Schedule H

Oral, Intramuscular

• Tablet 50 mg

• Tablet 100 mg

• Tablet 200 mg

• Capsule 50 mg

• Capsule 100 mg

• Oral suspension 100 mg/5 mL (limited availability)

• Injection 100 mg/2 mL (IM)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Schizophrenia — Acute Phase (Predominantly Positive Symptoms)

Parameter Dosing Details

Starting dose 200–400 mg twice daily

Titration Increase by 200–400 mg every 2–3 days based on response

Usual maintenance dose 400–800 mg/day in 2 divided doses

Maximum dose 1600 mg/day (specialist supervision required)

Key Clinical Notes:

• Higher doses (800–1600 mg/day) primarily target positive symptoms

• Divide total daily dose into 2 doses for better tolerability

• Response typically evident within 2–4 weeks

1. Schizophrenia — Predominantly Negative Symptoms

Parameter Dosing Details

Starting dose 50–100 mg twice daily

Titration Increase gradually by 50–100 mg weekly if needed

Usual maintenance dose 200–600 mg/day

Maximum dose 800 mg/day

Key Clinical Notes:

• Lower doses exploit preferential presynaptic D2 blockade

• May improve apathy, social withdrawal, and blunted affect

• Avoid exceeding 600 mg/day for negative symptom targeting

1. Acute Psychotic Agitation (Short-term) — IM Route Only

Parameter Dosing Details

Starting dose 100–200 mg IM

Titration May repeat every 8–12 hours based on response

Usual maintenance dose Not applicable (short-term use)

Maximum dose 400 mg/day IM

Key Clinical Notes:

• Duration: Maximum 3–5 days; reassess if continued need

• Switch to oral formulation as soon as clinically feasible

• Monitor for acute dystonia and hypotension post-injection

1. Dysthymia (Adjunctive Use)

Parameter Dosing Details

Starting dose 50 mg once daily

Titration Increase to 100–150 mg/day after 1–2 weeks if tolerated

Usual maintenance dose 100–200 mg/day

Maximum dose 200 mg/day

Key Clinical Notes:

• Used as adjunct in treatment-resistant cases

• Duration: Minimum 6–12 weeks to evaluate efficacy

• Limited formal approval; used in Indian psychiatric practice

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

Indication Dose Duration Notes

Functional GI Disorders (functional dyspepsia, irritable bowel syndrome) (OFF-LABEL) 50 mg twice or thrice daily 4–6 weeks Evidence: Indian gastroenterology practice; small RCTs supportive

Vertigo (OFF-LABEL) 50–100 mg twice daily 2–4 weeks Specialist only; Used by some ENT/neurologists in India

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

⛔ NOT APPROVED for general paediatric use — Safety and efficacy not established in children.

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

Indication Age Dosing Notes

Childhood-onset Schizophrenia / Severe Behavioural Disorders (OFF-LABEL) ≥14 years Starting: 3–5 mg/kg/day in 2 divided doses; Titration: Increase by 2–3 mg/kg/day every 1–2 weeks; Maximum: 10 mg/kg/day or 600 mg/day (whichever is lower) Child psychiatrist supervision mandatory

Safety Monitoring Required:

• Weight and BMI monitoring

• Prolactin levels (baseline and periodic)

• EPS assessment

• Sedation monitoring

• ECG if cardiac risk factors present

⚠️ Use below 14 years: Not recommended except under specialist child psychiatry supervision with documented justification.

Note: Sulpiride is predominantly renally excreted; not significantly removed by dialysis.

• Known hypersensitivity to sulpiride or other benzamides

• Pheochromocytoma

• Acute porphyria

• Prolactin-dependent tumours (pituitary prolactinoma, prolactin-secreting breast carcinoma)

• Concomitant use with levodopa (pharmacological antagonism)

• Parkinson's disease or parkinsonian features (risk of worsening motor symptoms)

• Pre-existing hyperprolactinaemia

• QT prolongation or risk factors (electrolyte imbalance, cardiac disease, concurrent QT-prolonging drugs)

• History of epilepsy or seizure disorder (lowers seizure threshold)

• Renal impairment (dose adjustment mandatory)

• Elderly patients (increased sensitivity to adverse effects)

• Depression with suicidal ideation

• Diabetes mellitus

Parameter Details

Risk category Limited human data; animal studies show reproductive toxicity

Recommendation Avoid unless benefit clearly outweighs risk; not first-line in pregnancy

Preferred alternatives Olanzapine, risperidone, haloperidol (better established pregnancy data per AIIMS/ICMR practice)

Monitoring Fetal growth surveillance; neonatal monitoring for EPS and withdrawal symptoms if used in third trimester

Parameter Details

Compatibility Not recommended — excreted in breast milk in moderate to high levels

Expected levels in milk Moderate to high

Preferred alternatives Low-dose olanzapine or quetiapine (lower milk penetration)

