Schedule H (Prescription only)

Oral, Intramuscular (short-acting)

Formulation Strengths Available

Tablets 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg

Orally disintegrating tablets (ODT) 5 mg, 10 mg

Intramuscular injection (short-acting) 10 mg/vial

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Schizophrenia (Adults)

Route: Oral

Parameter Dosing

Starting dose 5–10 mg once daily (typically initiate at 10 mg in acute psychosis)

Titration May increase by 5 mg increments every 5–7 days based on response and tolerability

Usual maintenance dose 10–20 mg once daily

Maximum dose 20 mg/day

Clinical Notes:

• Assess clinical response over 2–4 weeks before dose escalation

• Initiate metabolic monitoring from baseline

• Lower starting dose (5 mg) preferred in elderly, hepatic impairment, or those prone to hypotension

1. Acute Mania in Bipolar Disorder (Monotherapy or Adjunct)

Route: Oral

Parameter Dosing

Starting dose 10–15 mg once daily

Titration Adjust by 5 mg increments every 24–48 hours based on response

Usual maintenance dose 10–20 mg/day

Maximum dose 20 mg/day

Clinical Notes:

• When combined with mood stabiliser (lithium, valproate), monitor for additive sedation and metabolic effects

• Response typically evident within first week

• Consider earlier metabolic screening in patients with pre-existing risk factors

1. Bipolar Disorder — Maintenance Therapy

Route: Oral

Parameter Dosing

Starting dose Continue effective dose from acute phase

Titration Adjust to lowest effective dose based on tolerability

Usual maintenance dose 5–15 mg/day

Maximum dose 20 mg/day

Clinical Notes:

• Reassess need for antipsychotic continuation periodically

• Long-term metabolic monitoring essential

• May be used as monotherapy or adjunct with mood stabiliser

1. Acute Agitation in Schizophrenia or Bipolar Mania

Route: Intramuscular

Parameter Dosing

Starting dose 5–10 mg IM

Repeat dosing May repeat 5–10 mg IM after 2 hours if required

Maximum dose 20 mg/day (combined IM doses); maximum 3 injections in 24 hours

Clinical Notes:

• Onset of action: 15–30 minutes

• Do NOT administer within 1 hour of parenteral benzodiazepine

• Monitor for orthostatic hypotension, respiratory depression

• Transition to oral therapy as soon as clinically feasible

Secondary Indications — Adults (Off-label, if any)

Indication Dose Duration Notes

Treatment-resistant depression (adjunct to antidepressant) — OFF-LABEL 2.5–10 mg/day; start at 2.5–5 mg 6–12 weeks; reassess continuation Specialist only; supported by international RCTs and common Indian psychiatrist practice

Aggression/agitation in dementia — OFF-LABEL 2.5–5 mg/day Short-term only (4–6 weeks maximum) Increased mortality risk in elderly with dementia; use only when non-pharmacological measures fail; specialist supervision essential

Evidence basis: International meta-analyses; Indian specialist psychiatry practice protocols

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

1. Schizophrenia (Age ≥13 years)

Route: Oral

Parameter Dosing

Starting dose 2.5–5 mg once daily

Titration Increase by 2.5–5 mg every 5–7 days based on response

Usual maintenance dose 5–15 mg/day

Maximum dose 20 mg/day

Safety Monitoring:

• Monitor for somnolence, weight gain, extrapyramidal symptoms

• Baseline and periodic metabolic screening (fasting glucose, lipid profile)

• Regular weight and BMI monitoring

1. Bipolar Disorder — Acute Mania (Age ≥13 years)

Route: Oral

Parameter Dosing

Starting dose 2.5–5 mg once daily

Titration Increase gradually to 10–15 mg/day based on response

Usual maintenance dose 10–15 mg/day

Maximum dose 20 mg/day

Safety Monitoring:

• Close monitoring of metabolic profile and behavioural changes

• Assess for treatment-emergent suicidality

• Monitor prolactin levels if symptomatic

Secondary Indications — Paediatric Doses (Off-label, if any)

Not applicable.

Age Restriction Statement:

Not recommended below 13 years of age except under child and adolescent psychiatry specialist supervision in tertiary care settings.

Mild to moderate impairment No dose adjustment required

Severe impairment Use with caution; may have altered pharmacokinetics and increased sensitivity to adverse effects

Haemodialysis Not significantly dialysed; no supplemental dose required

• Known hypersensitivity to olanzapine or any excipient

• Acute angle-closure glaucoma (uncontrolled)

• Severe CNS depression or comatose states

• Concurrent administration of IM olanzapine with parenteral benzodiazepines (within 1 hour)

• Elderly patients with dementia-related psychosis (increased risk of cerebrovascular events and mortality)

• Parkinson's disease or dementia with Lewy bodies (may exacerbate parkinsonism)

• Pre-existing metabolic syndrome, diabetes mellitus, or obesity

• Cardiovascular disease or conditions predisposing to hypotension

• History of seizures (lowers seizure threshold)

• Prostatic hypertrophy or paralytic ileus (anticholinergic effects)

• History of neutropenia or leukopenia

• Concurrent use of other CNS depressants

Parameter Details

Risk category Use only if benefit clearly outweighs risk

Indian practice Not routinely recommended in first trimester; may continue in stable patients with specialist input

Preferred alternatives Haloperidol (more established safety data in pregnancy)

When to use Severe psychosis or mania when alternatives unsuitable; second/third trimester preferred

Monitoring Maternal weight, blood glucose; fetal growth ultrasound; neonatal assessment for EPS and sedation at delivery

