Concise Prescribing Info
Quetiapine fumarate
Management of the manifestations of schizophrenia. Monotherapy for the acute management of manic episodes associated w/ bipolar disorder; acute management of depressive episodes associated w/ bipolar I & bipolar II disorder.
Dosage/Direction for Use
Schizophrenia Initially 25 mg bd, titrated w/ increments of 25-50 mg bd, as tolerated, to a target dose of 300 mg/day bd w/in 4-7 days. Dose adjustments should generally occur at intervals of not less than 2 days. Bipolar mania Usual dose given bd, titration rate: 100 mg/day on day 1; 200 mg/day on day 2; 300 mg/day on day 3; 400 mg/day on day 4; up to 600 mg/day on day 5; up to 800 mg/day on day 6. Bipolar depression Usual dose given once daily, titration rate: 50 mg/day on day 1; 100 mg/day on day 2; 200 mg/day on day 3; 300 mg/day on day 4. Can be further titrated up to 600 mg by day 8. Usual target dose: 300 mg/day.
May be taken with or without food.
Special Precautions
Not indicated in elderly patients w/ dementia. Acute discontinuation symptoms after abrupt cessation of therapy. Gradually w/draw drug over a period of at least 1-2 wk. Disruption of the body's ability to reduce core body temp. May induce orthostatic hypotension, tachycardia, dizziness, & sometimes syncope, especially during initial dose titration period. Risk of QT prolongation; cardiomyopathy & myocarditis; worsening of metabolic parameters (wt, blood glucose, lipids); elevation in prolactin levels; hypothyroidism; dysphagia & aspiration; constipation & intestinal obstruction; neutropenia, granulocytopenia, agranulocytosis; venous thromboembolism; transaminase elevations, primarily ALT; pancreatitis; neuroleptic malignant syndrome; tardive dyskinesia especially in elderly women & extrapyramidal symptoms; sleep apnea & related disorders; urinary retention; lenticular changes during long-term use; severe cutaneous adverse reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis & drug reaction w/ eosinophilia & systemic symptoms). May have an antiemetic effect that may mask signs of toxicity due to overdosage of other drugs or may mask symptoms of disease eg, brain tumour or intestinal obstruction. Rare cases of priaprism w/ antipsychotic use. Caution in patients w/ history of seizures or w/ conditions associated w/ a lowered seizure threshold. Reports of quetiapine misuse, abuse, tolerance, &/or physical dependence; caution in patients w/ history of alcohol or drug abuse. Monitor patients for suicidal ideation/behavior or clinical worsening. Potential effect on cognitive & motor performance; caution when performing activities requiring mental alertness eg, operating a motor vehicle or hazardous machinery. False positive results in enzyme immunoassays for methadone & TCAs. Patients w/ renal or hepatic impairment. Pregnancy. Risk of extrapyramidal &/or w/drawal symptoms following delivery in neonates exposed to antipsychotics during 3rd trimester of pregnancy. Avoid breast-feeding while on treatment. Not recommended in childn <18 yr. Elderly.
Adverse Reactions
Somnolence, dizziness, dry mouth, discontinuation symptoms, elevations in serum triglyceride levels, elevations in total cholesterol (predominantly LDL cholesterol), decreases in HDL cholesterol, wt gain, decreased Hb, extrapyramidal symptoms. Schizophrenia: Postural hypotension, elevated ALT levels. Bipolar depression: Sedation, constipation.
Drug Interactions
Caution when combined w/ other centrally acting drugs; drugs known to cause electrolyte imbalance or increase QT interval; other medications w/ anticholinergic properties & may affect voiding. Avoid alcoholic beverages while taking quetiapine. May enhance effects of certain antihypertensive agents. May antagonize the effects of levodopa & dopamine agonists. Reduced exposure w/ hepatic enzyme inducers (eg, carbamazepine, phenytoin, barbiturates, rifampicin). Increased conc w/ CYP3A4 inhibitors (eg, ketoconazole, erythromycin, clarithromycin, diltiazem, verapamil, nefazodone). Increased plasma conc w/ divalproex. Increased clearance w/ thioridazine.
MIMS Class
ATC Classification
N05AH04 - quetiapine ; Belongs to the class of diazepines, oxazepines and thiazepines antipsychotics.
pms-Quetiapine FC tab 100 mg
100's;6 × 10's;9 × 10's
pms-Quetiapine FC tab 200 mg
100's;6 × 10's;9 × 10's
pms-Quetiapine FC tab 25 mg
100's;6 × 10's
pms-Quetiapine FC tab 50 mg
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