Schedule H

Oral, Intramuscular (IM)

Formulation Type Strengths Available

Tablets 25 mg, 50 mg, 100 mg, 200 mg

Syrup 25 mg/5 mL

Injection 25 mg/mL (1 mL and 2 mL ampoules) — for IM use

Note: Intravenous (IV) administration is NOT routinely recommended due to risk of severe hypotension and should be reserved only for exceptional circumstances in ICU settings under close monitoring. Oral and IM are standard routes.

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Schizophrenia and Other Psychotic Disorders

Oral Administration:

Parameter Dosing

Starting dose 25–50 mg two to three times daily

Titration Increase by 25–50 mg/day every 3–5 days based on response and tolerability

Usual maintenance dose 200–600 mg/day in 2–3 divided doses

Maximum dose 1000 mg/day (under specialist supervision only)

Intramuscular Administration (Acute Psychotic Agitation):

Parameter Dosing

Starting dose 25–50 mg IM as single dose

Titration May repeat every 6–8 hours as needed

Usual maintenance dose 25–50 mg IM every 6–8 hours

Maximum dose 400 mg/day IM

Clinical Notes:

• Deep IM injection into gluteal muscle preferred

• Monitor blood pressure for at least 30 minutes post-injection (risk of hypotension)

• Transition to oral therapy as soon as clinically feasible

• Lower starting doses in elderly, debilitated, or hepatically impaired patients

1. Acute Mania (as Adjunct Therapy)

Parameter Dosing

Starting dose 50–100 mg two to three times daily orally

Titration Increase as required every 2–3 days

Usual maintenance dose 200–400 mg/day in divided doses

Maximum dose 600 mg/day

Clinical Notes:

• Typically used in combination with mood stabilisers (Lithium, Valproate)

• Short-term use preferred; transition to maintenance mood stabiliser therapy

• Specialist psychiatrist supervision required

1. Intractable Nausea and Vomiting (Including Chemotherapy-Induced)

Parameter Dosing

Starting dose 10–25 mg orally every 6–8 hours OR 25 mg IM every 6–8 hours

Titration Not applicable for this indication

Usual maintenance dose 25–50 mg every 6–8 hours

Maximum dose 75–100 mg/day for antiemetic use

Clinical Notes:

• Short-term use only (preferably ≤48–72 hours)

• Not first-line antiemetic; reserve for refractory cases

• Taper if used beyond 48 hours

1. Intractable Hiccups

Parameter Dosing

Starting dose 25 mg orally three times daily

Titration May increase to 50 mg TID if needed

Usual maintenance dose 25–50 mg three times daily

Maximum dose 150 mg/day for this indication

Clinical Notes:

• Duration: Usually 3–5 days

• Investigate and treat underlying cause

• Discontinue once hiccups resolve

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes Evidence Basis

Hyperactive/Agitated Delirium 25–50 mg orally or IM every 6–8 hours Short-term until delirium resolves OFF-LABEL; Specialist/ICU only; Haloperidol often preferred Indian ICU protocols; institutional practice

Tetanus-Induced Spasms (Adjunct) 25–50 mg IM every 6–8 hours Until spasms controlled OFF-LABEL; Specialist/ICU only; used alongside benzodiazepines and muscle relaxants Older WHO modules; Indian ICU protocols

Porphyria (Acute Attack — Symptomatic Relief) 25–50 mg IM every 6–8 hours During acute attack OFF-LABEL; Specialist only Limited case-based evidence

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

1. Psychotic Disorders / Severe Behavioural Disorders

1–5 years 0.5 mg/kg/day in 2–3 divided doses Increase every 3–5 days as tolerated 1–2 mg/kg/day 40 mg/day

6–12 years 0.5–1 mg/kg/day in 2–3 divided doses Increase every 3–5 days 1–3 mg/kg/day 75 mg/day

12 years 25 mg two to three times daily As per adult titration 75–200 mg/day 300 mg/day (specialist supervision)

1. Nausea and Vomiting (Short-Term)

1–5 years 0.5 mg/kg orally or IM every 6–8 hours (max 40 mg/day)

6–12 years 0.5 mg/kg every 6–8 hours (max 75 mg/day)

12 years 10–25 mg every 6–8 hours

Clinical Notes:

• Duration: Maximum 24–48 hours for antiemetic use

• Use under close supervision only

Safety Monitoring in Paediatrics:

• ECG before initiation (QTc interval)

• Monitor for extrapyramidal symptoms (especially acute dystonia — more common in children)

• Sedation level and cognitive function

• Weight and growth parameters

• Avoid long-term use unless under regular specialist review

Secondary Indications — Paediatric (Off-label)

Not applicable. No established off-label paediatric indications beyond above.

