Active substanceDrotaverineDrotaverine
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  • Dosage form: & nbsppills
    Composition:

    1 the tablet contains:

    Active substance: drotaverina hydrochloride (in terms of 100 % substance) - 40 mg;

    Excipients: lactose monohydrate (sugar milk), calcium stearate, carboxymethyl starch sodium (primogel), potato starch.

    Description:Tablets of yellow with a greenish shade of color, rounded biconvex.
    Pharmacotherapeutic group:Spasmolytic agent
    ATX: & nbsp

    A.03.A.D.02   Drotaverine

    Pharmacodynamics:

    Myotropic antispasmodic, isoquinoline derivative. The chemical structure and pharmacological properties are close to papaverine, but it has a stronger and longer action. Reduces the flow of calcium ions into smooth muscle cells (inhibits phosphodiesterase, leads to the accumulation of intracellular cyclic adenosine monophosphoric acid).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 muscle can be used as an antispasmodic in cases when drugs from the group of m-holinoblockers are contraindicated (closed-angle glaucoma, prostatic hyperplasia).

    Pharmacokinetics:

    When taken orally, absorption is high, the half-absorption period is 12 min. Bioavailability - 100 %. Evenly distributed on the tissues, penetrates into the smooth muscle cells. Time to reach the maximum concentration in the blood - 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.

    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.

    - Dysmenorrhea, threatening miscarriage, threatening premature birth.


    In carrying out some instrumental studies, cholecystography.
    Contraindications:

    Hypersensitivity, marked hepatic and renal failure, lactation period, children under 12 years of age, lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

    Carefully:

    Pronounced atherosclerosis of the coronary arteries, prostatic hyperplasia, angle-closure glaucoma, pregnancy.

    Dosing and Administration:

    Adults prescribe inside for 40-80 mg (1-2 tablets) 2-3 times a day, children over 12 years: 40 mg (1 tablet) 1-2 times a day.

    Side effects:Dizziness, headache, insomnia, palpitation, lowering blood pressure, feeling hot, sweating, nausea, constipation, allergic skin reactions.
    Overdose:

    Symptoms: in large doses violates atrial-ventricular conduction, reduces the excitability of the heart muscle, can cause heart failure and respiratory center depression.

    Treatment: the patient should be under the careful supervision of a physician and receive symptomatic and supportive treatment.It is recommended to induce vomiting and / or rinse the stomach.

    Interaction:

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

    Strengthens the effect of papaverine, bendazole and other antispasmodics (including m-holinoblokatorov), lowering arterial pressure caused by tricyclic antidepressants, quinidine and procainamide.

    Reduces the spasmogenic activity of morphine.

    Phenobarbital increases the severity of spasmolytic action of drotaverine.

    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.

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

    10 tablets per contour cell pack.

    For 20 tablets in cans of polymer type BP.

    Each jar or 2 contour squares with instructions for use are placed in a cardboard pack.

    By 100 contour cell packs with an equal number of instructions for use in a cardboard box.

    Storage conditions:

    In a dry, protected from light 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 expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:P N003583 / 01
    Date of registration:13.04.2009
    The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp16.06.2016
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