Active substancePapaverinePapaverine
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  • Dosage form: & nbspinjection
    Composition:

    Composition per ml:

    Active substance: papaverine hydrochloride 20.0 mg

    Excipients: disodium edetate - 0.05 mg, methionine - 0.1 mg, water for injection - up to 1.0 ml

    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:

    Papaverin lowers the tone of smooth muscles and therefore has a vasodilating and spasmolytic effect. It is an inhibitor of the enzyme phosphodiesterase. It causes intracellular accumulation of cyclic 3,5-adenosine monophosphate and a decrease in the content of calcium ions, which leads to relaxation of the smooth muscles of the internal organs (gastrointestinal tract, respiratory and genitourinary system) and vessels. The effect of papaverine on the central nervous system is poorly expressed, but in large doses it has a sedative effect.In large doses reduces the excitability of the heart muscle and slows intracardiac conduction.

    Pharmacokinetics:

    Bioavailability on average - 54%. The connection with plasma proteins is 90%. Well distributed, penetrates through the histohematological barriers. Metabolised in the liver. The half-life (T1/2) - 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 of the abdominal cavity organs, bronchi, peripheral vessels and vessels of the brain, urinary tract, renal colic. As an auxiliary medicine for premedication.

    Contraindications:

    Increased sensitivity to the drug, impaired atrioventricular conduction, glaucoma, severe liver failure, coma, respiratory depression, advanced age (risk of hyperthermia), children up to 6 months.

    Carefully:

    Conditions after traumatic brain injury, chronic renal failure, insufficiency of adrenal function, 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 for the mother exceeds the potential risk for the fetus / child.

    Dosing and Administration:

    Intramuscularly, subcutaneously or intravenously. Single dose for adults and children from 12 years is 20.0 - 40.0 mg (1-2 ml of a solution of 20.0 mg / ml); the interval between administrations is not less than 4 hours. Intravenous administration is made by diluting the solution of papaverine (20.0 mg / ml) 10-20 ml of isotonic sodium chloride solution. 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, lowering of arterial pressure, ventricular extrasystole, drowsiness, headache, nausea, constipation, increased sweating, increased activity of "liver" transaminases, eosinophilia.

    With rapid intravenous administration, it is possible to develop atrioventricular blockade, cardiac rhythm disturbances.
    Overdose:

    Symptoms: impaired vision (double vision), weakness, lower 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 is possible. With simultaneous use with anticholinergics, anticholinergic effects may be enhanced. With simultaneous use with alprostadil for intracavernous administration, there is a risk of priapism.

    Special instructions:

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

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

    In connection with the possible development of weakness, visual impairment, lowering blood pressure, drowsiness, care should be taken when driving vehicles and engaging in certain activities that require increased concentration of attention and quick motor reaction.

    Form release / dosage:

    Solution for injection 20 mg / ml.

    Packaging:

    2 ml per ampoule of colorless neutral glass type I with a colored break ring or with a colored dot and a notch or without a kink ring, a colored dot and a notch. Ampoules can additionally be applied one, two or three color rings and / or two-dimensional barcode, and / or alphanumeric encoding or without additional color rings, a two-dimensional barcode, alphanumeric encoding.

    5 ampoules per circuit cell packaging made of polyvinylchloride film and aluminum foil foil or polymer film, or without foil and without film. Or 5 ampoules are placed in a prefabricated form (tray) made of cardboard for consumer containers with cells for packing ampoules.

    One or two contour squares or cardboard trays, together with an instruction for use and a scarifier or knife, ampoule, or without a scarifier and a knife ampullum, are placed in a cardboard package (bundle).

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C.

    Do not freeze.

    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:LP-002381
    Date of registration:21.02.2014
    The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp21.08.2015
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