WARNINGS
IMODIUM® (loperamide hydrochloride) should not be used in the case of acute dysentery, which is characterized by blood in stools and high fever.
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 some patients with acute ulcerative colitis, and in pseudomembranous colitis associated with broad-spectrum antibiotics, agents which inhibit intestinal motility or delay intestinal transit time have been reported to induce toxic megacolon.
IMODIUM® therapy should be discontinued promptly if abdominal distention, constipation, or ileus occurs.
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®.
PRECAUTIONS
GENERAL
Extremely rare allergic reactions including anaphylaxis and anaphylactic shock have been reported.
In acute diarrhea, if clinical improvement is not observed in 48 hours, the administration of IMODIUM® (loperamide hydrochloride) should be discontinued. Patients with hepatic dysfunction should be monitored closely for signs of CNS toxicity because of the apparent large first pass biotransformation.
INFORMATION FOR PATIENTS
Patients should be advised to check with their physician if their diarrhea does not improve after a couple of days or if they note blood in their stools or develop a fever.
DRUG INTERACTIONS
There was no evidence in clinical trials of drug interactions with concurrent medications.
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
In an 18-month rat study with doses up to 133 times the maximum human dose (on a mg/kg basis), there was no evidence of carcinogenesis. Mutagenicity studies were not conducted. Reproduction studies in rats indicated that high doses (150-200 times the human dose) could cause marked female infertility and reduced male fertility.
PREGNANCY
Teratogenic Effects Pregnancy Category B
Reproduction studies in rats and rabbits have revealed no evidence of impaired fertility or harm to the fetus at doses up to 30 times the human dose. Higher doses impaired the survival of mothers and nursing young. The studies offered no evidence of teratogenic activity. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
NURSING MOTHERS
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when IMODIUM® is administered to a nursing woman.
PEDIATRIC USE
See the "Warnings" Section for information on the greater variability of response in this age group.
In case of accidental overdosage of IMODIUM® by children, see "Overdosage" Section for suggested treatment.
|
