Schedule H (Prescription only)

Oral, Intramuscular (IM), Intravenous (off-label in ICU settings)

Formulation Strengths Available

Tablets 0.25 mg, 0.5 mg, 1.5 mg, 5 mg, 10 mg, 20 mg

Oral solution 2 mg/mL

Injection (short-acting, IM) 5 mg/mL (as lactate)

Long-acting depot injection (IM) Haloperidol decanoate 50 mg/mL, 100 mg/mL (in sesame oil)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Schizophrenia and Acute Psychosis (Adults)

Route: Oral

Parameter Dosing

Starting dose 1.5–5 mg/day in divided doses

Titration Increase by 0.5–5 mg/day every 2–3 days based on response and tolerability

Usual maintenance dose 5–15 mg/day (single or divided doses)

Maximum dose 30 mg/day (higher doses only under psychiatric supervision)

Clinical Notes:

• Use lowest effective dose; avoid rapid dose escalation

• Assess for extrapyramidal symptoms at each visit

• Consider prophylactic anticholinergic if EPS history present

1. Acute Agitation / Psychosis (Short-Acting IM Injection)

Route: Intramuscular

Parameter Dosing

Starting dose 2.5–5 mg IM

Repeat dosing May repeat every 4–8 hours based on clinical need

Maximum dose 20 mg/day

Clinical Notes:

• Onset of action: approximately 20–30 minutes

• Monitor closely for EPS, sedation, and hypotension

• Reduce dose in elderly or those with cardiovascular disease

• Ensure resuscitation facilities are available

1. Chronic Psychosis / Maintenance Therapy (Long-Acting Depot)

Route: Intramuscular (deep gluteal injection only)

Parameter Dosing

Starting dose 25–100 mg IM every 4 weeks

Titration Adjust by 50 mg increments; evaluate response over 1–2 injection cycles

Usual maintenance dose 50–200 mg IM every 4 weeks

Maximum dose 300 mg IM every 4 weeks

Clinical Notes:

• Initiate only after oral tolerability confirmed

• Overlap with oral haloperidol for 2–3 weeks during initial depot dosing

• Use deep gluteal IM injection only; avoid deltoid

• Conversion: approximately 10–15× the daily oral dose = monthly depot dose

1. Tourette's Syndrome

Route: Oral

Parameter Dosing

Starting dose 0.5–2 mg/day in divided doses

Titration Increase by 0.5 mg weekly as needed

Usual maintenance dose 2–5 mg/day

Maximum dose 10 mg/day

Clinical Notes:

• Reserved for severe, functionally impairing tics unresponsive to behavioural therapy

• Monitor for tardive dyskinesia with prolonged use

• Consider periodic dose reduction trials

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

Indication Dose Duration Notes

Delirium (short-term management) — OFF-LABEL 0.5–2 mg oral or IM every 8–12 hours PRN ≤7 days Specialist only; avoid in elderly if possible; ECG monitoring recommended

Huntington's Disease (chorea control) — OFF-LABEL 1–5 mg/day oral in divided doses; titrate slowly As per specialist guidance Movement disorder specialist supervision required

Evidence basis: Indian geriatric and ICU practice protocols; meta-analyses supporting short-term use in ICU delirium

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

1. Schizophrenia / Severe Behavioural Disturbance

Minimum age: ≥3 years (specialist paediatric psychiatry oversight mandatory)

3–12 years 0.25–0.5 mg/day in 2–3 divided doses Increase by 0.25–0.5 mg every 5–7 days 0.05 mg/kg/day or 5 mg/day (whichever lower)

≥13 years 0.5–1.5 mg/day in 2–3 divided doses Titrate slowly based on response 5–10 mg/day

Clinical Notes:

• Monitor closely for extrapyramidal symptoms and sedation

• Baseline ECG recommended before initiation

• Regular weight and metabolic monitoring required

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

Indication Age Dose Notes

Tourette's Disorder — OFF-LABEL ≥7 years Starting: 0.25–0.5 mg/day; Maximum: 5 mg/day Use only when non-pharmacological therapy fails; monitor for acute dystonia

Evidence basis: Indian specialist paediatric psychiatry practice; international consensus guidelines

Age Restriction Statement:

Not recommended below 3 years of age except under specialist paediatric psychiatry supervision in tertiary care settings.

Mild to moderate impairment No dose adjustment required

Severe impairment Use with caution; increased CNS sensitivity; start at lower dose

Haemodialysis Not significantly dialysed; no supplemental dose required

• Comatose states

• Severe CNS depression (alcohol or drug-induced)

• Parkinson's disease or dementia with Lewy bodies

• Severe cardiovascular disease (prolonged QTc, recent myocardial infarction, uncompensated heart failure)

• Known hypersensitivity to haloperidol or other butyrophenones

• Concomitant use with drugs known to cause significant QT prolongation

• Elderly patients (heightened sensitivity to EPS, sedation, orthostatic hypotension)

• History of seizures (lowers seizure threshold)

• Hyperthyroidism (increased EPS susceptibility)

• Electrolyte imbalance (hypokalaemia, hypomagnesaemia — correct before use)

• Cardiovascular disease (baseline ECG recommended)

• History of neuroleptic malignant syndrome

• Prolonged use (risk of tardive dyskinesia)