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

Parameter Recommendation

Starting dose 50–100 mg/day

Titration Slow; increase by 50 mg every 7–10 days

Maximum dose Generally ≤400 mg/day

Extra risks Falls, orthostatic hypotension, extrapyramidal symptoms, cognitive impairment, urinary retention

Other considerations Avoid IM route if possible; assess renal function before dosing

Interacting Drug/Class Effect Management

Levodopa Mutual pharmacological antagonism at dopamine receptors CONTRAINDICATED — avoid combination

QT-prolonging drugs (amiodarone, sotalol, erythromycin, haloperidol, citalopram) Additive QT prolongation; risk of torsades de pointes AVOID combination or use with extreme caution with ECG monitoring

CNS depressants (benzodiazepines, opioids, barbiturates) Enhanced sedation and respiratory depression Avoid or use significantly reduced doses

Alcohol Potentiates CNS depression Counsel strict avoidance

Antihypertensives Additive hypotensive effect Monitor blood pressure closely

Interacting Drug/Class Effect Management

SSRIs (fluoxetine, paroxetine) Increased risk of EPS Monitor closely for movement disorders

Carbamazepine, phenytoin Enzyme induction may reduce sulpiride efficacy Monitor clinical response; consider dose adjustment

Metoclopramide, domperidone Additive dopamine blockade; increased EPS risk Avoid combination

Diuretics (causing hypokalaemia) Increased QT prolongation risk Monitor electrolytes; correct hypokalaemia

Antacids, sucralfate May reduce sulpiride absorption Administer 2 hours apart

• Weight gain

• Hyperprolactinaemia (galactorrhoea, amenorrhoea, gynaecomastia, sexual dysfunction)

• Somnolence

• Dizziness

• Orthostatic hypotension

• Extrapyramidal symptoms (akathisia, tremor, rigidity) — dose-related

• Insomnia or agitation (paradoxical; more common at low doses)

• Constipation

• Dry mouth

Adverse Effect Clinical Action

Neuroleptic malignant syndrome (hyperthermia, rigidity, autonomic instability, altered consciousness) Immediate discontinuation; supportive care; ICU if severe

QT prolongation / Torsades de pointes Discontinue; ECG monitoring; cardiology consultation

Seizures Discontinue; evaluate for underlying cause

Agranulocytosis (rare) Discontinue; haematology consultation

Tardive dyskinesia Reduce dose or discontinue; may be irreversible

Severe hyperprolactinaemia with complications Dose reduction or switch to prolactin-sparing antipsychotic

Phase Parameters

Baseline ECG (QTc), renal function (eGFR/serum creatinine), serum prolactin, weight/BMI, fasting glucose

After initiation/dose change Within first week: blood pressure, sedation level, EPS assessment; ECG if high dose or cardiac risk factors

Long-term Every 3–6 months: weight/BMI, prolactin (if symptomatic), EPS/tardive dyskinesia screening, menstrual history in women; Periodic: renal function, ECG (if on high doses)

• Sulpitac (Sun Pharma)

• Espiride (Sun Pharma)

• Dogmatil (Sanofi)

• Supiride (Intas)

• Sulpigold (Alkem)

• Eglonyl (Sanofi)

• Various other generics

• Not included in NLEM 2022

• Not under NPPA price control

• Government supply: Limited to select psychiatric institutions

1. Biphasic dose-response: Low doses (50–300 mg/day) preferentially block presynaptic D2 autoreceptors, enhancing dopamine release and targeting negative symptoms; higher doses block postsynaptic receptors for positive symptom control.

1. Prolactin monitoring essential: Sulpiride causes more pronounced hyperprolactinaemia than most other antipsychotics — routinely enquire about menstrual irregularities, galactorrhoea, and sexual dysfunction.

1. Paradoxical activation: Doses below 100 mg/day may cause paradoxical agitation or insomnia due to preferential presynaptic blockade — increase dose if this occurs.

1. Renal dosing is critical: Unlike most antipsychotics, sulpiride is predominantly renally excreted (>90% unchanged) — always calculate eGFR before prescribing.

1. Metabolic advantage: Lower risk of significant weight gain and metabolic syndrome compared to olanzapine and clozapine, making it useful in metabolically vulnerable patients.

1. GI off-label use: Widely used by gastroenterologists in India for functional dyspepsia at low doses (50 mg TDS) — effective but watch for EPS with prolonged use.

sulpiride; schizophrenia; antipsychotic; benzamide; dopamine-antagonist; hyperprolactinaemia; QT-prolongation; renal-dose-adjust; negative-symptoms; psychiatry-specialist; non-NLEM

RxIndia v1.0 — 12 Jan 2025

• CDSCO approved product labelling

• National Formulary of India (NFI) 2021

• Indian Pharmacopoeia

• API Textbook of Medicine

• Indian Psychiatric Society Clinical Practice Guidelines

• AIIMS Psychiatry Department prescribing protocols

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• Harrison's Principles of Internal Medicine

• Indian hospital psychiatry formularies