difenoxin
Regulatory sources consulted
Approved indications
- Adjunctive treatment of acute nonspecific diarrhea and acute exacerbations of chronic functional diarrhea.
Contraindications
Absolute
- Diarrhea associated with organisms that invade the intestinal mucosa or pseudomembranous colitis; children under 2 years; hypersensitivity to difenoxin or atropine; and jaundice.
Clinical warnings
- Major warning · Overdose can cause respiratory depression and coma. Do not use in children under 2; correct dehydration or electrolyte imbalance before administration. — DailyMed/FDA label
Drug interactions
- ModerateMonoamine oxidase inhibitors
Mechanism: It may precipitate a hypertensive crisis.
Recommendation: Avoid concomitant use.
DailyMed/FDA label
- ModerateAlcohol, narcotics, barbiturates, or tranquilizers
Mechanism: Potentiation of central nervous system and respiratory depression.
Recommendation: Avoid or monitor closely if the combination is essential.
DailyMed/FDA label
Adverse events
Common (≥1%)
Nausea · vomiting · dry mouth · dizziness · drowsiness · headache
Rare but serious
Respiratory depression · coma · toxic megacolon · paralytic ileus · anaphylaxis