, burning, or painful urination; difficulty in speaking; dizziness or lightheadedness; dryness of mouth or unpleasant taste; fast or pounding heartbeat; frequent urge to urinate; headache; heavy bleeding with menstrual period; inability to have or keep an erection; increased sensitivity of skin to sunlight; increased sweating; itching, redness or other discoloration of skin; loss of appetite; lower back or side pain; nausea or vomiting; pain; severe sunburn; sleepiness or unusual drowsiness; tooth disorder; twitching; weight loss; memory impairment; insomnia.

Rare Side Effects

Rare side effects include: Abnormal thinking, including disorientation, delusions (holding false beliefs that cannot be changed by facts), or loss of sense of reality; agitation; behavior changes, including aggressive behavior, bizarre behavior, decreased inhibition, or outbursts of anger; convulsions (seizures); hallucinations (seeing, hearing, or feeling things that are not there); hypotension (low blood pressure); muscle weakness; skin rash or itching; sore throat, fever, and chills; trouble in sleeping; ulcers or sores in mouth or throat (continuing); uncontrolled movements of body, including the eyes; double vision; unusual bleeding or bruising; unusual excitement, nervousness, or irritability; unusual tiredness or weakness (severe); yellow eyes or skin.

BLACK BOX WARNING

Risks from concomitant use with opioids:

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.

WARNING

Dependence and Withdrawal Reactions, Including Seizures.

Certain adverse clinical events, some life threatening, are a direct consequence of physical dependence to alprazolam. These include a spectrum of withdrawal symptoms; the most important is seizure. Even after relatively short-term use at the doses recommended for the treatment of transient anxiety and anxiety disorder (i.e., 0.75 to 4.0 mg per day), there is some risk of dependence. Spontaneous reporting system data suggest that the risk of dependence and its severity appear to be greater in patients treated with doses greater than 4 mg/day and for long periods (more than 12 weeks). However, in a controlled post marketing discontinuation study of panic disorder patients, the duration of treatment (3 months compared to 6 months) had no effect on the ability of patients to taper to zero dose. In contrast, patients treated with doses of alprazolam greater than 4 mg/day had more difficulty tapering to zero dose than those treated with less than 4 mg/day.

The importance of dose and the risks of Alprazolam as a treatment for panic disorder. Because the management of panic disorder often requires the use of average daily doses of alprazolam above 4 mg, the risk of dependence among panic disorder patients may be higher than that among those treated for less severe anxiety. Experience in randomized placebo-controlled discontinuation studies of patients with panic disorder showed a high rate of rebound and withdrawal symptoms in patients treated with alprazolam compared to placebo-treated patients.

Relapse or return of illness was defined as a return of symptoms characteristic of panic disorder (primarily panic attacks) to levels approximately equal to those seen at baseline before active treatment was initiated. Rebound refers to a return of symptoms of panic disorder to a level substantially greater in frequency, or more severe in intensity than seen at baseline. Withdrawal symptoms were identified as those which were generally not characteristic of panic disorder and which occurred for the first time more frequently during discontinuation than at baseline.

In a controlled clinical trial in which 63 patients were randomized to alprazolam and where withdrawal symptoms were specifically sought, the following were identified as symptoms of withdrawal: heightened sensory perception, impaired concentration, dyssomnia, clouded sensorium, paresthesia, muscle cramps, muscle twitch, diarrhea, blurred vision, appetite decrease, and weight loss. Other symptoms, such as anxiety and insomnia, were frequently seen during discontinuation, but it could not be determined if they were due to return of illness, rebound, or withdrawal.

In two controlled trials of 6 to 8 weeks duration where the ability of patients to discontinue medication was measured, 71 %-93% of patients treated with alprazolam tapered completely off therapy compared to 89%-96°/o of placebo-treated patients. In a controlled post marketing discontinuation study of panic disorder patients, the duration of treatment (3 months compared to 6 months) had no effect on the ability of patients to taper to zero dose.

Seizures attributable to alprazolam were seen after drug discontinuance or dose reduction in 8 of 1980 patients with panic disorder or in patients participating in clinical trials where doses of alprazolam greater than 4 mg/day for over 3 months were permitted. Five of these cases clearly occurred during abrupt dose reduction or discontinuation from daily doses of 2 to 10 mg. Three cases occurred in situations where there was not a clear relationship to abrupt dose reduction or discontinuation. In one instance, seizure occurred after discontinuation from a single dose of 1 mg after tapering at a rate of 1 mg every 3 days from 6 mg daily. In two other instances, the relationship to taper is indeterminate; in both of these cases the patients had been receiving doses of 3 mg daily prior to seizure. The duration of use in the above 8 cases ranged from 4 to 22 weeks. There have been occasional voluntary reports of patients developing seizures while apparently tapering gradually from alprazolam. The risk of seizure seems to be greatest 24-72 hours after discontinuation.

Status Epilepticus and its Treatment

The medical event voluntary reporting system shows that withdrawal seizures have been reported in association with the discontinuation of Alprazolam. In most cases, only a single seizure was reported; however, multiple seizures and status epilepticus were reported as well.

lnterdose Symptoms

Early morning anxiety and emergence of anxiety symptoms between doses of Alprazolam have been reported in patients with panic disorder taking prescribed maintenance doses of alprazolam. These symptoms may reflect the development of tolerance or a time interval between doses which is longer than the duration of clinical action of the administered dose. In either case, it is presumed that the prescribed dose is not sufficient to maintain plasma levels above those needed to prevent relapse, rebound or withdrawal symptoms over the entire course of the interdosing interval. In these situations, it is recommended that the same total daily dose be given divided as more frequent administrations.

Risk of Dose Reduction

Withdrawal reactions may occur when dosage reduction occurs for any reason. This includes purposeful tapering, but also inadvertent reduction of dose (eg, the patient forgets, the patient is admitted to a hospital). Therefore, the dosage of alprazolam should be reduced or discontinued gradually.

CNS Depression and Impaired Performance

Because of its CNS depressant effects, patients receiving alprazolam should be cautioned against engaging in hazardous occupations or activities requiring complete mental alertness such as operating machinery or driving a motor vehicle. For the same reason, patients should be cautioned about the simultaneous ingestion of alcohol and other CNS depressant drugs during treatment with alprazolam.

Risk of Fetal Harm

Benzodiazepines can potentially cause fetal harm when administered to pregnant women. If alprazolam is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Because of experience with other members of the benzodiazepine class, alprazolam is assumed to be capable of causing an increased risk of congenital abnormalities when administered to a pregnant woman during the first trimester. Because use of these drugs is rarely a matter of urgency, their use during the first trimester should almost always be avoided. The possibility that a woman of childbearing potential may be pregnant

at the time of institution of therapy should be considered. Patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physicians about the desirability of discontinuing the drug.

Suicide

As with other psychotropic medications, the usual precautions with respect to administration of the drug and size of the prescription are indicated for severely depressed patients or those in whom there is reason to expect concealed suicidal ideation or plans. Panic disorder has been associated with primary and secondary major depressive disorders and increased reports of suicide among untreated patients.

Mania

Episodes of hypomania and mania have been reported in association with the use of alprazolam in patients with depression.

See PDR for an all-inclusive list of side effects.

ZOLOFT

Most Common Side Effects: Common possible side effects in people who take ZOLOFT include: nausea, loss of appetite, diarrhea or indigestion, change in sleep habits including increased sleepiness or insomnia, increased sweating, sexual problems including decreased libido and ejaculation failure, tremor or

shaking, feeling tired or fatigued, agitation.

Caution

ZOLOFT and other antidepressant medicines may cause serious side effects, including:

1. Suicidal thoughts or actions: Zoloft and other antidepressants may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed. Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. Watch for these changes and call your healthcare provider right away if you notice: new or

sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. Pay particular attention to such changes when Zoloft is started or the dose is changed. Keep follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.

Other side effects in children and adolescents include: abnormal increase in muscle movement or agitation, nosebleed, urinating more often,

urinary incontinence, aggressive reaction, heavy menstrual periods, possible slowed growth rate and weight change. Your child's height and weight should be monitored during treatment with ZOLOFT.

Zoloft may also be associated with these side effects and your healthcare provider should be contacted immediately:

2. Feeling anxious or trouble sleeping.

3. Serotonin Syndrome: This condition can be life-threatening and may include:

agitation, hallucinations, coma or other changes in mental status, coordination problems or muscle twitching (overactive reflexes), racing

heartbeat, high or low blood pressure, sweating or fever, nausea, vomiting, or diarrhea, muscle rigidity.

4. Severe allergic reactions: trouble breathing, swelling of the face, tongue, eyes or mouth, rash, itchy welts (hives) or blisters, alone or with

fever or joint pain.

5. Abnormal bleeding: ZOLOFT and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the

blood thinner warfarin (Coumadin®, Jantoven®), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.

6. Seizures or convulsions.

7. Manic episodes, greatly increased energy, severe trouble sleeping, racing thoughts, reckless behavior, unusually grand ideas, excessive

happiness or irritability, talking more or faster than usual.

8. Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.

9. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include: headache, weakness or feeling unsteady, confusion, problems concentrating or thinking or memory problems.

Do not stop Zoloft without first talking to your healthcare provider. Stopping Zoloft too quickly may cause serious symptoms including: anxiety, irritability, high or low mood, feeling restless or changes in sleep habits; headache, sweating, nausea, dizziness; electric shock-like sensations, shaking, confusion.

Warning

BLACK BOX WARNING

Suicidality and Antidepressant Drugs

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents and young adults in short-term studies of major depressive disorder (MOD) and other psychiatric disorders. Anyone considering the use of ZOLOFT or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves

associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. ZOLOFT is not approved for use in pediatric patients except for patients with obsessive-compulsive disorder (OCD).

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA-Close observation for suicidal thinking or unusual changes in behavior.

See PDR for an all-inclusive list of side effects.

ZYPREXA

Most Common Side Effects: abnormal walking or balance; clumsiness; headache; constipation; dizziness; dizziness or fainting when getting up suddenly from a lying or sitting position (orthostatic hypotension); drowsiness; dry mouth; sleepiness or unusual drowsiness; unsteadiness; weakness; weight gain/increased appetite; elevated cholesterol, elevated glucose, elevated prolactin levels; injection site reaction; agitation; behavior problems; difficulty in speaking or swallowing; restlessness or need to keep moving; stiffness of arms or legs; trembling or shaking of hands and fingers; peripheral edema.

Less Common Side Effects: changes in vision; chest pain; fever; flu-like symptoms; difficulty speaking; runny nose; lip smacking or puckering; mood or mental changes such as anger, anxiety, giddiness, loss of memory, or nervousness; muscle spasms of face, neck, and back; personality disorder; muscle twitching or jerking; nervousness; puffing of cheeks; rapid or worm-like movements of tongue; rhythmic movement of muscles; slow or fast heartbeat; swelling of feet or ankles; twitching movements; twitching, twisting, uncontrolled repetitive movements of tongue, lips, face, arms, or legs; uncontrolled chewing movements; uncontrolled jerking or twisting movements of hands, arms and legs; uncontrolled movements of lips, tongue, or cheeks; unusual or incomplete body or facial movements; unable to achieve orgasm; delayed or impaired ejaculation; decreased sexual interest or function; changes with menstruation; development of breasts in males; falling; cough; loss of bladder control; abdominal pain; diarrhea; gas; vaginal discharge; increased risk of viral infection; abdnormal dreams; joint pain; muscle stiffness; tremor.

Rare Side Effects: Although rare, contact your doctor as soon as possible if any of the following side effects occur: pounding or abnormal heartbeat; hair loss; warmth or fever; incresed sensitivity of the skin to the sun; heavy menstrual bleeding; bloating; intestinal obstruction; nausea; difficulty with urination; swelling of the tongue, lips, or face; slurring of words or mumbling; confusion; chills; coma; joint pain; hangover effect; seizure; changed or poor posture; new or worsening thoughts of suicide; bone pain or fractures; frequent urination; difficulty breathing; rash or hives; fainting; painful, long lasting erection; yellowing of the eyes or skin; development of lesions or bumps on the skin; muscle pain; delirium.

Caution:
Extrapyramidal symptoms (EPS)

Patients have reported muscle spasms of the neck and back; shuffling walk; tic-like (jerky) movements of the head, face and neck; trembling and shaking of the hands and fingers; inability to move eyes; mask-like face; loss of balance control; blurred vision; difficulty speaking or swallowing. Additionally, though not common, Tardive Dyskinesia has been reported. Tardive Dyskinesia presents with lip smacking or puckering, puffing of cheeks, rapid or fine worm-like movement of tongue, uncontrolled chewing movement, or uncontrolled movements of arms and legs may occur and may not go away after stopping use of the medication.

