Concomitant specific therapy must be given in those with infectious diarrhoea; hepatic dysfunction; infants; pregnancy, lactation.
Lactation: Not known if distributed in breast milk; use caution
Indication
Diarrhea
Contra Indication
Conditions when inhibition of peristalsis is undesirable (e.g. ileus or megacolon); antibiotic induced colitis; active inflammatory bowel disease; if abdominal distention develops during use; abdominal pain in the absence of diarrhoea.
Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.
Mode of Action
Loperamide inhibits peristalsis and prolongs transit time by acting directly on intestinal wall muscles. It also reduces faecal volume, increases viscosity and decreases fluid and electrolyte loss.. Slows intestinal motility through opioid receptor; has direct effects on circular and longitudinal muscle;.
Interaction
Bioavailability increased by co-trimoxazole, ritonavir, saquinavir. Respiratory depression reported when administered with quinidine. Loperamide increases GI absorption of desmopressin and decreases exposure to saquinavir.
Pregnancy Category Note
Pregnancy category: B
Lactation: Not known if distributed in breast milk; use caution
Adult Dose
Acute Diarrhea
4 mg initially, then 2 mg after each loose stool; not to exceed 16 mg/day (8 mg/day for self-medication); discontinue if no improvement seen within 48 hours
Chronic Diarrhea
4 mg initially, then 2 mg after each loose stool until controlled, and then 4-8 mg/day in divided doses
Traveler's Diarrhea
4 mg after first loose stool, then 2 mg after each subsequent stool; not to exceed 8 mg/day
Child Dose
Acute Diarrhea
First Day of Treatment
2-6 years (13-20 kg): 1 mg q8hr PO
6-8 years: (20-30 kg): 2 mg q12hr PO
8-12 years (>30 kg): 2 mg q8hr PO
Second & Subsequent Doses
0.1 mg/kg PO after each loose stool; not to exceed dose recommended for first 24 hours
Chronic Diarrhea
0.08-0.24 mg/kg/day PO divided q12hr
Traveler's Diarrhea
<6 years: Safety and efficacy not established
6-8 years: 2 mg after first loose stool, then 1 mg after each subsequent stool; not to exceed 4 mg/day
8-12 years: 2 mg after first loose stool, then 1 mg after each subsequent stool; not to exceed 6 mg/day
>12 years: 4 mg after first loose stool, then 2 mg after each subsequent stool; not to exceed 8 mg/day
Renal Dose
N/A
Administration
May be taken with or without food.
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