Imodium capsules 2 mg. №20

Description

IMODIUM №20 COMPOSITION:
active substance: loperamide;
1 capsule contains 2 mg of loperamide hydrochloride
Excipients: lactose, corn starch, talc, magnesium stearate capsule shell: iron oxide yellow (E172), iron oxide black (E172), titanium dioxide (E 171), indigo (E 132), erythrosine (E 127), gelatin.

IMODIUM №20 DOSAGE FORM
Capsules.

IMODIUM №20 MAIN PHYSICAL AND CHEMICAL PROPERTIES:
size 4 capsules with a green cap and a dark gray body, containing a white powder.

PHARMACOLOGICAL GROUP
Antidiarrheal drugs; agents used to treat infectious and inflammatory bowel diseases. Peristalsis suppressants. Loperamide. ATX code A07D A03.

PHARMACOLOGICAL PROPERTIES

Pharmacological.
Loperamide hydrochloride binds to opiate receptors in the intestinal wall. As a result, the release of acetylcholine and prostaglandins is suppressed, which leads to a decrease in propulsive peristalsis and an increase in the transit time of the contents through the digestive tract, as well as the ability of the intestinal wall to absorb fluid and electrolytes. Loperamide hydrochloride increases the tone of the anal sphincter, thereby reducing fecal incontinence and the urge to defecate.

Pharmacokinetics.
Absorption: Most of the oral loperamide is absorbed in the intestine, but as a result of intense first pass metabolism, the systemic bioavailability is only about 0.3%.
Distribution The results of studies of the distribution of loperamide in rats show a high affinity for the intestinal wall with preferential binding to receptors of the longitudinal layer of the muscular membrane. The protein binding of loperamide is 95%, mainly with albumin. Preclinical data have shown that loperamide is a substrate for P-glycoprotein.
Metabolism Loperamide is almost completely extracted by the liver, where it is predominantly metabolized, conjugated and excreted in the bile. Oxidative N-demethylation is the main metabolic pathway of loperamide, this process is mediated mainly by the isoforms CYP3A4 and CYP2C8. As a result of the very intense first pass effect through the liver, plasma concentrations of the unchanged drug remain very low.
Elimination: The half-life of loperamide in humans is approximately 11:00 with a range of 9-14 hours. Excretion of unchanged loperamide and its metabolites mainly with feces.
Pediatric patients: No pharmacokinetic studies have been performed in pediatric patients. The pharmacokinetic behavior of loperamide and drug interactions with loperamide are expected to be similar to those seen in adults.

INDICATIONS
Symptomatic treatment of acute diarrhea in adults and children over 12 years of age.
Symptomatic treatment of acute episodes of diarrhea due to irritable bowel syndrome in adults (over 18 years of age) after initial diagnosis by a doctor.

CONTRAINDICATIONS
Imodium is contraindicated:

patients with hypersensitivity to loperamide hydrochloride or to any of the components of the drug;
children under 12 years old;
patients with acute dysentery, characterized by the presence of blood in the stool and increased body temperature;
patients with acute ulcerative colitis or pseudomembranous colitis associated with the use of broad-spectrum antibiotics;
patients with bacterial enterocolitis caused by microorganisms of the families Salmonella, Shigella and Campylobacter.
Imodium should not be used at all if suppression of peristalsis is to be avoided due to the risk of significant complications, including intestinal obstruction, megacolon, and toxic megacolon.
Stop taking the drug immediately if constipation, bloating, or intestinal obstruction develops.