Active substancePapaverinePapaverine
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  • Dosage form: & nbspsolution for intravenous and intramuscular administration
    Composition:

    1 ml of the solution contains:

    active substance: papaverine hydrochloride 20 mg

    Excipients: disodium edetate (Trilon B) 0.05 mg, methionine 0.1 mg, water for injection up to 1 ml.
    Description:

    Transparent lightly colored liquid.

    Pharmacotherapeutic group:Spasmolytic agent.
    ATX: & nbsp

    A.03.A.D   Papaverine and its derivatives

    A.03.A.D.01   Papaverine

    Pharmacodynamics:

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

    Pharmacokinetics:Adsorption depends on the dosage form. Bioavailability on average - 54%. The connection with plasma proteins is 90%. Well distributed, penetrates through the histohematological barriers. Metabolised in the liver. T1 / 2 - 0,5-2 hours (can extend up to 24 hours). It is excreted by the kidneys in the form of metabolites. Completely removed from the blood during hemodialysis.
    Indications:

    Spasms of smooth muscles of abdominal cavity organs, 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; age up to 1 year; hypersensitivity to the drug. Glaucoma, severe hepatic insufficiency, elderly age (risk of hyperthermia development).

    Carefully:

    Conditions after traumatic brain injury, chronic renal failure, insufficiency of adrenal function, 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:

    The drug is administered intramuscularly or intravenously. 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. Intravenous administration is performed by diluting 2 % solution of the preparation 10-20 ml isotonic sodium chloride solution. For children aged 1 to 12 years, the maximum single dose is 0.3 mg / kg body weight.

    Side effects:

    Possible: allergic reactions, lower blood pressure, increased activity of "liver" transaminases, eosinophilia, drowsiness, headache, nausea, constipation, increased sweating. With rapid intravenous administration, as well as with the use of high doses, it is possible to develop atrioventricular blockade, a violation of the heart rhythm.

    Overdose:

    Diplopia, weakness, lowering blood pressure, drowsiness.

    Treatment: symptomatic (maintaining blood pressure).

    Interaction:

    Papaverin reduces the aitiparkinsonic effect of levodopa, reduces the hypotensive effect of methyldopa.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 of the drug is not established.

    Form release / dosage:

    A solution for intravenous and intramuscular administration of 20 mg / ml.

    Packaging:

    2 ml per ampoule polymer from high-density polyethylene or from low-pressure polyethylene, or from polyethylene for medical purposes, or from polyethylene or polypropylene for infusion solutions and injections.

    For polymer ampoules, labels from label paper, writing or label text are applied directly to the ampoule by a polymer method of drop-jet printing.

    For 10, 100 ampoules of polymer with instructions for use are placed in a pack of cardboard.

    Storage conditions:

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

    Keep out of the reach of children.

    Shelf life:3 years.
    Do not use after the expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-008983/08
    Date of registration:17.11.2008
    The owner of the registration certificate:UPDATE OF PFC, CJSC UPDATE OF PFC, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp22.08.2015
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