Difenoxin
in MOTOFEN
What it isMu agonist antidiarrheal, the active metabolite of diphenoxylate, combined with atropine.
Why this oneMore potent per milligram than diphenoxylate.
What limits itCNS penetration at higher doses gives euphoria and dependence, which the atropine is added to deter. Avoid in invasive colitis and in young children.
FDA-approved for
- diarrhea (1978)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Acute nonspecific diarrhea; acute exacerbation of chronic functional diarrhea | Adults | 2 tablets, then 1 tablet after each loose stool or 1 tablet q3–4h PRN | 1 tablet after each loose stool / q3–4h PRN | 8 tablets/24h |
Renal Undefined
Hepatic Undefined
Total dose during any 24-hour period should not exceed 8 tablets.
Instructions
- Discontinue if no clinical improvement within 48 hours
- Treatment beyond 48 hours is usually not necessary
- Keep in a child-resistant container out of reach of children (overdose may cause severe respiratory depression, coma, permanent brain damage, or death)
Contraindications
- Diarrhea from organisms that penetrate the intestinal mucosa (toxigenic E. coli, Salmonella, Shigella)
- Pseudomembranous colitis associated with broad-spectrum antibiotics
- Children under 2 years of age
- Jaundiced patients
Cautions
- Overdose may cause severe respiratory depression and coma, possibly leading to permanent brain damage or death
- Contains a small amount of atropine (0.025 mg/tablet); anticholinergic effects unlikely except perhaps in children
- Antiperistaltic agents may prolong/worsen diarrhea in the contraindicated infectious conditions
Adverse reactions
- Nausea, vomiting, dry mouth, epigastric distress, constipation
- Dizziness/light-headedness, drowsiness, headache
- Burning eyes, blurred vision
Pregnancy Pregnancy Category C; use only if potential benefit justifies risk to the fetus.
Lactation Undefined
⚠ BOXED WARNING
- Not for children under 6; overdose causes severe respiratory depression
Classes and tags
Clinical profile
Mechanism of action: Difenoxin ballicule
