ZOLAN 10/MG FC TAB 30/FC TAB

Indications

Approved Uses

Schizophrenia; Bipolar I disorder-acute manic or mixed episodes and maintenance (relapse prevention) in patients who responded to olanzapine.

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: 10-15 mg once daily (10 mg if with lithium/valproate; 15 mg monotherapy); range 5-20 mg/day; max 20 mg/day. Bipolar maintenance: 5-20 mg/day (continue effective dose).

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/day (oral)

Children's Dosage

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

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 when multiple factors that reduce clearance are present (e.g., female, non‑smoker); smokers may require higher doses due to CYP1A2 induction; titrate based on response/tolerability.

How to Take

Oral: take once daily; may be taken with or without food; swallow the film‑coated tablet whole with water (do not crush/chew unless clinically necessary).

Side Effects

Common Side Effects

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

Side Effect Frequency

Very common (≥10%): weight gain, somnolence/sedation, increased appetite. Common (1-10%): dizziness, orthostatic hypotension, constipation, dry mouth, fatigue, peripheral edema, akathisia/tremor, increased prolactin, elevated liver enzymes, hyperglycemia and dyslipidemia (including increased cholesterol/triglycerides). Rare/serious: tardive dyskinesia, neuroleptic malignant syndrome, seizures, severe hyperglycemia/diabetic ketoacidosis, blood dyscrasias.

Safety & Warnings

Age Restriction

Not approved for children <13 years for schizophrenia/bipolar I mania; for olanzapine/fluoxetine (not this product) not approved <10 years for bipolar depression or treatment‑resistant depression.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Key interactions: CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin) ↑ olanzapine levels; CYP1A2 inducers (e.g., smoking, carbamazepine, rifampin) ↓ levels; additive CNS depression with alcohol/benzodiazepines/opioids; additive hypotension with antihypertensives; antagonism of levodopa/dopamine agonists; additive anticholinergic effects with anticholinergics.

Food Interaction

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

Alcohol Interaction

Avoid

Special Populations

Breastfeeding

Caution

Children

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

Elderly

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

Kidney Impairment

No dosage adjustment generally required in renal impairment; olanzapine is not meaningfully removed by dialysis-use clinical caution in severe renal disease.

Liver Impairment

Consider a lower starting dose (e.g., 5 mg once daily) and titrate cautiously in hepatic impairment; use caution in severe hepatic impairment with close monitoring.

Storage & Patient Advice

Missed Dose

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

Stopping the Medicine

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

Overdose

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

Pharmacology

Mechanism of Action

Multi‑receptor antagonist: dopamine (primarily D2) and serotonin (5‑HT2A/2C) antagonism with additional H1, muscarinic, and α1‑adrenergic receptor blockade contributing to efficacy and adverse effects.

Onset of Action

Sedation can occur within hours after a dose; antipsychotic/antimanic symptom improvement typically begins within 1-2 weeks, with fuller effect over ~4-6 weeks; oral Tmax is about 5-8 hours.

Duration of Effect

Approximately 24 hours, allowing for once-daily dosing.

Half-Life

Terminal half-life typically ranges ~21-54 hours (mean about 30-33 hours).

Excretion

Approximately 57% excreted in urine and ~30% in feces, predominantly as metabolites (minimal unchanged drug).

Product Information

Available Dosage Forms

For this SFDA product: film‑coated tablet (oral). (Other olanzapine forms exist in some markets: orodispersible tablet; short‑acting IM injection; long‑acting IM depot.)

Composition per Dose

Each film-coated tablet: 10 mg olanzapine

Generic Availability

Yes

Psych Class

Antipsychotic-Atypical

Controlled Substance

No

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