Active substanceDrotaverineDrotaverine
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  • Dosage form: & nbsppills
    Composition:

    Composition per one tablet:

    Active substance: drotaverina hydrochloride (in terms of 100% substance) 40.0 mg.

    Excipients: lactose monohydrate 51.2 mg, potato starch 44.0 mg, povidone 2.5 mg, magnesium stearate 0.8 mg, stearic acid 0.6 mg, citric acid monohydrate 0.9 mg.

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

    A.03.A.D.02   Drotaverine

    Pharmacodynamics:

    Refers to the antispasmodic action of myotropic action, the isoquinoline derivative. The chemical structure and pharmacological properties are close to papaverine, but it has a stronger and longer action. Inhibits phosphodiesterase IV, which leads to the accumulation of intracellular adenosine monophosphoric acid, and as a consequence to the inactivation of a light chain of myosin kinase, resulting in relaxation of the smooth muscles of the internal organs. Regardless of the type of vegetative innervation, drotaverine acts on the smooth muscles of the gastrointestinal tract, biliary, genito-urinary and vascular systems. In the myocardium and vessels, the enzyme hydrolyzing cAMP is phosphodiesterase III, which explains the absence of serious cardiovascular side effects (CVS) and unexplained therapeutic effect with CCC.

    Pharmacokinetics:

    When taken orally, absorption is high, the half-absorption period is 12 min. Bioavailability is 100%. Evenly distributed in tissues, penetrates smooth muscle cells. Time to reach the maximum concentration (TCmAh) - 2 hours. 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 blood-brain barrier (BBB).

    Indications:

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

    In the combination therapy: pylorospasm, gastroduodenitis, peptic ulcer and duodenal ulcer, spastic constipation, spastic colitis, proctitis, tenesmus, pyelitis. Tensor headache.

    In carrying out some instrumental studies, cholecystography.

    Contraindications:

    Individual intolerance, expressed by hepatic, renal, heart failure, AV-blockade II-III degree, lactation period. Children under 12 years. Patients with rare hereditary diseases, intolerance to galactose, deficiency of lactase or glucose-galactose malabsorption should not take the drug.

    Carefully:

    Assign the drug to patients with severe atherosclerosis of the coronary arteries, arterial hypotension, prostatic hyperplasia, glaucoma, during pregnancy.

    Dosing and Administration:

    Adults prescribe inside for 40-80 mg (1-2 tablets) 2-3 times a day. Children over 12 years of age, the drug is prescribed 40 mg (1 tablet) 1-3 times a day.

    Side effects:

    Possible - dizziness, headache, insomnia, palpitations, arterial hypotension, a feeling of heat, sweating, allergic dermatitis, nausea, constipation.

    Inform your doctor about any unwanted or unpleasant reactions and sensations.

    Overdose:

    There are no data on overdose in relation to the drug.

    Interaction:

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

    Special instructions:

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

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

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

    Form release / dosage:

    Tablets of 40 mg.

    Packaging:

    For 10 or 20 tablets in a contour mesh package.

    2 (10 tablets) contour packs or 5 (10 tablets) of contiguous cell packs with instructions for use are placed in a pack of cardboard.

    1200 (20 tablets) of contoured cell packs with an equal number of instructions for use are placed in a cardboard box (for hospitals).

    Storage conditions:

    Keep in dry the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    4 years.

    After expiration date the drug should not be used.

    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-007460/10
    Date of registration:30.07.2010 / 17.10.2013
    The owner of the registration certificate:IRBITSK HFZ, OJSC IRBITSK HFZ, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp16.02.2016
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