PRANZA 5/MG TAB 30/TAB

Indications

Approved Uses

Schizophrenia; Bipolar I disorder-acute manic or mixed episodes (monotherapy or with lithium/valproate) and maintenance treatment (including continuation after response).

Off-Label Uses

Common off-label uses include delirium/agitation (especially in medically ill), chemotherapy-induced nausea/vomiting (including refractory cases), anorexia-cachexia/appetite stimulation in cancer, and adjunctive use in treatment-resistant depression (note: olanzapine/fluoxetine is the approved combination product for some depressive indications in certain jurisdictions).

Dosage & Administration

Dosing by Condition

Schizophrenia (adults): start 5-10 mg once daily; target ~10 mg/day; range 5-20 mg/day (max 20 mg/day). Bipolar I acute mania/mixed: monotherapy start 15 mg once daily; with lithium/valproate start 10 mg once daily; range 5-20 mg/day (max 20 mg/day). Bipolar maintenance: typically 5-20 mg once daily (often 10 mg/day), individualized to response/tolerability.

Initial Dose

5-10 mg once daily (schizophrenia); 15 mg once daily (bipolar mania monotherapy); 10 mg once daily (bipolar mania combination therapy)

Maintenance Dose

5-20 mg once daily depending on indication and response

Maximum Dose

20 mg per day

Children's Dosage

Schizophrenia (ages 13-17): Initial: 2.5-5mg/day; Target: 10mg/day; Max: 20mg/day. Bipolar I Disorder (ages 13-17): Initial: 2.5-5mg/day; 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 patients, those predisposed to hypotension, and in hepatic impairment; smoking (CYP1A2 induction) can lower levels and stopping smoking can raise levels-monitor and adjust dose accordingly; strong CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin) may require dose reduction.

How to Take

Oral use: take once daily (usually in the evening due to sedation risk), with or without food; swallow the film‑coated tablet whole with water.

Side Effects

Common Side Effects

Weight gain and increased appetite; somnolence/sedation; dizziness; dry mouth; constipation; orthostatic hypotension; metabolic changes (hyperglycemia/diabetes risk, increased triglycerides and cholesterol); extrapyramidal symptoms such as akathisia/tremor (less common than with FGAs).

Side Effect Frequency

Very common (≥10%): weight gain, somnolence/sedation, increased appetite; metabolic changes such as increased glucose and increased lipids are also common and may be very common depending on study/definition. Common (1-10%): dizziness, orthostatic hypotension, constipation, dry mouth, fatigue, peripheral edema, akathisia/EPS, increased liver enzymes, increased prolactin. Uncommon/rare: seizures, neutropenia, QT prolongation, tardive dyskinesia, neuroleptic malignant syndrome, rhabdomyolysis.

Safety & Warnings

Contraindications

Known hypersensitivity to olanzapine or any excipients.

Warnings & Precautions

Boxed/class warning: increased mortality (and cerebrovascular events) in elderly with dementia-related psychosis; major metabolic monitoring (weight/BMI, glucose/A1c, lipids); orthostatic hypotension/syncope; somnolence and impaired judgment; seizure risk; TD/NMS vigilance; caution in hepatic impairment and with other CNS depressants/anticholinergics.

Age Restriction

Approved for adolescents ≥13 years and adults for schizophrenia; for bipolar I mania/mixed episodes generally ≥13 years (indication-dependent).

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

CNS depressants (incl. alcohol/benzodiazepines) ↑ sedation; CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin) ↑ olanzapine levels; CYP1A2 inducers (e.g., smoking, carbamazepine, rifampicin) ↓ levels; antihypertensives ↑ orthostatic hypotension; dopamine agonists/levodopa antagonized; anticholinergics additive anticholinergic effects.

Interaction Severity

MAJOR: Strong CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin) ↑ olanzapine levels-consider dose reduction/monitor toxicity; smoking and CYP1A2 inducers (e.g., carbamazepine, rifampin) ↓ levels-monitor efficacy/consider dose increase; IM olanzapine with parenteral benzodiazepines-avoid/space due to cardiorespiratory depression risk. MODERATE: Other CNS depressants (alcohol, opioids, benzodiazepines) additive sedation/respiratory depression; antihypertensives additive hypotension; dopamine agonists/levodopa pharmacodynamic antagonism.

