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Content:
Each tablet or 5 mL of liquid contains:
Antidiarrheal: Diphenoxylate HCl, 2.5 mg.
Anticholinergic: Atropine sulfate, 0.025 mg.
Action/Kinetics:
Chemically related to the narcotic analgesic drug meperidine but without the analgesic properties. Inhibits GI motility and has a constipating effect. May aggravate diarrhea due to organisms that penetrate the intestinal mucosa (e.g.,
Escherichia coli, Salmonella, Shigella) or in antibiotic-induced pseudomembranous colitis. High doses over prolonged periods may cause euphoria and physical dependence. The product also contains small amounts of atropine sulfate which will prevent abuse by deliberate overdosage.
Onset: 45-60 min.
t
1/2, diphenoxylate: 2.5 hr;
diphenoxylic acid: 12-24 hr.
Duration: 2-4 hr. Metabolized in the liver to the active diphenoxylic acid and excreted through the urine.
Uses:
Symptomatic treatment of chronic and functional diarrhea. Also, diarrhea associated with gastroenteritis, irritable bowel, regional enteritis, malabsorption syndrome, ulcerative colitis, acute infections, food poisoning, postgastrectomy, and drug-induced diarrhea. Therapeutic results for control of acute diarrhea are inconsistent. Also used in the control of intestinal passage time in clients with ileostomies and colostomies.
Contraindications:
Obstructive jaundice, liver disease, diarrhea associated with pseudomembranous enterocolitis after antibiotic therapy or enterotoxin-producing bacteria, children under the age of 2.
Special Concerns:
Use with caution during lactation, when anticholinergics may be contraindicated, and in advanced hepatic-renal disease or abnormal renal functions. Children (especially those with Down syndrome) are susceptible to atropine toxicity. Children and geriatric clients may be more sensitive to the respiratory depressant effects of diphenoxylate. Dehydration, especially in young children, may cause a delayed diphenoxylate toxicity.
Side Effects:
GI: N&V;, anorexia, abdominal discomfort, paralytic ileus, megacolon.
Allergic: Pruritus,
angioneurotic edema swelling of gums.
CNS: Dizziness, drowsiness, malaise, restlessness, headache, depression, numbness of extremities,
respiratory depression, coma.
Topical: Dry skin and mucous membranes, flushing.
Other: Tachycardia, urinary retention, hyperthermia.
Overdose Management:
Symptoms: Dry skin and mucous membranes, flushing,
hyperthermia mydriasis, restlessness, tachycardia followed by miosis, lethargy, hypotonic reflexes, nystagmus,
coma, severe (and possibly fatal) respiratory depression.
Treatment: Gastric lavage, induce vomiting, establish a patent airway, and assist respiration. Activated charcoal (100 g) given as a slurry. IV administration of a narcotic antagonist. Administration may be repeated after 10-15 min. Observe client and readminister antagonist if respiratory depression returns.
Drug Interactions:
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Alcohol / Additive CNS depression
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Antianxiety agents / Additive CNS depression
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Barbiturates / Additive CNS depression
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MAO inhibitors /
Chance of hypertensive crisis
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Narcotics /
Effect of narcotics
How Supplied:
See Content
Dosage
?Oral Solution, Tablets
Adults, initial: 2.5-5 mg (of diphenoxylate) t.i.d.-q.i.d.;
maintenance: 2.5 mg b.i.d.-t.i.d.
Pediatric, 2-12 years: 0.3-0.4 mg/kg/day (of diphenoxylate) in divided doses.
Pediatric/Dose
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2-3 years / 0.75-1.5 mg q.i.d.
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3-4 years / 1-1.5 mg q.i.d.
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4-5 years / 1-2 mg q.i.d.
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5-6 years / 1.25-2.25 mg q.i.d.
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6-9 years / 1.25-2.5 mg q.i.d.
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9-12 years / 1.75-2.5 mg q.i.d.
Based on 4 mL/tsp or 2 mg of diphenoxylate. Each tablet or 5 mL of liquid preparation contains 2.5 mg diphenoxylate hydrochloride and 25 mcg of atropine sulfate. Dosage should be maintained at initial levels until symptoms are under control; then reduce to maintenance levels.
