ZYPREXA 5/MG FC TAB 28/FC TAB

Indications

Approved Uses

Schizophrenia; Bipolar I disorder (acute manic or mixed episodes; and maintenance/relapse prevention in responders); Treatment-resistant depression as olanzapine/fluoxetine combination (where approved).

Off-Label Uses

Common off-label uses include acute agitation (including in delirium), behavioral symptoms in dementia (use discouraged/boxed warning risk), augmentation in major depressive disorder (when not using the fixed olanzapine/fluoxetine product), PTSD-related symptoms, and anorexia/cachexia; chemotherapy-induced nausea/vomiting is also used in some settings (often with other antiemetics).

Dosage & Administration

Dosing by Condition

Schizophrenia (adults): start 5-10 mg once daily; usual target ~10 mg/day; range 5-20 mg/day (max 20 mg/day). Bipolar I acute mania/mixed: monotherapy start 15 mg once daily OR adjunct to lithium/valproate start 10 mg once daily; range 5-20 mg/day (max 20 mg/day). Bipolar I maintenance: continue effective dose (commonly 5-20 mg/day). Olanzapine/fluoxetine for TRD: use the fixed combination product per label (olanzapine component commonly 5-20 mg/day depending on strength).

Initial Dose

Schizophrenia (Adults): 5-10 mg once daily; Bipolar I Disorder (manic or mixed episodes, Adults): 10-15 mg once daily

Maintenance Dose

5-20 mg once daily, adjusted based on clinical response and tolerability

Maximum Dose

20 mg per day.

Children's Dosage

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

Dose Adjustment Notes

Consider lower starting dose (e.g., 5 mg once daily) in elderly/debilitated patients or when factors may slow metabolism (female, geriatric age, non-smoker) and titrate cautiously; smokers may require higher doses and dose may need reduction after smoking cessation; hepatic impairment warrants cautious dosing; renal impairment usually does not require adjustment.

How to Take

Oral coated tablet: swallow whole with water once daily; may be taken with or without food; take at the same time each day.

Side Effects

Common Side Effects

Somnolence/sedation, weight gain, increased appetite, dizziness, dry mouth, constipation, orthostatic hypotension, fatigue/asthenia; metabolic changes (hyperglycemia, dyslipidemia) are common clinically and require counseling/monitoring.

Side Effect Frequency

Very common (>10%): weight gain, somnolence. Common (1-10%): increased appetite, dizziness, orthostatic hypotension, constipation, dry mouth, asthenia/fatigue, peripheral edema, akathisia/parkinsonism, increased prolactin, increased cholesterol/triglycerides, hyperglycemia, and elevated liver enzymes.

Safety & Warnings

Contraindications

Known hypersensitivity to olanzapine or to any of its components (excipients).

Warnings & Precautions

Boxed warning: increased mortality in elderly with dementia-related psychosis (not approved); metabolic monitoring (weight/BMI, glucose, lipids); risk of NMS and tardive dyskinesia; orthostatic hypotension (caution in cardiovascular disease/dehydration/antihypertensives); seizure risk; hepatic impairment caution; dysphagia/aspiration risk; blood dyscrasias (neutropenia) monitoring if clinically indicated; counsel on sedation and impairment.

Age Restriction

Not approved for use in children <13 years (oral olanzapine is approved in adolescents ≥13 years for schizophrenia and bipolar I mania; safety/efficacy not established below 13).

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

CNS depressants (including alcohol/benzodiazepines) increase sedation; CYP1A2 inducers (e.g., smoking, carbamazepine) decrease olanzapine levels; CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin) increase levels; may enhance hypotensive effects of antihypertensives; antagonizes dopamine agonists/levodopa; activated charcoal reduces absorption (separate if used).

Interaction Severity

MAJOR: Fluvoxamine (strong CYP1A2 inhibition) markedly increases olanzapine exposure; avoid or reduce dose/monitor closely. MAJOR: Parenteral olanzapine with parenteral benzodiazepines-risk of excessive sedation/respiratory depression/hypotension (avoid close co-administration). MODERATE: CYP1A2 inducers (carbamazepine, smoking) decrease levels; CYP1A2 inhibitors (ciprofloxacin) increase levels; additive hypotension with antihypertensives; antagonism with levodopa/dopamine agonists; additive CNS depression with alcohol/benzodiazepines (oral).

Food Interaction

No restriction.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Category C

Children

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

Elderly

Start at 5 mg/day; titrate slowly with careful monitoring of blood pressure, metabolic parameters, and cognitive status. Not approved for dementia-related psychosis

Kidney Impairment

No routine dose adjustment required; consider a lower starting dose (5 mg) and cautious titration in severe renal impairment or frail patients.

Liver Impairment

Consider a lower starting dose (e.g., 5 mg once daily) and titrate cautiously in hepatic impairment.

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly; taper gradually under medical supervision to reduce withdrawal symptoms and relapse risk.

Overdose

Symptoms may include somnolence/sedation, agitation, tachycardia, dysarthria, confusion, EPS, hypotension, respiratory depression, and coma; management is supportive (airway/ventilation, cardiac monitoring), consider activated charcoal if appropriate, treat hypotension with IV fluids/vasopressors avoiding epinephrine/dopamine when possible due to alpha-blockade; no specific antidote-seek emergency care.

Patient Counseling

Take once daily as prescribed (same time each day); may cause drowsiness-avoid driving/alcohol until effects are known; rise slowly to reduce dizziness/orthostasis; do not stop abruptly without clinician advice; monitor weight and report signs of high blood sugar (increased thirst/urination) or severe muscle stiffness/fever/confusion; keep follow-up for metabolic monitoring (glucose/HbA1c, lipids, weight/BP); tell your clinician about smoking changes and all other medicines.

Monitoring Requirements

Baseline and periodic: weight/BMI and waist circumference, blood pressure, fasting glucose or HbA1c, fasting lipid profile; assess for EPS/tardive dyskinesia, sedation and orthostasis; consider LFTs and CBC if clinically indicated; monitor for symptoms of hyperglycemia and other metabolic adverse effects.

Pharmacology

Mechanism of Action

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

Duration of Effect

Per-dose antipsychotic/sedative effect is approximately 24 hours (supports once-daily dosing); full therapeutic benefit may take 4-6 weeks to develop.

Half-Life

Approximately 21-54 hours (mean ~30-33 hours).

Metabolism

Hepatic metabolism primarily via CYP1A2 and direct glucuronidation; CYP2D6 is a minor pathway; major metabolites include 10-N-glucuronide and 4′-N-desmethyl olanzapine (inactive).

Excretion

Approximately 57% recovered in urine and ~30% in feces (predominantly as metabolites); about 7% is excreted unchanged in urine.

Protein Binding

Approximately 93% protein bound (mainly to albumin and α1-acid glycoprotein).

Product Information

Available Dosage Forms

Film-coated (coated) tablets; orally disintegrating tablets (Zydis); short-acting intramuscular injection (powder for solution).

Composition per Dose

Each coated tablet: 5 mg olanzapine

Generic Availability

Yes

OTC Alternatives

No OTC alternative.

Psych Class

Antipsychotic-Atypical

Controlled Substance

No

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 17-06-2026