Schedule H

Oral

Tablets: 2.5 mg, 5 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

✅ Functional Dyspepsia (Non-ulcer Dyspepsia)

Parameter Recommendation

Starting dose 2.5–5 mg orally three times daily, 15–30 minutes before meals

Titration May increase to 5 mg TID based on clinical response after 1 week

Usual maintenance dose 5 mg TID

Maximum dose 15 mg/day

Duration Short-term use (2–4 weeks); reassess if continued beyond

Clinical note Evaluate symptom relief within 2 weeks; discontinue if no benefit

✅ Gastroesophageal Reflux Disease (GERD) – Adjunct therapy

Parameter Recommendation

Starting dose 5 mg orally TID, 15–30 minutes before meals

Titration Not typically required

Usual maintenance dose 5 mg TID

Maximum dose 15 mg/day

Duration 2–4 weeks as adjunct to PPI therapy

Clinical note Not first-line monotherapy; use only in patients with documented dysmotility component or inadequate response to acid suppression alone

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

Indication Dose Duration Notes Evidence

Diabetic gastroparesis (OFF-LABEL) 5 mg TID before meals 2–4 weeks initially Specialist only Limited RCTs; used in Indian GI specialist practice

Chronic idiopathic constipation (OFF-LABEL) 5 mg OD–BD before meals Evaluate response within 2 weeks Specialist only Based on prokinetic class effect; limited Indian data

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

✅ Functional Dyspepsia / GERD adjunct

<12 years Not recommended — Safety data insufficient; use only under paediatric gastroenterologist supervision

12–18 years 2.5–5 mg TID before meals 15 mg/day Short-term use only (≤2 weeks); monitor for adverse effects

Safety Monitoring: Monitor for extrapyramidal symptoms, QT prolongation (baseline ECG in at-risk patients), and CNS effects.

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

Not applicable.

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

• Known hypersensitivity to mosapride or other benzamide derivatives

• Gastrointestinal haemorrhage, mechanical obstruction, or perforation

• Prolactin-secreting pituitary tumours (prolactinoma)

• Patients with known QT prolongation or congenital long QT syndrome

• Concurrent use with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir)

• Elderly patients: increased susceptibility to QT prolongation and CNS effects

• Pre-existing cardiac arrhythmias or electrolyte disturbances (hypokalaemia, hypomagnesaemia)

• Concurrent use with other QT-prolonging medications

• Renal or hepatic impairment

• History of seizure disorder

• Avoid prolonged use beyond 4 weeks unless under specialist supervision

• Patients on CNS depressants

Parameter Details

Risk category Not formally classified in India; limited human data

Overall safety Use only if potential benefit clearly outweighs risk

Preferred alternatives Domperidone (short-term, with caution), dietary/lifestyle measures

When to use Only when non-pharmacological measures fail; specialist input advised

Monitoring Maternal ECG if prolonged therapy; fetal wellbeing assessment

Parameter Details

Compatibility Probably compatible; limited data available

Drug levels in milk Expected to be low (based on similar benzamide agents)

Preferred alternatives Domperidone if prokinetic required

Infant monitoring Observe for sedation, feeding difficulties, irritability

Parameter Recommendation

Starting dose 2.5 mg BD–TID

Titration Slow; increase only if tolerated after 7–10 days

Maximum dose 10 mg/day preferred

Special risks QT prolongation, orthostatic hypotension, CNS effects (drowsiness, confusion), falls

Monitoring Baseline ECG recommended; periodic ECG if continued beyond 2 weeks

Interacting Drug Effect/Mechanism Action

QT-prolonging agents (fluoroquinolones, macrolides, Class IA/III antiarrhythmics, ondansetron, certain antipsychotics) Additive QT prolongation; risk of torsades de pointes Avoid combination or monitor ECG closely

Strong CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, clarithromycin) Increased mosapride plasma levels Avoid concurrent use

Levodopa Antagonistic effect on gastric motility Avoid unless essential; monitor efficacy

MAOIs Potential for adverse interactions Avoid concurrent use

Interacting Drug Effect/Mechanism Action

SSRIs (fluoxetine, sertraline) Additive GI and potential serotonergic effects Monitor for GI symptoms and behavioural changes

Anticholinergics (dicyclomine, hyoscine) Reduced prokinetic efficacy Avoid co-prescription if possible

CNS depressants (benzodiazepines, opioids, antihistamines) Additive sedation Use with caution; counsel patient

Antacids/PPIs No significant pharmacokinetic interaction May be co-administered

Moderate CYP3A4 inhibitors (diltiazem, verapamil, erythromycin) May increase mosapride levels Monitor for adverse effects

• Diarrhoea or loose stools

• Abdominal cramps or discomfort

• Headache

• Dizziness

• Dry mouth

• Nausea

Adverse Effect Notes

QT prolongation and ventricular arrhythmias Requires baseline and periodic ECG in at-risk patients; discontinue if QTc prolongation detected

Extrapyramidal symptoms (rare) More likely in elderly; discontinue immediately if occurs

Seizures Discontinue permanently

Severe allergic reactions (angioedema, anaphylaxis) Requires immediate discontinuation and emergency management

Hepatotoxicity (rare) Monitor LFTs if signs of liver dysfunction appear

Timing Parameter

Baseline ECG (especially in elderly, cardiac risk factors, or concurrent QT-prolonging drugs); LFTs if hepatic disease suspected; electrolytes if at risk

After initiation Assess for CNS effects, GI symptoms within first week

Long-term use (if continued >4 weeks) Periodic ECG; reassess indication; monitor for involuntary movements

• Mosid® (Cipla)

• Moza® (Sun Pharma)

• Mosapride (generic)

• Mosakind® (Mankind)

• Mozafast® (Macleods)

Note: Fixed-dose combinations with PPIs (e.g., with Rabeprazole, Pantoprazole) are available; use with caution and prefer monotherapy when possible.

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

• Limit use to short-term (2–4 weeks); reassess indication if continued beyond this duration

• Preferred over metoclopramide in younger patients due to lower risk of extrapyramidal symptoms

• Lower propensity for hyperprolactinaemia compared to domperidone and metoclopramide

• Always assess baseline ECG in elderly or those on concurrent QT-prolonging medications

• Consider domperidone as alternative in pregnant/lactating patients if prokinetic needed

• Not effective for mechanical obstruction; rule out organic pathology before initiating therapy

• Avoid concurrent strong CYP3A4 inhibitors

mosapride; prokinetic; functional dyspepsia; GERD; benzamide; 5-HT4 agonist; QT prolongation; gastroenterology; Schedule H; India

RxIndia v1.0 — 14 Jan 2025

• CDSCO (Approved formulations and product inserts)

• Indian Pharmacopoeia / National Formulary of India (NFI)

• AIIMS Drug Formulary (Gastrointestinal section)

• API Textbook of Medicine (Functional GI disorders chapter)

• Indian Society of Gastroenterology (clinical practice recommendations)

• Harrison's Principles of Internal Medicine, 21st Edition (GI motility disorders)

• Goodman & Gilman's The Pharmacological Basis of Therapeutics (prokinetic agents)