Active substanceDrotaverineDrotaverine
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  • Dosage form: & nbsppills
    Composition:

    1 tablet contains drotaverina hydrochloride - 80 mg,

    auxiliary substances: sugar milk (lactose), potato starch, talcum, magnesium stearate, microcrystalline cellulose, sodium croscarmellose (impellose).

    Description:

    Tablets are yellow with a greenish tint of color, biconvex, oblong with rounded ends with a risk.

    Pharmacotherapeutic group:Spasmolytic agent
    ATX: & nbsp

    A.03.A.D.02   Drotaverine

    Pharmacodynamics:

    Myotropic antispasmodic. The chemical structure and pharmacological properties of the drug is close to papaverine, but it has a stronger and longer action. Reduces the intake of calcium ions in 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. The presence of direct influence on smooth muscles 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 is 100%. Evenly distributed in tissues, penetrates smooth muscle cells. Time to reach the maximum concentration of the drug in the blood plasma (TSmAh) - 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 (dyskinesia of bile ducts and gall bladder by hyperkinetic type, cholecystitis, postcholecystectomy syndrome); pyelitis; spastic constipation, spastic colitis, proctitis, tenesmus; pilorospazm, gastroduodenitis, peptic ulcer of the stomach and duodenum (in the phase of exacerbation,in the complex therapy - for a pain relief syndrome of a spastic character). Spasm of peripheral, cerebral arteries. Algodismenorea.

    Contraindications:

    Hypersensitivity, marked hepatic and renal insufficiency; lactation period, children under 12 years.

    Intolerance to galactose, deficiency of lactase or glucose-galactose malabsorption.

    Carefully:

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

    Dosing and Administration:

    Inside, children over 12 years - 40 mg 3 times a day, adults - 40-80 mg 3 times a day. The maximum daily intake for adults is 240 mg.

    Side effects:

    Dizziness, palpitation, a feeling of heat, increased sweating, lowering blood pressure, allergic skin reactions.

    Overdose:

    Symptoms: in large doses violates the atrioventricular conductivity, reduces the excitability of the heart muscle, can cause cardiac arrest and paralysis of the respiratory center.

    Symptomatic treatment: Activated carbon, intravenously sodium bicarbonate solution for lactic acidosis, intravenous fluids for maintenance of intravascular volume, calcium can be used at the occurrence of undesirable cardiovascular effects, dopamine as a vasopressor. When ventricular arrhythmias occur, treatment of arrhythmia; with bradycardia, a calcium solution can be used, atropine, isoproterenol, or the driver of heart rhythm with ineffectiveness of other agents.

    Interaction:

    With simultaneous application drotaverine can weaken the antiparkinsonian effect of levodopa. Strengthens the effect of papaverine, bendazole and other antispasmodics (including m-holinoblokatorov), increases the reduction in arterial pressure caused by tricyclic antidepressants, quinidine and procainamide. Reduces the spasmogenic activity of morphine. Phenobarbital increases the severity of spasmolytic action of drotaverine.

    Special instructions:

    When treating peptic ulcer and duodenum drotaverine apply 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 motor vehicles and practicing other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions (within 1 h after taking).
    Form release / dosage:

    Tablets 80 mg.

    Packaging:

    By 5, 10, 14 or 20 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

    For 1, 2, 3, 4, 5 or 6 contour squares, together with the instructions for use, are placed in a pack of cardboard.

    For 10, 14 or 20 tablets are placed in a can of polymer with a lid or a glass jar with a lid. On cans stick labels from paper label. Banks along with the instructions for use are placed in a pack of cardboard.

    Storage conditions:

    Store in a dry, dark place at a temperature of no higher than 25 ° C. Keep out of 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:LSR-009167/09
    Date of registration:13.11.2009
    The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp16.06.2016
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