OLENZA 5/MG TAB 30/TAB

Indications

Approved Uses

Schizophrenia; acute manic or mixed episodes associated with bipolar I disorder; maintenance treatment of bipolar I disorder (in patients who responded to olanzapine for acute mania).

Off-Label Uses

Examples of off-label uses include delirium/agitation (non-IM settings), chemotherapy-induced nausea and vomiting (CINV), Tourette syndrome/tics, and adjunctive use in treatment-resistant mood disorders (distinct from the approved olanzapine/fluoxetine indication).

Dosage & Administration

Dosing by Condition

Schizophrenia: Initial 5-10 mg/day, maintenance 10 mg/day, max 20 mg/day. Bipolar mania (monotherapy): Initial 10-15 mg/day, maintenance 5-20 mg/day, max 20 mg/day. Bipolar mania (adjunct with lithium/valproate): Initial 10 mg/day, maintenance 5-20 mg/day, max 20 mg/day

Initial Dose

5-10 mg once daily.

Maintenance Dose

5-20 mg once daily.

Maximum Dose

20 mg once daily.

Children's Dosage

Schizophrenia (13-17 years): Initial 2.5-5 mg/day, target 10 mg/day, max 20 mg/day. Bipolar I Mania (13-17 years): Initial 2.5-5 mg/day, target 10 mg/day, max 20 mg/day.

Dose Adjustment Notes

Consider a lower starting dose (e.g., 5 mg once daily) in elderly/debilitated patients, those with hepatic impairment, or when multiple factors may reduce clearance (e.g., female sex, older age, non-smoker); titrate cautiously. Smoking (CYP1A2 induction) can lower olanzapine exposure and smoking cessation can increase exposure, so reassess dose when smoking status changes.

How to Take

Remove the orally disintegrating tablet from the blister immediately before use by peeling back the foil (do not push through); place on the tongue and allow it to dissolve, then swallow with saliva (water is not required but may be used). The tablet may also be dispersed in a small amount of water or other suitable beverage and taken immediately. May be taken with or without food; take once daily as prescribed.

Side Effects

Common Side Effects

Somnolence/sedation, weight gain, increased appetite, dizziness, orthostatic hypotension, dry mouth, constipation, fatigue/asthenia; metabolic changes such as hyperglycemia and dyslipidemia can occur.

Safety & Warnings

Contraindications

Known hypersensitivity to olanzapine or to any excipients/components of the formulation.

Warnings & Precautions

Key warnings/precautions: not approved for dementia-related psychosis (↑ mortality; ↑ cerebrovascular events), metabolic monitoring (weight/BMI, glucose, lipids), NMS, tardive dyskinesia, orthostatic hypotension/bradycardia (caution in cardiovascular disease/dehydration), sedation and CNS depression, seizure risk, anticholinergic effects (caution in BPH, narrow-angle glaucoma, ileus), hepatic impairment (cautious titration), leukopenia/neutropenia (CBC if history/low WBC), and hyperprolactinemia.

Age Restriction

Not approved/recommended for children <13 years; adolescent use (13-17 years) is indication- and country-label dependent and requires specialist supervision.

Driving Warning

May Cause Drowsiness

Drug Interactions

Food Interaction

No restriction.

Special Populations

Pregnancy

Consult Doctor

Children

Schizophrenia (13-17 years): Initial 2.5-5 mg/day, target 10 mg/day, max 20 mg/day. Bipolar I Mania (13-17 years): Initial 2.5-5 mg/day, target 10 mg/day, max 20 mg/day.

Elderly

Start at 5 mg/day; titrate slowly with close monitoring for orthostatic hypotension, sedation, and metabolic effects. Not recommended for elderly patients with dementia-related psychosis

Kidney Impairment

No routine dosage adjustment required in renal impairment; use clinical caution in severe renal dysfunction.

Liver Impairment

Consider a lower starting dose (e.g., 5 mg/day) and titrate cautiously in hepatic impairment; use extra caution in moderate-severe impairment.

Storage & Patient Advice

Overdose

Symptoms may include somnolence/sedation, agitation, anticholinergic effects, tachycardia, hypotension, dysarthria, EPS, respiratory depression, coma (rarely arrhythmias/QT changes); management is supportive (airway/ventilation, cardiovascular monitoring), consider activated charcoal if early, and no specific antidote-seek emergency care.

Patient Counseling

Explain ODT use (peel foil, place on tongue to dissolve; water optional), take once daily as prescribed, avoid alcohol/other sedatives, use caution driving until effects known, rise slowly to reduce dizziness, do not stop abruptly without prescriber advice, monitor/mitigate weight gain and metabolic risk (diet/activity; scheduled glucose/lipids), report signs of hyperglycemia and urgent symptoms such as fever/rigidity/confusion or abnormal movements, and inform the clinician about smoking status changes.

Monitoring Requirements

Baseline and periodic: weight/BMI and waist circumference, blood pressure, fasting plasma glucose or HbA1c, fasting lipid profile; assess for extrapyramidal symptoms/tardive dyskinesia and sedation. Consider LFTs and CBC when clinically indicated (e.g., hepatic disease, history of low WBC).

Pharmacology

Mechanism of Action

Atypical antipsychotic with antagonism at dopamine (primarily D2) and serotonin (primarily 5‑HT2A) receptors, with additional affinity for 5‑HT2C, H1, muscarinic, and alpha-1 receptors contributing to efficacy and adverse effects.

Bioavailability

Oral bioavailability is approximately 60% (subject to first-pass metabolism); the orally disintegrating tablet is bioequivalent to the conventional oral tablet.

Product Information

Available Dosage Forms

For OLENZA specifically: orally disintegrating tablet (5 mg) in blister pack of 30 tablets.

Composition per Dose

Each orally disintegrating tablet: 5 mg olanzapine

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Psych Class

Antipsychotic-Atypical

Controlled Substance

No

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