Schedule H

Oral, Intramuscular

Form Strengths

Tablets 1 mg, 5 mg, 10 mg

Injection (IM) 1 mg/mL ampoule

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Schizophrenia (Acute and Chronic)

Adults:

Parameter Dosing

Starting dose 2–5 mg/day in 1–2 divided doses

Titration Increase by 2–5 mg every 3–5 days based on response and tolerability

Usual maintenance dose 5–15 mg/day

Maximum dose 20 mg/day (higher doses only under specialist supervision)

Clinical Notes:

• Lower doses (5–10 mg/day) often adequate for maintenance therapy

• Use minimum effective dose to reduce extrapyramidal symptom (EPS) risk

• Prophylactic anticholinergic (e.g., trihexyphenidyl 2 mg BD) may be considered if EPS emerges

1. Severe Anxiety (Short-term only — where benzodiazepines contraindicated or not tolerated)

Adults:

Parameter Dosing

Starting dose 1–2 mg twice daily

Titration Increase gradually if needed

Usual maintenance dose 2–4 mg/day

Maximum dose 6 mg/day

Duration Limit to 2–4 weeks

Clinical Notes:

• Routine use for anxiety is now discouraged; safer alternatives preferred

• Reserve for refractory cases or when benzodiazepines are contraindicated

• Avoid long-term use due to tardive dyskinesia risk

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes

Persistent nausea/vomiting (antiemetic) — OFF-LABEL 1–2 mg up to 3 times/day Short-term only Historical use; rarely employed now; Specialist only

Agitation in dementia — OFF-LABEL Start 0.5–1 mg/day; titrate slowly Short-term; minimum effective dose Increased mortality risk in elderly with dementia; Specialist psychogeriatric supervision mandatory

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

1. Schizophrenia / Psychotic States (Age 12–18 years)

Parameter Dosing

Starting dose 1 mg/day

Titration Increase every 5–7 days in 1–2 mg increments

Usual maintenance dose 2–10 mg/day in divided doses

Maximum dose 10 mg/day

Safety Notes:

• High risk of extrapyramidal symptoms; monitor closely in first 2 weeks

• Concurrent monitoring for sedation, acute dystonia essential

• Consider prophylactic anticholinergic if EPS history

Secondary Indications — Paediatric (Off-label)

Indication Dose Duration Notes

Severe behavioural disturbance in autism/IDD — OFF-LABEL Start 0.5–1 mg at night; max 5 mg/day Short-term Specialist only; Monitor EPS, weight, prolactin

⚠️ Not recommended in children below 12 years except under specialist psychiatric supervision

Mild to moderate impairment No dose adjustment required

• Avoid IM formulation in patients with poor urine output (accumulation risk)

• Hypersensitivity to trifluoperazine or any phenothiazine

• Bone marrow suppression or history of agranulocytosis

• Severe CNS depression or comatose states

• Parkinson's disease

• Narrow-angle glaucoma

• Congenital long QT syndrome or uncorrected hypokalaemia

• Concurrent use with drugs causing significant QT prolongation

• History of seizures or epilepsy (lowers seizure threshold)

• Cardiovascular disease including arrhythmias

• Hepatic impairment

• Prostatic hypertrophy (urinary retention risk)

• Elderly patients with dementia (increased stroke/mortality risk)

• Hyperthyroidism

• Myasthenia gravis

• Avoid abrupt withdrawal after prolonged use

• History of neuroleptic malignant syndrome (NMS)

Aspect Recommendation

Overall safety Use only if benefits clearly outweigh risks; limited human data

Trimester-specific Third trimester exposure associated with neonatal EPS and withdrawal symptoms

Preferred alternatives Haloperidol (for acute psychosis); atypical antipsychotics under specialist guidance

Monitoring Fetal growth, neonatal tone, feeding, and withdrawal signs if exposed near term

Aspect Recommendation

Compatibility Not recommended unless benefits outweigh risks

Milk levels Low to moderate excretion in breast milk

Preferred alternatives Short-term haloperidol with monitoring; avoid antipsychotics if clinically feasible

Infant monitoring Observe for sedation, poor feeding, irritability, extrapyramidal signs

Aspect Recommendation

Starting dose 1 mg/day

Titration Very slow; increase in 1 mg increments every 5–7 days

Key risks Falls, orthostatic hypotension, confusion, EPS, QT prolongation

Special caution Avoid in dementia-related psychosis unless clearly indicated; increased cerebrovascular event and mortality risk