Neuroleptic Malignant Syndrome (NMS)
Use may be associated with NMS. Monitor for changes in thinking, fever, muscle stiffness, and/ autonomic instability (unable to exercise, abnormal sweating, loss of appetite, loss of bladder control, difficulty with ejaculation, burry vision). Call your doctor as soon as possible if you believe you may have NMS.

QT prolongation
This drug has the potential to prolong the QT interval of the heart. Caution should be exercised by those who have a history of QT prolongation, heart syndromes such as Congenital Long QT Syndrome (CLQTS), or by those who have multiple risk factors for QT prolongation.

Driving and operating heavy machinery
Olanzapine may cause drowsiness or dizziness, which could make driving, operating heavy machinery, or participating in other activities requiring alertness dangerous. Be sure you know how this medication affects you before participating in these activities.

Blood disorder
Check with your doctor immediately if you develop fever, chills, sore throat, or sores in the mouth. These may be signs of a very serious blood problem that has occurred rarely in patients taking olanzapine. This medication also has the potential to increase bleeding/

Orthostatic hypotension
Orthostatic hypotension is when one feels dizzy while getting up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

Fall risk
This medication increases the risk of experiencing a fall due to drowsiness and dizziness. Caution should be exercised by those who have a history of falls.

Weight gain
This medication has been associated with increased appetite and weight gain.

Seizure
This medication may, in rare cases, cause individuals to experience a seizure. Caution should be exercised in those who have a history of seizures.

Suicide

This medication has the potential to cause new or worsening thoughts of suicide. If you experience these, immediately call your doctor.

Withdrawal
This medication should not be suddenly stopped as it may cause an individual to experience symptoms of withdrawal. Please speak with your physician before stopping this medication.

Anticholinergic effects
May cause symptoms such as confusion, agitation, constipation, dry mouth, blurred vision, or difficultly urinating.

Warning: [Black Box Warning]: Increased mortality in elderly patients with dementia-related psychosis: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration, 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients between 1.6 and 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was approximately 4.5%, compared with a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patient is not clear. Olanzapine is not approved for treatment of patients with dementia-related psychosis.

Warning: [Black Box Warning]: Postinjection delirium/sedation syndrome (Zyprexa Relprevv): Adverse reactions with signs and symptoms consistent with olanzapine overdose, in particular, sedation (including coma) and/or delirium, have been reported following injections of olanzapine extended release (ER). Olanzapine ER must be administered in a registered health care facility with ready access to emergency response services. After each injection, patients must be observed at the health care facility by a health care provider for at least 3 hours. Because of this risk, olanzapine ER is available only through a restricted distribution program called Zyprexa Relprevv Patient Care Program, and requires health care provider, health care facility, patient, and pharmacy enrollment.

See PDR for an all-inclusive list of side effects.

1. I can refuse to give consent or can withdraw my consent at any time with written notification to the prescriber. This will not affect my right to change my decision at a later date. If I withdraw consent after a medication is started, I realize that the medication may not be discontinued immediately. Rather, it will be tapered as rapidly as medically safe and then discontinued so as to prevent an adverse medical consequence, such as seizures, due to rapid medication withdrawal.

2. Questions regarding this medication can be discussed with the prescriber can assist in making any necessary arrangements.

3. Questions regarding any behavior support plan or behavior intervention plan, which correspond with the use of the medication, can be directed to the client’s social worker, case manager, psychologist, and/or therapist.

4. I have the right to request a review at any time of my record, with some limitations at the prescriber’s discretion for the risk to client and the benefit versus harm of knowing the record.

5. I have a legal right to file a complaint if I feel that client rights have been inappropriately restricted. The client’s social worker, case manager, or agency/facility client rights specialist may be contacted for assistance.

6. My consent permits the dose to be changed within the anticipated dosage range without signing another consent.

7. I understand the reasons for the use of the medication, its potential risks and benefits, other alternative treatment(s), and the probable consequences that may occur if the proposed medication is not given. I have been given adequate time to study the information and find the information to be specific, accurate, and complete.

8. This medication consent is for a period effective immediately and not to exceed fifteen (15) months from the date of my signature. The need for and continued use of this medication will be reviewed at least quarterly by the prescriber. The goal, on behalf of the client, will be to arrive at and maintain the client at the minimum effective dose.

9. Psychiatric medications can fall into these general categories and risks / benefits of these medications may overlap (List not inclusive):

a. Antipsychotics: Aripiprazole, Cariprazine, Lurasidone, Olanzapine, Paliperidone, Quetiapine, Risperidone, and Ziprasidone.

b. Antidepressants: Bupropion, Duloxetine, Escitalopram, Fluoxetine, Mirtazapine, and Sertraline.

c. Anxiolytics/ Other Antianxiety: Alprazolam, Buspirone, Hydroxyzine, Lorazepam, and Prazosin.

d. ADHD: Atomoxetine, Clonidine, and Guanfacine.

e. Memory: Donepezil and Memantine.

Adderall; Adderall XR - (dextroamphetamine and amphetamine)

Most Common Side Effects: Anxiety; crying; depersonalization; dry mouth; dysphoria; euphoria; fast, pounding, or irregular heartbeat or pulse; hyperventilation; irritability; mental depression; nervousness; paranoia; quick to react or overreact emotionally; rapidly changing moods; restlessness; shaking; shortness of breath; trouble sleeping; false sense of well-being. After these stimulant effects have worn off, drowsiness, trembling, unusual tiredness or weakness may occur.

Less Common Side Effects: Increased risk of infection; lower back or side pain with painful or difficult urination; tightness in chest; wheezing; accidental injury; bloody or cloudy urine; blurred vision; changes in sexual desire or decreased sexual ability; constipation; cramps; diarrhea; difficulty forming words or sentences; dizziness or lightheadedness; headache; heavy bleeding with menstrual period; inability to have or keep an erection; increased sensitivity of skin to sunlight; increased sweating; itching, redness or other discoloration of skin; loss of appetite; nausea or vomiting; sleepiness or unusual drowsiness; tooth infection; twitching; weight loss.

Rare Side Effects: Check with your doctor immediately if any of the following rare side effects occur: Chest pain; high fever; skin rash or hives; uncontrolled movements of head, neck, arms, and legs; difficulty breathing; swelling of the face, tongue, or lips.

Caution

*Withdrawal

Do not suddenly stop taking this medication. If this medication is suddenly stopped after taking for a longer period of time (months), drowsiness, trembling, unusual tiredness or weakness, or mental depression may occur. Also, with long-term use or high doses, you may experience difficulty breathing; dizziness or feeling faint; increased blood pressure; mood or mental changes; pounding heartbeat. When considering stopping this medication, please speak with your doctor.

* Driving and Operating Heavy Machinery

This medication may cause you to feel dizzy or drowsy. It is recommended to avoid driving, operating heavy machinery, or performing any other task that may be dangerous if not fully alert until you know how this medication affects you.

* Serotonin Syndrome

Potentially life-threatening serotonin syndrome (SS) may occur when dextroamphetamine/amphetamine is used in combination with other serotonergic agents (eg, SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, St. John's wort, tryptophan), agents that impair metabolism of serotonin (eg, MAOIs) or CYP2D6 inhibitors that impair metabolism of dextroamphetamine/amphetamine. Use of these drugs with MAOIs is contraindicated. If use of dextroamphetamine/amphetamine with serotonergic drugs or CYP2D6 inhibitors is needed, initiate dextroamphetamine/amphetamine at a low dose and monitor patient closely for signs and symptoms of SS. Discontinue treatment (and any concomitant serotonergic agent) immediately if signs/symptoms arise.

* Altered Appetite in Children

Appetite suppression may occur; particularly in children. Use of stimulants has been associated with weight loss and slowing growth rate; monitor growth rate and weight during treatment. Treatment interruption may be necessary in patients who are not increasing in height or gaining weight as expected.

* Seizures

If you experience seizures while taking this medication, please call your doctor promptly.

* Vision Changes

If you notice changes in your vision, including blurry vision, please call your doctor right away.

Warning: [Black Box Warning]: Amphetamines have a high potential for abuse. Particular attention should be paid to the possibility of subjects obtaining amphetamines for non-therapeutic use or distribution to others, and the drugs should be prescribed or dispensed sparingly. Administration of amphetamines for prolonged periods of time may lead to drug dependence and must be avoided.

Warning: [Black Box Warning]: Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events. CNS stimulants, such as Adderall, may increase heart rate and blood pressure; in pediatric patients, the observed mean increase in heart rate was 3 to 6 bpm and blood pressure was 2 to 4 mm Hg. Use with caution in patients with hypertension, heart failure, recent MI, ventricular arrhythmia, and other cardiovascular conditions that might be exacerbated by increases in blood pressure or heart rate. Some products are contraindicated in patients with moderate to severe hypertension or hyperthyroidism.

Adhansia XR; Aptensio XR; Concerta; Cotempla XR-ODT; Jornay PM; Metadate ER; Methylin; QuilliChew ER; Quillivant XR; Relexxii; Ritalin; Ritalin LA. – (methylphenidate)

Most Common Side Effects: Insomnia (difficulty falling asleep or staying asleep), headache, irritability, weight loss, decreased appetite, dry mouth, nausea.

Less Common Side Effects: Chest pain; abnormally fast heartbeat; increased blood pressure; lack of emotion; increased bruising; restlessness; vertigo; increased risk for upper respiratory tract infections; constipation; back pain; skin changes; fever; joint pain; skin rash or hives; increased anger; dizziness; drowsiness; muscle aches; nausea; nervousness; runny nose; hair loss; stomach pain; talking, feeling, and acting with excitement.

Rare Side Effects: Check with your doctor immediately if any of the following rare side effects occur: Black, tarry stools; blistering, burning, itching, peeling, skin rash, redness, or other signs of irritation at site of patch; blood in urine or stools; blurred vision or other changes in vision; convulsions; crusting, dryness, or flaking of skin; muscle cramps; uncontrolled vocal outbursts and/or tics (uncontrolled and repeated body movements); unusual bleeding or bruising; severe chest pain. Get emergency help immediately if any of the following symptoms of overdose occur: Agitation; confusion (severe); convulsions; dryness of mouth or mucous membranes; false sense of well-being; fast, pounding, or irregular heartbeat; fever; flushing; hallucinations (seeing, hearing, or feeling things that are not there); headache (severe); increased blood pressure; increased sweating; large pupils; muscle twitching; overactive reflexes; sweating; trembling or shaking; vomiting.

Caution

• Cardiovascular Risk

CNS stimulant treatment has been associated with sudden death in children and adolescents with preexisting structural cardiac abnormalities and sudden death, stroke, and heart attack have been reported in adults. If you do experience any symptoms such as an abnormally fast heartbeat, chest pain, or unusual chest tightness, please call your doctor immediately.

• Blood Circulation Changes

This medication, in rare instances, may cause parts of the body, such as fingers or toes, to become numb and turn blue or purple. This is seen when blood is not reaching the affected part of the body. If you do notice numbing, changing color of the skin, or breakdown of the skin, please call your doctor immediately.

• Priapism (Prolonged Erection)

Prolonged (>4 hours), painful, and non-painful erections, sometimes requiring surgical intervention, have been reported in pediatric and adult patients, according to the manufacturers' labeling and a 2013 FDA warning. If you do experience this, please call your doctor immediately.

• Vision Changes

If you do notice a change in your vision, such as increased blurriness or double vision, please call your doctor immediately.

• Seizure Risk

This medication may increase the risk of experiencing a seizure in those who have a history of seizures. If experienced, please call your doctor.

• Psychiatric Risk

Use with caution in patients with preexisting psychosis (may exacerbate symptoms of behavior and thought disorder) or bipolar disorder (may induce mixed/manic episode). New-onset psychosis or mania may occur with stimulant use. Patients should be screened for bipolar disorder and risk factors for developing a manic episode prior to treatment.

• Pediatric Risk

Use of stimulants has been associated with decreased appetite, weight loss, and slowing of growth rate; monitor growth rate, height, and weight during treatment. Treatment interruption may be necessary in patients who are not increasing in height or gaining weight as expected.

