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June 29, 2016


Company: KRKA Pharma Dublin Ltd.
Legal category: Prescription. GMS. Sport permitted.
Active ingredient: Olanzapine 2.5mg, 5mg, 7.5mg, 10mg, 15mg.
Description: Round, slightly biconvex, slightly yellow tablets with possible individual yellow spots. 5mg, 7.5mg, 10mg and 15mg marked with strength.
Presentations: 2.5mg-28, €22.13; 5mg-28, €44.25; 7.5mg-56, €132.76; 10mg-28, €88.51; 15mg-28, €120.70.
Indications: Treatment of schizophrenia. Treatment of moderate to severe manic episode. Prevention of recurrence of manic episodes in patients with bipolar disorder whose manic episode has responded to olanzapine treatment.
Pharmacology: Olanzapine is an antipsychotic, antimanic and mood stabilising agent that demonstrates a broad pharmacologic profile across a number of receptor systems.
Dosage: Adult: Schizophrenia: Initially 10mg as a single daily dose. Bipolar Disorder: Manic episode, initially 15mg as single daily dose in monotherapy or 10mg daily in combination therapy. Prevention, initially 10mg daily or same dose as prior treatment of manic episode. Continue olanzapine in combination therapy as required if new manic/mixed/depressive episode occurs. All indications: Adjust if necessary within range of 5-20mg daily. Renal/hepatic impairment: Consider 5mg initially; increase with caution. Elderly: As per adults; lower starting dose (5mg) may be used. Children: Under 18 years, not recommended.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Known risk of narrow-angle glaucoma. Lactation.
Special precautions: Not recommended: Dementia-related psychosis and/or behavioural disturbances, dopamine agonist associated psychosis in Parkinson’s disease patients. May occur: Neuroleptic malignant syndrome (rarely), sudden cardiac death, venous thromboembolism (take preventive measures). Hyperglycaemia and/or development or exacerbation of diabetes occasionally associated with ketoacidosis or coma (including fatal) reported rarely (monitor for signs of hyperglycaemia). Regularly monitor patients for lipid alterations. If tardive dyskinesia occurs consider dose reduction or discontinuation. Caution: Impaired hepatic function, elevated ALT/AST, prostatic hypertrophy, paralytic ileus and related conditions, bone marrow depression, history of seizures. Monitor blood pressure periodically in patients >65 years. Pregnancy (use only if benefits outweigh risks). Driving/ using machinery. Contains lactose.
Drug interactions: Not recommended: Anti-Parkinsonian drugs. Caution: CYP1A2 inducers (e.g. smoking, carbamazepine), CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin), activated charcoal (take 2 hours apart), dopamine agonists, CNS depressants (including alcohol), products known to increase QTc interval, potentially hepatotoxic medicines.
Adverse drug reactions: Eosinophilia, elevated cholesterol, glucose and triglyceride levels, glucosuria, increased appetite, dizziness, akathisia, parkinsonism, dyskinesia, orthostatic hypotension, mild and transient anticholinergic effects (including constipation and dry mouth), transient asymptomatic elevations of hepatic aminotransferases (ALT, AST), rash, asthenia, fatigue, oedema.

Full prescribing information and references available from KRKA Pharma Dublin Ltd.