Active substanceDrotaverineDrotaverine
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  • Dosage form: & nbsppills
    Composition:

    Composition per one tablet.

    Active substance:

    Drotaverina hydrochloride - 0.04 g

    Excipients

    lactose monohydrate (sugar milk) - 0.0700 g

    potato starch - 0.0216 g

    Povidone K-30 0.0042 g

    crospovidone - 0.0014 g

    talc - 0.0014 g

    magnesium stearate - 0.0014 g

    Description:Tablets of yellow with a greenish shade of color, flat-cylindrical, with a facet, marked "R" on one side or without it.
    Pharmacotherapeutic group:Spasmolytic agent
    ATX: & nbsp

    A.03.A.D.02   Drotaverine

    Pharmacodynamics:

    Myotropic antispasmodic, isoquinoline derivative. By chemical structure and pharmacological properties close to papaverine, but has a stronger and prolonged action. Reduces the intake of calcium ions in the smooth muscle cells (inhibits phosphodiesterase, leads to the accumulation of intracellular cyclic adenosine monophosphate). 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-holinoblokatorov (closed angle glaucoma, prostatic hyperplasia) are contraindicated.

    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. The maximum concentration in blood plasma is 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 in diseases of the bile ducts: cholecystolithiasis, cholangiolithiasis, cholecystitis, pericholecystitis, cholangitis, inflammation of the papilla of the duodenum.

    Spasm of smooth muscles in diseases of the urinary tract: nephrourolythiasis, urethrolithiasis, pyelitis, cystitis, bladder spasm.

    As an auxiliary therapy: with spasms of smooth muscles of the gastrointestinal tract: gastric ulcer and duodenal ulcer, gastritis,spasm of cardia and pylorus, enteritis, colitis, spastic colitis with constipation and irritable bowel syndrome with flatulence; 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 research (incl. cholecystography.
    Contraindications:

    Hypersensitivity to the components of the drug, pronounced hepatic, renal failure, lactation period, children under 3 years of age, galactose intolerance, lactase deficiency, glucose-galactose malabsorption.

    Carefully:

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

    Pregnancy and lactation:

    Controlled studies in pregnant women have not been conducted, but the potential benefit can justify the use of drotaverine for the mother, despite the possible risk to the fetus. Contraindicated during breastfeeding.

    Dosing and Administration:

    Adults, inside of 40-80 mg (1-2 tablets) 2-3 times a day.

    Children, inside at the age of 3-6 years - 40-120 mg in 2-3-admission, the maximum daily dose - 120 mg; 6-18 years - 80-200 mg in 2-5 receptions, the maximum daily dose - 240 mg.

    Side effects:

    Dizziness, headache, insomnia, palpitations, tachycardia, fever, increased sweating, nausea, constipation, lowering of blood pressure, allergic skin reactions, angioedema, hives, rash, itching.

    Overdose:

    Symptoms: exceeding doses violates atrioventricular 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. Phenobarbital increases the severity of spasmolytic action of drotaverine.Reduces the spasmogenic activity of morphine.

    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:

    By 10, 14, 20, 50 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered or paper packaging.

    2, 5 contour cell packs of 10 tablets labeled "R" or 2 contour packs of 14 tablets labeled "R" with instructions for use are placed in a pack of cardboard.

    2, 5 contour squares for 10 tablets without "R" labeling or 2 contour packs for 14 tablets without "R" labeling, with instruction for use put in a pack of cardboard.

    20 out-of-round cell packs of 10 tablets without labeling "R" with an equal number of instructions for use are placed in a pack of cardboard.

    Contourcell packagings of 10, 20, 50 tablets without labeling "R" with an equal number of instructions for use are placed in a group package.
    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 printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LS-002398
    Date of registration:07.02.2011 / 19.05.2015
    The owner of the registration certificate:UPDATE OF PFC, CJSC UPDATE OF PFC, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp27.01.2016
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