Active substanceDrotaverineDrotaverine
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  • Dosage form: & nbspinjection
    Composition:

    Active substance:

    drotaverina hydrochloride in terms of 100% anhydrous substance - 20 mg

    Excipients:

    sodium disulfite (sodium metabisulphite) - 1 mg;

    ethanol (ethyl alcohol) 95 % - 67 mg;

    disodium edetate (Trilon B) 0.1 mg;

    benzethonium chloride (benzethonium chloride) 0.1 mg;

    sodium sulfite anhydrous - 0.2 mg;

    citric acid - 0.825 mg;

    sodium citrate -1.65 mg;

    water for injection - up to 1 ml.

    Description:Transparent or slightly opalescent liquid from light yellow to greenish-yellow color.
    Pharmacotherapeutic group:Spasmolytic agent
    ATX: & nbsp

    A.03.A.D.02   Drotaverine

    Pharmacodynamics:

    Myotropic antispasmodic. 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, does not penetrate the central nervous system. The presence of a direct effect on smooth muscle can be used as an antispasmodic in cases where drugs from the group of M-holinoblokatorov (closed-angle glaucoma, prostatic hyperplasia) are contraindicated.

    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:

    Spasms of smooth muscles associated with diseases of the biliary tract: cholecystolithiasis, cholangiolithiasis, cholecystitis, pericholecystitis, cholangitis, papillitis. Spasms of smooth muscles of the urinary tract: nephrolithiasis, urethrolithiasis, pyelitis, cystitis, bladder tenesmus.

    As an auxiliary therapy (when the form of tablets can not be used): with spasms of smooth muscles of gastrointestinal origin: peptic ulcer of stomach and duodenum, gastritis, spasms of cardia and pylorus, enteritis, colitis; with gynecological diseases: dysmenorrhea.

    Contraindications:

    - Hypersensitivity to the active substance or to any of the excipients of the drug;

    - severe hepatic or renal insufficiency;

    - severe chronic heart failure;

    - childhood;

    - the period of childbirth;

    - the period of lactation.

    Carefully:Pronounced atherosclerosis of the coronary arteries, prostatic hyperplasia, glaucoma, arterial hypotension, pregnancy.
    Pregnancy and lactation:

    The use of the drug in pregnancy is possible only in the case when the expected benefit for the mother exceeds the risk to the fetus.

    If you need to use the drug during lactation, you must stop breastfeeding.

    Dosing and Administration:

    Adults: The daily average dose is 40-240 mg of drotaverine hydrochloride (divided by 1-3 doses per day) intramuscularly, subcutaneously.In acute colic (renal or cholelithiasis) - 40-80 mg intravenously slowly (duration of administration is approximately 30 sec).

    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 case of an overdose, patients should be under close medical supervision and should be given symptomatic therapy and treatment aimed at maintaining the basic functions of the body.

    Interaction:

    Phosphodiesterase inhibitors like papaverine weaken the antiparkinsonian effect of levodopa. When administering drotaverin simultaneously with levodopa possibly strengthening rehydration and tremor.

    Drotaverin enhances the spasmolytic effect of papaverine, bendazole and other antispasmodics, including m-holinoblokatory.

    Strengthens the hypotension caused by tricyclic antidepressants, quinidine and procainamide.

    Reduces the spasmogenic activity of morphine.

    Phenobarbital enhances the spasmolytic effect of drotaverine.

    Special instructions:

    The drug contains sodium disulfite, which can cause allergic reactions, including anaphylactic symptoms and bronchospasm of sensitive individuals, especially in persons with bronchial asthma or allergic diseases in the anamnesis. In the case of hypersensitivity to sodium, disulfite parenteral use of the drug should be avoided.

    With intravenous administration of the drug, patients with low blood pressure should be in a horizontal position in connection with the risk of collapse.
    Effect on the ability to drive transp. cf. and fur:

    After parenteral (especially intravenous) administration of the drug, it is recommended to refrain from driving management and other activities requiring a high concentration of attention, speed of psychomotor reactions within 1 hour.

    Form release / dosage:

    Solution for injection 20 mg / ml.

    Packaging:

    2 ml into the ampoules of the light-protective glass. For 10 ampoules, together with the instruction for use and the ampoule opening opener or ampoule scarifier, is placed in a cardboard box.

    5 ampoules per contour cell packaging made of polyvinyl chloride film. 2 contour mesh packages together with instructions for use and a knife for opening ampoules or a scarifier ampullum are placed in a pack of cardboard

    When using ampoules with notches, rings and break points, the ampoule opener opener or ampoule scarifier is allowed not to be inserted.

    Storage conditions:

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

    Keep out of the reach of children.

    Shelf life:

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

    Terms of leave from pharmacies:On prescription
    Registration number:LS-002559
    Date of registration:30.12.2011
    The owner of the registration certificate:DALHIMFARM, OJSC DALHIMFARM, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp29.11.2015
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