Generic Name and Formulations:
Quetiapine (as fumarate) 50mg, 150mg, 200mg, 300mg, 400mg; ext-rel tabs.

Company:
AstraZeneca Pharmaceuticals
Indications for SEROQUEL XR:
Monotherapy for acute manic or mixed episodes in bipolar I disorder; or as an adjunct to lithium or valproate for acute manic or mixed episodes and maintenance treatment. Depressive episodes associated with bipolar disorder. Adjunct to antidepressants for major depressive disorder (MDD).

Adult:
Swallow whole. Take on an empty stomach or with light meal. Give once daily in the PM. Depressive episodes due to bipolar disorder: 50mg on day 1, then 100mg on day 2, then 200mg on day 3, then 300mg on day 4; max 300mg/day. Mania: Give once daily in the PM. 300mg on day 1, then 600mg on day 2, then titrate to effective dose beginning on day 3, usually 400–800mg/day. Maintenance: usual range 400–800mg/day. Adjunct to MDD: 50mg/day on days 1 and 2, then 150mg/day on day 3, then titrate to effective dose, usual range: 150–300mg/day. Elderly, debilitated, or risk of postural hypotension: titrate more slowly to lower target dose. Elderly or hepatic impairment: initially 50mg/day; may increase at increments of 50mg/day. Concomitant CYP3A4 inhibitors or inducers, reinitiation of treatment: see full labeling. Switching from Seroquel immediate-release: give XR at equivalent total daily dose taken once daily.

Children:
Swallow whole. Take on an empty stomach or with light meal. Give once daily in the PM. <10yrs: not established. 10–17yrs: Mania: 50mg on day 1, then 100mg on day 2, then 200mg on day 3, then 300mg on day 4, then 400mg on day 5; may further increase up to target range of 400–600mg/day; max 600mg/day.

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 behavior 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. Do eye exam initially and every 6 months. History of breast cancer. Reeva luate 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). Labor & delivery. Pregnancy (Cat.C). Nursing mothers: not recommended.

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. 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).

See Also:
SEROQUEL

Pharmacological Class:
Dibenzothiazepine.

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; rarely: tardive dyskinesia, neuroleptic malignant syndrome.

How Supplied:
XR—60; Tabs 25mg, 50mg, 100mg, 200mg, 400mg—100; 300mg—60
Indications for SEROQUEL XR:
Schizophrenia.

Adult:
Swallow whole. Take on an empty stomach or with light meal. Initially 300mg once daily in the PM; may increase at 1-day intervals in increments of up to 300mg/day. Usual range: 400–800mg/day; max 800mg/day. Maintenance: 400–800mg/day. Elderly, debilitated, or risk of postural hypotension: titrate more slowly to lower target dose. Elderly or hepatic impairment: initially 50mg/day; may increase in increments of 50mg/day. Concomitant CYP3A4 inhibitors or inducers, reinitiation of treatment: see full labeling. Switching from Seroquel immediate-release: give XR at equivalent total daily dose taken once daily.

Children:
Swallow whole. Take on an empty stomach or with light meal. Give once daily in the PM. <13yrs: not established. 13–17yrs: 50mg on day 1, then 100mg on day 2, then 200mg on day 3, then 300mg on day 4, then 400mg on day 5; may further increase up to target range of 400–800mg/day; max 800mg/day.

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 behavior 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. Do eye exam initially and every 6 months. History of breast cancer. Reeva luate 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). Labor & delivery. Pregnancy (Cat.C). Nursing mothers: not recommended.

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. 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).

See Also:
SEROQUEL

Pharmacological Class:
Dibenzothiazepine.

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; rarely: tardive dyskinesia, neuroleptic malignant syndrome.

How Supplied:
XR—60; Tabs 25mg, 50mg, 100mg, 200mg, 400mg—100; 300mg—60