Schedule H

Oral, Intramuscular, Intravenous

• Tablets: 25 mg, 50 mg, 75 mg

• Sustained-release tablets: 75 mg

• Injection: 25 mg/mL (2 mL ampoule)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

✅ Functional Dyspepsia / Gastroparesis

Parameter Recommendation

Starting dose 25 mg orally three times daily, 30 minutes before meals

Titration May increase to 50 mg TID based on clinical response after 1–2 weeks

Usual maintenance dose 75–150 mg/day in divided doses (TID)

Maximum dose 150 mg/day

Duration Review after 4–6 weeks; avoid prolonged use without reassessment

Clinical note Preferred for dyspepsia with bloating; monitor for hyperprolactinaemia on extended use

✅ Gastroesophageal Reflux Disease (GERD) – Adjunct to PPI

Parameter Recommendation

Starting dose 25 mg orally twice daily, 30 minutes before meals

Titration May increase to 50 mg BD if inadequate response

Usual maintenance dose 50–100 mg/day in divided doses

Maximum dose 100 mg/day

Duration 4–8 weeks; reassess efficacy before continuation

Clinical note Use as adjunct when PPI monotherapy insufficient; not for acid suppression alone

✅ Irritable Bowel Syndrome (IBS) – Bloating-predominant / Dysmotility type

Parameter Recommendation

Starting dose 25 mg orally twice daily before meals

Titration Increase to 50 mg BD based on response

Usual maintenance dose 50–100 mg/day

Maximum dose 100 mg/day

Duration 2–4 weeks; reassess if no improvement

Clinical note Most useful when bloating and early satiety are dominant symptoms

✅ Acute Schizophrenia (Positive symptoms) — Specialist Only

Parameter Recommendation

Starting dose 100 mg orally twice daily

Titration Increase gradually over 5–7 days based on response and tolerability

Usual maintenance dose 200–400 mg/day in 2–3 divided doses

Maximum dose 400 mg/day

Duration Short-term use; alternative antipsychotics preferred for long-term management in India

Clinical note Psychiatrist supervision mandatory; limited use for this indication in Indian practice

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

Indication Dose Duration Notes Evidence

Chronic vestibular/central vertigo (OFF-LABEL) 25 mg BD–TID ≤4 weeks Specialist only Indian neurologist practice; no CDSCO approval for this indication

Negative symptoms of schizophrenia (OFF-LABEL) 100–300 mg/day in divided doses Variable Psychiatrist only Meta-analyses support efficacy; limited use in India

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

✅ Functional Dyspepsia / GERD (Adjunct)

<12 years Not recommended — Use only under paediatric gastroenterologist supervision if essential

12–18 years 25 mg BD, 30 minutes before meals 75 mg/day Short-term use (≤4 weeks); monitor closely for adverse effects

Safety Monitoring:

• Monitor for extrapyramidal symptoms at each visit

• Watch for galactorrhoea, menstrual irregularities in adolescent females

• Baseline ECG if cardiac risk factors present

Secondary Indications – Paediatric (Off-label, if any)

Not applicable.

Age restriction statement: Not recommended in children under 12 years except under specialist paediatric gastroenterologist supervision. No validated paediatric dosing for psychiatric indications in India.

Mild impairment (CrCl 50–80 mL/min) No dose adjustment required

Moderate impairment (CrCl 30–50 mL/min) Reduce dose by 50%; monitor for CNS effects

Severe impairment (CrCl <30 mL/min) Reduce dose to one-third of usual; use with caution; close monitoring essential

Haemodialysis No specific data available; avoid use or use with extreme caution under specialist supervision

Peritoneal dialysis No specific data available

• Known hypersensitivity to levosulpiride or other substituted benzamides

• Prolactin-dependent tumours (prolactinoma, breast carcinoma)

• Known QT prolongation or congenital long QT syndrome

• Phaeochromocytoma

• Epilepsy or history of seizure disorder

• Gastrointestinal haemorrhage, mechanical obstruction, or perforation

• Concurrent use with levodopa (antagonistic interaction)

• Severe renal insufficiency (unless dose carefully adjusted)

• Elderly patients: higher risk of extrapyramidal symptoms, QT prolongation, falls

• Parkinson's disease or parkinsonism: may exacerbate motor symptoms

• History of mania or bipolar affective disorder

• Pre-existing hyperprolactinaemia: risk of galactorrhoea, gynaecomastia, amenorrhoea

• Concurrent use with other QT-prolonging medications

• Patients on CNS depressants

• Cardiac arrhythmias or electrolyte disturbances

• Renal or hepatic impairment

Parameter Details

Risk category Not formally classified in India; limited human data; animal studies suggest risk at high doses

Overall safety Avoid unless potential benefit clearly outweighs risk

Preferred alternatives Domperidone (for prokinetic use); safer antipsychotics (haloperidol, olanzapine) if psychiatric indication

When to use Only if essential and under specialist supervision

Monitoring Maternal QT interval; fetal movements and wellbeing assessment

Parameter Details

Compatibility Not recommended; drug excreted in breast milk

Drug levels in milk Likely low to moderate

Preferred alternatives Domperidone (short-term, for prokinetic use); risperidone or haloperidol (if antipsychotic needed)

