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Content:
Each tablet contains:
Antidiarrheal: Difenoxin HCl, 1 mg.
Anticholinergic: Atropine sulfate, 0.025 mg.
Action/Kinetics:
Related chemically to meperidine; thus, atropine sulfate is incorporated to prevent deliberate overdosage. Difenoxin is the active metabolite of diphenoxylate and is effective at one-fifth the dosage of diphenoxylate. Slows intestinal motility by a local effect on the GI wall.
Peak plasma levels: 40-60 min. The drug and its inactive metabolites are excreted through both the urine and feces.
Uses:
Management of acute nonspecific diarrhea and acute worsening of episodes of chronic functional diarrhea.
Contraindications:
Diarrhea caused by
Escherichia coli, Salmonella or
Shigella; pseudomembranous colitis caused by broad-spectrum antibiotics; jaundice; children less than 2 years of age. Hypersensitivity to difenoxin or atropine. Lactation.
Special Concerns:
Use with caution in ulcerative colitis, liver and kidney disease, lactation, and in clients receiving dependence-producing drugs or in those who are addiction prone. Safety and effectiveness in children less than 12 years of age have not been determined.
Side Effects:
GI: N&V;, dry mouth, epigastric distress, constipation.
CNS: Lightheadedness, dizziness, drowsiness, headache, tiredness, nervousness, confusion, insomnia.
Ophthalmic: Blurred vision, burning eyes.
Overdose Management:
Symptoms: Initially include dry skin and mucous membranes, hyperthermia, flushing, and tachycardia. These are followed by hypotonic reflexes, nystagmus, miosis, lethargy, coma, and
respiratory depression (may occur up to 30 hr after overdose taken).
Treatment: Naloxone may be used to treat respiratory depression.
Drug Interactions:
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Antianxiety agents / Potentiation or addition of CNS depressant effects
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Barbiturates / Potentiation or addition of CNS depressant effects
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Ethanol / Potentiation or addition of CNS depressant effects
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MAO inhibitors / Precipitation of hypertensive crisis
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Narcotics / Potentiation or addition of CNS depressant effects
How Supplied:
See Content
Dosage
?Tablets
Adults, initial: 2 tablets (2 mg difenoxin);
then, 1 tablet (1 mg difenoxin) after each loose stool or 1 tablet q 3-4 hr as needed. Total dose during a 24-hr period should not exceed 8 mg (i.e., 8 tablets).