Warning: [Black Box Warning]: Abuse and Dependence

Chronic abusive use can lead to a marked tolerance and psychological dependence with varying degree of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Should be given cautiously to patients with a history of drug dependence or alcoholism. Careful supervision required during drug withdrawal from abusive use since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

Dexedrine - (dextroamphetamine)

Most Common Side Effects: Anxiety; dry mouth; feeling depressed; crying or depersonalization (not wanting to interact with others); euphoria; fast, pounding, or irregular heartbeat; irritability; nervousness or restlessness; paranoia; quick to react or emotionally overreacting; rapidly changing moods; shaking or trembling; shortness of breath (panic attack); false sense of well-being. After stimulant effects have worn off, you may experience drowsiness, unusual tiredness or weakness, or mental depression.

Less Common Side Effects: increased blood pressure; slower growth during childhood; hyperthyroidism (symptoms of nervousness, hyperactive energy, mood swings, difficulty falling or staying asleep, feeling tired, feeling sensitive to heat, muscle weakness, diarrhea, needing to urinate more often, feeling thirsty, itchiness, losing interest in sexual activity, hair loss, weight loss, or excessive sweating.); constipation; unpleasant taste in the mouth; altered speech; severe headache; dizziness; blurred vision or other changes to vision; decreased ability to obtain or keep an erection in males; decreased or increased interest in sexual activity.

Rare Side Effects: Although rare, please contact your doctor as soon as possible if any of the following side effects occur: chest pain; unusually high fever; skin rash or hives; uncontrolled movements of head, neck, arms, and legs; weakness on one side of the body; difficulty thinking; fainting; vomiting; loss of sexual function; seizures; dark urine; difficulty urinating; muscle pain or weakness; development of blue or red hands and feet; erection lasting more than 4 hours; numbness or burning in the hands or feet; extreme pain; thoughts of suicide or worsening depression; hallucinations; or signs of an allergic reaction (swollen face, tongue, lips, arms, or legs; severe itching or rash;

difficulty taking, swallowing, or breathing; unusual hoarseness).

Caution

• Withdrawal: Do not abruptly stop taking this medication. If you have questions concerning this medication, please contact your doctor first and they will help you find an appropriate plan. After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor if you notice any of the following side effects: mental depression; nausea or vomiting; stomach cramps or pain; trembling; unusual tiredness or weakness

• Driving and operating heavy machinery

This medication may impair your ability to drive, operate heavy machinery, or participate in any other activities requiring full awareness. Do not participate in these activities until you know how this medication affects you.

• Tourette’s syndrome

Stimulants, such as dextroamphetamine, may make the muscle or verbal tics in Tourette’s worse. If you or your child experiences and increase in tics while taking this medication, please call your doctor. Stimulants should generally be avoided in this population.

• Raynaud’s disease

Although rare, episodes of ulcers or skin changes in the fingers or toes have been reported while taking this medication. If you notice ulceration or other skin changes on your fingers or toes after starting this medication, call you doctor right away.

• Rhabdomyolysis

Although rare, rhabdomyolysis is usually first identified by muscle pain or weakness. If you notice unusual muscle pain or weakness, and you cannot identify a cause, such as exercise, please call your doctor right away.

• Serotonin syndrome

Potentially life-threatening serotonin syndrome may occur when dextroamphetamine is used in combination with other serotonergic agents (eg, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, St. John's wort, tryptophan). Symptoms of serotonin syndrome include restless, overactive muscle reflexes, shivering, excessive sweating, tremors, agitation, fever, confusion, and pounding heartbeat.

• Insomnia management

For patients taking the short-acting form of this medicine: Take the last dose for each day at least 6 hours before bedtime to help prevent trouble in sleeping. For patients taking the long-acting form of this medicine: Take the daily dose when you wake up to help prevent trouble in sleeping. These capsules or tablets should be swallowed whole. For the extended release (ER), or long-acting form, DO NOT break, crush, or chew them before swallowing.

Warning: [BLACK BOX WARNING]: Abuse and dependence potential: Amphetamines have a high potential for abuse. Particular attention should be paid to the possibility of subjects obtaining amphetamines for non-therapeutic use or distribution to others, and the drugs should be prescribed or dispensed sparingly. Administration of amphetamines for prolonged periods of time may lead to drug dependence and must be avoided.

Warning: [BLACK BOX WARNING]: Cardiovascular events: Misuse of amphetamines may cause sudden death and serious cardiovascular adverse event. Use has been associated with serious cardiovascular events including sudden death in patients with preexisting structural cardiac abnormalities or other serious heart problems (sudden death in children and adolescents; sudden death, stroke and MI in adults.

Focalin, Focalin XR - (Dexmethylphenidate)

Most Common Side Effects: headache; insomnia (difficulty falling asleep or staying asleep); jitteriness; anxiety; dry mouth; abdominal pain; decreased appetite.

Less Common Side Effects: dizziness; depression; changes in emotion; itchy skin; nausea; heartburn; acidic taste in mouth or stomach acid regurgitation; vomiting; anorexia; chest or throat pain; nasal congestion; fever; weight loss; stunted growth in children; drug dependence;increased blood pressure.

Rare Side Effects: Although rare, please check with your doctor as soon as possible if any of the following side effects occur: blurred vision or changes in vision; anxiety; bigger, dilated, or enlarged pupils (black part of eye); loss of consciousness; chest pain or discomfort; severe mental confusion; severe dizziness; fainting; false or unusual sense of well-being; fast, slow, or irregular heartbeat; fever; hallucinations; severe headache; holding false beliefs that cannot be changed by fact; hyperventilation; increased sensitivity of eyes to light; irritability; lightheadedness; muscle twitching; nervousness; changes in hearing; redness of the face, neck, arms and occasionally, upper chest;

restlessness; seizures; shortness of breath; excessive sweating; tremors such as shakiness; severe muscle pain; swelling of the face, tongue or lips; an erection lasting more than 4 hours.

Caution

• Withdrawal

Do not abruptly stop taking this medication. If you have questions concerning this medication, please contact your doctor first and they will help you find an appropriate plan. After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor if you notice any of the following side effects: mental depression; nausea or vomiting; stomach cramps or pain; trembling; unusual tiredness or weakness

• Tourette’s syndrome

Stimulants, such as dexmethylphenidate, may make the muscle or verbal tics in Tourette’s worse. If you or your child experiences

and increase in tics while taking this medication, please call your doctor. Stimulants should generally be avoided in this population.

• Raynaud’s disease

Although rare, episodes of ulcers or skin changes in the fingers or toes have been reported while taking this medication. If you

notice ulceration or other skin changes on your fingers or toes after starting this medication, call you doctor right away.

• Rhabdomyolysis

Although rare, rhabdomyolysis is usually first identified by muscle pain or weakness. If you notice unusual muscle pain or

weakness, and you cannot identify a cause, such as exercise, please call your doctor right away.

• Serotonin syndrome

Potentially life-threatening serotonin syndrome may occur when dexmethylphenidate is used in combination with other serotonergic agents (eg, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, St. John's wort, tryptophan). Symptoms of serotonin syndrome include restless, overactive muscle reflexes, shivering, excessive sweating, tremors, agitation, fever, confusion, and pounding heartbeat.

• Cardiovascular events

CNS stimulant treatment has been associated with sudden death in children and adolescents with preexisting structural cardiac abnormalities and sudden death, stroke, and MI have been reported in adults.

• Psychosis

Use with caution in patients with preexisting psychosis (may exacerbate symptoms of behavior and thought disorder) or bipolar disorder (may induce mixed/manic episode). New-onset psychosis or mania may occur with stimulant use. Patients should be screened for bipolar disorder and risk factors for developing a manic episode prior to treatment (eg, comorbid or history of depressive symptoms; family history of suicide, bipolar disorder, or depression); consider discontinuation if psychotic or manic symptoms (eg, delusional thinking, hallucinations, mania) occur.

• Insomnia management

For patients taking the short-acting form of this medicine: Take the last dose for each day at least 6 hours before bedtime to help prevent trouble in sleeping. For patients taking the long-acting form of this medicine: Take the daily dose when you wake up to help prevent trouble in sleeping. These capsules or tablets should be swallowed whole. For the extended release (XR), or long-acting form, DO NOT break, crush, or chew them before swallowing.

Warning: [Black Box Warning]: Abuse and dependence: Amphetamines have a high potential for abuse. Particular attention should be paid to the possibility of subjects obtaining amphetamines for non-therapeutic use or distribution to others, and the drugs should be prescribed or dispensed sparingly.

Drug dependence--Administration of amphetamines for prolonged periods of time may lead to drug dependence and must be avoided.

Serious Adverse Events—Misuse of amphetamines may cause sudden death and serious cardiovascular adverse event

Chronic abusive use can lead to a marked tolerance and psychological dependence with varying degree of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Should be given cautiously to patients with a history of drug dependence or alcoholism. Careful supervision required during drug withdrawal from abusive use since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up. Should be given cautiously to emotionally unstable patients, such as those with a history of drug dependence or alcoholism, because such patients may increase dosage

on their own initiative. Careful supervision required during drug withdrawal, since severe depression as well as the effects of chronic over activity can be unmasked. Long term follow-up may be required because of the patient's basic personality disturbances.

Vyvanse - (Lisdexamfetamine)

Most Common Side Effects

Most common side effects include: loss of appetite, upper abdominal pain, vomiting, dry mouth, trouble sleeping, and irritability.

Less Common Side Effects

Dizziness, anxiety, and diarrhea. Check with your doctor as soon as possible if any of the following common side effects occur: chest pain with movement, unexplained fainting, or arrythmias. Monitor blood pressure and heart rate during treatment.

Rare Side Effects

Rare side effects to report immediately to your doctor include chest pain; skin rash, hives, or anaphylaxis; uncontrolled movements of head, neck, arms, and legss; chest pain or heart changes. Rare side effects include myocardial infarction, peripheral vascular disease (such as Raynaud's disease), sudden cardiac death, tachycardia, ventricular hypertrophy, cerebrovascular accident, and seizure.

Caution

* Psychiatric

In patient with psychosis, treatment may worsen psychotic symptoms or manic symptoms (hallucinations, delusional thinking, or mania). These symptoms may occur with no prior history of these disorders; stopping the medication may be necessary. For patients with bipolar, treatment may induce a mixed/manic episode.

* Serotonin Syndrome

Potentially life-threatening serotonin syndrome (SS) may occur when used in combination with other serotonergic agents (eg, MAOIs (including IV methylene blue and linezolid), SSRIs, serotonin norepinephrine reuptake inhibitors, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St John's wort), or CYP2D6 inhibitors that may increase amphetamine exposure; consider alternative therapy or adjust dosage if concomitant use is necessary. Monitoring recommended; immediately discontinue both agents if symptoms occur

* Altered Appetite in Children/Adults

Appetite suppression may occur; particularly in children. Use of stimulants has been associated with weight loss and slowing growth rate; monitor growth rate and weight during treatment. Treatment interruption may be necessary in patients who are not increasing in height or gaining weight as expected.

* Renal The dose of medication needs to be reduced for patients with severe kidney disease or renal impairment.

* Cardiovascular

Avoid using in patient with structural cardiac abnormalities or other serious cardia conditions (such as cardiomyopathy, serious

heart arrhythmia, and coronary artery disease).

Serious Adverse Event

• Hypersensitivity and allergies

Avoid using Vyvanse if there is a known hypersensitivity to amphetamine products due to post marketing reports of anaphylactic reactions, Stevens-Johnson syndrome, angioedema, and allergic reactions.

• Use with MAOI (monoamine oxidase inhibitor) medications

Taking this medication with or within 14 days of MAOIs including linezolid (antibiotic) or IV methylene blue, may result in hypertensive crisis.

Warning: Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events.

CNS stimulants may increase heart rate and blood pressure; use with caution in patients with hypertension, heart failure, recent MI, ventricular arrhythmia, structural cardiac abnormalities, and other cardiovascular conditions that might be exacerbated by increases in blood pressure or heart rate.

Black Box Warning: High Abuse/Diversion Potential--Amphetamines have a high potential for abuse. Particular attention should be paid to the possibility of subjects obtaining amphetamines for non-therapeutic use or distribution to others, and the drugs should be prescribed or dispensed sparingly.

(phenobarbital)

Less Common Side Effects

Check with your doctor as soon as possible if any of the following less common side effects occur: heartburn and/or vomiting. Other less common side effects include: chest discomfort or pain; drowsiness; fast heartbeat; headache; muscle cramps; nausea; nervousness or restlessness; trembling; trouble in sleeping.

