Active substanceDrotaverineDrotaverine
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  • Dosage form: & nbsppills
    Composition:

    Composition per one tablet

    Active substance:

    Drotaverina hydrochloride, 0.040 g

    in terms of 100% of the substance

    Excipients:

    lactose monohydrate - 0.0629 g

    Povidone (collidon 25) 0.0042 g

    crospovidone (collidine CL) 0.0014 g

    magnesium stearate - 0.0014 g

    potato starch - 0.0280 g

    talc - 0.0021 g

    Weight of a tablet - 0.140 g

    Description:Tablets are yellow with a greenish shade of color, flat-cylindrical shape, with a facet and a risk. Marble is allowed.
    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 ionized active calcium into smooth muscle cells by inhibiting phosphodiesterase and intracellular accumulation of CAMP.Reduces the tone of smooth muscles of internal organs, reduces their motor activity, dilates blood vessels. Does not affect the autonomic nervous system, does not penetrate the central nervous system. Due to direct influence on smooth muscles, it can be used as an antispasmodic in cases when drugs from the group of holinoblockers are contraindicated (closed-angle glaucoma, prostate adenoma).

    Pharmacokinetics:

    Absorption is high, the half-absorption period is 12 min.

    Bioavailability is 100%.

    Indications:

    Spasm of smooth muscles of internal organs: renal colic, biliary colic, dyskinesia of bile ducts and gall bladder by hyperkinetic type, intestinal colic; pielit, cholecystitis; spastic constipation, spastic colitis, proctitis, tenesmus; pilorospazm, peptic ulcer of stomach and duodenum (in the phase of exacerbation, as part of complex therapy), pain syndrome with spasms of peripheral arterial vessels (endarteritis), cerebral vessels, coronary arteries; Algodismenorea, threatening miscarriage, threatening premature birth; spasm of throat of the uterus during labor, prolonged opening of the throat,afterpains. For carrying out some instrumental studies, cholecystography.

    Contraindications:

    Hypersensitivity, cardiogenic shock, arterial hypotension, zakratougolnaya glaucoma, prostate adenoma, severe hepatic and renal failure, lactation period, children under 3 years.

    Carefully:

    Pronounced atherosclerosis of the coronary arteries.

    Pregnancy and lactation:

    Drotaverine does not have teratogenic and embryotoxic effects.

    However, the use of the drug is recommended only after a careful weighing of the ratio of expected benefits and possible risks.

    Due to the lack of necessary clinical data drotaverine it is not recommended to appoint during lactation (breast-feeding).

    Dosing and Administration:

    Inside.

    Adults - 40-80 mg 3 times a day.

    Children aged 3 to 6 years - 40-120 mg in 2-3 divided doses, the maximum daily dose - 120 mg; from 6 to 18 years - 80-200 mg in 2-5 receptions, the maximum daily dose - 240 mg.

    Side effects:

    Possible - dizziness, palpitations, arterial hypotension, nausea, constipation, allergic reactions.

    Overdose:

    Symptoms: disturbance of atrial-gastric conduction, decreased excitability of the heart muscle, cardiac arrest and paralysis of the respiratory center.

    Treatment: symptomatic therapy.

    Interaction:

    Relieves the antiparkinsonian effect of levodopa (increased rigidity and tremor).

    Strengthens the spasmolytic effect of papaverine, bendazole and other antispasmodics, including m-holinoblokatory.

    Reduces the spasmogenic activity of morphine.

    Phenobarbital enhances the spasmolytic effect of drotaverine.

    Special instructions:

    When treating gastric ulcer and duodenal ulcer are used in combination with other antiulcer drugs.

    Effect on the ability to drive transp. cf. and fur:

    When administered orally in therapeutic doses drotaverine does not affect the ability to drive vehicles, work with machinery and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:Tablets of 40 mg.
    Packaging:

    For 10 or 25 tablets in a contour mesh package. For 20 or 50 tablets in cans of polymeric.Each bank or 2 contourcell packs of 25 tablets, or 1, 2, or 5 contour cell packs of 10 tablets, together with the instructions for use are placed in a cardboard pack. Contoured cell packs of 10 tablets together with an equal number of instructions for use are placed in a group package.

    Storage conditions:

    In a dry, the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

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

    Terms of leave from pharmacies:Without recipe
    Registration number:LS-001518
    Date of registration:01.04.2011
    The owner of the registration certificate:TATHIMFARMPREPARATY, JSC TATHIMFARMPREPARATY, JSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp18.01.2016
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