Interacting Drug/Class Effect Recommendation

QT-prolonging drugs (amiodarone, macrolides, fluoroquinolones) Additive QT prolongation; torsades de pointes risk Avoid combination

Levodopa/dopamine agonists Antagonism of antiparkinson effects Avoid concurrent use

CNS depressants (opioids, benzodiazepines, alcohol) Additive sedation; respiratory depression Avoid or use with extreme caution

Strong CYP2D6 inhibitors (fluoxetine, paroxetine) Elevated trifluoperazine levels Monitor closely; consider dose reduction

Interacting Drug/Class Effect Recommendation

Antihypertensives Potentiation of hypotensive effect Monitor blood pressure

Antiepileptics (phenytoin, carbamazepine) Lowered seizure threshold; altered metabolism Monitor seizure control

Rifampicin Reduced trifluoperazine levels (CYP induction) Monitor clinical response

Lithium Increased risk of neurotoxicity/encephalopathy Monitor closely; check lithium levels

Anticholinergic drugs (TCAs, benztropine) Increased anticholinergic toxicity Monitor for urinary retention, constipation, confusion

• Extrapyramidal symptoms (tremor, rigidity, akathisia, acute dystonia)

• Sedation, drowsiness

• Dry mouth, constipation, blurred vision

• Orthostatic hypotension

• Weight gain

• Hyperprolactinaemia (menstrual irregularities, galactorrhoea, gynaecomastia)

Adverse Effect Clinical Action

Tardive dyskinesia Often irreversible; consider discontinuation; refer to specialist

Neuroleptic malignant syndrome (NMS) Medical emergency — discontinue immediately; supportive care; consider dantrolene

Agranulocytosis Rare; discontinue if unexplained infection/fever; check FBC urgently

QT prolongation / Torsades de pointes Discontinue; ECG monitoring; correct electrolytes

Cholestatic jaundice / Hepatitis Discontinue; monitor LFTs

Seizures Dose-related; reduce dose or discontinue

Phase Parameters

Baseline FBC, LFTs, ECG (if cardiac risk factors), fasting glucose, lipid profile, prolactin, baseline EPS assessment

After initiation Monitor for EPS within first 1–2 weeks; dystonia may occur within 24–48 hours

Ongoing (chronic use) ECG if high-dose therapy; LFTs every 6 months; regular assessment for tardive dyskinesia; watch for NMS (fever, rigidity, autonomic instability)

Brand Name Manufacturer

Espazine Sandoz

Trinicalm Micro Labs

Triflu Sun Pharma

Triz Abbott

Stelazine GSK (limited availability)

• Also available in FDCs with antidepressants (e.g., amitriptyline) and anxiolytics

• NLEM status: Not included in current NLEM

• Available in government mental health supply chains

1. Lowest effective dose principle: Essential to minimise EPS and tardive dyskinesia risk — titrate slowly and maintain at minimum therapeutic dose

1. Anticholinergic prophylaxis: Consider trihexyphenidyl 2 mg BD if early EPS emerges; not routinely required for all patients

1. NMS vigilance: Fever with rigidity and autonomic instability requires immediate drug discontinuation and emergency management

1. Avoid for anxiety long-term: Use for anxiety should be strictly short-term (2–4 weeks); safer alternatives (SSRIs, non-pharmacological) preferred

1. Elderly dementia patients: Higher stroke and mortality risk; use only when clearly indicated under psychogeriatric supervision

1. Patient/caregiver education: Counsel on recognising early signs of EPS (stiffness, restlessness) and tardive dyskinesia (involuntary movements)

trifluoperazine; schizophrenia; typical antipsychotic; phenothiazine; EPS risk; tardive dyskinesia; India-available; elderly-caution; not breastfeeding-safe; hepatic-dose-reduce; psychiatry

RxIndia v1.1 — 10 Jan 2025

• CDSCO Approved Formulations List

• Indian Pharmacopoeia

• AIIMS Pharmacology Drug Formulary

• API Textbook of Medicine

• ICMR Guidelines on Mental Health

• Indian Psychiatric Society Clinical Practice Recommendations

• WHO Model List of Essential Medicines (supportive reference)

• Standard Pharmacology Textbooks (Goodman & Gilman, Katzung)