Product Description.:
MYLAN 2100, MYLAN 2100
capsule , brown , oblong oblong
Black ink
IMODIUM? (loperamide hydrochloride), 4-(p-chlorophenyl)-4-hydroxy-N, N-dimethyl- a, a-diphenyl-1-piperidinebutyramide monohydrochloride, is a synthetic antidiarrheal for oral use.
IMODIUM? is available in 2mg capsules.
The inactive ingredients are: Lactose, cornstarch, talc, and magnesium stearate. IMODIUM? capsules contain FD&C Yellow No. 6.
INDICATIONS
IMODIUM? (loperamide hydrochloride) is indicated for the control and symptomatic relief of acute nonspecific diarrhea and of chronic diarrhea associated with inflammatory bowel disease. IMODIUM? is also indicated for reducing the volume of discharge from ileostomies.
SIDE EFFECTS
Clinical Trial Data
The adverse effects reported during clinical investigations of IMODIUM? (loperamide hydrochloride) are difficult to distinguish from symptoms associated with the diarrheal syndrome. Adverse experiences recorded during clinical studies with IMODIUM? were generally of a minor and self-limiting nature. They were more commonly observed during the treatment of chronic diarrhea.
The adverse events reported are summarized irrespective of the causality assessment of the investigators.
WARNINGS
Fluid and electrolyte depletion often occur in patients who have diarrhea. In such cases, administration of appropriate fluid and electrolytes is very important. The use of IMODIUM? does not preclude the need for appropriate fluid and electrolyte therapy.
In general, IMODIUM should not be used when inhibition of peristalsis is to be avoided due to the possible risk of significant sequelae including ileus, megacolon and toxic megacolon. IMODIUM must be discontinued promptly when constipation, abdominal distention or ileus develop.
Treatment of diarrhea with IMODIUM is only symptomatic. Whenever an underlying etiology can be determined, specific treatment should be given when appropriate (or when indicated).
Patients with AIDS treated with IMODIUM for diarrhea should have therapy stopped at the earliest signs of abdominal distention. There have been isolated reports of toxic megacolon in AIDS patients with infectious colitis from both viral and bacterial pathogens treated with loperamide hydrochloride. {ref EDMS-PSDB-2564186, pg 12}
IMODIUM? should be used with special caution in young children because of the greater variability of response in this age group. Dehydration, particularly in younger children, may further influence the variability of response to IMODIUM?.
