Active substancePapaverinePapaverine
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  • Dosage form: & nbspinjection
    Composition:

    Active substance:

    papaverine hydrochloride - 20 grams

    Excipients: disodium edetate (disodium salt ethylenediaminetetraacetic acid, trilon B) 0.05 g, methionine 0.1 g, water for injection up to 1 l.

    Description:

    Transparent, slightly colored liquid.

    Pharmacotherapeutic group:Spasmolytic agent.
    ATX: & nbsp

    A.03.A.D   Papaverine and its derivatives

    A.03.A.D.01   Papaverine

    Pharmacodynamics:

    Reduces the tone of smooth muscles and therefore has a vasodilating and spasmolytic effect. It is an inhibitor of the enzyme phosphodiesterase, causes intracellular accumulation of cyclic 3,5-adenosine monophosphate and a decrease in the calcium content, which leads to a violation of contractility of smooth muscles and their relaxation during spastic conditions. The effect of papaverine on the central nervous system is poorly expressed, only in large doses it has a slight sedative effect.In large doses reduces the excitability of the heart muscle and slows intracardiac conduction.

    Pharmacokinetics:

    It penetrates through the histohematological barriers. The connection with proteins is 90%. Metabolised in the liver. The half-life is 0.5-2 hours. It is excreted by the kidneys (in the form of metabolites). It is in hemodialysis.

    Indications:

    Spasms of smooth muscles of the abdominal cavity organs, bronchi, peripheral vessels and vessels of the brain, urinary tract, renal colic. It is used as an aid for premedication.

    Contraindications:

    Comatose state, respiratory depression, violation of atrioventricular conduction, glaucoma, severe hepatic insufficiency, elderly age (risk of hyperthermia), children under 6 months of age, hypersensitivity to the drug components.

    Carefully:

    Condition after cerebrospinal trauma, chronic renal failure, failure of function adrenal glands, hypothyroidism, prostatic hyperplasia, supraventricular tachycardia, shock states.

    Pregnancy and lactation:In pregnancy and lactation, the safety of the drug is not established.
    Dosing and Administration:

    Intramuscularly, subcutaneously or intravenously. A single dose for adults is 20-40 mg (1-2 ml of a solution of 20 mg / ml); the interval between administrations is not less than 4 hours. Intravenous administration is made by diluting a solution of papaverine (20 mg / ml) 10-20 ml of isotonic sodium chloride solution. For elderly patients, the initial single dose should not exceed 10 mg. For children aged 6 months to 12 years, the maximum single dose is 0.3 mg / kg body weight.

    Side effects:

    There may be allergic reactions, atrio-ventricular blockade, ventricular extrasystole, drowsiness, headache, nausea, constipation, increased sweating, lowering of blood pressure, increased activity of "liver" transaminases, eosinophilia; redness, swelling, or pain at the injection site.

    Overdose:

    Symptoms: diplopia, weakness, lowering blood pressure, drowsiness. Treatment: symptomatic (maintenance of arterial pressure).

    Interaction:

    Papaverin reduces the antiparkinsonian effect of levodopa. In combination with barbiturates, the spasmolytic effect of papaverine hydrochloride is enhanced.When combined with tricyclic antidepressants, procainamide, reserpine, quinidine sulfate, hypotensive effect may be enhanced.

    Special instructions:

    Intravenously, the drug should be administered slowly and under the supervision of a doctor. During the treatment period, alcohol intake should be excluded.

    In pregnancy and lactation, the safety of the drug is not established.

    The vasodilating effect is reduced by smoking.

    Form release / dosage:

    Solution for injection 20 mg / ml in ampoules of 2 ml.

    Packaging:

    For 10 ampoules together with the instruction for use and a knife ampoule or scarifier ampoule in boxes or packs of cardboard.

    Storage conditions:

    List B. At a temperature of 17 to 25 ° C, in a place protected from light and inaccessible to 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:P N000503 / 01
    Date of registration:27.04.2012
    The owner of the registration certificate:VEROPHARM SA VEROPHARM SA Russia
    Manufacturer: & nbsp
    Information update date: & nbsp21.08.2015
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