Orion Pharma


Concise Prescribing Info
Schizophrenia; acute manic episodes associated w/ bipolar I disorder; depressive episodes associated w/ bipolar disorder; maintenance treatment of bipolar I disorder as adjunct to lithium or valproate.
Dosage/Direction for Use
Adult Schizophrenia Total daily dose for the first 4 days: 50 mg (day 1), 100 mg (day 2), 200 mg (day 3) & 300 mg (day 4). May be titrated to 300-450 mg/day. Dose range: 150-750 mg/day. Administer bd. Manic episodes associated w/ bipolar disorder Total daily dose for the first 4 days: 100 mg (day 1), 200 mg (day 2), 300 mg (day 3) & 400 mg (day 4). May be adjusted up to 800 mg/day by day 6 in increments ≤200 mg/day. Dose range: 200-800 mg/day. Administer bd. Depressive episodes associated w/ bipolar disorder Dose titration: 50 mg (day 1), 100 mg (day 2), 200 mg (day 3) & 300 mg (day 4). May be titrated to 400 mg on day 5 & up to 600 mg by day 8. Administer once daily at bedtime. Maintenance treatment of bipolar I disorder as adjunct therapy to lithium or valproate Total dose: 400-800 mg/day. Administer bd. Elderly, renal or hepatic impairment 25 mg/day increased daily in 25-50 mg increments to an effective dose.
May be taken with or without food: Avoid grapefruit juice.
Concomitant administration w/ CYP450 3A4 inhibitors. Galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption.
Special Precautions
CV disease or history of QT prolongation, cerebrovascular disease or other conditions predisposing to hypotension. History of seizures; extrapyramidal symptoms; tardive dyskinesia; neuroleptic malignant syndrome; Not for the treatment of patients w/ dementia-related psychosis or patients w/ risk factors for stroke; suicidal ideation; existing low WBC & history of drug-induced neutropenia. Monitor DM patients regularly for worsening of glucose control; increased lipids. Patients w/ congenital long QT syndrome, CHF, heart hypertrophy, hypokalaemia & hypomagnesaemia. Treatment should be w/drawn gradually. May impair ability to drive or operate machinery. Pregnancy & lactation. Childn & adolescent.
Adverse Reactions
Dry mouth, w/drawal symptoms, elevations in serum triglycerides & total cholesterol, wt gain, dizziness, somnolence.
Drug Interactions
CYP450 3A4 inhibitors eg HIV-PIs, azole antifungal agents, erythromycin, clarithromycin & nefazodone. Centrally-acting drugs & alcohol. Ketoconazole, grapefruit juice, carbamazepine, phenytoin, drugs causing electrolyte imbalance.
MIMS Class
ATC Classification
N05AH04 - quetiapine ; Belongs to the class of diazepines, oxazepines and thiazepines antipsychotics.
Ketipinor film-coated tab 100 mg
Ketipinor film-coated tab 200 mg
Ketipinor film-coated tab 25 mg
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