Active substanceDrotaverineDrotaverine
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  • Dosage form: & nbsppills
    Composition:

    Each tablet contains, as an active ingredient, 40 mg or 80 mg of drotaverine hydrochloride. Excipients: starch 37 mg, microcrystalline cellulose 55 mg, polyvinylpyrrolidone 3 mg, magnesium stearate 1.5 mg, talc 3 mg.

    Description:

    Round biconvex tablets are yellow.

    Pharmacotherapeutic group:Spasmolytic agent
    ATX: & nbsp

    A.03.A.D.02   Drotaverine

    Pharmacodynamics:

    Myotropic antispasmodic. The chemical structure and pharmacological properties are close to papaverine, but it has a stronger and longer action. Reduces the flow of Ca2+ in smooth muscle cells (inhibits phosphodiesterase, leads to the accumulation of intracellular cAMP). Reduces the tone of the smooth muscles of internal organs and intestinal motility, dilates the blood vessels. Does not affect the autonomic nervous system, does not penetrate the central nervous system.

    The presence of a direct effect on smooth muscles can be used as an antispasmodic in cases,when drugs from the group of M-cholinoblockers are contraindicated (closed-angle glaucoma, prostate adenoma).

    Pharmacokinetics:

    When taken orally, absorption is high, the half-absorption period is 12 min. Bioavailability is 100%. Evenly distributed on the tissues, penetrates into the smooth muscle cells. Tmah -2 h. The connection with plasma proteins is 95-98%. It is mainly excreted by the kidneys, to a lesser extent - with bile. Does not penetrate the BBB.

    Indications:

    Prevention and treatment of functional conditions and pain syndrome associated with spasm of smooth muscles in chronic gastroduodenitis, chronic cholecystitis, cholelithiasis, postcholecystectomy syndrome, peptic ulcer and duodenal ulcer, cardio-and pilorospasm, spastic colitis. They are also used for spasms of peripheral arterial vessels, cerebral vessels, kidney stone disease, algodismenore, to reduce uterine contractions and to relieve spasm of the cervix during labor, during instrumental research.

    Contraindications:

    Hypersensitivity to the components of the drug. Pronounced hepatic, renal, heart failure; AV-blockade II-III degree, cardiogenic shock, arterial hypotension.

    Carefully:

    With caution appoint the drug to patients with severe atherosclerosis of the coronary arteries, prostate adenoma, glaucoma, during pregnancy and lactation.

    Dosing and Administration:

    Adults prescribe inside 40-80 mg 2-3 times a day. Children under the age of 6 years are prescribed a single dose of 10-20 mg, from 6 to 12 years - 20 mg 1-2 times a day.

    Side effects:

    Dizziness, palpitations, arterial hypotension, fever, sweating, allergic skin reactions.

    Overdose:

    In large doses violates atrioventricular conduction, reduces the excitability of the heart muscle, can cause heart failure and respiratory center paralysis.

    Interaction:

    With simultaneous application it can weaken the antiparkinsonian effect of levodopa.

    Strengthens the action of papaverine, bendazole and other antispasmodics (including M-holinoblokatorov), hypotension caused by tricyclic antidepressants, quinidine and procainamide.

    Reduces the spasmogenic activity of morphine.

    Phenobarbital increases the severity of the spasmolytic effect of the corticosteroid.

    Form release / dosage:Tablets 40 mg, 80 mg.
    Packaging:

    10 tablets per blister. By 1, 2, 3,4, 5 or 10 blisters in a pack of cardboard along with instructions for the use of a medicinal product for medical use.

    For 30, 50 or 100 tablets in polystyrene containers with a lid of polyethylene; one container together with instructions for the use of the medicinal product for medical use in a pack of cardboard.

    Storage conditions:

    List B. At a temperature not higher than 25 ° C, in a dry place inaccessible to children.

    Shelf life:

    3 years. Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N014468 / 01-2002
    Date of registration:20.11.2008
    The owner of the registration certificate:Shraya Life Senses Pvt. Ltd.Shraya Life Senses Pvt. Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspSHREYA LIFE SENENSIZ Pvt.Ltd. SHREYA LIFE SENENSIZ Pvt.Ltd. India
    Information update date: & nbsp16.06.2016
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