What is the recommended adult dose of mosapride citrate for functional dyspepsia, gastro‑oesophageal reflux disease, chronic gastritis, or gastroparesis, and how should dosing be adjusted in elderly patients or those with moderate renal impairment?

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Mosapride Citrate Dosing

The standard adult dose of mosapride citrate is 5 mg three times daily before meals for functional dyspepsia, chronic gastritis, gastro-oesophageal reflux disease, or gastroparesis. 1, 2, 3

Standard Dosing Regimen

  • Administer 5 mg three times daily (TID) before each meal for all approved gastrointestinal indications including functional dyspepsia, chronic gastritis, GERD, and gastroparesis 1, 2, 3

  • Treatment duration should be 4 weeks minimum to assess therapeutic response, with symptom assessment performed at the end of this period 2, 3

  • Higher doses (10 mg twice daily or 7.5 mg three times daily) showed no additional benefit over 5 mg TID in controlled trials, making dose escalation unnecessary 4

Clinical Positioning in Treatment Algorithm

  • Mosapride should not be used as first-line therapy for functional dyspepsia or GERD 5, 6

  • For functional dyspepsia: First complete H. pylori testing/eradication, then trial PPIs for 4-8 weeks, and only consider mosapride after these steps fail 5, 6

  • For GERD: Use mosapride only as adjunct therapy to standard-dose PPIs (e.g., lansoprazole 30 mg daily), particularly in patients with severe symptoms (symptom scores >18 points) 2

  • Mosapride is most effective for postprandial distress syndrome (PDS) symptoms within the functional dyspepsia spectrum 5

Special Population Adjustments

Elderly Patients

  • No specific dose adjustment is documented in the available evidence for elderly patients 1, 2, 3, 7, 4
  • The standard 5 mg TID regimen was used across age groups in clinical trials without age-specific modifications 1, 4

Renal Impairment

  • No specific dosing guidance exists for patients with moderate renal impairment in the available literature 1, 2, 3, 7, 4
  • Unlike other prokinetics that require renal dose adjustment, mosapride dosing recommendations do not address kidney function 8

Efficacy Considerations

  • Mosapride demonstrated mixed efficacy in controlled trials: effective in open-label studies but failed to show superiority over placebo in the largest randomized controlled trial 4

  • When combined with lansoprazole for GERD, mosapride provided additional benefit only in the subgroup with severe symptoms (pre-treatment scores >18), achieving greater symptom reduction than lansoprazole alone (mean difference 5.34 points, 95% CI 0.28-10.40) 2

  • Mosapride significantly reduced total acid exposure time and number of reflux episodes in 24-hour pH monitoring studies at 40 mg four times daily, though this higher dose is not standard practice 7

Safety Profile

  • Excellent tolerability with adverse events occurring in <5% of patients, including diarrhea/loose stools, dry mouth, malaise, and headache 1

  • No cardiac safety concerns reported, specifically no QT prolongation, distinguishing it from domperidone 3, 6

  • No significant adverse effects occurred in clinical trials using the standard 5 mg TID dosing 3

Critical Pitfalls to Avoid

  • Do not use mosapride as monotherapy for GERD or functional dyspepsia without first attempting acid suppression with PPIs 5, 6, 2

  • Do not escalate beyond 5 mg TID, as dose-finding studies showed no incremental benefit at 10 mg BID or 7.5 mg TID 4

  • Do not expect universal efficacy: the largest placebo-controlled trial showed no significant difference between mosapride and placebo in overall functional dyspepsia populations 4

  • Recognize that mosapride has weak recommendation with low-quality evidence according to major gastroenterology societies, contrasting with strong recommendations for PPIs and tricyclic antidepressants 5, 6

References

Research

[The effect of mosapride on quality of life in functional dyspepsia].

The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi, 2004

Guideline

Acotiamide Treatment for Functional Dyspepsia

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Guideline

Treatment of Functional Dyspepsia with Amitriptyline

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2026

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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