Parameter Details

Compatibility Compatible with caution; low-dose short-term use acceptable

Drug level in milk Low to moderate

Preferred alternatives Risperidone (lower milk transfer); haloperidol

Infant monitoring Sedation, feeding difficulties, excessive weight gain, developmental milestones

Parameter Recommendation

Starting dose 2.5–5 mg once daily

Titration Slow; increase at intervals of at least 5–7 days

Special risks Sedation, falls, orthostatic hypotension, extrapyramidal symptoms, cognitive worsening

Dementia-related psychosis Avoid if possible; increased mortality and cerebrovascular event risk; use only as last resort with documented informed consent

Interacting Drug Effect Recommendation

Parenteral benzodiazepines (lorazepam, diazepam IM/IV) Severe hypotension, respiratory depression, excessive sedation Do NOT administer IM olanzapine within 1 hour of parenteral benzodiazepine

Carbamazepine CYP1A2 induction; significantly reduces olanzapine levels May need to increase olanzapine dose by 50%; monitor clinical response

Ciprofloxacin, fluvoxamine Strong CYP1A2 inhibition; significantly increases olanzapine levels Reduce olanzapine dose; monitor for toxicity

Levodopa / dopamine agonists Antagonises dopaminergic effects Avoid combination; may worsen parkinsonism

QT-prolonging agents (quinidine, amiodarone, sotalol) Additive QT prolongation risk Avoid combination if possible; ECG monitoring if essential

Interacting Drug Effect Recommendation

Valproate Additive sedation; possible metabolic effects Monitor CNS status; periodic LFTs and CBC

Antihypertensives Additive orthostatic hypotension Monitor blood pressure; adjust doses as needed

SSRIs (fluoxetine, paroxetine) May increase olanzapine levels via CYP2D6 inhibition Monitor for enhanced effects and sedation

Rifampicin CYP1A2 induction; may reduce olanzapine levels Monitor clinical response; may need dose adjustment

Oral hypoglycaemics / Insulin Olanzapine may worsen glycaemic control Monitor blood glucose closely; adjust antidiabetic therapy as needed

Smoking (tobacco) CYP1A2 induction; reduces olanzapine levels Smokers may need higher doses; monitor if smoking cessation occurs

• Weight gain (significant; most pronounced in first 6 months)

• Somnolence and sedation

• Increased appetite

• Dizziness

• Dry mouth

• Constipation

• Orthostatic hypotension

• Peripheral oedema

• Dyslipidaemia

• Elevated liver enzymes (transient)

Adverse Effect Notes

Neuroleptic malignant syndrome (NMS) Hyperthermia, rigidity, autonomic dysfunction; discontinue immediately, urgent supportive care

Tardive dyskinesia May be irreversible; monitor with chronic use; consider dose reduction or discontinuation

Severe hyperglycaemia / Diabetic ketoacidosis May occur even without prior diabetes; monitor glucose; discontinue if DKA develops

Agranulocytosis / Leukopenia Rare; monitor CBC if febrile illness develops

Seizures Dose-dependent risk; use caution in patients with seizure history

Venous thromboembolism Increased risk; consider in immobile patients

Cerebrovascular events Increased risk in elderly with dementia

Phase Parameters

Baseline Weight, BMI, waist circumference, fasting glucose, HbA1c, fasting lipid profile, CBC, LFTs, blood pressure, personal/family history of diabetes and cardiovascular disease

After initiation (1–2 weeks) Sedation level, orthostatic blood pressure, extrapyramidal symptoms

At 3 months Weight, fasting glucose, fasting lipids

Long-term (every 6–12 months) Weight, BMI, fasting glucose, HbA1c, lipid profile, LFTs, CBC, movement disorder assessment (AIMS scale for tardive dyskinesia)

• Oleanz® (Sun Pharma)

• Olanex® (Torrent)

• Oliza® (Intas)

• Olipar® (Ipca)

• Olanz® (Micro Labs)

• Psychozap® (Alkem)

• Oleanz Meltab® (ODT – Sun Pharma)

Fixed-dose combination with Fluoxetine available (e.g., Oleanz Plus®) for treatment-resistant depression — specialist use only.

Subject to NPPA ceiling price for select strengths under NLEM; government supply available in psychiatric care facilities.

• Weight gain is most pronounced in first 6 months; early dietary counselling and exercise recommendations are essential

• Orally disintegrating tablets (ODT) are useful for patients with compliance issues or suspected "cheeking" behaviour

• Do NOT administer IM olanzapine within 1 hour of parenteral benzodiazepines — risk of profound hypotension and respiratory compromise

• Smokers metabolise olanzapine faster (CYP1A2 induction); if patient stops smoking, reduce dose by approximately 30% to avoid toxicity

• For acute agitation, transition to oral therapy as soon as feasible to minimise injection-related risks

• Compared to risperidone, olanzapine has lower EPS risk but higher metabolic liability; choose based on individual patient risk profile

• In elderly with dementia, olanzapine carries black-box warning for increased mortality — exhaust non-pharmacological approaches first

schizophrenia; bipolar disorder; atypical antipsychotic; metabolic syndrome; weight gain; elderly-caution; dementia-avoid; pregnancy-caution; NLEM India; CYP1A2 substrate

RxIndia v1.0 — 01 Apr 2025

• CDSCO product database

• Indian Pharmacopoeia / National Formulary of India

• NLEM 2022

• AIIMS Psychopharmacology Clinic Protocols

• API Textbook of Medicine

• Indian Psychiatric Society Clinical Practice Guidelines

• Goodman & Gilman's Pharmacological Basis of Therapeutics

• WHO Essential Medicines List (supportive for paediatric data)

• International RCTs/meta-analyses (for off-label indications)