In vitro and animal studies show that IMODIUM® (loperamide hydrochloride) acts by slowing intestinal motility and by affecting water and electrolyte movement through the bowel. Loperamide binds to the opiate receptor in the gut wall. Consequently, it inhibits the release of acetylcholine and prostaglandins, thereby reducing propulsive peristalsis, and increasing intestinal transit time. Loperamide increases the tone of the anal sphincter, thereby reducing incontinence and urgency.

IMODIUM® (loperamide hydrochloride) is indicated for the control and symptomatic relief of acute nonspecific diarrhea in patients 2 years of age and older and of chronic diarrhea in adults associated with inflammatory bowel disease. IMODIUM® is also indicated for reducing the volume of discharge from ileostomies.

IMODIUM® is contraindicated in pediatric patients less than 2 years of age due to the risks of respiratory depression and serious cardiac adverse reactions (see CONTRAINDICATIONS). Avoid IMODIUM® dosages higher than recommended in adult or pediatric patients 2 years of age and older due to the risk of serious cardiac adverse reactions (See WARNINGS, OVERDOSAGE). (1 capsule = 2 mg). Patients should receive appropriate fluid and electrolyte replacement as needed. See package insert for complete information.

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. See package insert for complete information.

IMODIUM® is contraindicated in:
•pediatric patients less than 2 years of age due to the risks of respiratory depression and serious cardiac adverse reactions (see WARNINGS).
•patients with a known hypersensitivity to loperamide hydrochloride or to any of the excipients.
•patients with abdominal pain in the absence of diarrhea.
•patients with acute dysentery, which is characterized by blood in stools and high fever.
•patients with acute ulcerative colitis.
•patients with bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella, and Campylobacter.
•patients with pseudomembranous colitis (e.g., Clostridium difficle) associated with the use of broad-spectrum antibiotics.

Allergic Reactions: Extremely rare allergic reactions including anaphylaxis and anaphylactic shock have been reported. Hepatic Impairment: The effects of hepatic impairment on the pharmacokinetics of loperamide have not been studied. Use IMODIUM® with caution in such patients because the systemic exposure to loperamide may be increased due to reduced metabolism. Monitor patients with hepatic impairment closely for signs of central nervous system (CNS) toxicity. See package insert for complete information.