Active substanceDrotaverineDrotaverine
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  • Dosage form: & nbspinjection
    Composition:

    1 ml of the solution contains:

    active substance: drotaverina hydrochloride - 20 mg;

    Excipients: Sodium metabisulfite - 1 mg of ethanol (ethyl alcohol 95% based on the total) - 63.75 mg sodium sulfite anhydrous - 0.2 mg disodium edetate (Trilon B) - 0.1 mg, benzethonium chloride - 0.1 mg citric acid, calculated on an anhydrous - 0.825 mg of sodium citrate - 1.65 mg water for injection - up to 1 ml.

    Description:

    Transparent or slightly opalescent liquid from light yellow to intense yellow or greenish-yellow to intense yellow with shades of green.

    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 the 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:

    Absorption is high, the half-absorption period is 12 min. Bioavailability is 100%. Evenly distributed in tissues, penetrates smooth muscle cells. The time to reach the maximum concentration is 2 hours. The connection with plasma proteins is 95-98%. The half-life is 2.4 hours (after intravenous administration). It is mainly excreted by the kidneys, to a lesser extent - with bile. Does not penetrate the blood-brain barrier.

    Indications:

    Spasm of smooth muscles of internal organs (renal colic, biliary colic, intestinal colic, dyskinesia of biliary tract and gallbladder according to hyperkinetic type, cholecystitis, postcholecystectomy syndrome); pyelitis.

    As a part of the combined therapy: pilorospasm, gastroduodenitis, peptic ulcer of stomach and duodenum, spastic constipation, spastic colitis, proctitis, tenesmus.

    Tensor headache.

    Algodismenorea, threatening miscarriage, threatening premature birth; spasm of the throat of the uterus during labor, prolonged opening of the throat, postnatal fights.

    In carrying out some instrumental studies, cholecystography.

    Contraindications:

    Hypersensitivity, marked hepatic and renal failure, lactation period.

    Carefully:

    Arterial hypotension, pregnancy.

    Dosing and Administration:

    Adults intramuscularly, subcutaneously - 40-80 mg 1-3 times a day.

    For relief of hepatic and renal colic - intravenously slowly, 40-80 mg.

    Children under the age of 6 years - in a single dose of 10-20 mg, the maximum daily dose - 120 mg; 6-12 years single dose - 20 mg, maximum daily dose - 240 mg; multiplicity of appointment - 1-2 times a day.

    Side effects:

    Dizziness, headache, insomnia, palpitation, lowering blood pressure, allergic reactions, nausea, constipation.

    With intravenous injection - collapse.

    Interaction:

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

    Special instructions:

    In the treatment of gastric ulcer and duodenal ulcer used in combination with other antiulcer drugs.

    When administered intravenously, the patient should be in a horizontal position (risk of collapse).

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

    During the treatment period it is necessary to refrain from driving motor vehicles and practicing other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions (within 1 h after parenteral, especially intravenous administration).

    Form release / dosage:Injection.
    Packaging:

    2 ml per ampoule of light-protective glass. 5 ampoules in a contour mesh package made of PVC film. One or two contour packs together with the instructions for use, with an ampoule or scarifier ampoule ceramic knife, are placed in a pack of cardboard.

    Or 10 ampoules per box of cardboard and paper paste. Each box is supplied with instructions for use, an ampoule knife or a ceramic ampoule scarifier. A box is pasted with a label-parcel post.

    Storage conditions:

    List B. In the dark place at a temperature of 10 ° C to 25 ° C. Do not freeze.

    Keep out of the reach of children.

    Shelf life:

    2 years.Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:P N000601 / 01
    Date of registration:20.11.2008 / 21.11.2014
    The owner of the registration certificate:MOSHIMFARM PREPARATES them. N.А.Semashko, OJSC MOSHIMFARM PREPARATES them. N.А.Semashko, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp16.06.2016
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