Seroquel Generic Name & Formulations
Legal Class
Rx
General Description
Quetiapine (as fumarate) 25mg, 50mg, 100mg, 200mg, 300mg, 400mg; tabs.
Pharmacological Class
Dibenzothiazepine.
See Also
How Supplied
XR—60; Tabs 25mg, 50mg, 100mg, 200mg, 400mg—100; 300mg—60
Manufacturer
Seroquel Indications
Indications
Acute treatment of manic episodes in bipolar I disorder, as monotherapy and as an adjunct to lithium or divalproex. Depressive episodes associated with bipolar disorder in adults. Maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex in adults.
Seroquel Dosage and Administration
Adult
Mania: 100mg/day in 2 divided doses on day 1, then increase in increments of up to 100mg/day in 2 divided doses, to target 400mg/day by day 4; then may increase in increments of up to 200mg/day to max 800mg/day in divided doses by day 6. Usual range 400–800mg/day. Maintenance: usually 400–800mg/day in two divided doses; or may continue on same stabilized dose. Depressive episodes due to bipolar disorder: Give at bedtime. 50mg on day 1, then 100mg on day 2, then 200mg on day 3, then 300mg on day 4; max 300mg/day. Elderly, debilitated, or risk of postural hypotension: titrate more slowly to lower target dose. Elderly: initially 50mg/day. Hepatic impairment: initially 25mg/day; titrate daily by 25–50mg/day to effective dose. Concomitant CYP3A4 inhibitors or inducers, reinitiation of treatment: see full labeling.
Children
Mania: <10yrs: not established. 10–17yrs: 25mg twice daily on day 1, then 50mg twice daily on day 2, then 100mg twice daily on day 3, then 150mg twice daily on day 4, then 200mg twice daily on day 5; may further increase in increments up to 100mg/day to target range of 400–600mg/day (may give 3 times daily); max: 600mg/day. Bipolar depression, maintenance: <18yrs: not established.
Seroquel Contraindications
Not Applicable
Seroquel Boxed Warnings
Boxed Warning
Increased mortality in elderly patients with dementia-related psychosis. Suicidal thoughts and behaviors.
Seroquel Warnings/Precautions
Warnings/Precautions
Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Increased risk of suicidal thoughts and behavior in children, adolescents, and young adults; monitor closely for worsening or unusual changes in all patients. Exclude neuroleptic malignant syndrome if fever or other symptoms occur. Diabetes. Monitor for hyperglycemia, hyperlipidemia: do fasting blood glucose and lipids testing initially and during therapy. Monitor for weight gain. Cardio- or cerebrovascular disease. Monitor BP in children and adolescents initially and during therapy. Increased risk of QT prolongation (eg, family history, cardiovascular disease, elderly, CHF, heart hypertrophy). Avoid in cardiac arrhythmias (eg, bradycardia), hypokalemia, hypomagnesemia, congenital prolongation of the QT interval. Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline. Hepatic dysfunction. Seizure risk. Risk of aspiration pneumonia. Exposure to extreme heat. Dehydration. Hypovolemia. Urinary retention. Significant prostatic hypertrophy. Perform fall risk assessments when initiating and recurrently on long-term therapy. Do eye exam initially and every 6 months. History of breast cancer. Reevaluate periodically. Avoid abrupt cessation. Write ℞ for smallest practical amount. Debilitated. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy. Nursing mothers.
Seroquel Pharmacokinetics
See Literature
Seroquel Interactions
Interactions
Avoid drugs that prolong QT interval including Class 1A (eg, quinidine, procainamide) or Class III antiarrhythmics (eg, amiodarone, sotalol), antipsychotics (eg, ziprasidone, chlorpromazine, thioridazine), antibiotics (eg, gatifloxacin, moxifloxacin), and others (eg, pentamidine, methadone, levomethadyl acetate). Potentiates CNS effects with alcohol (avoid), other CNS depressants. Potentiated by CYP3A4 inhibitors (eg, azole antifungals, indinavir, ritonavir, nefazodone, others); adjust dose. Antagonized by CYP3A4 inducers (eg, phenytoin, carbamazepine, phenobarbital, rifampin, avasimibe, St. John's wort); adjust dose. Potentiates antihypertensives, lorazepam. Antagonizes effects of levodopa, dopamine agonists. Caution with drugs having anticholinergic effects.
Seroquel Adverse Reactions
Adverse Reactions
Somnolence, dry mouth, constipation, dizziness, increased appetite, dyspepsia, weight gain, fatigue, dysarthria, nasal congestion, asthenia, abdominal pain, postural hypotension, pharyngitis, lethargy, hyperglycemia, hypothyroidism, hyperprolactinemia; increased ALT (transient), total cholesterol +/or triglycerides; leukopenia, neutropenia, agranulocytosis, intestinal obstruction; rarely: tardive dyskinesia (consider discontinuation), neuroleptic malignant syndrome.
