Active substanceDrotaverineDrotaverine
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  • Dosage form: & nbspinjection
    Composition:

    One ampoule (2 ml of solution) contains 40 mg of drotaverine hydrochloride as the active substance.

    Excipients: sodium metabisulphite (sodium disulphite), ethyl alcohol (ethanol), water for injection.

    Description:

    Transparent solution from light yellow to intensely yellow color. A greenish shade is allowed.

    Pharmacotherapeutic group:Spasmolytic agent
    ATX: & nbsp

    A.03.A.D.02   Drotaverine

    Pharmacodynamics:

    Myotropic antispasmodic. Reduces the flow of calcium ions into smooth muscle cells (inhibits phosphodiesterase, leads to the accumulation of intracellular cAMP). 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 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 blood 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; marked hepatic, renal, heart failure; atrioventricular block II-III degree; cardiogenic shock; arterial hypotension.

    Carefully:Pronounced atherosclerosis of the coronary arteries, prostatic hyperplasia, glaucoma, pregnancy and lactation.
    Dosing and Administration:

    Intramuscularly or subcutaneously, 2-4 ml (40-80 mg) 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 required, 2-4 ml (40-80 mg) of the drug is injected slowly into 10-20 ml of a 0.9% 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 intravenous injection - collapse, atrioventricular blockade, arrhythmias, oppression of the respiratory center. With rapid intravenous injection, nausea and vomiting may occur.

    Overdose:

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

    Interaction:

    With simultaneous application 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 the spasmolytic effect of drotaverine hydrochloride.

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

    Avoid driving and caring for other activities that require high concentration of attention, speed of psychomotor reactions during 1 h after parenteral (especially intravenous) administration.

    Form release / dosage:Solution for injection 20 mg / ml.
    Packaging:

    Solution for injection 20 mg / ml in ampoules of light-protective glass 2 ml each.

    5 ampoules per contour cell box (pallet).1, 2 or 4 contour squares (pallet) with instructions for use are placed in a box or a pack of cardboard.

    When using ampoules with incisions or a fracture ring, a scarifier ampoule or a knife for opening ampoules is not inserted.

    Storage conditions:

    List B. In a dry, the dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

    Shelf life:

    2 years. Do not use after the expiration date stated on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-001103/08
    Date of registration:27.02.2008
    The owner of the registration certificate:BIOMED them. I.I.Mechnikova, OJSC BIOMED them. I.I.Mechnikova, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp16.06.2016
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