Generic Name and Formulations:
Difenoxin HCl 1mg, atropine sulfate 0.025mg; tabs.
Valeant Pharmaceuticals, Inc
Indications for MOTOFEN:
Adjunctive therapy in the management of acute nonspecific diarrhea and acute exacerbations of chronic functional diarrhea.
Initially 2mg, then 1mg after each loose stool or 1mg every 3–4 hours as needed. Max 8mg/24hrs. Discontinue use if no improvement after 48hrs.
Diarrhea associated with organisms that penetrate the intestinal mucosa (eg, toxigenic E. coli, Salmonella species, Shigella) and pseudomembranous colitis associated with broad spectrum antibiotics. Children <2yrs old. Jaundice.
Monitor fluid and electrolyte balance. Withhold dose if severe dehydration or electrolyte imbalance occurs. Acute ulcerative colitis; discontinue if abdominal distention occurs or if other untoward symptoms develop. Advanced hepatorenal disease or abnormal liver function tests; hepatic coma may be precipitated. Children with Down's syndrome. Pregnancy (Cat.C). Nursing mothers: not recommended.
Opioid + anticholinergic.
Avoid in patients in whom anticholinergic drugs are contraindicated. Hypertensive crisis possible with concomitant MAOIs. May potentiate barbiturates, tranquilizers, narcotics, alcohol; monitor.
GI upset, dry mouth, epigastric distress, constipation, dizziness, drowsiness, headache, tiredness, nervousness, insomnia, confusion.
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