Seroquel Clinical Trials
See Literature
Seroquel Note
Not Applicable
Seroquel Patient Counseling
See Literature
Seroquel Generic Name & Formulations
Legal Class
Rx
General Description
Quetiapine (as fumarate) 25mg, 50mg, 100mg, 200mg, 300mg, 400mg; tabs.
Pharmacological Class
Dibenzothiazepine.
See Also
How Supplied
XR—60; Tabs 25mg, 50mg, 100mg, 200mg, 400mg—100; 300mg—60
Manufacturer
Seroquel Indications
Indications
Schizophrenia.
Seroquel Dosage and Administration
Adult
Initially 25mg twice daily on day 1; increase by 25–50mg 2–3 times daily on days 2 and 3; target 300–400mg/day in 2–3 divided doses by day 4; may adjust at 2-day intervals by 25–50mg twice daily. Usual range 150–750mg/day; max 750mg/day. Maintenance: 400–800mg/day; max 800mg/day. Elderly, debilitated, or risk of postural hypotension: titrate more slowly to lower target dose. Elderly: initially 50mg/day. Hepatic impairment: initially 25mg/day; titrate daily by 25–50mg/day to effective dose. Concomitant CYP3A4 inhibitors or inducers, reinitiation of treatment: see full labeling.
Children
<13yrs: not established. 13–17yrs: 25mg twice daily on day 1, then 50mg twice daily on day 2, then 100mg twice daily on day 3, then 150mg twice daily on day 4, then 200mg twice daily on day 5; may further increase in increments up to 100mg/day to target range of 400–800mg/day (may give 3 times daily); max: 800mg/day. Maintenance: not established.
Seroquel Contraindications
Not Applicable
Seroquel Boxed Warnings
Boxed Warning
Increased mortality in elderly patients with dementia-related psychosis. Suicidal thoughts and behaviors.
Seroquel Warnings/Precautions
Warnings/Precautions
Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Increased risk of suicidal thoughts and behavior in children, adolescents, and young adults; monitor closely for worsening or unusual changes in all patients. Exclude neuroleptic malignant syndrome if fever or other symptoms occur. Diabetes. Monitor for hyperglycemia, hyperlipidemia: do fasting blood glucose and lipids testing initially and during therapy. Monitor for weight gain. Cardio- or cerebrovascular disease. Monitor BP in children and adolescents initially and during therapy. Increased risk of QT prolongation (eg, family history, cardiovascular disease, elderly, CHF, heart hypertrophy). Avoid in cardiac arrhythmias (eg, bradycardia), hypokalemia, hypomagnesemia, congenital prolongation of the QT interval. Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline. Hepatic dysfunction. Seizure risk. Risk of aspiration pneumonia. Exposure to extreme heat. Dehydration. Hypovolemia. Urinary retention. Significant prostatic hypertrophy. Perform fall risk assessments when initiating and recurrently on long-term therapy. Do eye exam initially and every 6 months. History of breast cancer. Reevaluate periodically. Avoid abrupt cessation. Write ℞ for smallest practical amount. Debilitated. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy. Nursing mothers.
Seroquel Pharmacokinetics
See Literature
Seroquel Interactions
Interactions
Avoid drugs that prolong QT interval including Class 1A (eg, quinidine, procainamide) or Class III antiarrhythmics (eg, amiodarone, sotalol), antipsychotics (eg, ziprasidone, chlorpromazine, thioridazine), antibiotics (eg, gatifloxacin, moxifloxacin), and others (eg, pentamidine, methadone, levomethadyl acetate). Potentiates CNS effects with alcohol (avoid), other CNS depressants. Potentiated by CYP3A4 inhibitors (eg, azole antifungals, indinavir, ritonavir, nefazodone, others); adjust dose. Antagonized by CYP3A4 inducers (eg, phenytoin, carbamazepine, phenobarbital, rifampin, avasimibe, St. John's wort); adjust dose. Potentiates antihypertensives, lorazepam. Antagonizes effects of levodopa, dopamine agonists. Caution with drugs having anticholinergic effects.
Seroquel Adverse Reactions
Adverse Reactions
Somnolence, dry mouth, constipation, dizziness, increased appetite, dyspepsia, weight gain, fatigue, dysarthria, nasal congestion, asthenia, abdominal pain, postural hypotension, pharyngitis, lethargy, hyperglycemia, hypothyroidism, hyperprolactinemia; increased ALT (transient), total cholesterol +/or triglycerides; leukopenia, neutropenia, agranulocytosis, intestinal obstruction; rarely: tardive dyskinesia (consider discontinuation), neuroleptic malignant syndrome.
Seroquel Clinical Trials
See Literature
Seroquel Note
Not Applicable
Seroquel Patient Counseling
See Literature
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