Generic Name and Formulations:
Quetiapine (as fumarate) 25mg, 50mg, 100mg, 200mg, 300mg, 400mg; tabs.
Company:
AstraZeneca Pharmaceuticals
Monotherapy for acute mania in bipolar I disorder; or as an adjunct to lithium or valproate for acute mania and maintenance treatment. Depressive episodes associated with bipolar disorder.
≥17yrs: 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/day on day 1, then 100mg/day on day 2, then 200mg/day on day 3, then 300mg/day on day 4. May increase to 400mg/day on day 5 and then 600mg/day on day 8 if maintenance is 600mg/day. Efficacy seen at both 300mg/day and 600mg/day (no additional benefit seen at 600mg/day). Elderly, debilitated, or risk of postural hypotension: titrate more slowly to lower target dose. Hepatic impairment: initially 25mg/day; titrate daily by 25–50mg/day to effective dose.
<10yrs: not recommended. 10–17yrs: Mania: 50mg/day in 2–3 divided doses on day 1, then 100mg/day in 2–3 divided doses on day 2, then 200mg/day in 2–3 divided doses on day 3, then 300mg/day in 2–3 divided doses on day 4, then 400mg/day in 2–3 divided doses on day 5; may further increase in increments up to 100mg/day to target range of 400–600mg/day.
Dibenzothiazepine.
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. Hepatic dysfunction. Seizure risk. Exclude neuroleptic malignant syndrome if fever or other symptoms occur. Risk of aspiration pneumonia. Exposure to extreme heat. Dehydration. Hypovolemia. Do eye exam initially and every 6 months. History of breast cancer. Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline. Reevaluate periodically. Avoid abrupt cessation. Write ℞ for smallest practical amount. Suicidal ideation (monitor). Elderly (not for dementia-related psychoses; may increase risk of death). Debilitated. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Labor & delivery. Pregnancy (Cat.C). Nursing mothers: not recommended.
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. Antagonized by CYP3A inducers (eg, thioridazine, phenytoin, carbamazepine, phenobarbital, rifampin); adjust dose. Potentiates antihypertensives, lorazepam. Antagonizes effects of levodopa, dopamine agonists. Caution with drugs that interfere with temperature regulation (eg, anticholinergics) and with CYP3A inhibitors (eg, azole antifungals, erythromycin).
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; rarely: tardive dyskinesia, neuroleptic malignant syndrome.
XR—60, 500; Tabs 25mg, 50mg—100, 1000; 100mg, 200mg, 400mg—100; 300mg—60
Schizophrenia.
≥17yrs: 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 800mg/day, all in divided doses. Maintenance: continue at the lowest dose to maintain remission. Elderly, debilitated, or risk of postural hypotension: titrate more slowly to lower target dose. Hepatic impairment: initially 25mg/day; titrate daily by 25–50mg/day to effective dose.
<13yrs: not recommended. 13–17yrs: 50mg/day in 2–3 divided doses on day 1, then 100mg/day in 2–3 divided doses on day 2, then 200mg/day in 2–3 divided doses on day 3, then 300mg/day in 2–3 divided doses on day 4, then 400mg/day in 2–3 divided doses on day 5; may further increase in increments up to 100mg/day to target range of 400–800mg/day. Maintenance: continue at the lowest dose to maintain remission.
Dibenzothiazepine.
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. Hepatic dysfunction. Seizure risk. Exclude neuroleptic malignant syndrome if fever or other symptoms occur. Risk of aspiration pneumonia. Exposure to extreme heat. Dehydration. Hypovolemia. Do eye exam initially and every 6 months. History of breast cancer. Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline. Reevaluate periodically. Avoid abrupt cessation. Write ℞ for smallest practical amount. Suicidal ideation (monitor). Elderly (not for dementia-related psychoses; may increase risk of death). Debilitated. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Labor & delivery. Pregnancy (Cat.C). Nursing mothers: not recommended.
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. Antagonized by CYP3A inducers (eg, thioridazine, phenytoin, carbamazepine, phenobarbital, rifampin); adjust dose. Potentiates antihypertensives, lorazepam. Antagonizes effects of levodopa, dopamine agonists. Caution with drugs that interfere with temperature regulation (eg, anticholinergics) and with CYP3A inhibitors (eg, azole antifungals, erythromycin).
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; rarely: tardive dyskinesia, neuroleptic malignant syndrome.
XR—60, 500; Tabs 25mg, 50mg—100, 1000; 100mg, 200mg, 400mg—100; 300mg—60