Active substanceDrotaverineDrotaverine
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  • Dosage form: & nbsppills
    Composition:

    Composition of the preparation:

    Active substance: drotaverina hydrochloride - 40 mg.

    Excipients: lactose monohydrate (sugar milk) - 63 mg, potato starch - 32 mg, magnesium stearate -1 mg, talc - 3 mg, methylcellulose water-soluble - 1 mg.

    Description:Tablets of yellow with a greenish shade of color flat-cylindrical with a facet.
    Pharmacotherapeutic group:Spasmolytic agent
    ATX: & nbsp

    A.03.A.D.02   Drotaverine

    Pharmacodynamics:

    Myotropic antispasmodic, isoquinoline derivative. Inhibits phosphodiesterase IV, which leads to the accumulation of intracellular cyclic adenosine monophosphate and, as a consequence, to the inactivation of a light chain of myosin kinase, resulting in relaxation of smooth muscle.

    Regardless of the type of vegetative innervation, drotaverine acts on smooth muscles in the gastrointestinal tract, biliary, genito-urinary and vascular systems. In the myocardium and vessels, the enzyme hydrolysing cyclic adenosine monophosphate is phosphodiesterase III, which explains the absence of serious side effects from the cardiovascular system and the unexplained therapeutic effect on the cardiovascular system.

    Pharmacokinetics:

    Quickly and fully absorbed in the gastrointestinal tract. Bioavailability when taken orally is close to 100%, the half-absorption period is 12 minutes. Evenly distributed on the tissues, penetrates into the smooth muscle cells. It is mainly excreted by the kidneys, to a lesser extent - with bile. Does not penetrate the blood-brain barrier.

    Indications:

    - spasms of smooth muscles associated with diseases of the biliary tract (cholecystolithiasis, cholangiolithiasis, cholecystitis, pericholecystitis, papillitis);

    - spasms of smooth muscles of the urinary tract (nephrolithiasis, urethrolithiasis, pyelitis, cystitis, bladder tenesmus).

    As an auxiliary therapy:

    - with spasms of smooth muscles of the gastrointestinal tract (peptic ulcer of the stomach and duodenum, gastritis,spasms of cardia and pylorus, enteritis, colitis, spastic colitis with constipation and mucous colitis with flatulence);

    - tensor headache;

    - with gynecological diseases (dysmenorrhea).

    Contraindications:

    Hypersensitivity to the active substance or any of the components of the drug, severe renal or hepatic insufficiency, severe heart failure (low cardiac output syndrome), lactation period, children under 18 years of age. Do not take people suffering from lactose intolerance, lactase deficiency or glucose-galactose malabsorption.

    Carefully:With arterial hypotension, severe atherosclerosis of the coronary arteries, prostatic hyperplasia, glaucoma, during pregnancy.
    Dosing and Administration:

    Inside. Adults on 40-80 mg (1-2 tablets) 2-3 times a day.

    Side effects:

    Gastrointestinal disorders (nausea, constipation), disorders of the nervous system (headache, dizziness, insomnia); cardiovascular disorders (rapid heart rate, arterial hypotension), allergic reactions (including allergic dermatosis).

    Overdose:

    Atrioventricular blockade, cardiac arrest, paralysis of the respiratory center.

    Treatment: withdrawal of the drug, symptomatic therapy. There is no specific antidote.

    Interaction:

    Strengthens the effect of other antispasmodics (including m-holinoblokatorov), arterial hypotension caused by tricyclic antidepressants, quinidine, procainamide. Reduces spasmogenic activity of morphine, antiparkinsonian properties of levodopa. The spasmolytic effect of drotaverin increases with simultaneous use with phenobarbital.

    Special instructions:In the treatment of gastric ulcer and duodenal ulcer are used in combination with other antiulcer drugs.
    Form release / dosage:

    Tablets of 40 mg.

    Packaging:

    6, 10 or 12 tablets in a contour mesh package.

    1, 2, 3, 4 or 5 contour mesh packages together with instructions for use in a pack of cardboard.

    50 tablets in a bank OS type BDS or in a bank polymer type BP with instructions for use in a pack of cardboard.

    Storage conditions:

    In a dry place protected from light. Keep out of the reach of children.

    Shelf life:

    3 years. Do not use after the time specified on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-004859/10
    Date of registration:28.05.2010 / 29.12.2014
    The owner of the registration certificate:Anzhero-Sudzhensky Chemical-Pharmaceutical Plant, LLC Anzhero-Sudzhensky Chemical-Pharmaceutical Plant, LLC
    Manufacturer: & nbsp
    Information update date: & nbsp16.06.2016
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