• Avoid abrupt withdrawal after long-term therapy

Parameter Details

Risk category Limited human data; use only if benefit clearly outweighs risk

Indian practice Not routinely recommended; low-dose haloperidol may be considered if essential

When to use Severe psychosis when alternatives unsuitable; preferably second trimester onwards

Monitoring Fetal cardiac monitoring if used chronically; neonatal assessment for EPS at delivery

Parameter Details

Compatibility Compatible with breastfeeding in low doses with caution

Drug level in milk Low; present in small quantities

Preferred alternatives Short-acting haloperidol at lowest effective dose; consider atypical antipsychotics with better safety data

Infant monitoring Sedation, feeding difficulties, abnormal movements, developmental milestones

Parameter Recommendation

Starting dose (oral) 0.25–1 mg/day

Starting dose (IM) 0.5–2 mg

Titration Very slow; allow 5–7 days between dose adjustments

Special risks Falls, sedation, orthostatic hypotension, parkinsonism, cognitive impairment, increased mortality in dementia-related psychosis

Long-acting depot Avoid unless oral tolerability well established

Interacting Drug Effect Recommendation

QT-prolonging agents (erythromycin, moxifloxacin, azithromycin, ondansetron, amiodarone) Additive QT prolongation; risk of torsades de pointes Avoid combination; if essential, monitor ECG closely

Levodopa / dopamine agonists Antagonises dopaminergic effect Avoid in Parkinson's disease

Carbamazepine, phenytoin CYP3A4 induction; reduced haloperidol levels May need dose increase; monitor clinical response

Ritonavir, ketoconazole, itraconazole CYP3A4 inhibition; increased haloperidol levels Reduce haloperidol dose; monitor for toxicity

Metoclopramide Additive extrapyramidal effects Avoid combination

Interacting Drug Effect Recommendation

Valproate Additive CNS depression Monitor sedation; adjust doses if needed

Fluoxetine, paroxetine CYP2D6 inhibition; may increase haloperidol levels and EPS risk Monitor for EPS; consider dose reduction

Lithium Risk of encephalopathic syndrome (rare) Monitor for confusion, tremor, fever; use combination cautiously

Antihypertensives Additive hypotension Monitor blood pressure; adjust doses accordingly

Rifampicin CYP3A4 induction; reduced haloperidol levels Monitor clinical response; may need dose increase

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

• Sedation and drowsiness

• Insomnia

• Orthostatic hypotension

• Dry mouth

• Blurred vision

• Constipation

• Weight gain

• Hyperprolactinaemia (galactorrhoea, amenorrhoea)

Adverse Effect Notes

QT prolongation / Torsades de pointes May be fatal; discontinue immediately and obtain ECG

Neuroleptic malignant syndrome Hyperthermia, rigidity, altered consciousness, autonomic instability; stop drug immediately, urgent supportive care

Tardive dyskinesia Often irreversible; monitor with long-term use; consider dose reduction or discontinuation

Agranulocytosis Rare; monitor CBC if febrile illness or prolonged therapy

Seizures Lowers seizure threshold; use caution in epilepsy

Phase Parameters

Baseline ECG (QTc interval), CBC, LFTs, renal function, serum electrolytes (K+, Mg2+), neurological examination

After initiation / dose change Sedation level, EPS assessment, orthostatic blood pressure, QTc if cardiac risk factors

Long-term ECG annually in high-risk patients, EPS screening at each visit, CBC every 6 months, prolactin levels if symptomatic, AIMS scale for tardive dyskinesia

• Serenace® (RPG Life Sciences)

• Halodol® (Abbott)

• Trancodol® (Torrent)

• Senorm® (Intas)

• Longerex® Depot (Sun Pharma)

• Halopace® (Mankind)

Fixed-dose combinations not commonly used.

Under NLEM; government supply available in psychiatric care facilities.

• Always confirm oral tolerability before initiating depot formulation

• Correct hypokalaemia and hypomagnesaemia before administering parenteral haloperidol to reduce arrhythmia risk

• Consider prophylactic anticholinergic (e.g., trihexyphenidyl 2 mg BD) for patients on chronic haloperidol to prevent EPS

• Avoid high-dose parenteral use in elderly patients with delirium — increased mortality risk

• Baseline and periodic ECG monitoring is essential in patients with cardiac risk factors or on concomitant QT-prolonging drugs

• Haloperidol has minimal anticholinergic effects compared to other typical antipsychotics, making it relatively suitable for elderly (with caution)

• For acute agitation, combination with promethazine IM may allow lower haloperidol doses

schizophrenia; antipsychotic; haloperidol; acute psychosis; typical antipsychotic; EPS; QT prolongation; depot injection; delirium; NLEM India

RxIndia v1.0 — 02 May 2025

• CDSCO product database

• Indian Pharmacopoeia

• AIIMS Standard Treatment Guidelines

• API Textbook of Medicine

• NLEM 2022

• Indian Psychiatric Society Clinical Practice Guidelines

• WHO Essential Medicines List

• Goodman & Gilman's Pharmacological Basis of Therapeutics

• Indian ICU Delirium protocols (for off-label use)

• Meta-analyses on delirium management (for off-label evidence)