Classes
DEA Class; Rx
Common Brand Names; Motofen
- Antidiarrheals
Description
Oral, antidiarrheal agent
Contains difenoxin (synthetic opiate agonist structurally related to meperidine) and atropine (added in subtherapeutic quantities to discourage abuse or overdosage)
Indications
For adjunctive treatment in the management of acute nonspecific diarrhea and acute exacerbations of chronic functional diarrhea.
Contraindications
<2 years old
Hypersensitivity, infectious diarrhea, jaundice
GI obstruction, hemorrhage, intestinal atony, myasthenia gravis, obstructive uropathy, reflux esophagitis, ulcerative colitis
Adverse Effects
1-10%
- Nausea (6.7%)
- Somnolence (4%)
- Vomiting (3.3%)
- Xerostomia (3.3%)
- Headache (2.5%)
- Dizziness
- Lightheadedness
- Abdominal discomfort
- Anticholinergic effects
Warnings
Closed-angle glaucoma, esophageal achalasia
Hepatorenal disease, abnormal liver function
Improvement of symptoms within 48 hr, if not, unlikely to be effective
Do not exceed recommended dosage; reduce initial dosage for maintenance
Pregnancy, breastfeeding
Pregnancy and Lactation
Pregnancy Category: C
Lactation: enters breast milk/not recommended
Maximum Dosage
8 mg/24 hours PO.
8 mg/24 hours PO.
8 mg/24 hours PO.
12 years: 8 mg/24 hours PO.
2—11 years: Safety and efficacy have not been established.
< 2 years: Contraindicated.
Contraindicated.
Contraindicated.
How supplied
difenoxin hcl/atropine
tablets: Schedule IV
- 1 mg/0.025 mg