Clear Statement: Use in children below 1 year of age is NOT RECOMMENDED except in tertiary care settings under specialist supervision for specific indications.

Mild to moderate impairment No dose adjustment required

• Comatose states

• Severe CNS depression (including alcohol or sedative-induced)

• Bone marrow suppression or history of agranulocytosis with phenothiazines

• Pheochromocytoma

• Known QT prolongation or history of ventricular arrhythmias

• Severe cardiovascular disease (decompensated heart failure, recent MI)

• Known hypersensitivity to chlorpromazine, other phenothiazines, or any excipient

• Concurrent use with drugs causing significant QT prolongation (Amiodarone, Sotalol, Class IA antiarrhythmics)

• Parkinson's disease or parkinsonian features — may worsen symptoms significantly

• History of seizures or epilepsy — lowers seizure threshold

• Prostatic hypertrophy or urinary retention

• Narrow-angle glaucoma

• Pre-existing cardiovascular disease — monitor for hypotension and arrhythmias

• Electrolyte abnormalities (hypokalemia, hypomagnesemia) — increases arrhythmia risk

• Hypothyroidism

• Respiratory disease (risk of respiratory depression, especially with parenteral use)

• History of neuroleptic malignant syndrome

• Lewy body dementia or dementia with Parkinsonism — avoid if possible

• Elderly with dementia-related psychosis — increased mortality risk

• Exposure to extreme heat or strenuous exercise — impaired thermoregulation

• Myasthenia gravis

• Chronic alcoholism

Parameter Details

Risk category Limited human data; older studies suggest possible association with congenital malformations in first trimester; neonatal effects with third-trimester exposure

Preferred alternatives Second-generation antipsychotics (Olanzapine, Quetiapine, Risperidone) preferred for new initiation; Haloperidol if typical antipsychotic needed

When it may be used May be continued in women stable on therapy if benefit outweighs risk; avoid initiation in first trimester if possible

Monitoring Fetal growth ultrasound, neonatal assessment for extrapyramidal symptoms and withdrawal signs (floppy baby syndrome, feeding difficulties)

Parameter Details

Compatibility Not recommended if alternatives available

Drug levels in milk Moderate; may accumulate in infant due to long half-life

Preferred alternatives Risperidone, Olanzapine, Quetiapine (with monitoring)

Monitoring in infant Drowsiness, lethargy, feeding difficulties, poor weight gain, developmental milestones

Parameter Recommendation

Starting dose 10–25 mg once or twice daily (oral); 12.5–25 mg IM if parenteral required

Titration Very slow; increase at intervals of 5–7 days or longer

Extra risks Orthostatic hypotension and falls, excessive sedation, anticholinergic effects (confusion, constipation, urinary retention), extrapyramidal symptoms, tardive dyskinesia, QT prolongation, increased mortality in dementia-related psychosis

Special considerations Avoid in Lewy body dementia and Parkinson's disease dementia; use lowest effective dose for shortest duration; regular ECG and cognitive monitoring

Interacting Drug Effect Recommendation

QT-Prolonging Drugs (Amiodarone, Sotalol, Quinolones, Macrolides, Methadone, Haloperidol) Additive QT prolongation — risk of Torsades de Pointes Avoid combination; if essential, monitor ECG closely and correct electrolytes

CNS Depressants (Benzodiazepines, Opioids, Alcohol) Enhanced sedation, respiratory depression Avoid or reduce doses of both; close monitoring

Levodopa and Dopamine Agonists Pharmacodynamic antagonism — reduces efficacy of antiparkinsonian therapy Avoid in Parkinson's disease; if antipsychotic essential, consider Quetiapine or Clozapine

Strong CYP2D6 Inhibitors (Fluoxetine, Paroxetine, Bupropion) Increased chlorpromazine plasma levels Monitor for toxicity (sedation, hypotension, EPS); consider dose reduction

Epinephrine (Adrenaline) Paradoxical hypotension due to unopposed beta-adrenergic effect Avoid; use Norepinephrine if vasopressor needed

Interacting Drug Effect Recommendation

Anticholinergics (Trihexyphenidyl, Benztropine) Additive anticholinergic burden — risk of paralytic ileus, cognitive impairment, urinary retention Use lowest effective dose; monitor bowel function and cognition

Antihypertensives Additive hypotensive effect Monitor blood pressure; adjust antihypertensive if needed

Carbamazepine CYP induction reduces chlorpromazine levels; both drugs increase hepatotoxicity risk Monitor LFTs and clinical response; may need dose adjustment