Rare Side Effects

Check with your doctor if you experience these symptoms of toxicity: abdominal pain, continuing or severe; confusion or change in behavior; convulsions (seizures); dark or bloody vomit; diarrhea; dizziness or lightheadedness; fast and/or irregular heartbeat, continuing; nervousness or restlessness, continuing; trembling, continuing.

Warning

In small doses, the barbiturates may increase the reaction to painful stimuli. Taken by themselves, the barbiturates cannot be relied upon to relieve pain or even to produce sedation or sleep in the presence of severe pain.

Depakote; Depakote DR; Depakote ER; Depakote Sprinkles – (valproic acid)

Most Common Side Effects: abdominal or stomach cramps (mild to severe); change in menstrual periods; diarrhea; hair loss; indigestion; loss of appetite; nausea and vomiting; trembling of hands and arms; unusual weight loss or gain; body aches or pain; congestion; cough; dryness or sore throat; fever; hoarseness; runny nose; tender, swollen glands in neck; trouble swallowing; voice changes; dizziness; drowsiness; increased risk for infection; difficulty falling asleep or staying asleep; changes to vision, including double vision; headache.

Less Common Side Effects: behavioral, mood, or mental changes; confusion; uncontrolled eye movements; earache; faintness, or lightheadedness when getting up from a lying or sitting position suddenly; fast, irregular, pounding, or racing heartbeat or pulse; heavy, nonmenstrual vaginal bleeding; increase in seizures; loss of appetite; redness or swelling in ear; sweating; swelling of face, arms, hands, lower legs, or feet; tingling of hands or feet; tiredness and weakness; unusual bleeding or bruising; changes in menstrual period; constipation; rash;

dry mouth.

Rare Side Effects: Please call your doctor promptly if experiencing any of the following: clumsiness or unsteadiness; severe rash; swelling of the face, tongue, or lips; difficulty breathing; presence of blood or material that looks like coffee grounds in vomit; yellowing of eyes or skin.

Caution:

* Withdrawal

Anticonvulsants should not be discontinued abruptly because of the possibility of increasing seizure frequency. Please speak with your doctor before stopping this medication.

Warning:[Black Box Warning]: Liver toxicity

Liver failure resulting in fatalities has occurred in patients receiving valproic acid and its derivatives. Experience has indicated that children under the age of 2 years are at a considerable increased risk of developing fatal liver toxicity, especially those on multiple anticonvulsants, those with congenital metabolic disorders, those with severe seizure disorders accompanied by mental illness, and those with organic brain disease. When this drug is used in this patient group, it should be used with extreme caution and as a sole agent. The benefits of therapy should be weighed against the risks. Above this age group, experience in epilepsy has indicated that the incidence of fatal liver toxicity

decreases considerably in progressively older patient groups. These incidents usually have occurred during the first six months of treatment. Serious or fatal liver toxicity may be preceded by non-specific symptoms such as malaise, weakness, lethargy, facial edema, anorexia, and vomiting. In patients with epilepsy, a loss of seizure control may also occur. Patients should be monitored closely for the appearance of these symptoms. Liver function tests should be preformed prior to therapy and at frequent intervals thereafter, especially during the first six months.

Warning:[Black Box Warning]: Use Contraindicated with Mitochondrial Disease

There is an increased risk of valproate-induced acute liver failure and resultant deaths in patients with hereditary neurometabolic syndromes caused by DNA mutations of the mitochondrial DNA polymerase gamma (POLG) gene (eg, Alpers-Huttenlocher syndrome). Valproate is contraindicated in patients known to have mitochondrial disorders caused by POLG mutations and children younger than 2 years who are clinically suspected of having a mitochondrial disorder. In patients >2 years of age who are clinically suspected of having a hereditary mitochondrial disease, only use after other anticonvulsants have failed. This older group of patients should be closely monitored during treatment with valproate for the development of acute liver injury with regular clinical assessments and serum liver testing. POLG mutation screening should be performed in accordance with current clinical practice.

Warning:[Black Box Warning]: Teratogenicity

Valproate can produce teratogenic effects such as neural tube defects (e.g., spina bifida). Accordingly, the use of valproate products in women of childbearing potential requires that the benefits of its use be weighed against the risk of injury to the fetus. This is especially important when the treatment of a spontaneously reversible condition not ordinarily associated with permanent injury or risk of death (e.g., migraine) is contemplated.

Warning:[Black Box Warning]: Pancreatitis

Cases of life-threatening pancreatitis have been reported in both children and adults receiving valproate. Some of the cases have been described as internal bleeding with a rapid progression from initial symptoms to death. Cases have been reported shortly after initial use as well as after several years of use. Patients and guardians should be warned that abdominal pain, nausea, vomiting, and/or anorexia can be symptoms of pancreatitis that require prompt medical evaluation. If pancreatitis is diagnosed, valproate should ordinarily be discontinued. Alternative treatment for the underlying medical conditions should be initiated as clinically indicated.

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA

—Hepatotoxicity: Assess symptoms and LFTs at baseline and frequent intervals, especially within first 6 months.

—Pancreatitis: Patients should be informed of warning signs.

Eskalith; Eskalith-CR; Lithobid – (Lithium)

Most Common Side Effects: increased frequency of urination or loss of bladder control—more common in women than in men, usually beginning 2 to 7 years after start of treatment; increased thirst; nausea (mild); sleepiness; diarrhea; trembling of hands (slight); hypothyroidism—more common in women than in men, and may appear years after the start of treatment. Individuals with hypothyroidism may experience fatigue, constipation, dry skin, muscle weakness, increased sensitivity to the cold, hair loss, weight gain, menstrual changes,

or have the presence of a goiter.

Less Common Side Effects: confusion, poor memory or lack of awareness; fainting; fast or slow heartbeat; irregular pulse; stiffness of arms or legs; troubled breathing (especially during hard work or exercise); slurred speech; unusual tiredness or weakness; weight gain; skin rash; bloated feeling or pressure in the stomach; muscle twitching (slight); hair loss; worsening of psoriasis; swelling of the lips, tongue, or face; vomiting; dry mouth; swelling of the salivary glands; itchiness.

Rare Side Effects: Although rare, check with your doctor as soon as possible if any of the following side effects occur: blue color and pain in fingers and toes; coldness of arms and legs; severe dizziness; eye pain; headache; ringing in the ears; changes in vision; heart failure; seizures; reduced intellectual ability; hyperactive behavior; slowed movement; metallic taste; joint swelling.

Caution:

• Aspirin and NSAIDs

Try to minimize over-the-counter aspirin as well as NSAID medications such as naproxen and ibuprofen for acute fever/ pain relief as it could lead to toxic levels of lithium. Instead, it is recommended to use Tylenol (acetaminophen) for acute fever/ pain relief. If you are currently taking an NSAID medication, speak with your doctor and they can help safely manage your medication regimen.

• Overdose/ Toxicity

Early symptoms of overdose or toxicity: Diarrhea; drowsiness; lack of coordination; loss of appetite; muscle weakness; nausea or vomiting; slurred speech; trembling.

Late symptoms of overdose or toxicity: Blurred vision; clumsiness or unsteadiness; confusion; convulsions (seizures); dizziness; increase in amount of urine; ringing in the ears; trembling (severe).

• Dehydration

Caution – lithium levels will rise as an individual becomes dehydrated; some side effects can worsen. Be sure to stay properly hydrated while taking this medication.

• Hypothyroidism

Signs of low thyroid function: Dry, rough skin; hair loss; hoarseness; mental depression; sensitivity to cold; swelling of feet or lower legs; swelling of neck; unusual excitement.

• Driving and operating heavy machinery

This medication may make you drowsy or dizzy, which can impair your ability to drive, operate heavy machinery, or do any other activity that could be dangerous if not fully alert. Hold off on these activities until you know how this medication affects you.

• Serotonin Syndrome

Lithium can precipitate a potentially life-threatening serotonin syndrome, particularly when used in combination with other serotonergic agents (eg, selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, triptans, tricyclic antidepressants, fentanyl, tramadol, buspirone, St. John's wort, tryptophan) or agents that impair metabolism of serotonin (eg, monoamine oxidase inhibitors). Monitor patients closely for signs of serotonin syndrome, such as mental status changes (eg, agitation, hallucinations, delirium, coma), autonomic instability (e.g. tachycardia, labile BP, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular changes (eg, tremor, rigidity, myoclonus, hyperreflexia, incoordination), GI symptoms (eg, nausea, vomiting, diarrhea), and/or seizures.

Discontinue treatment (and any concomitant serotonergic agent) immediately if signs/symptoms arise and initiate supportive therapy.

• Pregnancy

Lithium has been known to cross the placenta during pregnancy, which may cause physical changes or malformations in an infant. This risk is elevated during the first trimester of pregnancy, and taking lithium while pregnant should be avoided if possible. However, if this medication is deemed necessary, your doctor will work to manage the dose to reduce the risk during pregnancy. If you are pregnant, or are planning to become pregnant, please let your doctor know so they can come up with a plan that works for you.

Warning: [Black Box Warning]: Monitoring: Toxicity is closely related to serum concentrations and may occur at doses close to therapeutic levels. Equipped facilities should be identified prior to initiation of therapy to provide prompt and accurate serum concentration data.

Monitoring recommendations related to black box data:

• Dosage must be individualized according to serum levels and clinical response. Regular monitoring of the patient's clinical state and serum lithium levels is necessary.

• Acute Mania: Desirable serum lithium levels are 1 to 1.5 mEq/L. Determine serum levels twice per week during acute phase, and until the serum levels and clinical condition have stabilized.

• Long term control: Desirable serum lithium levels are 0.6 to 1.2 mEq/L. In uncomplicated cases receiving maintenance therapy, determine serum levels at least every two months.

• Blood samples for serum lithium determinations should be drawn immediately prior to the next dose when concentrations are relatively stable. Total reliance must not be based on serum levels alone. Patient evaluation is required.

Lamictal, Lamictal XR (lamotrigine)

Most Common Side Effects: nausea; blurred or double vision or other changes in vision; clumsiness or unsteadiness; poor coordination; dizziness; tiredness: trouble sleeping; headache; constipation; vomitting; indigestion; minor rash.

Less Common Side Effects: abdominal pain; dryness of mouth; indigestion; loss of strength; menstrual pain; runny nose; slurred speech; trembling or shaking tiredness; vertigo; unusual weight gain or loss; anxiety; confusion; depression; irritability; other mood or mental changes; chest pain; continuous, uncontrolled back and forth and/or rolling eye movements; infection; increased urge to urinate; flatulence; regurgitation of stomach acid or acidic taste in mouth; anorexia; increased sexual drive; dry skin; insomnia (not able to fall asleep or stay asleep); cough; bloody nose; alcohol intolerance; fever.

Rare Side Effects: Although rare, contact your doctor as soon as possible if you experience any of the following side effects: a rash with blistering, peeling, or loosening of skin; liver failure; dark-colored urine; fever, chills, and/or sore throat; flu-like symptoms; itching; muscle cramps, pain, or weakness; red or irritated eyes; small red or purple spots on skin; sores, ulcer, or white spots on lips or in mouth; swelling of face, mouth, hands, or feet; swollen lymph nodes; anemia; trouble in breathing; unusual bleeding or bruising; unusual tiredness or weakness; yellow eyes or skin; memory loss.

Caution

* Driving and operating heavy machinery

This medication may make it dangerous to operate heavy machinery, drive a car, or perform any other task that requires mental alertness. Wait to participate in these activities until you know how this medication affects you.

* Aseptic Meningitis

Although rare, increased risk of developing aseptic meningitis has been reported; symptoms (eg, headache, neck rigidity, fever, nausea/vomiting, rash, fear of light) have generally occurred within 1 to 45 days following therapy initiation.

* Cardiovascular

This medication may increase the risk of heart rhythm problems in patient with heart disease. Lamotrigine may increase the risk of serious arrhythmias which can be life threatening for patients with structural or functional heart disorders. The risk or arrhythmias may increase further if used in combination with other medications that block sodium channels in the heart.

* Hemophagocytic lymphohistiocytosis

Hemophagocytic lymphohistiocytosis (HLH), a rare but life-threatening immune system reaction, has been reported with lamotrigine use. Symptoms may include fever, rash, enlarged spleen/liver, organ system dysfunction, and blood abnormalities. Onset usually occurs within the first several weeks after starting therapy.

