Apo-Quetiapine

Quetiapine fumarate

Schizophrenia; acute manic episodes associated w/ bipolar I disorder; depressive episodes associated w/ bipolar disorder. Preventing recurrence in maintenance treatment of bipolar I disorder (manic, mixed or depressive episode) as monotherapy or in combination w/ lithium or valproate.

Adult Schizophrenia Total daily dose for the 1st 4 days: 50, 100, 200 & 300 mg for day 1, 2, 3 & 4, respectively. From day 4 onwards, the dose should be titrated to 300-450 mg daily, may be adjusted to 150-750 mg daily. Doses are given bd. Manic episodes associated w/ bipolar disorder Total daily dose for the 1st 4 days: 100, 200, 300 & 400 mg for day 1, 2, 3 & 4, respectively as monotherapy or adjunct to mood stabilizers. Further dosage adjustments up to 800 mg daily (day 6) should be in increments of no >200 mg daily. May be adjusted to 200-800 mg daily. Usual effective dose: 400-800 mg daily. Max dose: 800 mg daily. Doses are given bd. Depressive episodes associated w/ bipolar disorder Titrate dose to 50, 100, 200 & 300 mg for day 1, 2, 3 & 4, respectively. Can be titrated to 400 mg (day 5) & up to 600 mg (day 8). Doses are given once daily at bedtime. Preventing recurrence in maintenance treatment of bipolar disorder Can be re-adjusted depending on clinical response & tolerability to 400-800 mg daily (in combination w/ lithium or valproate) or 300-800 mg daily (as monotherapy). Elderly, renal or hepatic impairment Initially 25 mg daily, increased daily in increments of 25-50 mg to an effective dose.

May be taken with or without food.

Hypersensitivity.

Not approved for dementia-related psychosis. Closely monitor patients for an increased risk of suicidal thoughts, self-harm & suicide (suicide-related events); w/ a history of suicide-related events or those exhibiting a significant degree of suicidal ideation prior to treatment commencement. Patients w/ major depressive disorder & other psychiatric disorders; w/ history of seizures; w/ known CV disease, cerebrovascular disease, other conditions predisposing to hypotension, family history of QT prolongation. Discontinue use in patients w/ neutrophil count <1 x 10⁹/L; if clinical manifestations of NMS appear; if severe cutaneous AR occur. Regularly monitor patients who are at risk for developing diabetes & w/ established DM diagnosis for worsening of glucose control. Monitor for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia & weakness. Possible increased triglycerides & cholesterol. Concomitant use w/ medicines known to increase QTc interval & neuroleptics for patients w/ increased risk of QT prolongation. Consider dose reduction or discontinuation if signs & symptoms of tardive dyskinesia appear. Possible acute w/drawal reactions; avoid abrupt cessation of treatment. Possible risk of VTE; dysphagia & aspiration pneumonia. Potential risk of somnambulism (sleep walking) & sleep-related eating disorder. May affect ability to drive or operate hazardous machines including motor vehicles; possible somnolence. Hepatic impairment. Pregnancy. Avoid breastfeeding during treatment. Childn & adolescents. Elderly w/ dementia.

Dry mouth; w/drawal (discontinuation symptoms); serum triglyceride levels & total cholesterol (predominantly LDL cholesterol) elevations, wt gain; dizziness, somnolence. Leukopenia; tachycardia; blurred vision; constipation, dyspepsia; mild asthenia, peripheral edema, irritability; ALT & AST elevations, decreased neutrophil count, increased blood glucose to hyperglycaemic level, serum prolactin elevations; syncope, extrapyramidal symptoms; increased appetite; rhinitis; orthostatic hypotension; abnormal dreams & nightmares.

Increased clearance w/ thioridazine, carbamazepine, phenytoin & other hepatic enzyme inducers (eg, barbiturates, rifampicin). Increased mean t_½; C_max & AUC, decreased mean oral clearance w/ ketoconazole. Potential interaction w/ potent CYP3A4 inhibitors (eg, azole antifungals, macrolides & PIs). Concomitant use w/ centrally-acting drugs & alcohol; drugs known to cause electrolyte imbalance or to increase QT interval.

Antipsychotics

N05AH04 - quetiapine ; Belongs to the class of diazepines, oxazepines and thiazepines antipsychotics.

POM