Rifampicin Enzyme induction reduces chlorpromazine efficacy Monitor clinical response; increase dose if needed

Phenytoin Enzyme induction reduces chlorpromazine levels Monitor clinical response

Metoclopramide Additive dopamine blockade — increased EPS risk Avoid concurrent use

Lithium Possible increased risk of neurotoxicity Use with caution; monitor for neurological signs

Antacids May reduce oral absorption of chlorpromazine Separate administration by 2 hours

• Sedation, drowsiness (very common with chlorpromazine)

• Orthostatic hypotension, dizziness

• Dry mouth, constipation, blurred vision (anticholinergic effects)

• Weight gain

• Extrapyramidal symptoms: acute dystonia, parkinsonism, akathisia

• Hyperprolactinemia — galactorrhoea, amenorrhoea, gynaecomastia, sexual dysfunction

• Photosensitivity reactions

• Nasal congestion

• Tachycardia

• Neuroleptic Malignant Syndrome (NMS) — hyperthermia, muscle rigidity, autonomic instability, altered consciousness; requires immediate discontinuation and hospitalisation

• Tardive Dyskinesia — potentially irreversible with prolonged use; regular AIMS screening required

• QT Prolongation, Torsades de Pointes — monitor ECG; avoid in patients with cardiac risk factors

• Agranulocytosis — rare but serious; presents with fever, sore throat, mucosal ulcers; requires immediate CBC and discontinuation if confirmed

• Cholestatic Jaundice, Hepatotoxicity — usually reversible; monitor LFTs if symptoms arise

• Seizures — lowers seizure threshold; use with caution in epilepsy

• Severe Hypotension — especially with parenteral administration; can cause syncope, falls

• Corneal and Lens Deposits, Pigmentary Retinopathy — with prolonged high-dose use

• Contact Dermatitis — in healthcare workers handling the drug (use gloves)

Phase Parameters to Monitor

Baseline ECG (QTc interval), blood pressure (lying and standing), weight, complete blood count, liver function tests, renal function, fasting glucose, lipid profile, electrolytes (potassium, magnesium), psychiatric assessment

After initiation / dose change Blood pressure (lying and standing) at each visit, ECG weekly during titration if risk factors present, sedation level, EPS assessment, mental status

Long-term LFTs and CBC every 3–6 months on chronic high-dose therapy, weight and metabolic parameters every 6 months, AIMS (Abnormal Involuntary Movement Scale) every 6 months, periodic ECG, prolactin level if symptoms arise, ophthalmological examination annually in prolonged high-dose use

Brand Name Manufacturer Formulations

Largactil Sanofi Tablets, Injection

Trinicalm Torrent Tablets

Chlorpromazine Various Generics Tablets, Syrup, Injection

Megatil Mankind Tablets

Note: Some fixed-dose combinations with Trihexyphenidyl are available (e.g., for EPS prophylaxis) — use only when specifically indicated; avoid routine co-prescription.

Note: Chlorpromazine injection IS included in NLEM India 2022. Widely available in government and private supply channels at affordable cost.

• High sedation profile: Chlorpromazine is one of the most sedating antipsychotics — useful for acute agitation but limits long-term tolerability; consider less sedating alternatives (Haloperidol, Risperidone) for maintenance.

• "Start low, go slow": Especially critical in elderly, debilitated, and hepatically impaired patients — chlorpromazine has significant hypotensive and anticholinergic effects.

• IM not IV: Routine IV use is NOT recommended due to severe hypotension risk; IM is the preferred parenteral route for acute situations.

• EPS prophylaxis is NOT routine: Do not automatically co-prescribe anticholinergics (Trihexyphenidyl) — reserve for patients who develop EPS symptoms.

• ECG before starting: Baseline and periodic ECG monitoring is essential due to QT prolongation risk — avoid in patients with baseline QTc >450 ms.

• Short-term for non-psychiatric indications: Antiemetic and anti-hiccup use should be strictly short-term (≤3–5 days); not first-line for these indications.

Chlorpromazine; schizophrenia; typical antipsychotic; first-generation antipsychotic; phenothiazine; sedating; EPS risk; QT prolongation; NMS; NLEM India; Schedule H; Psychiatry

RxIndia v1.0 — 11 Jun 2025

• CDSCO approved product inserts

• Indian Pharmacopoeia / National Formulary of India

• NLEM India 2022

• API Textbook of Medicine — Psychiatry chapter

• AIIMS Psychiatry Drug Formulary

• Indian Psychiatric Society Prescribing Guidelines

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• Harrison's Principles of Internal Medicine, 21st edition

• Indian ICU protocols (for off-label delirium and tetanus use)