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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