* Suicidal ideation

Although rare, there have been reports of new or worsening thoughts of suicide associated with lamotrigine. This may happen as early as one week after starting the medication. If you do experience this, call your doctor as soon as possible.

* Withdrawal (Patients with seizures/ epilepsy)

Anticonvulsants should not be discontinued abruptly because of the possibility of increasing seizure frequency; therapy should be withdrawn gradually to minimize the potential of increased seizure frequency, unless safety concerns require a more rapid withdrawal. Taper over at least 2 weeks if possible.

* Rash

If you do experience a rash on this medication, especially is accompanied by fever, blistering or falling off of the skin, or swollen lymph nodes, call you doctor as soon as possible. This is a potentially life-threatening reaction that requires prompt medical attention.

* Alcohol and CNS depressants

This medicine may increase the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics.

Warning: [Black Box Warning]: Serious Dermatological Reactions: Incidence in Epilepsy Treatment: Serious rashes requiring hospitalization (including Stevens Johnson Syndrome and toxic epidermal necrolysis, or rash-related death have been caused by lamotrigine). The rate of serious rash is greater in pediatric patients than in adults. Discontinuation of treatment have occurred in approximately 0.8% of pediatric patients (2 to 16 yrs) and in 0.3% in adults who have received the drug as adjunctive therapy for epilepsy.

Incidence in Bipolar/Mood Disorders Treatment: Adults In trials of bipolar and other mood disorders, the rate of serious rash was 0.08% in adult patients receiving this drug as initial monotherapy and 0.13% in adult patients receiving lamotrigine as adjunctive therapy.

Incidence in Epilepsy Treatment: Pediatric Patients In a prospectively followed cohort of 1,983 pediatric patients with epilepsy taking the adjunctive lamotrigine, there was 1 rash related death. Toxic epidermal necrolysis In worldwide post marketing experience, rare cases of toxic epidermal necrolysis (TEN) and/or rash related death have been reported in adult and pediatric patients, but the numbers are too few to permit a precise estimate of the rate.

Potential Risk Factors

Other than age, there are as yet no factors identified that are known to predict the risk of occurrence or the severity of rash associated with lamotrigine. Other possible risk factors (yet to be proven) include:

—concurrent use with valproate (includes valproic acid and divalproex sodium), or

—exceeding the recommended initial dose or dose escalation schedule; however, cases have been reported in the absence of these factors.

Onset, Duration, Discontinuation of Treatment

Onset: Almost all life-threatening rashes have occurred within 2 to 8 weeks of lamotrigine therapy but have also occurred after prolonged treatment (e.g., 6 months).

Duration cannot be relied upon as a means to predict the potential risk heralded by the first appearance of a rash.

Although benign rashes also occur with lamotrigine, it is not possible to predict reliably which rashes will prove to be serious of life threatening. Thus, the drug should be discontinued at the first sign of rash, unless the rash is clearly not drug related. Discontinuation of treatment may not prevent a rash from becoming life threatening or permanently disabling or disfiguring.

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA

—Discontinue at first sign of rash, unless the rash is not drug related.

—Discontinuation of treatment may not prevent rash from becoming life-threatening or permanently disabling.

Lyrica - (Pregabalin)

Most Common Side Effects

Most common side effects include swelling of the extremities, dizziness, drowsiness, headache, fatigue, weight gain, dry mouth, incoordination, and double vision.

Less Common Side Effects

Less common side effects include increased appetite, changes in blood pressure, abnormal gait, euphoria, confusion, insomnia, disturbance of speech, decreased sex drive, constipation, muscle spasms, muscle aches or weakness, tremor, vertigo, infection, and increased creatinine kinase levels.

Rare Side Effects

Rare side effects include abnormal dreams, agitation, slow movements, changes in mood, cardiac failure, movement disorders, pancreatitis, blood disorders, and severe rash.

Caution

Cardiovascular: Use with caution in patients with severe cardiovascular disease, including heart failure. Weight gain and/or swelling of extremities may occur. In addition, the effect of weight gain/swelling may be additive with the thiazolidinedione class of antidiabetic agents. Close monitoring recommended.

Endocrine and Metabolic: Weight gain has been reported.

Hematologic: May decrease platelet count. Severe decreases in platelet count are extremely rare.

Immunologic: Angioedema, including life-threatening cases, has been reported, especially in patients with prior episode of angioedema or concurrently taking medications associated with angioedema (eg ACE inhibitors). Discontinue immediately if symptoms develop.

Immunologic: Hypersensitivity reactions, including skin redness, blisters, hives, rash, dyspnea, and wheezing have been reported. Discontinue immediately if symptoms develop.

Musculoskeletal: Creatinine kinase elevations have been reported. Discontinue if marked elevations occur, or if myopathy is suspected or diagnosed.

Neurologic: Significant dizziness and somnolence or sedation have been reported. Use caution when performing tasks which require mental alertness (such as operating machinery or driving).

Ophthalmic: Vision-related events, including reduced visual acuity, visual field changes, and blurred vision have been reported.

Psychiatric: Suicidal ideation and behavior, worsening of depression, and unusual changes in mood or behavior may occur as early as 1 week following initiation. Monitoring of mood recommended. If mood changes, report concerns immediately to healthcare provider.

Renal: Dosage adjustments recommended in kidney impairment. Use of extended-release tablet not recommended in patients with diminished kidney function or in patients undergoing hemodialysis.

Withdrawal: Withdrawal seizure or other adverse effects (such as insomnia, nausea, headache, anxiety, hyperhidrosis, and diarrhea) may be precipitated by abrupt discontinuation. Tapering over minimum of 1 week is recommended.

Neurontin, Gralise - (gabapentin)

Most Common Side Effects: increased risk of viral infections; slurred speech; stumbling; falling; incoordination; dizziness; drowsiness; fatigue.

More common for patients 3-12 years of age: Fever, aggressive behaviors or other behavior problems; anxiety; concentration problems and change in school performance; crying; false sense of well-being; hyperactivity or increase in body movements; mental depression; reacting too quickly, too emotionally, or overreacting; rapidly changing moods; restlessness; suspiciousness or distrust.

Less Common Side Effects: hypertension (high blood pressure); swelling of the legs, arms, feet, or ankles; feeling too warm or feverish; skin rash; new lesions or sores on the skin; high blood glucose; constipation; increased risk of disease of the teeth or mouth; diarrhea; regurgitation of stomach acid or acidic taste in the mouth; nausea; upset stomach; flatulance; dry mouth; the inability to obtain or maintain an erection; increased risk of urinary tract infections; abnormal walk; changes or abnormal thinking; confusion; depression; changes to speech; emotional changes; lethargy; impaired memory; generalized pain; seizures; back pain; abnormally low energy; overactive, uncontrollable muscle activity; joint swelling; tremor; changes to vision; ear infection; difficulty breathing; bronchitis; cough; dry throat; runny nose; pneumonia; respiratory tract infection; accidental injury due to incoordination/ confusion.

Rare Side Effects: Although rare, please contact your doctor as soon as possible if any of the following side effects occur: signs of an allergic reaction (difficulty breathing; swelling of the throat, lips, tongue, or face; hives or severe rash); severe rash or formation of lesions on the skin, especially when accompanied by a fever; severely altered blood sugars; loss of menstrual period; changes in sexual desire or function; breast swelling; inability to ejaculate; inability to control bladder; yellowing of the eyes or skin; agitation; coma; severe confusion or other mental changes; hallucinations; severe impairement to movement; seizures.

Caution:

Driving and operating heavy machinery:

This medication has the potential to impair judgment, thinking, or motor skills. Be cautious about operating hazardous machinery, including automobiles, until reasonably certain that this medication does not affect you.

Allergic reaction:

May occur after the first dose or at any time during treatment. Discontinue therapy and seek immediate medical care if signs or symptoms of anaphylaxis or angioedema occur. Symptoms include: difficulty breathing; swelling of the throat, lips, tongue, or face; hives or severe rash.

Respiratory effects:

Serious, life-threatening, and fatal respiratory depression may occur in patients using gabapentin; risk may be increased with conditions such as chronic obstructive pulmonary disease, in the elderly, and with use of opioids and other CNS depressants (such as alcohol) at the same time as gabapentin. Tell your doctor what medications you are currently taking before starting gabapentin, as this will help ensure the safe use of this medication.

Withdrawal (especially for use in those with seizures/ epilepsy):

This medication should not be discontinued abruptly because of the possibility of increasing seizure frequency in patients with epilepsy or other withdrawal symptoms (eg, confusion, irritability, tachycardia, diaphoresis). Therapy should be withdrawn gradually over ≥1 week to minimize the potential of increased seizure frequency and to minimize unwanted side effects.

Warning: [Black Box Warning]: Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including gabapentin, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.

The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5-100 years) in the clinical trials analyzed.

The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.

Anyone considering prescribing gabapentin or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated. Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

Tegretol – (carbamazepine)

Most Common Side Effects

The most common side effects include dizziness, drowsiness, headache, nausea/vomiting, unintentional body movements, constipation, dry mouth, itch/rash, and blurred vision.

Less Common Side Effects

Less common side effects include repetitive uncontrollable eye movements, changes in blood pressure,speech disturbance, twitching, weakness, behavioral changes (especially in children), confusion, agitation, diarrhea, hives, aching joints or muscles, increased sensitivity of skin to sunlight, loss of appetite, stomach pain or discomfort.

Rare Side Effects

Rare but serious side effects include blood in urine or stool, nosebleeds or other unusual bleeding or bruising, electrolyte changes, congestive heart failure, a serious rash called Stevens Johnson Syndrome or Toxic Epidermal Necrolysis, suicidal behavior or ideation, pancreatitis, change in seizures, bone marrow suppression and other effects on blood cell counts, liver failure or toxicity causing yellowing of skin/eyes, kidney failure, pulmonary hypersensitivity, fever or infection, irregular, pounding, or unusually slow heartbeat, mental depression with restlessness and nervousness or other mood or mental changes, ringing, buzzing, or other unexplained sounds in the ears, visual hallucinations, change in eyesight, sudden decrease in amount of urine, swelling of face, hands, feet, or lower legs.

Caution

Notify physician if mood/mental changes,signs of an allergic reaction,swelling of extremities, difficulty urinating and/or shortness of breath occur.

Patients should be advised that anaphylactic reactions and angioedema may occur during treatment with Tegretol. Advise patients to immediately report signs and symptoms suggesting angioedema (swelling of the face, eyes, lips, or tongue, or difficulty in swallowing or breathing) and to stop taking the drug until they have consulted with their healthcare provider.

Warning

BLACK BOX WARNING

Hematological

Aplastic anemia and agranulocytosis has been reported with use of carbamazepine. Risk is 5-8 times greater than general population. However, the overall risk of these reactions in the untreated general population is low. Agranulocytosis: 6 patients/1 million population per year. Aplastic anemia: 2 patients/1 million population per year. Incidence data: Although reports of transient or persistent decreased platelet or white blood cell counts are not uncommon with carbamazepine use, data are not available to estimate accurately their incidence or

outcome. Outcomes: The vast majority of the cases of leukopenia have not progressed to the more serious conditions of aplastic anemia or agranulocytosis.

Serious Dermatologic Reactions and HLA-B*1502 Allele

Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson Syndrome (SJS), have been reported during treatment with carbamazepine. These reactions are estimated to occur in 1 to 6 per 10,000 new users in countries with mainly caucasian populations, but the risk in some Asian countries is estimated to be about 10 times higher. Studies in patients of Chinese ancestry have found a strong association between the risk of developing SJS/TEN and the presence of HLA-B*1502, an inherited allelic variant of the HLA-B gene. HLA-B*1502 is found almost exclusively in patients with ancestry across broad areas of Asia. Patients with ancestry in genetically at risk populations should be screened for the presence of HLA-B*1502 prior to initiating treatment with carbamazepine. Patients testing positive for the allele should not be treated with carbamazepine unless the benefit clearly outweighs the risk.

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA

Note: The following recommendations are part of the black box warning data.

Discontinuation of medication should be considered if any evidence of significant bone marrow depression develops. Because of the very low incidence of agranulocytosis and aplastic anemia the vast majority of minor hematologic changes observed during monitoring are unlikely to signal the development of either event.

The following recommendations are outlined in the Laboratory Test section of the package insert:

Perform complete pretreatment blood counts (including platelets and possibly reticulocytes and serum iron) and periodic monitoring through therapy. If low or decreased white blood cell count or platelet counts occur, monitor patient closely.

