Schedule H

Oral

• Tablets: 0.5 mg, 1 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

✅ Functional dyspepsia / Non-ulcer dyspepsia

Parameter Recommendation

Starting dose 0.5–1 mg orally three times daily, 15–30 minutes before meals

Titration Increase based on clinical response after 5–7 days

Usual maintenance dose 1 mg TID

Maximum dose 3 mg/day

Duration Short-term use preferred (≤4 weeks)

Clinical note Reassess if no symptomatic improvement within 7 days; not for long-term empiric use

✅ Gastroesophageal reflux with dysmotility component

Parameter Recommendation

Starting dose 1 mg orally TID, 15–30 minutes before meals

Titration Not typically required

Usual maintenance dose 1 mg TID

Maximum dose 3 mg/day

Duration ≤4 weeks

Clinical note Use only when acid suppression and lifestyle modifications provide inadequate response

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

Indication Dose Duration Notes Evidence

Diabetic gastroparesis (OFF-LABEL) 1 mg TID before meals ≤4 weeks Specialist only Limited small RCTs; not routinely used in India for this indication

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

✅ Functional nausea and dyspepsia

Age/Weight Dose Maximum Notes

<12 years Not recommended — Avoid unless under paediatric gastroenterologist supervision

12–18 years, <50 kg 0.1–0.2 mg/kg/day divided TID 1 mg TID Monitor closely for extrapyramidal symptoms

12–18 years, ≥50 kg 0.5 mg TID before meals 1 mg TID Limit therapy to ≤2 weeks

Safety monitoring: Observe for involuntary movements, dystonia, akathisia at each visit.

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

Indication Dose Duration Notes Evidence

Cyclical vomiting syndrome (OFF-LABEL) 0.1 mg/kg/dose TID 3–5 days during acute exacerbation Specialist only Limited observational data; specialist extrapolation from adult use

Age restriction statement: Not recommended in children <12 years except under paediatric gastroenterologist supervision.

• Known hypersensitivity to clebopride or other benzamide derivatives

• Parkinson's disease or parkinsonism

• Pheochromocytoma (risk of hypertensive crisis)

• Epilepsy or history of seizure disorder

• Gastrointestinal haemorrhage, mechanical obstruction, or perforation

• Concurrent use with levodopa

• Prolactin-dependent tumours (e.g., prolactinoma)

• Elderly patients — higher susceptibility to extrapyramidal adverse effects

• Concurrent use with other QT-prolonging medications

• History of depression or suicidal ideation

• Children and adolescents <16 years — increased extrapyramidal risk

• Renal or hepatic impairment

• Cardiac arrhythmias or pre-existing QT prolongation

• Patients at risk of hypotension

Parameter Details

Risk category Not formally classified in India; limited human data

Overall safety Use only if potential benefit outweighs risk to fetus

Trimester guidance Avoid in first trimester; use with caution in second and third trimesters

Preferred alternatives Domperidone (short-term), metoclopramide (with caution)

Monitoring Fetal movement, uterine activity in later pregnancy

Chronic use Avoid; reassess need frequently

Parameter Details

Compatibility Likely compatible; minimal data available

Excretion in milk Probably low levels (extrapolated from similar benzamides)

Preferred alternatives Domperidone (short course) if prokinetic required

Duration Avoid prolonged use during breastfeeding

Infant monitoring Drowsiness, irritability, feeding difficulties, weight gain

Parameter Recommendation

Starting dose 0.5 mg BD (lower than standard adult dose)

Titration Slower titration advised; increase only if tolerated after 7–10 days

Maximum dose 2 mg/day preferred; do not exceed 3 mg/day

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

Monitoring ECG if prolonged use required; neurological assessment at each visit

Interacting Drug Effect/Mechanism Action

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

Antipsychotics (haloperidol, risperidone, olanzapine) Additive dopamine blockade; markedly increased EPS risk Avoid combination

QT-prolonging agents (erythromycin, clarithromycin, amiodarone, sotalol, ondansetron) Additive QT prolongation; risk of torsades de pointes Avoid or monitor ECG closely

MAOIs Risk of hypertensive crisis Contraindicated

Interacting Drug Effect/Mechanism Action

SSRIs/SNRIs (fluoxetine, venlafaxine) Additive serotonergic or extrapyramidal effects Monitor for EPS and serotonin syndrome features

Anticholinergics (dicyclomine, hyoscine) Oppose prokinetic action of clebopride Avoid co-prescription if possible

Alcohol and sedatives Enhanced CNS depression Counsel patient; avoid concurrent use

Beta-blockers, antihypertensives Additive hypotensive effect Monitor blood pressure

Opioids (tramadol, morphine) Enhanced sedation; opposing GI motility effects Use with caution

• Drowsiness and sedation

• Fatigue

• Dry mouth

• Gastrointestinal upset (diarrhoea, abdominal cramps)

• Akathisia or restlessness (particularly in early therapy)

• Headache

• Dizziness

Adverse Effect Notes

Extrapyramidal symptoms (acute dystonia, akathisia, parkinsonism) Dose- and duration-dependent; discontinue if occurs

Tardive dyskinesia Risk with prolonged use; may be irreversible

Neuroleptic malignant syndrome Rare; requires immediate discontinuation and hospitalisation

QT prolongation and cardiac arrhythmias ECG monitoring advised in at-risk patients

Hyperprolactinaemia May cause galactorrhoea, gynaecomastia, menstrual irregularities, reduced libido

Timing Parameter

Baseline ECG (in patients with cardiac risk factors); LFTs (if hepatic dysfunction suspected); neurological examination

During therapy Monitor for involuntary movements (EPS), sedation, mood changes at each visit

Long-term use (>4 weeks) Not recommended; if continued, reassess indication, perform detailed neurological examination, repeat ECG

• Topiride® (Lupin)

• Cintapro® (Sun Pharma)

• Clebosun® (Unichem)

• Clebonorm® (USV)

Note: Fixed-dose combinations are not commonly marketed; prescribed as monotherapy.

NLEM/NPPA status: Not currently listed under NLEM or NPPA price control.

• Restrict use to short-term therapy (≤4 weeks) for functional dyspepsia or reflux with dysmotility component; reassess if no improvement within 7 days

• Extrapyramidal symptoms are dose- and duration-dependent — avoid exceeding 3 mg/day and prolonged therapy

• Domperidone is often preferred in India due to lower CNS penetration and reduced EPS risk; reserve clebopride for non-responders

• Obtain baseline ECG in patients on other QT-prolonging medications or with cardiac history before initiating therapy

• Avoid concurrent use with antipsychotics, levodopa, and MAOIs

• In elderly, start with lower dose (0.5 mg BD) and titrate cautiously

clebopride; prokinetic; functional dyspepsia; dopamine D2 antagonist; extrapyramidal risk; GERD; gastroesophageal reflux; short-term therapy; benzamide; domperidone alternative

RxIndia v1.0 — 14 Jan 2025

• CDSCO (Approved formulations and product inserts)

• Indian Pharmacopoeia / National Formulary of India (NFI)

• AIIMS Formulary (Gastrointestinal drugs section)

• API Textbook of Medicine (Functional dyspepsia management)

• Indian Society of Gastroenterology (clinical practice patterns)

• Select international RCTs/meta-analyses (cited for off-label diabetic gastroparesis indication only)