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active substance: loperamide;
1 capsule contains 2 mg of loperamide hydrochloride;
Excipients: lactose monohydrate, corn starch, talc, magnesium stearate; capsule: iron oxide yellow (E 172), iron oxide black (E 172), titanium dioxide (E 171), indigokarmina (E 132), erytrozyn (E 127), gelatin.
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Dosage form
The capsules.
Basic physical and chemical properties: size 4 capsules with a green cap and dark gray body, containing white powder.
Pharmacotherapeutic group
Drugs that inhibit peristalsis.
ATC Code A07D A03.
Pharmacological properties
Pharmacodynamics.
Loperamide hydrochloride binds to opiate receptors of the intestinal wall. Consequently inhibited the release of acetylcholine and prostaglandins, reducing thus propulsive peristalsis and increasing the content of the passage through the digestive tract, as well as the ability to intestinal wall absorption liquid. Loperamide hydrochloride increases the tone of the anal sphincter, thereby reducing incontinence of stool and the urge to defecate.
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Pharmacokinetics.
Absorption: most of loperamide taken orally absorbed from the gut, but the result of intense first-pass metabolism systemic bioavailability is only about 0.3%.
Distribution: the results of studies with loperamide distribution in rats show high affinity relative to the intestinal wall with a primary receptor binding layer of longitudinal muscle layer. Loperamide binding protein is 95%, mainly to albumin. Preclinical data have shown that loperamide is a substrate of P-glycoprotein.
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Metabolism: loperamide almost completely extracted liver where it is metabolized mainly, kon'yuhuyetsya and excreted in the bile. Oxidative N-demethylation are the primary metabolic pathways loperamide, this process is mediated mainly isoforms CYP3A4 and CYP2C8. Consequently, very intensive first-pass effect of the liver concentrations of unchanged drug in plasma are very low.
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