Topamax - (topiramate)

Most Common Side Effects

Abnormal sodium bicarbonate lab values and ammonia levels (metabolic acidosis), confusion, impaired psychomotor performance, memory impairment, mood disorder, feeling nervous, tired, loss of appetite, weight decrease, and change in taste or tingling of the tongue.

Less Common Side Effects

Infectious disease, fever, increased body temperature, reduced concentration span, and fatigue.

Rare Side Effects

Liver failure, drug induced encephalopathy, suicidal thoughts, kidney stones, and withdrawal symptom.

Check with your doctor:

Check with your doctor as soon as possible if any of the following side effects occur:

• Any vision problems, especially blurred vision, double vision, eye pain or rapidly decreasing vision uncontrolled back-and-forth or rolling eye movements, eye redness or irritation, increased eye pressure, or eye pain;

• burning, prickling, or tingling sensations;

• clumsiness or unsteadiness; confusion; continuous, dizziness; drowsiness; generalized slowing of mental and physical activity; memory problems; nervousness, trouble in concentrating or paying attention; unusual tiredness or weakness.

• menstrual changes; menstrual pain; nervousness; speech or language problems;

• back pain; chest pain; constipation; heartburn; hot flushes; increased sweating; leg pain or swelling;

• skin rash; itching; trouble breathing;

• blood in urine; loss of bladder control; decrease in sexual performance or desire; difficult or painful urination; frequent urination; lower back or side pain;

• hearing loss; ringing or buzzing in ears.

Caution

• Drowsiness/ Older patient with history of falls or fractures

Avoid activities requiring mental alertness and coordination until you know how this medication affects you. This medication may cause some people to feel unsteady or clumsy. It may cause trouble thinking clearly or cause tiredness, confusion, and drowsiness.

• Endocrine and Metabolic

Report symptoms of metabolic acidosis, hyperthermia, and the inability to sweat. These medicines may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine, since overheating may result in heat stroke. Also, hot baths or saunas may make you dizzy or faint while you are taking this medicine.

• Neurologic

Do not discontinue the medication abruptly as it may increase seizure activity. Report new or worsening depression, suicidal thoughts or behavior, or changes in mood or behavior.

• Eyes

Immediately report changes in vision, eye pain, blurred vision, or decreased visual acuity.

• Kidneys

Maintain adequate fluid intake to minimize the risk of kidney stones. It is important that you drink plenty of fluids every day during therapy with topiramate to help prevent kidney stones from forming.

• Pregnancy/Oral Contraceptives

This medication may cause fetal harm. The recommendation is to use contraceptives. This medication may decrease the effectiveness of estrogen containing birth control. You should use a different or additional means of birth control while you are using topiramate.

• Skin Reaction

Rare but serious allergic reactions such as a body rash, Stevens-Johnson syndrome, or toxic epidermal necrolysis may occur. Report any signs of skin irritation or rash immediately to your prescriber.

Contraindications

• Avoid recent alcohol use within 6 hours before or after topiramate use

• Metformin with topiramate poses an increased risk of metabolic acidosis

Warning

TOPAMAX may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

Metabolic Acidosis: Hyperchloremic, non-anion gap, metabolic acidosis (i.e., decreased serum bicarbonate below the normal reference range in the absence of chronic respiratory alkalosis) is associated with topiramate treatment. Such electrolyte imbalance has been observed with the use of topiramate in placebo-controlled clinical trials and in the post-marketing period. Generally, topiramate-induced metabolic acidosis occurs early in treatment although cases can occur at any time during treatment.

Some manifestations of acute or chronic metabolic acidosis may include hyperventilation, nonspecific symptoms such as fatigue and anorexia, or more severe sequelae including cardiac arrhythmias or stupor. Chronic, untreated metabolic acidosis may increase the risk for nephrolithiasis or nephrocalcinosis, and may also result in osteomalacia (referred to as rickets in pediatric patients) and/or osteoporosis with an increased risk for fractures. Chronic metabolic acidosis in pediatric patients may also reduce growth rates. A reduction in growth rate may eventually decrease the maximal height achieved.

Measurement of baseline and periodic serum bicarbonate during topiramate treatment is recommended. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing topiramate (using dose tapering). If the decision is made to continue patients on topiramate in the face of persistent acidosis, alkali treatment should be considered.

Acute Myopia and Secondary Angle Closure Glaucoma: A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving topiramate. Symptoms include acute onset of decreased visual acuity and/or ocular pain. Ophthalmologic findings can include myopia, anterior chamber shallowing, ocular hyperemia (redness) and increased intraocular pressure. Mydriasis may or may not be present. This syndrome may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma. Symptoms typically occur within 1 month of initiating topiramate therapy. In contrast to primary narrow angle glaucoma, which is rare under 40 years of age, secondary angle closure glaucoma associated with topiramate has been reported in pediatric patients as well as adults. The primary treatment to reverse symptoms is discontinuation of topiramate as rapidly as possible, according to the judgment of the treating physician. Other measures, in conjunction with discontinuation of topiramate, may be helpful. Elevated intraocular pressure of any etiology, if left untreated, can lead to serious sequelae including permanent vision loss.

Oligohidrosis and Hyperthermia: Oligohidrosis (decreased sweating), infrequently resulting in hospitalization, has been reported in association with topiramate use. Decreased sweating and an elevation in body temperature above normal characterized these cases. Some of the cases were reported after exposure to elevated environmental temperatures. The majority of the reports have been in children. Patients, especially pediatric patients, treated with topiramate should be monitored closely for evidence of decreased sweating and increased body temperature, especially in hot weather. Caution should be used when topiramate is prescribed with other drugs that predispose patients to heat-related disorders; these drugs include, but are not limited to, other carbonic anhydrase inhibitors and drugs with anticholinergic activity.

Withdrawal of AEDs: In patients with or without a history of seizures or epilepsy, antiepileptic drugs including topiramate should be gradually withdrawn to minimize the potential for seizures or increased seizure frequency. In situations where rapid withdrawal of topiramate is medically required, appropriate monitoring is recommended.

Trileptal - (oxcarbazepine)

Most Common Side Effects

Check with your doctor as soon as possible if any of the following side effects occur: change in vision; change in walking or balance; clumsiness or unsteadiness; cough, fever, sneezing, or sore throat; crying; dizziness; double vision; false sense of well-being; feeling of constant movement of self or surroundings; mental depression; sensation of spinning; uncontrolled back-and-forth and/or rolling eye movements.

Other more common possible side effects may include: abdominal pain; burning feeling in chest or stomach; nausea and vomiting; runny or stuffy nose; sleepiness or unusual drowsiness.

Less Common Side Effects

Check with your doctor as soon as possible if any of the following less common side effects occur: agitation; awkwardness; bloody or cloudy urine; blurred vision; bruising; confusion; congestion; convulsions (seizures); decreased urination; difficulty in focusing eyes; disorientation; faintness or light-headedness when getting up from a lying or sitting position; fast or irregular heartbeat; frequent falls; frequent urge to urinate; general feeling of illness; headache; hoarseness; increased thirst; itching of the vagina, with or without white vaginal discharge; loss of consciousness; memory loss; muscle cramps; pain or burning while urinating; pain or tenderness around eyes or cheekbones; poor control in body movements; problems with coordination; shaking or trembling of arms, legs, hands, and feet; shortness of breath; skin rash; stuffy or runny nose; tightness in chest; trouble in walking; troubled breathing; unusual feelings; unusual tiredness or weakness; wheezing.

Other less common side effects may include: acid or sour stomach; acne; back pain; belching; bloody nose; blurred vision; change in your sense of taste; constipation; diarrhea; difficulty in speaking; dryness of mouth; feeling of warmth and redness of face, neck, arms, and occasionally chest; heartburn; increased sweating; increased urination; nervousness; trouble in sleeping.

Rare Side Effects

Although rare, check with your doctor as soon as possible if any of the following side effects occur: anxiety; bleeding or crusting sores on lips; burning feeling in chest or stomach; chest pain; chills; decreased response to stimulation; hives or itching; irritability; joint pain; muscle pain or weakness; nervousness; purple spots on skin; rectal bleeding; redness, blistering, peeling, or loosening of skin; restlessness; sores, ulcers, or white spots in mouth or on lips; stomach upset; swelling of legs; swollen glands.

Caution

Do not take other medicines unless they have been discussed with your doctor. This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert).

This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

Oral contraceptives (birth control pills) containing estrogen or progestin, contraceptive progestin injections (e.g., Depo-Provera), and implant contraceptive forms of progestin (e.g., Norplant) may not work properly if you take them while you are taking oxcarbazepine. Unplanned pregnancies may occur. You should use a different or additional means of birth control while you are taking oxcarbazepine.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help.

Warning

Hyponatremia

Clinically significant hyponatremia (sodium <125 mmol/L) can develop during Trileptal® (oxcarbazepine) use. In the 14 controlled epilepsy studies, 2.5% of Trileptal-treated patients (38/1,524) had a sodium of less than 125 mmol/L at some point during treatment, compared to no such patients assigned placebo or active control (carbamazepine and phenobarbital for adjunctive and monotherapy substitution studies, and phenytoin and valproate for the monotherapy initiation studies). Clinically significant hyponatremia generally occurred during the first three months of treatment with Trileptal, although there were patients who first developed a serum sodium <125 mmol/L more than one year after initiation of therapy. Most patients who developed hyponatremia were asymptomatic but patients in the clinical trials were frequently monitored and some had their Trileptal dose reduced, discontinued, or had their fluid intake restricted for hyponatremia. Whether or not these maneuvers prevented the occurrence of more severe events is unknown. Cases of symptomatic hyponatremia have been reported during post-marketing use. In clinical trials, patients whose treatment with Trileptal was discontinued due to hyponatremia generally experienced normalization of serum sodium within a few days without additional treatment. Measurement of serum sodium levels should be considered for patients during maintenance treatment with Trileptal, particularly if the patient is receiving other medications known to decrease serum sodium levels (for example, drugs associated with inappropriate ADH secretion) or if symptoms possibly indicating hyponatremia develop (e.g., nausea, malaise, headache, lethargy, confusion, obtundation, or increase in seizure frequency or severity).

Anaphylactic Reactions and Angioedema.

Rare cases of anaphylaxis and angioedema involving the larynx, glottis, lips and eyelids have been reported in patients after taking the first or subsequent doses of Trileptal. Angioedema associated with laryngeal edema can be fatal. If a patient develops any of these reactions after treatment with Trileptal, the drug should be discontinued and an alternative treatment started. These patients should not be rechallenged with the drug.

Patients with a Past History of Hypersensitivity Reaction to Carbamazepine:

Patients who have had hypersensitivity reactions to carbamazepine should be informed that approximately 25%-30% of them will experience hypersensitivity reactions with Trileptal. For this reason patients should be specifically questioned about any prior experience with carbamazepine, and patients with a history of hypersensitivity reactions to carbamazepine should ordinarily be treated with Trileptal only if the potential benefit justifies the potential risk. If signs or symptoms of hypersensitivity develop, Trileptal should be discontinued immediately.

Multi-Organ Hypersensitivity:

Serious dermatological reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in both children and adults in association with Trileptal use. The median time of onset for reported cases was 19 days. Such serious skin reactions may be life threatening, and some patients have required hospitalization with very rare reports of fatal outcome. Recurrence of the serious skin reactions following rechallenge with Trileptal has also been reported. The reporting rate of TEN and SJS associated with Trileptal use, which is generally accepted to be an underestimate due to underreporting, exceeds the background incidence rate estimates by a factor of 3- to 10-fold. Estimates of the background incidence rate for these serious skin reactions in the general population range between 0.5 to 6 cases per million-person years. Therefore, if a patient develops a skin reaction while taking Trileptal, consideration should be given to discontinuing Trileptal use and prescribing another antiepileptic medication.

Suicidal Behavior and Ideation

Antiepileptic drugs (AEDs), including Trileptal, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide. The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed. The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5-100 years) in the clinical trials analyzed Drug Patients with The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications. Anyone considering prescribing Trileptal or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated. Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

Withdrawal of AEDs

As with all antiepileptic drugs, Trileptal should be withdrawn gradually to minimize the potential of increased seizure frequency.

1. I can refuse to give consent or can withdraw my consent at any time with written notification to the prescriber. This will not affect my right to change my decision at a later date. If I withdraw consent after a medication is started, I realize that the medication may not be discontinued immediately. Rather, it will be tapered as rapidly as medically safe and then discontinued so as to prevent an adverse medical consequence, such as seizures, due to rapid medication withdrawal.

