Active substanceDrotaverineDrotaverine
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  • Dosage form: & nbspinjection
    Composition:

    Active substance

    Drotaverina hydrochloride - 20.0 g

    in terms of absolutely dry matter

    Excipients

    Sodium disulphite 1.0 g

    Ethanol 95% - 66.0 g

    Water for injection - up to 1000 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:

    Spasmolytic of myotropic action. On the chemical structure and pharmacological action is close to papaverine, but has a stronger and longer action. Reduces the flow of ionized active calcium into smooth muscle cells by inhibiting phosphodiesterase and intracellular accumulation of cAMP. Reduces the tone and motor activity of the smooth muscles of the internal organs, dilates the blood vessels.Does not affect the autonomic nervous system and does not penetrate the central nervous system.

    Pharmacokinetics:

    With parenteral administration, the drug appears after 2-4 minutes. The maximum effect occurs in 30 minutes. It is released from the connection with plasma proteins gradually, providing a lasting effect. The elimination half-life is 2-4 hours. Metabolism is carried out in the liver, most of the metabolites are excreted by the kidneys.

    Indications:

    For the prevention and treatment of functional conditions and pain syndrome associated with spasm of smooth muscles in chronic gastroduodenitis, chronic cholecystitis, cholelithiasis, postcholecystectomy syndrome, peptic ulcer and duodenal ulcer, cardio- and pilorospasm, spastic colitis. They are also used for spasms of peripheral arterial vessels, cerebral vessels, renal-stone disease (renal colic), algodismenere, to reduce uterine contractions and to cervical spasm at delivery, while carrying out instrumental studies.

    Contraindications:

    Individual intolerance; marked hepatic, renal and heart failure; AV-blockade II- III degree.

    Carefully:

    With caution apply for severe atherosclerosis of the coronary arteries, prostate adenoma, glaucoma, arterial hypotension.

    Pregnancy and lactation:

    Use during pregnancy is recommended only after a careful weighing of the ratio of benefit and risk. Due to the lack of special studies during lactation, it is not recommended to prescribe the drug.

    Dosing and Administration:

    Intramuscularly or subcutaneously - 2-4 ml (40-80 mg) 1-3 times a day. A course of treatment - 2 weeks or more. If necessary, prolonged treatment is transferred to taking the drug inside.

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

    Children under the age of 6 years are prescribed a single 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.

    Do not mix in one syringe with a solution of euphyllin.

    Side effects:

    Dizziness, headache, insomnia, palpitation, arrhythmia, arterial hypotension, a feeling of heat, sweating, the development of allergic dermatitis, constipation. At intravenous introduction - a nausea and vomiting, a collapse.

    Overdose:

    Overdose may increase the side effects.

    Treatment: symptomatic.

    Interaction:

    With simultaneous application drotaverine can reduce the antiparkinsonian effect of levodopa.

    Special instructions:In the treatment of gastric ulcer and duodenal ulcer are used in combination with other antiulcer drugs. When administered intravenously, the patient should be in a horizontal position (risk of collapse).
    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 hour after intravenous administration).

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

    2 ml per ampoule of light-protective glass.

    5 ampoules are placed in a contour mesh package (with foil or paper, or without foil or paper).

    1, 2 or 5 contour mesh packages are placed in a pack of cardboard.

    10 ampoules are placed in a pack of cardboard with a loose leaf of paper or with special pockets.

    In each pack you put the instruction on application and scarifier.

    When using ampoules with notches, rings and dots, the scarifier is not put into the pack.

    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 expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:P N001472 / 01
    Date of registration:15.01.2009 / 26.12.2013
    The owner of the registration certificate:VIFITEH, CJSC VIFITEH, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp16.06.2016
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