OLAZINE 15MG 28TAB

Indications

Approved Uses

Schizophrenia; acute manic or mixed episodes associated with Bipolar I disorder; maintenance treatment of Bipolar I disorder (including maintenance after response in acute mania).

Off-Label Uses

Common off-label uses include delirium-related agitation (when antipsychotic is appropriate), treatment-resistant depression as augmentation (distinct from the approved olanzapine/fluoxetine combination for bipolar depression in some jurisdictions), and antiemetic use for chemotherapy-induced nausea/vomiting.

Dosage & Administration

Dosing by Condition

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

Initial Dose

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

Maintenance Dose

10-20mg once daily.

Maximum Dose

20mg per day.

Children's Dosage

Schizophrenia (adolescents 13-17 years): Initial 2.5-5mg once daily, target 10mg/day, max 20mg/day. Bipolar I Disorder (manic/mixed episodes, adolescents 13-17 years): Initial 2.5-5mg once daily, target 10mg/day, max 20mg/day.

Dose Adjustment Notes

Consider a lower starting dose (e.g., 5 mg once daily) and slower titration in elderly, debilitated, hepatic impairment, or patients predisposed to hypotension; smokers may require higher doses and stopping smoking may increase levels; strong CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin) can increase exposure and may require dose reduction.

How to Take

Swallow the 15 mg film‑coated tablet whole with water; may be taken with or without food; take once daily at the same time each day (often 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 can occur (hyperglycemia and increased lipids).

Safety & Warnings

Contraindications

Known hypersensitivity to olanzapine (or any component).

Warnings & Precautions

Warnings/precautions: boxed warning for increased mortality in elderly with dementia-related psychosis (not approved); metabolic monitoring (weight/BMI, glucose, lipids); risk of NMS and tardive dyskinesia; orthostatic hypotension/syncope (caution with cardiovascular/cerebrovascular disease and dehydration); seizure risk; leukopenia/neutropenia risk; caution in hepatic impairment; additive CNS depression with alcohol/sedatives; heat dysregulation/anticholinergic effects and aspiration risk in susceptible patients.

Age Restriction

Not approved for schizophrenia in patients <13 years; not approved for bipolar I mania/mixed episodes in patients <13 years; not approved for bipolar I maintenance in patients <13 years.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Key interactions: CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin) increase olanzapine levels; CYP1A2 inducers (e.g., carbamazepine, rifampin; smoking) decrease levels; additive CNS depression with alcohol/benzodiazepines/other sedatives; antagonizes levodopa/dopamine agonists; enhanced hypotension with antihypertensives; activated charcoal reduces absorption (if used for overdose).

Interaction Severity

MAJOR: Strong CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin) can markedly increase olanzapine exposure; IM olanzapine with parenteral benzodiazepines is associated with severe cardiorespiratory depression (relevant to IM, not this tablet). MODERATE: CYP1A2 inducers (e.g., smoking, carbamazepine, rifampin) can reduce levels/efficacy; additive CNS depression with alcohol/benzodiazepines/opioids; additive hypotension with antihypertensives; antagonism with levodopa/dopamine agonists. MINOR: Activated charcoal reduces absorption if given near dosing; antacids have minimal effect.

Food Interaction

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

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Category C

Children

Schizophrenia (adolescents 13-17 years): Initial 2.5-5mg once daily, target 10mg/day, max 20mg/day. Bipolar I Disorder (manic/mixed episodes, adolescents 13-17 years): Initial 2.5-5mg once daily, target 10mg/day, max 20mg/day.

Elderly

Initiate at 5mg/day; titrate slowly with careful monitoring for orthostatic hypotension, sedation, and metabolic effects; not recommended for dementia-related psychosis

Liver Impairment

Use with caution; consider a lower starting dose (e.g., 5 mg/day) and slower titration in hepatic impairment.

Storage & Patient Advice

Overdose

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

Patient Counseling

Take once daily as prescribed (with or without food) and do not stop abruptly without medical advice; may cause drowsiness-avoid driving/operating machinery until effects are known and avoid alcohol; expect possible weight gain and metabolic changes-follow diet/exercise advice and attend scheduled glucose/lipid/weight checks; rise slowly to reduce dizziness/orthostasis; seek urgent care for high fever/rigidity (NMS), severe uncontrolled movements, or symptoms of high blood sugar; inform clinicians if you start/stop smoking or start interacting medicines (e.g., fluvoxamine/ciprofloxacin).

Monitoring Requirements

Baseline and periodic: weight/BMI and waist circumference, blood pressure, fasting glucose or HbA1c, fasting lipid panel; assess for EPS/tardive dyskinesia and sedation; consider LFTs and CBC when clinically indicated.

Pharmacology

Mechanism of Action

Multi-receptor antagonist: dopamine (primarily D2) and serotonin (5‑HT2A/5‑HT2C) antagonism with additional affinity for histamine H1, muscarinic, and alpha‑1 adrenergic receptors.

Excretion

Excretion is primarily as metabolites: ~57% in urine and ~30% in feces.

Product Information

Available Dosage Forms

Olanzapine is available as oral tablets (including film‑coated), orally disintegrating tablets, short‑acting IM injection, and long‑acting IM depot injection (olanzapine pamoate).

Composition per Dose

Each film-coated tablet: 15mg olanzapine

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Psych Class

Antipsychotic-Atypical

Controlled Substance

No

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