What is the recommended dose of Lomotil (diphenoxylate hydrochloride with atropine sulfate) for treating diarrhea?

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Last updated: November 12, 2025View editorial policy

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Lomotil Dosing for Diarrhea

The recommended adult dose of Lomotil (diphenoxylate-atropine) is 2 tablets (5 mg diphenoxylate) four times daily initially (20 mg/day total), reduced to maintenance of 2 tablets daily once control is achieved, though loperamide is strongly preferred as first-line therapy due to superior efficacy and safety profile. 1

Why Lomotil Is Not First-Line

Loperamide should be used instead of Lomotil for acute diarrhea management. 2, 3 The American Gastroenterological Association recommends loperamide as first-line treatment because:

  • Lomotil is generally less effective than loperamide for acute diarrhea 2
  • Lomotil causes more central nervous system effects (sedation, dizziness) 2, 4
  • Lomotil has more peripheral anticholinergic side effects from the atropine component (dry mouth, blurred vision, urinary retention) 2, 4
  • Lomotil requires a prescription while loperamide is available over-the-counter 5

FDA-Approved Lomotil Dosing

Adults

  • Initial dose: 2 tablets (5 mg diphenoxylate) four times daily (20 mg/day total) 1
  • Maintenance: Reduce to as little as 2 tablets daily once control achieved 1
  • Duration: Clinical improvement should occur within 48 hours for acute diarrhea 1
  • Chronic diarrhea: If no improvement after 10 days at maximum dose (20 mg/day), further treatment unlikely to help 1

Children

  • Under 2 years: Contraindicated - do not use 1
  • Ages 2-13 years: Use only oral solution (not tablets), with special caution 1
  • Dosing: 0.3 mg/kg/day has been studied, though not recommended as first-line 6

Critical Safety Contraindications

Never use Lomotil in these situations: 3, 5

  • Severe dysentery with high fever or bloody stools 3
  • Suspected infectious diarrhea from invasive organisms (Shigella, Salmonella, STEC) 3, 5
  • Children under 2 years of age 1

The risk with invasive organisms is prolonged illness and toxic complications, as documented in a case of Shiga dysentery where Lomotil use led to a two-year course of intermittent diarrhea 7.

Preferred Alternative: Loperamide Dosing

For acute diarrhea, use loperamide instead: 8

  • Initial dose: 4 mg (2 tablets) 8
  • Maintenance: 2 mg after each unformed stool or every 2-4 hours 8
  • Maximum: 16 mg per day 8
  • Onset: Takes 1-2 hours to reach therapeutic effect 8

When Lomotil Might Be Considered

Lomotil is listed as a third-line option only after loperamide and octreotide have failed in cancer patients with therapy-associated diarrhea, and only after excluding infectious causes 3. In chronic diarrhea with fecal incontinence, Lomotil reduced stool frequency from 4.9 to 2.6 times/day and stool weight from 460 to 256 g/day 9.

Common Pitfalls to Avoid

  • Do not use in bloody diarrhea or high fever - this suggests invasive infection where antimotility agents can worsen outcomes 3, 5
  • Do not confuse with paregoric - these are different formulations with different dosing 8
  • Monitor for paralytic ileus - rare but serious complication with high-dose use 8
  • Avoid in neutropenic patients - requires careful risk-benefit assessment 3

References

Guideline

Diarrhea Treatment with Lomotil and Alternative Options

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Guideline

Lomotil Dosing and Safety Considerations

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Guideline

Mechanism of Action and Clinical Effects of Lomotil and Loperamide

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Research

A comparative trial of liquid lomotil and mist kaolin in childhood diarrhoea.

African journal of medicine and medical sciences, 1977

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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