ZYDIS
OLANZAPINE · by ELI LILLY
Composition
Tab/Cap 5 mg/7.5 mg/10 mg: Olanzapine 5 mg/7.5 mg/10 mg. Inj 210 mg/300 mg/405 mg: Olanzapine embonate 210 mg/300 mg/405 mg; powder for reconstitution with respective solvents; extended relea
Indications & Dosage
Schizophrenia, Combination therapy for mania, Prevention of recurrence in bipolar disorder: ORAL: Adult: 10 mg daily, adjusted according to response, usual dose 5-20 mg daily, doses greater than 10 mg daily only after reassessment, when one or more factors present that might result in slower metabolism(e.g. female gender, elderly, non-smoker) consider lower initial dose and more gradual dose increase; max. 20 mg per day. Monotherapy for mania: ORAL: Adult: 15 mg daily, adjusted according to response, usual dose 5-20 mg daily, doses greater than 15mgdaily only after reassessment, when one or more factors present that might result in slower metabolism(e.g. female gender, elderly, non-smoker) consider lower initial dose and more gradual dose increase; max. 20 mg per day. Control of agitation and disturbed behaviour in schizophrenia or mania: BY IM INJ: Adult: Initially 5-10 mg for 1 dose; usual dose 10 mg for 1 dose, followed by 5-10 mg after 2 hours if required, max. 3 injections daily for 3 days; max. daily combined oral and parenteral dose20 mg, when one or more factors present that might result in slower metabolism (e.g. female gender, elderly, non-smoker) consider lower initial dose and more gradual dose increase. Elderly: Initially 2.5-5 mg, followed by 2.5-5 mg after2 hours if required, max. 3 injections daily for3 days; max. daily combined oral and parenteral dose 20 mg, when one or more factors present that might result in slower metabolism (e.g. female gender, elderly, non-smoker) consider lower initial dose and more gradual dose increase.
Administration
For IM use only. Inject slowly deep into muscle. Extended release IM lnj: For IM gluteal injection only after needle insertion into muscle, aspirate to verify that no blood appears. Do no massage injection site.
Stability
Injection extended release: Store at 20C-25C; excursions permitted to 15C-30C. Dilute as directed to final concentration of 150 mg/ml following the reconstitution, it may be stored at room temperature and use within 24 hours. Shake well to resuspend prior to administration. Injection short acting: Store at 20C-25C; excursions permit-ted to 15C-30C. Do not freeze. Protect from light. Reconstitute 10 mg vial with 2.1 ml SWFI. Resulting solution is 5 mg/ml. Use within 1 hour.
Contraindications
Narrow angle glaucoma. With intramuscular use: Acute myocardial infarction, bradycardia, recent heart surgery, severe hypotension, sick sinus syndrome, unstable angina
Precautions
Hepatic or renal impairment, bone-marrow depression, diabetes mellitus, (risk of exacerbation or ketoacidosis), hypereosinophilic disorders, low leucocyte count, low neutrophil count, myeloproliferative disease, paralytic ileusprostatic hypertrophy, blood dyscrasias, seizures, tardive dyskinesia, elderly, female smokers. Monitor BP in elderly. Warn patients to report fever or muscle rigidity; suspect neuroleptic malignant syndrome.
Interactions
Hepatotoxic drugs, CNS active drugs, alcohol, drugs that increase OTC interval, charcoal, smoking.
Pregnancy
Contraindicated
Lactation
Contraindicated
Side Effects
Arthralgia, increased appetite, dizziness, peripheral oedema, orthostatic hypotension, hypercholesterolaemia, hypertriglyceridaemia, increased appetite, malaise, oedema, alopecia, amnesia, bradycardia, epistaxis, hepatitis, pancreatitis, rhabdomyolysis, somnolence, weight gain