OLAZINE 10MG 28TAB

Indications

Approved Uses

Schizophrenia; acute manic or mixed episodes associated with Bipolar I Disorder; maintenance treatment of Bipolar I Disorder; and (where included in labeling) acute mania in combination with lithium or valproate.

Off-Label Uses

Common off-label uses include agitation/psychosis in dementia (not recommended routinely due to increased mortality risk), delirium-related agitation, adjunctive treatment in resistant depression (more commonly as the olanzapine/fluoxetine combination), and chemotherapy-induced nausea/vomiting (in antiemetic regimens).

Dosage & Administration

Dosing by Condition

Schizophrenia (adults): start 5-10 mg once daily; usual maintenance 10-20 mg/day; max 20 mg/day. Bipolar I acute mania/mixed: start 10-15 mg once daily (monotherapy) or 10 mg once daily (with lithium/valproate); maintenance 5-20 mg/day; max 20 mg/day.

Initial Dose

5-10mg once daily for schizophrenia; 10-15mg once daily for bipolar mania.

Maintenance Dose

10mg once daily (range 5-20mg/day)

Maximum Dose

20mg per day.

Children's Dosage

Adolescents 13-17 years (schizophrenia or bipolar mania): Initial 2.5-5mg once daily, target 10mg once daily, max 20mg/day. Not approved under 13 years

Dose Adjustment Notes

Consider a lower starting dose (e.g., 5 mg once daily) in elderly/debilitated patients, those with hepatic impairment, or patients predisposed to hypotension; titrate cautiously. Smoking induces CYP1A2 and may lower olanzapine exposure (higher doses may be needed), while CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin) can increase exposure (dose reduction may be needed).

How to Take

Swallow the film-coated tablet whole with water; may be taken with or without food; take once daily at the same time each day (often given in the evening if sedation occurs).

Side Effects

Common Side Effects

Weight gain, increased appetite, somnolence, dizziness, dry mouth, constipation, orthostatic hypotension, fatigue/asthenia; metabolic changes (hyperglycemia, dyslipidemia) are also clinically common/important.

Safety & Warnings

Contraindications

None with olanzapine monotherapy

Warnings & Precautions

Key warnings/precautions: not approved for dementia-related psychosis (↑ mortality/CVAE); monitor weight, glucose, and lipids (metabolic syndrome); risk of NMS and tardive dyskinesia; somnolence and orthostatic hypotension (caution with cardiovascular disease/dehydration/antihypertensives); seizure risk; anticholinergic effects (caution in prostatic hypertrophy/constipation/ileus risk); hepatic impairment-cautious dosing; avoid abrupt discontinuation.

Age Restriction

Not approved for schizophrenia in <13 years; not approved for bipolar I mania/mixed episodes in <13 years (adolescents ≥13 may be treated per labeling).

Driving Warning

Avoid Driving

Drug Interactions

Food Interaction

No clinically significant food interaction; may be taken with or without food.

Special Populations

Children

Adolescents 13-17 years (schizophrenia or bipolar mania): Initial 2.5-5mg once daily, target 10mg once daily, max 20mg/day. Not approved under 13 years

Elderly

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

Kidney Impairment

No routine dosage adjustment required in renal impairment; consider cautious dosing in severe renal impairment/elderly based on tolerability.

Liver Impairment

Consider a lower starting dose (e.g., 5 mg/day) and cautious titration in hepatic impairment, particularly moderate impairment; use caution in severe impairment.

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered unless it is close to the next scheduled dose; if close, skip and resume the regular schedule-do not double doses.

Stopping the Medicine

Do not stop abruptly; taper gradually under medical supervision (to reduce relapse and possible withdrawal symptoms such as insomnia, nausea, sweating).

Patient Counseling

Take once daily at the same time; may take with or without food; if drowsy, take in the evening and avoid driving/machinery until effects are known. Avoid alcohol and other sedatives unless advised. Do not stop abruptly without prescriber guidance. Monitor weight and report symptoms of high blood sugar; keep appointments for metabolic monitoring. Rise slowly to reduce dizziness/orthostatic hypotension. Inform the clinician about smoking status and any new medicines (especially fluvoxamine/ciprofloxacin or carbamazepine/rifampin). Seek urgent care for high fever/rigidity/confusion (possible NMS) or uncontrolled movements.

Pharmacology

Mechanism of Action

Multi-receptor antagonist with primary dopamine D2 and serotonin 5-HT2A antagonism; also antagonizes 5-HT2C, H1, muscarinic, and alpha-1 receptors, contributing to efficacy and adverse effects.

Product Information

Available Dosage Forms

For this product (OLAZINE): film-coated tablet for oral use (10 mg). Other olanzapine dosage forms that may exist in general include orally disintegrating tablets and short-acting IM injection; long-acting IM depot is a separate product/formulation and is not interchangeable with oral tablets.

Composition per Dose

Each film-coated tablet: Olanzapine 10mg

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Psych Class

Antipsychotic-Atypical

Controlled Substance

No

Legal Disclaimer - Al Mujtama Pharmacy

The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment.

Al Mujtama Pharmacy assumes no legal or medical liability for:

• Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist
• Any discrepancy between the information provided and the product's package insert or SFDA guidelines
• Any misuse of medication resulting from personal interpretation of the content displayed

Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication.

By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation.

Your health is a trust - always consult your doctor first.