2. Questions regarding this medication can be discussed with the prescriber can assist in making any necessary arrangements.

3. Questions regarding any behavior support plan or behavior intervention plan, which correspond with the use of the medication, can be directed to the client’s social worker, case manager, psychologist, and/or therapist.

4. I have the right to request a review at any time of my record, with some limitations at the prescriber’s discretion for the risk to client and the benefit versus harm of knowing the record.

5. I have a legal right to file a complaint if I feel that client rights have been inappropriately restricted. The client’s social worker, case manager, or agency/facility client rights specialist may be contacted for assistance.

6. My consent permits the dose to be changed within the anticipated dosage range without signing another consent.

7. I understand the reasons for the use of the medication, its potential risks and benefits, other alternative treatment(s), and the probable consequences that may occur if the proposed medication is not given. I have been given adequate time to study the information and find the information to be specific, accurate, and complete.

8. This medication consent is for an indefinite period and is effective immediately. The need for and continued use of this medication will be reviewed at least quarterly by the prescriber. The goal, on behalf of the client, will be to arrive at and maintain the client at the minimum effective dose.

9. Psychiatric medications can fall into these general categories and risks / benefits of these medications may overlap (List not inclusive):

a. Stimulants: Adderall, Concerta, Dexedrine, Ritalin, Focalin, Vyvanse

b. Mood Stabilizers/Antiepileptics: Depakote, Eskalith, Lamictal, Lyrica, Neurontin, Phenobarbital, Tegretol, Topamax, Trileptal

c. I can refer to the PDR for an all-inclusive list of side-effects

Consent to Treat with an Approved Opioid Medication

I hereby authorize and give voluntary consent to “AMental.health / A Clean Me” to administer or prescribe opioid pharmacotherapy (methadone, buprenorphine or buprenorphine/naloxone) as an element in the treatment for my dependence on heroin or other opioid drugs. The procedures to treat my condition have been explained to me, and I understand that it will involve my taking the prescribed opioid medication at the scheduled interval by the Program Medical Directors, or his/her designee, which will help control my dependence on heroin or other opioid drugs.

It has been explained to me that methadone, buprenorphine or buprenorphine/naloxone is an opioid medication which can be harmful if taken without medical supervision. I further understand that opioid treatment medications are addictive medications and may, like other drugs used in medical practice, produce adverse results. The alternative methods of treatment, the possible risks involved, and the possibilities of complications have been explained to me, but I still desire to receive methadone, buprenorphine or buprenorphine/naloxone due to the risk of my return to heroin or other opioid drugs.

The goal of medication assisted opioid treatment is total rehabilitation of the patient. I realize that for some patients, medication assisted treatment may continue for relatively long or indefinite periods of time, and I shall be afforded detoxification under medical supervision. I also understand that during the course of treatment, certain conditions may make it necessary to use additional or different procedures than those explained to me. I understand that these alternate procedures shall be used when in the Program Medical Directors; professional judgment, it is considered advisable.

FEMALE PATIENT OF CHILDBEARING AGE ONLY

To the best of my knowledge, I am NOT pregnant at this time. Besides the possible risks involved with the long-term use of methadone, buprenorphine or buprenorphine/naloxone, I further understand that, like heroin or other narcotic drugs, information on its effects on pregnant women and on their unborn children cannot guarantee that it will not produce significant or serious side effects.

It has been explained to me, and I understand, that methadone, buprenorphine or buprenorphine/naloxone is transmitted to the unborn child and will cause physical dependence. Thus if I am pregnant and suddenly stop taking methadone, buprenorphine or buprenorphine/naloxone, the unborn child or I may show signs of withdrawal which may adversely affect my pregnancy or the child.

I shall use no other drugs without approval of the Medical Director or his/her authorized assistant, since these drugs, particularly as they might interact with methadone, buprenorphine or buprenorphine/naloxone may harm me or my unborn child.) will inform any other physician who sees the child after birth, of my current or past participation in a medication assisted opioid treatment program in order that she/he may properly care for my child and me.

I understand that for a brief period following the birth, the child may show temporary irritability or other ill effects due to my use of methadone, buprenorphine or buprenorphine/naloxone. It is essential for the child's physician to know of my participation in a medication assisted opioid treatment program so that she may provide appropriate medical treatment for the child.

All the above possible effects of methadone, buprenorphine or buprenorphine/naloxone have been explained to me, and I understand that studies conducted on the long-term use of the drug do not assure complete safety to my child. With full knowledge of this, I consent to its use and promise to inform the Medical director or one of his/her assistants immediately if I become pregnant.

Suboxone® (a tablet with buprenorphine and naloxone) is an FDA approved medication for treatment of people with heroin or other opioid addiction. Buprenorphine can be used for detoxification or for maintenance therapy. Maintenance therapy can continue as long as medically necessary. There are other treatments for opiate addiction, including methadone, naltrexone, and some treatments without medications that include counseling, groups and meetings.

If you are dependent on opiates - any opiates - you should be in as much withdrawal as possible when you take the first dose of buprenorphine. If you are not in withdrawal, buprenorphine can cause severe opiate withdrawal. For that reason, you should take the first dose in the office and remain in the office for at least 2-4 hours. We recommend that you arrange not to drive after your first dose, because some patients get drowsy until the correct dose is determined for them.

Some patients find that it takes several days to get used to the transition from the opiate they had been using to buprenorphine. During that time, any use of other opiates may cause an increase in symptoms. After you become stabilized on buprenorphine, it is expected that other opiates will have less effect. Attempts to override the buprenorphine by taking more opiates could result in an opiate overdose. You should not take any other medication without discussing it with the physician first.

Combining buprenorphine with alcohol or other sedating medications is dangerous. The combination of buprenorphine with benzodiazepines (such as Valium®, Librium®, Ativan®, Xanax®, Klonopin®, etc.) has resulted in deaths.

Although sublingual buprenorphine has not been shown to be liver-damaging, your doctor will monitor your liver tests while you are taking buprenorphine. (This is a blood test.)

The form of buprenorphine (Suboxone®) you will be taking is a combination of buprenorphine with a short-acting opiate blocker (Naloxone). It will maintain physical dependence, and if you discontinue it suddenly, you will likely experience withdrawal. If you are not already dependent, you should not take buprenorphine, it could eventually cause physical dependence.

Buprenorphine tablets/Film must be held under the tongue until they dissolve completely. You will be given your first dose at the clinic, and you will have to wait as it dissolves, and for two hours after it dissolves, to see how you react. It is important not to talk or swallow until the tablet dissolves. This can take up to ten minutes. Buprenorphine is then absorbed over the next 30 to 120 minutes from the tissue under the tongue.

Buprenorphine will not be absorbed from the stomach if it is swallowed. If you swallow the tablet, you will not have the important benefits of the medication, and it may not relieve your withdrawal.

Most patients end up at a daily dose of 2mg to 16 mg of buprenorphine. Beyond that dose, the effects of buprenorphine plateau, so there may not be any more benefit to increase in dose. It may take several weeks to determine just the right dose for you. The first dose is usually 2mg to 6mg.

If you are transferring to Suboxone® from methadone maintenance, your dose has to be tapered until you have been below 30mg for at least a week. There must be at least 24 hours (preferably longer) between the time you take your last methadone dose and the time you are given your first dose of buprenorphine. Your doctor will examine you for clear signs of withdrawal, and you will not be given buprenorphine until you are in withdrawal.

By signing this form, I agree that I shall inform any doctor who may treat me for any medical or psychiatric problem that I am enrolled in an opioid treatment program, since the use of other drugs in conjunction with opioid medications prescribed by the treatment program may cause me harm.

I agree that I will authorize and maintain valid Releases of Confidential Information for the clinic to freely communicate with my other health care providers about pertinent aspects of my opioid treatment. I certify that no guarantee or assurance has been made as to the results that may be obtained from medication assisted opioid addiction treatment. With full knowledge of the potential benefits and possible risks involved, I consent to medication assisted treatment, since I realize that I would otherwise continue to be dependent on heroin or other opioid drugs. I have read and understand these details about Medication Assisted treatment. I wish to be treated.

Prescription Monitoring Program Intake Notice

FALSIFICATION OF INTAKE INFORMATION

I understand that I am to provide accurate and honest information. Falsification of intake information including failure to disclose treatment history, medical care, prescribed medications or funding status may result in denial of admission to “AMental.health / A Clean Me” or immediate discharge from treatment. I further understand that I may not be eligible to reapply for a minimum of one year.

WASHINGTON STATE PRESCRIPTION MONITORING PROGRAM

“AMental.health / A Clean Me” utilizes the Washington State Prescription Monitoring Program (PMP) to ensure safe and effective outpatient addiction treatment. In addition to verifying what prescriptions you have received prior to admission to treatment here “AMental.health / A Clean Me” will be able to monitor your prescriptions while you receive buprenorphine treatment here.

WHAT IS PRESCRIPTION REVIEW?

Prescription Review is a secure online database that will be used across Washington State to improve public health. All practitioners are able to review their patient's prescribed medication history before they prescribe or dispense drugs. All clinics and provider offices will be connected to this centralized system. It will allow them to communicate with one another and look for duplicate prescribing, possible misuse, drug interactions, and other potential concerns.

WHO CAN ACCESS THE DATA?

Physicians, pharmacists, dentists, physician assistants, nurse practitioners, and other licensed clinicians and professionals authorized by the Washington State Department of Health. The system is secure to make sure confidential information is protected.

INDIVIDUAL DISCLOSURE OF PROTECTED HEALTH INFORMATION

I understand that my (the individual’s) health/recovery information is private and confidential. I understand that “AMental.health / A Clean Me” works hard to protect my (the individual’s) privacy and preserve the confidentiality of my (the individual’s) health/recovery information.

I understand that “AMental.health / A Clean Me” may use and disclose my (the individual’s) health/recovery information to provide treatment to me (the individual), to handle billing and payment, and to take care of other health care operations.

In general, there will be no other uses and disclosures of this information unless I permit it. I understand that sometimes the law may require the release of this information without my permission. These situations are very unusual. One example: If an individual threatened to hurt someone. “AMental.health / A Clean Me” has a detailed document called the “Notice of Privacy Practices”. It contains more detailed information about how we may use and disclose individual health/recovery information. I understand that I have a legal right to read the “Notice of Privacy Practices”.

“AMental.health / A Clean Me” may update this “Notice of Privacy Practice”. If I ask, “AMental.health / A Clean Me” will provide me with the most current “Notice of Privacy Practice”.

Under the terms of this consent, I can ask “AMental.health / A Clean Me” to restrict how my (the individual’s) health/recovery information is used or disclosed to carry out treatment, payment, or healthcare operations. I understand that “AMental.health / A Clean Me” does not have to agree to my (the individual’s) request. If “AMental.health / A Clean Me” does agree to my (the individual’s) request, I understand that “AMental.health / A Clean Me” will follow the agreed limits.

I may cancel this consent in writing at any time by doing the following: Writing, signing, and dating a letter to “AMental.health / A Clean Me”. The letter must state that I want to revoke my (the individual’s) consent to authorize the use and disclosure of my (the individual’s) health/recovery information for treatment, payment, and health care options. If I revoke my consent as noted above, “AMental.health / A Clean Me” does not have to provide any further health care services to me (the individual).

Clinic Policies, Procedures and Rules

1. I agree to keep appointments and let appropriate staff know if I will be unable to show up as scheduled.

2. I agree to report my history and my symptoms honestly to “AMental.health / A Clean Me” LLC physicians, nurses, and counselors. I also agree to inform “AMental.health / A Clean Me” LLC staff of all other physicians and dentists whom I am seeing; of all prescription and non-prescription drugs I am taking; of any alcohol or street drugs I have recently been using; and whether I have become pregnant or have developed hepatitis.

3. I agree to cooperate with witnessed urine drug testing whenever requested by “AMental.health / A Clean Me” LLC staff, to confirm if I have been using any alcohol, prescription drugs, or street drugs.

4. I have been informed that buprenorphine, as found in Suboxone, is a narcotic analgesic, and thus it can produce a "high"; I know that taking Suboxone regularly can lead to physical dependence and addiction, and that if I were to abruptly stop taking Suboxone after a period regular use, I could experience symptoms of opiate withdrawal.

