ZOLAN 5/MG FC TAB 30/FC TAB

Indications

Approved Uses

Schizophrenia; acute manic or mixed episodes of bipolar I disorder; maintenance treatment of bipolar I disorder (including prevention of recurrence in responders).

Off-Label Uses

Common off-label uses include behavioral/psychological symptoms of dementia (agitation/aggression-use discouraged/restricted due to boxed warning), delirium-related agitation, Tourette syndrome/tics, and antiemetic use in refractory nausea/vomiting (including chemotherapy-related) in some protocols; other psychiatric adjunct uses exist but evidence varies.

Dosage & Administration

Dosing by Condition

Schizophrenia (adults): start 5-10 mg once daily; usual target 10 mg/day; adjust in 5 mg increments; max 20 mg/day. Acute mania/mixed episodes (bipolar I): 10-15 mg once daily (monotherapy typically 15 mg; with lithium/valproate typically 10 mg); maintenance bipolar I: 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 mg once daily (range 5-20 mg/day)

Maximum Dose

20 mg per day

Children's Dosage

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

Dose Adjustment Notes

Consider a lower starting dose (e.g., 5 mg once daily) and slower titration in elderly/frail patients, those with hepatic impairment, or patients predisposed to hypotension; smokers may need higher doses (CYP1A2 induction) and dose reduction may be needed if smoking is stopped; strong CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin) may require dose reduction.

How to Take

Swallow the 5 mg film‑coated tablet whole with water once daily; may be taken with or without food; take at the same time each day (often in the evening if sedation occurs).

Safety & Warnings

Contraindications

Known hypersensitivity to olanzapine or any excipients.

Warnings & Precautions

Boxed warning: increased mortality in elderly patients with dementia-related psychosis (not approved for this use) and increased risk of cerebrovascular adverse events; monitor metabolic parameters (weight/BMI, glucose, lipids); risk of NMS and tardive dyskinesia; orthostatic hypotension/falls; sedation; seizure risk; anticholinergic effects (caution in narrow-angle glaucoma, urinary retention, ileus); hepatic effects (monitor if liver disease); blood dyscrasias (monitor if history/low WBC); caution with aspiration risk.

Age Restriction

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

Drug Interactions

Interaction Severity

MAJOR: IM olanzapine with parenteral benzodiazepines (avoid due to severe sedation/cardiorespiratory depression); strong CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin) can markedly increase levels-consider dose reduction/monitoring. MODERATE: CYP1A2 inducers (smoking, carbamazepine, rifampin) can reduce levels-may require dose increase; additive CNS depression with alcohol/other sedatives; additive hypotension with antihypertensives. OTHER: Dopamine agonists/levodopa may be antagonized.

Food Interaction

No clinically meaningful food effect; may be taken with or without food.

Special Populations

Pregnancy

Not assigned (risk summary: Neonates exposed to antipsychotic drugs during 3rd trimester at risk of abnormal muscle movements and withdrawal symptoms

Children

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

Elderly

Start at a lower dose (e.g., 5mg), titrate slowly, and monitor for side effects, especially hypotension.

Liver Impairment

No routine adjustment for mild-moderate hepatic impairment, but consider a lower starting dose (e.g., 5 mg/day) and titrate cautiously; use caution in hepatic 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 the missed dose and resume the regular schedule-do not double doses.

Patient Counseling

Take exactly as prescribed (often once daily; evening dosing may reduce daytime sedation); do not stop abruptly without prescriber advice; may cause drowsiness-avoid driving/machinery until effects known; avoid alcohol; stand up slowly to reduce orthostatic dizziness; monitor and manage weight with diet/exercise and attend follow-ups for weight, glucose/A1c and lipids; report symptoms of hyperglycemia (increased thirst/urination/hunger), severe muscle stiffness/fever/confusion (possible NMS), or new/worsening involuntary movements (EPS/tardive dyskinesia); tell your clinician if you smoke or change smoking status (can alter olanzapine levels).

Monitoring Requirements

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

Pharmacology

Duration of Effect

Clinically supports once‑daily dosing (~24‑hour effect); elimination half‑life is about 30 hours (range roughly 21-54 hours).

Half-Life

Elimination half-life is approximately 21-54 hours (mean ~30-33 hours), varying with factors such as smoking, sex, and age.

Bioavailability

Oral bioavailability is approximately 60% due to first-pass metabolism

Metabolism

Extensively hepatic metabolism primarily via CYP1A2, with minor contribution from CYP2D6, plus direct glucuronidation; metabolites include glucuronide conjugates and N-desmethyl olanzapine.

Product Information

Available Dosage Forms

Film‑coated oral tablet; orodispersible/orally disintegrating tablet; short‑acting intramuscular injection; long‑acting intramuscular depot injection (olanzapine pamoate) in some markets.

Composition per Dose

Each film-coated tablet contains: 5mg Olanzapine.

Generic Availability

Yes

OTC Alternatives

No OTC alternative.

Psych Class

Antipsychotic-Atypical

Controlled Substance

No

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