Active substanceDrotaverineDrotaverine
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  • Dosage form: & nbspinjection
    Composition:

    In 1 ampoule contains active substance: drotaverina hydrochloride - (in terms of 100% substance) - 40 mg.

    Excipients: sodium disulfite - 2 mg, ethyl alcohol 95% - 132 mg, water for injection up to 2 ml.

    Description:

    Transparent liquid from light yellow to intensely yellow color or from greenish-yellow to intensely yellow with a greenish tinge.

    Pharmacotherapeutic group:Spasmolytic agent
    ATX: & nbsp

    A.03.A.D.02   Drotaverine

    Pharmacodynamics:

    Myotropic antispasmodic. 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 cAMP). Reduces the tone of smooth muscles of internal organs and intestinal motility, dilates blood vessels.Does not affect the vegetative - nervous system, does not penetrate into the central 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-cholinoblockers are contraindicated (closed-angle glaucoma, prostatic hyperplasia).

    With parenteral administration, the drug appears in 2-4 minutes. The maximum effect occurs in 30 minutes.

    Pharmacokinetics:Evenly distributed on the tissues, penetrates into the smooth muscle cells. The connection with plasma proteins is 95-98%. Half-life is 2-4 hours. 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 chronic gastroduodenitis, chronic cholecystitis, cholelithiasis, postcholecystectomy syndrome, peptic ulcer and duodenal ulcer, cardio- and pilorospasm, spastic colitis; spasm of peripheral arterial vessels, cerebral vessels, renal colic, algodismenorea, to reduce uterine contractions and to relieve spasm of the cervix during labor, during instrumental research.

    Contraindications:

    Individual intolerance; expressed hepatic, renal, heart failure; AV-blockade II-III degree, cardiogenic shock, arterial hypotension.

    Carefully:With caution - pronounced arteriosclerosis of the coronary arteries, prostatic hyperplasia, glaucoma, pregnancy and lactation.
    Dosing and Administration:

    Intramuscularly or subcutaneously, 2-4 ml 1 - 3 times a day. Duration of treatment is 1-2 weeks. If necessary, prolonged treatment is transferred to taking the drug inside.

    In cases where a rapid effect is needed, 2-4 ml of the drug is administered intravenously slowly in 10-20 ml of 0.9% isotonic sodium chloride solution or 5% dextrose solution.

    Children under 6 years are usually administered at a dose of 10-20 mg 1-2 times a day, children older than 6 years - in a dose of 20 mg 1-2 times a day.

    Side effects:

    Dizziness, palpitation, lowering blood pressure, feeling hot, sweating, allergic skin reactions.

    With iv introduction - collapse, AV blockade, arrhythmia, oppression of the respiratory center.

    Overdose:

    In large doses violates atrioventricular conduction, reduces the excitability of the heart muscle, can cause heart failure and respiratory center paralysis.

    Interaction:

    With simultaneous application can weaken the antiparkinsonian effect of levodopa.

    Strengthens the action 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 the spasmolytic effect of drotaverine hydrochloride.

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

    Avoid driving the car and doing other activities that require high concentration of attention, speed of psychomotor reactions within 1 hour after parenteral (especially IV) administration.

    Form release / dosage:Solution for injection 2%.
    Packaging:

    Solution for injection 2% in ampoules of light-protective glass 2 ml each. 5 ampoules in the outline of the cell. 1, 2, 3, 4, 5 contour mesh packages together with instructions for use and a scarifier or knife ampoule in a pack of cardboard. When using ampoules with notches, the scarifier ring or the ampoule knife is not inserted.

    Storage conditions:

    In the dark place at a temperature of 15 to 25 ° C.

    Keep out of the reach of children.

    Shelf life:4 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:P N000335 / 01
    Date of registration:14.07.2008 / 28.11.2014
    The owner of the registration certificate:BRYNTSALOV-A, CJSC BRYNTSALOV-A, CJSC Russia
    Manufacturer: & nbsp
    FERIN, SAAO Republic of Belarus
    Information update date: & nbsp21.01.2016
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