Infant monitoring Feeding pattern, drowsiness, irritability, weight gain, extrapyramidal signs

Parameter Recommendation

Starting dose 25 mg OD–BD (lower end of dosing range)

Titration Slow; increase only after 1–2 weeks if tolerated

Maximum dose 75 mg/day preferred; do not exceed 100 mg/day

Special risks Extrapyramidal symptoms, sedation, orthostatic hypotension, QT prolongation, falls, confusion

Monitoring Baseline ECG; neurological examination; blood pressure monitoring

Interacting Drug Effect/Mechanism Action

QT-prolonging agents (amiodarone, sotalol, haloperidol, macrolides, fluoroquinolones) Additive QT prolongation; risk of torsades de pointes Avoid combination or monitor ECG closely

Levodopa Antagonism of dopaminergic effect; reduced anti-parkinsonian efficacy Avoid concurrent use

Other antipsychotics Dual dopamine blockade; markedly increased extrapyramidal risk Avoid combination

Dopamine agonists (bromocriptine, cabergoline, pramipexole) Pharmacodynamic antagonism Avoid concurrent use

CNS depressants (opioids, benzodiazepines, sedating antihistamines) Additive sedation and respiratory depression Use with caution; reduce doses if essential

Interacting Drug Effect/Mechanism Action

SSRIs (fluoxetine, sertraline) Increased risk of QT prolongation; possible extrapyramidal effects Monitor ECG and for movement disorders

Metoclopramide Duplication of D2 blockade; increased dystonia and EPS risk Avoid co-prescription

Antihypertensives Additive orthostatic hypotension Monitor blood pressure; titrate cautiously

Proton pump inhibitors No significant pharmacokinetic interaction May be co-prescribed; common in practice

Anticoagulants No direct interaction; increased fall risk due to sedation may increase bleeding complications Monitor INR; counsel about fall prevention

Antiepileptics May lower seizure threshold Use with caution; monitor seizure control

• Drowsiness and fatigue

• Headache

• Nausea, abdominal discomfort

• Extrapyramidal symptoms (dose-dependent): akathisia, restlessness, tremor

• Galactorrhoea, menstrual disturbances

• Mild weight gain

• Dry mouth

• Dizziness

Adverse Effect Notes

QT prolongation and torsades de pointes May be life-threatening; discontinue immediately; cardiac monitoring required

Neuroleptic malignant syndrome Rare; presents with fever, rigidity, autonomic instability; requires immediate discontinuation and hospitalisation

Severe extrapyramidal reactions (acute dystonia, oculogyric crisis, parkinsonism) Discontinue; treat with anticholinergics (e.g., promethazine, trihexyphenidyl)

Tardive dyskinesia Risk with prolonged use; may be irreversible

Hyperprolactinaemia-related complications Gynaecomastia, sexual dysfunction, osteoporosis with long-term use

Seizures Drug lowers seizure threshold; discontinue permanently if seizure occurs

Timing Parameter

Baseline ECG (QT interval) in high-risk patients or if prolonged use planned; serum prolactin if extended therapy anticipated; renal and hepatic function tests

After initiation/dose change Monitor for extrapyramidal symptoms within first 1–2 weeks; assess sedation and orthostatic blood pressure

Long-term use (>4–6 weeks) Periodic ECG if continued therapy; menstrual history and signs of galactorrhoea in women; prolactin levels if symptomatic; weight and metabolic parameters

• Lesuride® (Sun Pharma)

• Levipride® (Micro Labs)

• Levosulpiride® (generic, multiple manufacturers)

• Nexipride® (Torrent)

• Sulpigold® (Alkem)

NLEM/NPPA status: Not listed under NLEM 2022; not under NPPA price control.

• Levosulpiride is the levo-enantiomer of sulpiride with preferential peripheral (prokinetic) activity at lower doses; distinguish from racemic sulpiride

• Consider alternative prokinetics (domperidone, itopride) if hyperprolactinaemia is a concern or in females of reproductive age

• Avoid use beyond 4–6 weeks without clear indication due to cumulative risk of extrapyramidal symptoms and endocrine adverse effects

• Always start at lower doses in elderly and titrate slowly; baseline ECG recommended

• For psychiatric indications, specialist consultation is mandatory; levosulpiride is not first-line for chronic schizophrenia in India

• Injectable formulation useful for acute nausea/vomiting in hospital settings but requires ECG monitoring

levosulpiride; prokinetic; functional dyspepsia; gastroparesis; benzamide; D2 antagonist; extrapyramidal risk; QT prolongation; hyperprolactinaemia; gastroenterology; Schedule H; India

RxIndia v1.0 — 14 Jan 2025

• CDSCO (Approved product inserts and formulations)

• Indian Pharmacopoeia / National Formulary of India (NFI)

• API Textbook of Medicine, 11th Edition (Functional GI disorders)

• AIIMS Drug Formulary (Gastrointestinal and Psychiatric sections)

• ICMR Guidelines on Gastrointestinal Disorders

• Indian Psychiatric Society Practice Guidelines

• NLEM 2022 (Reference for absence from list)

• Goodman & Gilman's The Pharmacological Basis of Therapeutics (D2 receptor pharmacology)

• Meta-analyses (for off-label psychiatric indications only)