Active substancePapaverinePapaverine
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  • Dosage form: & nbspinjection
    Composition:

    1 ml of the solution contains: papaverine hydrochloride - 20 mg.

    Excipients: disodium edetate (disodium ethylenediaminetetraacetic acid) - 0.05 mg, L-methionine (methionine) - 0.1 mg, water for injection - up to 1 ml.

    Description:Transparent liquid with a greenish-yellow hue.
    Pharmacotherapeutic group:Spasmolytic agent.
    ATX: & nbsp

    A.03.A.D   Papaverine and its derivatives

    A.03.A.D.01   Papaverine

    Pharmacodynamics:

    Papaverine hydrochloride is a myotropic antispasmodic. Reduces the tone and reduces the contractile activity of smooth muscles and therefore has a vasodilating and spasmolytic effect. It causes an enlargement of the arteries, promotes an increase in blood flow, incl. cerebral. When used in moderate therapeutic doses of papaverine, the hydrochloride has little effect on the central nervous system. In large doses reduces the excitability of the heart muscle and slows intracardiac conduction.It is an inhibitor of the enzyme phosphodiesterase and causes intracellular accumulation of cyclic 3,5-adenosine monophosphate, which leads to a violation of contractility of smooth muscles and their relaxation during spastic states.

    Indications:

    Spasms of cerebral vessels, peripheral vessels (endarteritis, etc.); angina pectoris (as part of complex therapy), cholecystitis, pilorospasm, spastic colitis, spasms of the urinary tract, renal colic, bronchospasm.

    It is used as an aid in premedication.

    Contraindications:

    Hypersensitivity, coma, respiratory depression, violation of atrioventricular conduction, glaucoma, impaired liver function, advanced age (risk of hyperthermia), children's age (up to 1 year).

    Carefully:

    With caution and in small doses, the drug should be prescribed for elderly and debilitated patients, as well as for patients with craniocerebral trauma, impaired renal function, hypothyroidism, adrenal insufficiency, prostatic hypertrophy, and patients with supraventricular tachycardia and who are in shock.

    Pregnancy and lactation:In pregnancy and lactation, the safety and efficacy of the drug is not established.
    Dosing and Administration:The drug is administered subcutaneously, intramuscularly and intravenously. Under the skin and intramuscularly inject 1 to 2 ml of solution 2-4 times at day. Intravenous - 1 - 2 ml of 2% solution with preliminary dilution at 10-20 ml isotonic sodium chloride solution. It should be administered very slowly and cautiously, given that the drug can cause the development of an atrioventricular block, ventricular extrasystoles and ventricular fibrillation.
    A single dose for adults is 0.02-0.04 g (1-2 ml of a 2% solution); the interval between administrations is not less than 4 hours. For elderly patients, the initial single dose should not exceed 0.01 g. For children from 1 year to 12 years, the maximum single dose is 0.3 mg / kg body weight.

    Side effects:

    Possible allergic reactions, nausea, drowsiness, lower blood pressure, constipation, increased blood levels of transaminases, eosinophilia, increased sweating. With rapid intravenous administration, as well as with the application of high doses, it is possible to develop atrioventricular blockade, violation of the heart rate.

    Overdose:

    Symptoms: visual impairment (double vision), weakness, drowsiness, hypotension.

    Treatment: gastric lavage (milk, Activated carbon), maintenance of arterial pressure.

    Interaction:

    Papaverine hydrochloride reduces the antiparkinsonian effect of levodopa. In combination with barbiturates, the spasmolytic effect of papaverine hydrochloride is enhanced. When combined with tricyclic antidepressants, novocainamide, 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 and efficacy of the drug is not established. It should be borne in mind that the effectiveness of the drug is reduced by smoking.
    Form release / dosage:

    Solution for injection 20 mg / ml.

    Packaging:

    2 ml each into neutral glass ampoules of grade НС-1 or НС-3.

    5 ampoules per contour cell packaging made of polyvinyl chloride film.

    2 contour squares in a pack of cardboard.

    10 ampoules per box of cardboard.

    Each instruction pack and box is supplied with instructions for use, an ampoule knife or a scarifier (when packing ampoules with a kink ring, notches and dots, the ampoule knife or scarifier does not insert).

    Storage conditions:List B. In 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.
    Terms of leave from pharmacies:On prescription
    Registration number:P N001069 / 01
    Date of registration:06.02.2009
    The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp21.08.2015
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