Onzapin OD

Onzapin OD

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: Place in the mouth & allow to dissolve completely; it can then be swallowed w/ saliva. Alternatively, disperse in a full glass of water or other beverages (orange juice/apple juice/milk/coffee) immediately prior to taking.
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. Very rare reports of hyperglycaemia &/or development or exacerbation of diabetes. Reports of cerebrovascular adverse events. Risk of transient, asymptomatic elevations of ALT &/or AST, especially in early treatment; tardive dyskinesia especially w/ long-term exposure; VTE; 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. Discontinue treatment in case of signs & symptoms indicative of NMS or unexplained high fever w/o additional clinical manifestations of NMS. Periodically measure BP in patients >65 yr. Acute symptoms eg, sweating, insomnia, tremor, anxiety, nausea, or vomiting w/ abrupt treatment discontinuation. Limited data on co-medication w/ lithium & valproate. No clinical data available on olanzapine & carbamazepine co-therapy. Caution w/ concomitant medicines known to cause neutropenia; other centrally acting medicines & alcohol; direct & indirect dopamine agonists; medicinal products known to increase QTc interval. Contains aspartame, which may be harmful to patients w/ phenylketonuria. 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. No experience in childn.
Adverse Reactions
Somnolence; wt gain; elevated prolactin plasma levels. Eosinophilia; dizziness, akathisia, parkinsonism, dyskinesia; mild, transient anticholinergic effects including constipation & dry mouth; increased appetite, elevated glucose levels; orthostatic hypotension; asthenia, oedema; transient, asymptomatic elevations of hepatic aminotransferases especially in early treatment.
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/ CNS depressants.
MIMS Class
Antipsychotics
ATC Classification
N05AH03 - olanzapine ; Belongs to the class of diazepines, oxazepines and thiazepines antipsychotics
Presentation/Packing
Form
Onzapin OD tab 10 mg
Packing/Price
28's
Form
Onzapin OD tab 5 mg
Packing/Price
28's
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