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Duspatalin

 

Trade name: Duspatalin®

DOSAGE FORM:

Prolonged-release capsules

COMPOSITION:

Active ingredient: Each retard capsule contains 200 mg of mebeverine hydrochloride.

Excipients: Magnesium stearate; metacryl acid copolymer; talc; hypromelloze; methylhydroxypropyl-cellulose, methacryl and ethacryl acid copolymer; glycerol triacetate; hard gelatin capsule: gelatin, titanium dioxide.

DESCRIPTION:

Hard white opaque gelatin capsules No. 1 with «245» imprinted on the shell of a capsule and with «S» and «V» on its cap. The contents of the capsules are white or almost white granules.

PHARMACOTHERAPEUTIC GROUP:

Spasmolytic.

PHARMACOLOGICAL ACTION:

This is a myotropic spasmolytic that directly affects the smooth muscles of the gastrointestinal tract (chiefly the large bowel). It eliminates spasm, without exerting any effect on normal intestinal motility. The drug has no anticholinergic activity.

PHARMACO-KINETICS:

When orally used, duspatalin undergoes presystemic hydrolysis and it is undetectable in the plasma. The drug is hepatiсаllу metabolized to veratric acid and mebeverine alcohol. It is mainly excreted by kidneys as metabolites, in small quantities by bile. Mebeverine capsules have the properties of prolonged release. Significant accumulation of the drug does not occur even after its multiple use.

INDICATIONS:

Gastrointestinal spasm (including that caused by an organic disease), intestinal colic, biliary colic, irritable colon syndrome.

Children aged above 12 years

Gastrointestinal functional disorders accompanied by abdominal pain.

CONTRAINDICATIONS:

Hypersensitivity to any components of the drug.

PREGNANCY AND LACTATION:

Animal experiments have revealed no teratogenic effect of the drug. However, it is necessary to compare maternal benefits with potential fetal risks when the drug is administered to pregnant women. When administered in therapeutic doses, mebeverine does not penetrate into breast milk so this drug may be used during lactation.


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