Difenoxin hcl/Atropine

DEA Class;  Rx

Common Brand Names; Motofen

  • Antidiarrheals

Oral, antidiarrheal agent
Contains difenoxin (synthetic opiate agonist structurally related to meperidine) and atropine (added in subtherapeutic quantities to discourage abuse or overdosage)

For adjunctive treatment in the management of acute nonspecific diarrhea and acute exacerbations of chronic functional diarrhea.

<2 years old

Hypersensitivity, infectious diarrhea, jaundice

GI obstruction, hemorrhage, intestinal atony, myasthenia gravis, obstructive uropathy, reflux esophagitis, ulcerative colitis

1-10%

  • Nausea (6.7%)
  • Somnolence (4%)
  • Vomiting (3.3%)
  • Xerostomia (3.3%)
  • Headache (2.5%)
  • Dizziness
  • Lightheadedness
  • Abdominal discomfort
  • Anticholinergic effects

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 Category: C

Lactation: enters breast milk/not recommended

Adults

8 mg/24 hours PO.

Geriatric

8 mg/24 hours PO.

Adolescents

8 mg/24 hours PO.

Children

12 years: 8 mg/24 hours PO.
2—11 years: Safety and efficacy have not been established.
< 2 years: Contraindicated.

Infants

Contraindicated.

Neonates

Contraindicated.

difenoxin hcl/atropine

tablets: Schedule IV

  • 1 mg/0.025 mg

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