Company: Actavis Ireland Ltd.
Legal category: Prescription. GMS. Sport permitted.
Active ingredient: Film-coated tablets: Olanzapine 2.5mg, 5mg, 7.5mg, 10mg, 15mg. Orodispersible tablets: Olanzapine 5mg, 10mg, 15mg, 20mg.
Description: Film-coated tablets: 2.5mg, 5mg, 7.5mg, 10mg: White, round, biconvex tablets marked O, O1, O2 and O3, respectively, on one side. 15mg: Light blue oval biconvex tablets marked O on one side. Orodispersible tablets: Yellow, round, biconvex, tablets marked O, O1, O2 and O3 respectively.
Presentations: Film-coated tablets: 2.5mg-28; 5mg-28; 7.5mg-56; 10mg-28; 15mg-28. Prices available upon request. Orodispersible tablets: 5mg-28; 10mg-28; 15mg-28; 20mg-28. Prices available upon request.
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. Neuroleptic malignant syndrome may rarely occur. Hyperglycaemia and/or development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, (including fatal) reported rarely. Venous thromboembolism may occur; take preventive measures. 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. Film-coated tablets contain lactose and soy lecithin. Orodispersible tablets contain aspartame.
Drug interactions: Not recommended: Anti-Parkinsonian drugs. Caution: CYP1A2 inducers (e.g. smoking, carbamazepine), CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin), activated charcoal (take 2 hrs apart), dopamine agonists, CNS depressants (incl. alcohol), medicinal products known to increase QTc interval, potentially hepatotoxic medicines.
Adverse drug reactions: Eosinophilia, elevated cholesterol levels, elevated glucose levels, elevated 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 Actavis Ireland Ltd. Telephone: 1890 333231. Fax: 021 4619049. Email: firstname.lastname@example.org