Onzapin

Onzapin

olanzapine

Manufacturer:

Teva

Distributor:

Zuellig
Concise Prescribing Info
Contents
Olanzapine
Indications/Uses
Treatment of schizophrenia. Treatment of moderate to severe manic episode. Prevention of recurrence in patients w/ bipolar disorder whose manic episode has responded to olanzapine treatment.
Dosage/Direction for Use
Schizophrenia Initially 10 mg daily. Subsequently adjust dose based on individual clinical status w/in range of 5-20 mg daily. Manic episode Initially 15 mg as a single daily dose in monotherapy, or 10 mg daily in combination therapy. Subsequently adjust dose based on individual clinical status w/in range of 5-20 mg daily. Prevention of recurrence in bipolar disorder Initially 10 mg daily. Subsequently adjust dose based on individual clinical status w/in range of 5-20 mg daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Patients w/ known risk of narrow-angle glaucoma.
Special Precautions
Not approved & not recommended for the treatment of dementia-related psychosis &/or behavioural disturbances. Not recommended in the treatment of dopamine agonist-associated psychosis in patients w/ Parkinson's disease. Discontinue treatment in case of signs & symptoms indicative of NMS or unexplained high fever w/o additional clinical manifestations of NMS. Observe patients for signs & symptoms of hyperglycaemia. Patients w/ DM or w/ risk factors for DM should be monitored regularly for worsening of glucose control. Regularly monitor wt. Risk of undesirable lipid alterations; transient, asymptomatic elevations of ALT &/or AST, especially in early treatment; VTE; tardive dyskinesia especially w/ long-term exposure; sudden cardiac death; DRESS. Caution in patients w/ prostatic hypertrophy, or paralytic ileus & related conditions; low leukocyte &/or neutrophil counts for any reason, history of drug-induced bone marrow depression/toxicity, bone marrow depression caused by concomitant illness, RT or chemotherapy, hypereosinophilic conditions or myeloproliferative disease; patients w/ history of seizures or are subject to factors which may lower the seizure threshold; renal &/or hepatic impairment; elderly ≥65 yr. Periodically measure BP in patients >65 yr. Acute symptoms eg, sweating, insomnia, tremor, anxiety, nausea, or vomiting w/ abrupt treatment discontinuation. Caution w/ concomitant medicines known to cause neutropenia; medicinal products known to increase QTc interval; other centrally acting medicines & alcohol; direct & indirect dopamine agonists. Patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Do not use if hypersensitive to peanut or soya. May affect ability to drive & use machines. Neonates exposed to antipsychotic drugs during the 3rd trimester of pregnancy are at risk for extrapyramidal &/or w/drawal symptoms following delivery. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Do not breast-feed while on treatment. Not indicated/recommended in childn & adolescents <18 yr.
Adverse Reactions
Somnolence; wt gain; elevated prolactin plasma levels. Eosinophilia; elevated cholesterol, glucose & triglyceride levels, glucosuria, increased appetite; dizziness, akathisia, parkinsonism, dyskinesia; orthostatic hypotension; mild, transient anticholinergic effects including constipation & dry mouth; transient, asymptomatic elevations of hepatic aminotransferases especially in early treatment; rash; asthenia, fatigue, oedema.
Drug Interactions
Decreased conc w/ smoking & carbamazepine (CYP1A2 inducers). Increased conc w/ fluvoxamine or other CYP1A2 inhibitors eg, ciprofloxacin. Decreased bioavailability w/ activated charcoal. May antagonise effects of direct & indirect dopamine agonists. Caution w/ alcohol, CNS depressants; drugs known to increase QTc interval. Not recommended w/ anti-Parkinsonian medicinal products in patients w/ Parkinson's disease & dementia.
MIMS Class
Antipsychotics
ATC Classification
N05AH03 - olanzapine ; Belongs to the class of diazepines, oxazepines and thiazepines antipsychotics
Presentation/Packing
Form
Onzapin FC tab 10 mg
Packing/Price
28's
Form
Onzapin FC tab 5 mg
Packing/Price
28's
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