5. I have been informed that Suboxone is to be placed under the tongue for It to dissolve and be absorbed, and that it should never be injected or taken IV. I have been Informed that injecting Suboxone after taking Suboxone or any other opiate regularly could lead to sudden and severe opiate withdrawal.

6. I have been informed that Suboxone is a powerful drug and is to be respected, and that supplies of it must be protected from theft or unauthorized use, since persons who want to get high by using it or who want to sell it for profit, may be motivated to steal my take-home prescription supplies of Suboxone. I have a means to store take-home prescription supplies of Suboxone safely, where it cannot be taken accidentally by children

7. or pets, or stolen by unauthorized users. I agree that if my Suboxone pills are swallowed by anyone besides me, 1 will call 911 or Poison Control at 1-800-222-1222 immediately.

8. I agree that if my “AMental.health / A Clean Me” LLC doctor recommends that my home supplies of Suboxone should be kept in the care of a responsible member of my family or another third - party, I will abide by such recommendations.:

9. I will be careful with my take-home prescription supplies of Suboxone, and agree that I have been informed that if I report that my supplies have been lost or stolen, that my doctors will not be requested or expected to provide me with makeup supplies. This means that if I run out of my medication supplies it could result in my experiencing symptoms of opiate withdrawal. Also, I agree that if there has been a theft of my medications, I will report this to the police and will bring a copy of the police report to my next “AMental.health / A Clean Me” LLC visit. I can be asked to come into the clinic RANDOMLY for medication count.

10. I agree to bring my bottle of Suboxone in with me for every appointment with my “AMental.health / A Clean Me” LLC doctor so that the remaining supplies can be counted.

11. I agree to take my Suboxone as prescribed, to not skip doses, and that I will not adjust the dose without talking with my “AMental.health / A Clean Me” LLC doctor about this so that changes in orders can be properly communicated by “AMental.health / A Clean Me” LLC to my pharmacy.

12. I agree that I will not drive a motor vehicle or use power tools or other dangerous machinery during my first days of taking Suboxone, to make sure that I can tolerate taking it without becoming sleepy or clumsy as a side-effect of taking it.

13. I agree that 1 will arrange transportation to and from “AMental.health / A Clean Me” LLC facilities during my first days of taking Suboxone so that I do not have to drive myself to and from the clinic or hospital.

14. I have been informed that it can be dangerous to mix Suboxone with alcohol or another sedative drug such as Valium, Ativan, Xanax, Klonopin, or any other benzodiazepine drug - so dangerous that it could result in an accidental overdose, over-sedation, coma, or death. I agree to use no alcoholic beverages and to take no sedative drugs at any time while being treated with Suboxone. I have been informed that my “AMental.health / A Clean Me” LLC doctor will almost certainly discontinue my buprenorphine treatment with Suboxone if I violate this agreement

15. I am not pregnant, and will not attempt to become pregnant, If a female, I will not have unprotected sex while I am taking Suboxone, because of the unknown safety of buprenorphine during pregnancy. I have been informed that my “AMental.health / A Clean Me” LLC doctor will almost certainly discontinue my buprenorphine treatment with Suboxone if I become pregnant.

16. I want to be in recovery from addiction to all drugs, and I have been informed that any active addiction to other drugs besides heroin and other opiates must be treated by counseling and other methods. I have been informed that buprenorphine, as found in Suboxone, is a treatment designed to treat opiate dependence, not addiction to other classes of drugs.

17. I agree that medication management of addiction with buprenorphine, as found in Suboxone, is only one part of treatment of my addiction, and I agree to participate in a regular program of professional counseling at “AMental.health / A Clean Me” LLC while being treated with Suboxone.

18. I agree that professional counseling for addiction has the best results when patients are also open to support from peers who are also pursuing recovery.

19. I agree to participate in a regular program of peer/self-help while being treated with Suboxone.

20. I agree that the support of loved ones is an Important part of recovery, and I agree to invite significant persons in my life to participate in my treatment at “AMental.health / A Clean Me” LLC.

21. I agree that a network of support, and communication among persons in that network, is an important part of my recovery. I will be asked for my authorization, if required (which it almost always is) to allow telephone, email, or face-to-face contact, as appropriate, between “AMental.health / A Clean Me” LLC staff from my treatment team, and outside parties, including physicians, therapists, probation and parole officers, and other parties, when the “AMental.health / A Clean Me” LLC staff has decided that open communication about my case, on my behalf, is necessary.

22. I agree that I will be open and honest with my counselors and inform “AMental.health / A Clean Me” LLC staff about cravings, potential for relapse to the extent that I am aware of such, and specifically about any relapse which has occurred - before a drug test result shows it. –

23. I have been given a copy of “AMental.health / A Clean Me” LLC Clinic procedures, including hours of operation, the clinic phone number, and responsibilities to me as a recipient of addiction treatment services, including buprenorphine treatment with Suboxone. –

- ? All new patients will initially be followed once a week for 4 to 8 weeks.

- ? All co-pays due at service, unpaid bills will result in suspension from the clinic till the bills are paid in full. - ? After 4 to 8 weeks, if the patient has been compliant, had no relapse and is doing well, can be seen every other week.

- ? Patients will continue to be seen every other week as long as they are enrolled in the treatment program. (With few exceptions.)

- ? All patients will be encouraged to enroll in Chemical dependency counseling. This can be at the facility (when available). We have Community resources for counseling. This information will be provided to the patients.

- ? Urine toxicology will be done at each visit and randomly. If a patient's failure or refusal to provide a urine sample upon request, for whatever reason, will result in the recording of a positive urine drug screen. Patients will be expected to make a good faith effort to provide a urine sample. Any patient who fails to leave a urine sample will not receive a prescription renewal.

YOU WILL BE REQUIRED TO LEAVE A URINE SAMPLE PRIOR TO YOUR MEDICAL ASSESSMENT.

- ? Patients will need to get baseline and regular blood tests for liver function.

- ? Women of child bearing age will need to get a monthly urine pregnancy test.

-? Violations of any of the rules set by “AMental.health / A Clean Me” may be grounds for termination of treatment.

- ? If you appear intoxicated by drugs or alcohol to any clinic staff during the induction phase, you will not be given your buprenorphine dose on that day. Moreover, if you appear intoxicated when meeting with the physician or counselor your treatment status will be reviewed and your buprenorphine prescription term could be shortened or not renewed. Repeated intoxication will be grounds for discharge from treatment.

The following behaviors will not be tolerated, and may result in termination of your treatment. These actions fall into three categories:

A. Actions which will result in immediate treatment termination (no taper, no medication refills, no access to program premises, no appeal, no readmission):

- 1. Threats of or actual physical violence against any program staff member or patient.

– 2. Destruction of agency, staff or other patient property.

- 3. Bringing a weapon into the building or surrounding premises.

- 4. FALSIFYING A DRUG SCREEN IN ANY WAY IS GROUNDS FOR IMMEDIATE TERMINATION FROM THE PROGRAM WITHOUT - - POSSIBILITY OF BEING REINSTATED. THERE ARE NO EXCEPTIONS TO THIS RULE.

- 5. If you do not have the prescribed medication in your system when it is expected to be there you could be terminated from the program.

B. Actions which may result in immediate discharge or an involuntary buprenorphine taper.

- 1. Holding, passing, or selling drugs or drug paraphernalia, alcohol at program site. - 2. Diversion of buprenorphine dose.

- 3. Receiving buprenorphine or methadone from another provider (double dosing). - - 4. Falsification of intake or other requested treatment information.

C. Actions which may result in an involuntary buprenorphine taper:

- 1. Evidence of continued use of drugs and/or alcohol

- 2. Loitering in or around the program site (loitering is defined as staying on clinic premises for longer than 15 minutes without a required clinical reason).

A patient who has been placed on an administrative (involuntary) taper will be notified in writing of this action the day the taper will start. The patient has the right to appeal this decision.

Sound Center for Integrated Health will be enforcing the following appointment policies. Any exceptions can only be approved by Manager or by one of the providers and will require documentation from jail, hospital, court, etc.

- Patients are required to keep their scheduled appointments. Make every effort when scheduling your appointment to make sure it is for a time that you are going to be able to keep. If you are unable to keep an appointment or if you need to reschedule an appointment you must do so BEFORE the scheduled time. If you miss your scheduled appointment you will be rescheduled for your usual day the following week. A missed Monday appointment will not longer be rescheduled for Tuesday. There are different providers on Mondays and Tuesdays, for continuity of care patients will be followed exclusively by the provider they are assigned to.

- Being more than 15 minutes late for your scheduled appointment will be considered a missed appointment and you will be rescheduled for the following week.

- If you miss an appointment you will be required to call and reschedule. If you show up the following clinic day without an appointment you will not be seen.

No patients will be admitted past 4:30 p.m.

We understand that If It Happens and the best laid plans can be derailed. Therefore, it is up to you to have a backup plan, a backup plan. This applies to work schedules, transportation, childcare, and anything else you can think of.

I HAVE READ AND UNDERSTAND ALL THE ABOVE CONSENTS, POLICIES AND PROCEDURES DESCRIBED AND AGREE TO ABIDE BY ALL THE RULES AND REGULATIONS OF “AMENTAL.HEALTH / A CLEAN ME” LLC.

I UNDERSTAND THE RISKS AND BENEFITS OF TREATMENT AND WISH TO PROCEED.

Confidentiality Patient Notice

THIS NOTICE DESCRIBES HOW MEDICAL AND DRUG AND ALCOHOL RELATED INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED AND HOW YOU CAN GET ACCESS TO THIS INFORMATION. PLEASE REVIEW IT CAREFULLY.

GENERAL INFORMATION: Information regarding your health care, including payment for health care, is protected by two federal laws: the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. 1320d et seq., 45 C.F.R, Parts 160 & 164, and the Confidentiality Law, 42 U.S.C. 280dd-2, 42 C.F.R. Part 2. Under these laws, “AMental.health / A Clean Me” LLC may not tell a person outside of “AMental.health / A Clean Me” LLC that you attend the program, nor may “AMental.health / A Clean Me” LLC disclose any information identifying you as an alcohol or drug abuser, or disclose any other protected information except as permitted by federal law.

Generally, you must sign a written consent before “AMental.health / A Clean Me” LLC can share information for any purpose. Written consent (with some exceptions) may be revoked either verbally or in writing. Under certain circumstances, federal law permits “AMental.health / A Clean Me” LLC to disclose information without your permission:

1. MEDICAL EMERGENCY: To help in the event of an emergency medical situation.

2. COURT ORDER: As required by the document 3

. CHILD ABUSE OR NEGLECT: “AMental.health / A Clean Me” LLC is required to report to Child Protective Services any situation in reasonable cause is suspected in an incident of child abuse or neglect, including sexual abuse (RCW 26.44).

4. THREATS OF HARM: Threats to harm self or someone else.

5. CRIME RELATED TO ETS: “AMental.health / A Clean Me” LLC will disclose information to law enforcement about a crime or threat against our property or personnel.

6. RESEARCH AND AUDIT: For research, audit or evaluation.

7. QUALIFIED SERVICE ORGANIZATION AGREEMENT: When “AMental.health / A Clean Me” LLC has a formal agreement with an organization / business associate.

YOUR RIGHTS: Under HIPAA you have the right to inspect and copy your own health information maintained try “AMental.health / A Clean Me” LLC, except to the extent that the information contains psychotherapy notes or information compiled for use in a civil, criminal, or administrative proceeding or in other limited circumstances. Under HIPAA you also have the right, with some exceptions, to amend health care information maintained in “AMental.health / A Clean Me” LLC records, and to request and receive an accounting of disclosures of your health related information made by “AMental.health / A Clean Me” LLC during the 6 years prior to your request. You also have the right to receive a paper copy of this notice. DUTIES: “AMental.health / A Clean Me” LLC is required by law to maintain the privacy of your health information and to provide you with notice of its legal duties and privacy practices with respect to your health information. “AMental.health / A Clean Me” LLC is required by law to abide by the terms of this notice.

“AMental.health / A Clean Me” LLC reserves the right to charge-the terms of this notice and to make new notice provisions effective for all protected health information it maintains. COMPLAINTS AND REPORTING VIOLATIONS: You may complain to “AMental.health / A Clean Me” LLC and the Secretary of the United States Department of Health and Human Services if you believe that your privacy rights have been violated under HIPAA. You will not be retaliated against for filing such a complaint.

Violation of the Confidentiality Law by a program is a crime. Suspected violations of the Confidentiality Law may be reported to the United States Attorney in the district where the violation occurs.

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