Jubrexa

Jubrexa

olanzapine

Manufacturer:

Jubilant Generics

Distributor:

Goldplus
Concise Prescribing Info
Contents
Olanzapine
Indications/Uses
Acute & maintenance treatment of schizophrenia & other psychoses where positive symptoms (eg, delusions, hallucinations, disordered thinking, hostility, suspiciousness) &/or negative symptoms (eg, flattened affect, emotional & social w/drawal, poverty of speech) are prominent. Alleviates secondary affective symptoms commonly associated w/ schizophrenia & related disorders. Clinical improvement maintenance during continuation therapy in patients who have shown an initial treatment response. Short-term treatment of acute manic episode associated w/ bipolar I disorder. Prevention of manic, mixed or depressive episodes in bipolar I disorder recurrence.
Dosage/Direction for Use
Adult Schizophrenia Starting dose: 10 mg daily. Subsequent dose: Individualized w/in 5-20 mg daily range. Dosage increase of more than the starting dose: ≥24-hr intervals. Manic episode Starting dose: 15 mg daily (monotherapy) or 10 mg daily (combination therapy). Subsequent dose: Individualized w/in 5-20 mg daily range. Dosage increase of more than the starting dose: ≥24-hr intervals. Preventing recurrence in bipolar disorder Starting dose: 10 mg daily. Subsequent dose: Individualized w/in 5-20 mg daily range. Dosage increase of more than the starting dose: ≥24-hr intervals. Patients already receiving olanzapine for manic episode Continue therapy for recurrence prevention of the same dose. Elderly ≥65 yr Starting dose: 5 mg daily. Renal &/or hepatic impairment Starting dose: 5 mg.
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
Closely monitor patients during treatment. Not for dementia-related psychosis &/or behavioural disturbances, & dopamine-agonist associated psychosis in patients w/ Parkinson's disease. Discontinue use if signs & symptoms indicative of neuroleptic malignant syndrome (NMS) develops or patient presents w/ unexplained fever w/o additional NMS clinical manifestations. Monitor for hyperglycaemia signs & symptoms. Regularly monitor for worsening of glucose control in patients w/ DM or DM risk factors; wt after starting treatment & quarterly thereafter; lipid alterations. Patients w/ prostatic hypertrophy or paralytic ileus & related conditions; w/ elevated ALT &/or AST; w/ hepatic impairment signs & symptoms; w/ preexisting conditions associated w/ limited hepatic functional reserve; treated w/ potentially hepatotoxic medicines. Discontinue w/ diagnosed hepatitis. Low leucocyte &/or neutrophil counts; concomitant use w/ neutropenia-causing drugs; history of drug-induced bone marrow depression/toxicity; bone marrow depression caused by concomitant illness, radiation therapy or chemotherapy; hypereosinophilic conditions or myeloproliferative disease. Concomitant use w/ medicines known to increase QTc interval, especially in elderly, in patients w/ congenital long QT syndrome, CHF, heart hypertrophy, hypokalaemia or hypomagnesaemia. Identify & take preventive measures for all possible venous thromboembolism risk factors (eg, immobilisation of patients). Combination w/ other centrally acting medicines & alcohol. History of seizures; factors which may lower seizure threshold. Risk of tardive dyskinesia in long term treatment. Potentially, sudden cardiac death. Contains aspartame; patients w/ phenylketonuria. Contains mannitol. May affect the ability to drive & use machines. Pregnancy (newborns exposed during 3rd trimester of pregnancy are at risk of ARs including extrapyramidal &/or w/drawal symptoms). Do not breastfeed during treatment. Carefully monitor newborns. Childn & adolescent <18 yr. Monitor BP periodically in elderly ≥65 yr for potential postural hypotension.
Adverse Reactions
Wt gain; somnolence; orthostatic hypotension; elevated plasma prolactin levels. Eosinophilia, leukopenia, neutropenia; elevated cholesterol, glucose & triglyceride levels, glucosuria, increased appetite; dizziness, akathisia, parkinsonism, dyskinesia; mild, transient anticholinergic effects (including constipation & dry mouth); transient, asymptomatic elevations of ALT, AST; rash; arthralgia; erectile dysfunction, decreased libido; asthenia, fatigue, oedema, pyrexia; increased alkaline phosphatase, high creatine phosphokinase, high γ-glutamyltransferase, high uric acid.
Drug Interactions
Pharmacokinetics may be affected by CYP1A2 inducers or inhibitors. Metabolism may be induced by smoking & carbamazepine. Inhibited metabolism w/ fluvoxamine. Reduced bioavailability w/ activated charcoal. May antagonise the effects of direct & indirect dopamine agonists. Caution during consumption of alcohol or products that can cause CNS depression; w/ QTc-interval increasing medicines. Not recommended to be used concomitantly w/ anti-Parkinsonian medicines in patients w/ Parkinson's disease & dementia.
MIMS Class
ATC Classification
N05AH03 - olanzapine ; Belongs to the class of diazepines, oxazepines and thiazepines antipsychotics
Presentation/Packing
Form
Jubrexa orodispersible tab 10 mg
Packing/Price
30's
Form
Jubrexa orodispersible tab 5 mg
Packing/Price
30's
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