Food Interaction

No restriction

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Caution

Children

Schizophrenia (ages 13-17): Initial: 2.5-5mg/day; Target: 10mg/day; Max: 20mg/day. Bipolar I Disorder (ages 13-17): Initial: 2.5-5mg/day; Target: 10mg/day; Max: 20mg/day.

Elderly

Start at 5 mg/day; titrate slowly; monitor closely for orthostatic hypotension, sedation, and metabolic effects. Not recommended for elderly patients with dementia-related psychosis.

Kidney Impairment

No routine dose adjustment required in renal impairment; use clinical caution in severe renal disease.

Liver Impairment

Start low (e.g., 5 mg once daily) and titrate cautiously in hepatic impairment; use caution in moderate-severe impairment.

Storage & Patient Advice

Storage Conditions

Store below 30°C. Protect from light and moisture.

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 withdrawal symptoms and relapse risk.

Overdose

Symptoms: somnolence/sedation, agitation, tachycardia, dysarthria, EPS, hypotension, respiratory depression, coma (± QT changes). Management: emergency care with airway/ventilation support, activated charcoal if appropriate, symptomatic/supportive care and cardiac monitoring; avoid epinephrine/dopamine for hypotension due to alpha-blockade (prefer norepinephrine).

Patient Counseling

Take PRANZA (olanzapine) exactly as prescribed (often once daily); do not stop abruptly without prescriber advice. It can cause marked drowsiness and dizziness/orthostatic hypotension-avoid alcohol, use caution with driving/machinery until you know your response, and rise slowly. Significant weight gain and metabolic effects can occur-monitor weight/BMI, fasting glucose/HbA1c and lipids as directed and follow diet/exercise advice. Seek urgent care for neuroleptic malignant syndrome symptoms (high fever, severe muscle stiffness, confusion/sweating), new or worsening involuntary movements (tardive dyskinesia/EPS), or signs of high blood sugar (excessive thirst/urination). Tell your clinician if you smoke or change smoking status (CYP1A2 induction can alter olanzapine levels) and keep follow-up appointments.

Monitoring Requirements

Baseline and periodic: weight/BMI and waist circumference; blood pressure; fasting plasma glucose or HbA1c; fasting lipid panel; assess for extrapyramidal symptoms/tardive dyskinesia; consider LFTs and CBC when clinically indicated; monitor for sedation and orthostatic hypotension.

Pharmacology

Mechanism of Action

Multi-receptor antagonist: dopamine (primarily D2) and serotonin (notably 5‑HT2A/5‑HT2C) antagonism, with additional affinity for histamine H1, muscarinic (M1-M5), and alpha‑1 adrenergic receptors.

Onset of Action

Sedation may occur within hours; improvement in agitation/mania may be seen within days; antipsychotic symptom improvement typically begins within 1-2 weeks with fuller effect over 4-6 weeks.

Duration of Effect

Clinical effects may persist for days after a dose due to a long elimination half-life (~30 hours; range ~21-54 hours), while dosing is typically once daily with ~24-hour coverage.

Half-Life

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

Bioavailability

Approximately 60% (oral bioavailability).

Metabolism

Extensive hepatic metabolism mainly via CYP1A2 and direct glucuronidation (UGT1A4); CYP2D6 is a minor pathway; metabolites include 10-N-glucuronide and 4′-N-desmethyl olanzapine.

Excretion

Urine ~57% and feces ~30% (mostly as metabolites); about 7% excreted unchanged in urine.

Protein Binding

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

Product Information

Available Dosage Forms

Oral tablets (including film‑coated) and orally disintegrating tablets; short‑acting intramuscular injection (powder for solution).

Composition per Dose

Each film-coated tablet: 5 mg olanzapine

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Psych Class

Antipsychotic-Atypical

Controlled Substance

No

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