Active substancePapaverinePapaverine
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  • Dosage form: & nbspinjection
    Composition:

    active substance: papaverine hydrochloride 20 mg / ml;

    Excipients: disodium edetate (Trilon B, ethylenediaminetetraacetic acid disodium salt), methionine, water for injection.

    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:

    Spasmolytic agent, has antihypertensive effect.

    Inhibits phosphodiesterase, causes accumulation in the cell of cyclic adenosine monophosphate and a decrease in the calcium content; reduces tone and relaxes the smooth muscles of the internal organs (gastrointestinal tract and genitourinary system) and vessels. In large doses reduces the excitability of the heart muscle and slows intracardiac conduction.

    The effect on the central nervous system is poorly expressed (in large doses a sedative effect is exerted).
    Pharmacokinetics:

    Bioavailability on average - 54%. The connection with plasma proteins is 90%. Distributed in the body, it penetrates through the histohematological barriers. Metabolised in the liver. The half-life is 0.5-2 hours (may extend to 24 hours). It is excreted by the kidneys in the form of metabolites. Completely removed from the blood during hemodialysis.

    Indications:

    Spasm of smooth muscles: abdominal organs (cholecystitis, pilorospasm, spastic colitis); renal colic; peripheral vessels of the lower extremities (endarteritis); vessels of the brain.

    As an auxiliary medicine for premedication.
    Contraindications:

    Hypersensitivity, atrioventricular blockade, glaucoma, severe hepatic insufficiency, advanced age (risk of hyperthermia), children's age (up to 6 months).

    Carefully:

    Condition after traumatic brain injury, chronic renal failure, adrenal insufficiency, hypothyroidism, prostatic hyperplasia, supraventricular tachycardia, shock states.

    Pregnancy and lactation:

    During pregnancy and during breastfeeding the drug is recommended to be used only when the expected benefit exceeds the potential risk.

    Dosing and Administration:

    Subcutaneously, intramuscularly - 1-2 ml of a solution of 20 mg / ml 2-4 times a day; intravenously slowly - 20 mg with preliminary dilution in 10-20 ml of 0.9% sodium chloride solution.

    The maximum single dose for children aged 6 months to 1 year is 1 mg, from 1 year to 12 years, the maximum single dose of 0.2 mg / kg body weight.

    Side effects:

    From the cardiovascular system: atrioventricular blockade, ventricular extrasystole, lowering of arterial pressure.

    On the part of the hematopoiesis system: eosinophilia.

    From the side of the liver: increased activity of "liver" transaminases.

    From the gastrointestinal tract: constipation.

    From the central nervous system: drowsiness.

    Allergic reactions: skin itch, skin rash, hives.

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

    Papaverin reduces the antiparkinsonian effect of levodopa and the hypotensive effect of methyldopa.

    In combination with barbiturates, the spasmolytic effect of papaverine is enhanced.

    When combined with tricyclic antidepressants, procainamide, reserpine, quinidine, an increase in the hypotensive effect of papaverine is possible.

    Special instructions:

    Intravenous should be administered slowly, under the supervision of a doctor. During the treatment period, ethanol intake should be excluded. The vasodilating effect is reduced by smoking.

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

    During treatment, it is necessary to abandon the management of vehicles or potentially dangerous mechanisms, since the drug may cause drowsiness.

    Form release / dosage:

    Solution for injection 20 mg / ml.

    Packaging:

    2 ml or 10 ml into neutral glass ampoules.

    By 10 ampoules, together with instructions for use and a knife for opening ampoules or a scarifier ampullum are placed in boxes of cardboard.

    5 ampoules (for ampoules of 2 ml) into a contour mesh package made of polyvinylchloride film EP-73 and foil of aluminum printed lacquered, or without foil.

    2 contoured cell packs 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 incisions, rings and break points, a scarifier ampoule or a knife for opening ampoules is not inserted.

    Storage conditions:

    List B. In the dark place.

    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 N002255 / 01
    Date of registration:19.01.2009
    The owner of the registration certificate:DALHIMFARM, OJSC DALHIMFARM, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp21.08.2015
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