Active substancePapaverinePapaverine
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  • Dosage form: & nbspinjection
    Composition:

    1 ml of the preparation contains:

    Active substance:

    Papaverine hydrochloride 20 mg

    Excipients:

    Methionine 0.1 mg

    Disodium edetate (Trilon B) 0.05 mg

    Water for injection - up to 1 ml

    Description:

    Transparent colorless or with a weak greenish-yellow liquid tint.

    Pharmacotherapeutic group:Spasmolytic agent.
    ATX: & nbsp

    A.03.A.D   Papaverine and its derivatives

    A.03.A.D.01   Papaverine

    Pharmacodynamics:

    Papaverine reduces the tone of smooth muscles and has a vasodilating and spasmolytic effect. 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. 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 - 54%. The connection with plasma proteins is 90%. The choir is distributed, it penetrates through the histogematic barriers. Metabolised in the liver. The half-life (T1/2 - 0.5 - 2 hours (an increase of up to 24 hours is possible). 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 (cholecystitis, pilorospasm, spastic colitis), bronchi (bronchospasm), peripheral vessels, cerebral vessels, urinary tract (renal colic). As an aid for premedication.

    Contraindications:

    Hypersensitivity to the components of the drug, violation of atrioventricular (AV) conduction, glaucoma, severe hepatic insufficiency, coma, respiratory depression, elderly age (risk of hyperthermia), children's age (up to 6 months).

    Carefully:

    With caution and in small doses, the drug should be given to weakened patients, as well as patients with craniocerebral trauma, impaired renal function, hypothyroidism,insufficiency of adrenal function, prostatic hypertrophy, as well as patients with supraventricular tachycardia and being in a state of shock.

    Pregnancy and lactation:

    During pregnancy and during breastfeeding, the safety and efficacy of the drug is not established. The use of the drug during pregnancy and lactation is possible only according to the doctor's prescription, if the intended benefit for the mother exceeds the potential risk to the fetus or the baby.

    Dosing and Administration:

    The drug is administered intramuscularly, subcutaneously or intravenously.

    A single dose for adults is 20-40 mg (1-2 ml of 20 mg / ml solution), the interval between administrations is at least 4 hours. Intravenous administration is made by diluting a 20 mg / ml solution of the drug 10-20 ml isotonic sodium chloride solution. For children aged 6 months to 12 years, the maximum single dose is 0.3 mg / kg body weight.

    In children aged 12 to 18 years, the dosing regimen corresponds to the dosing regimen in adults.

    The procedure for working with a polymer ampoule:

    1. Take an ampoule and shake it, holding it by the neck.

    2. Press the ampoule with your hand, while there should be no release of the drug,and rotate the movements and turn off the valve.

    3. Through the formed hole, immediately connect the syringe with the ampoule.

    4. Turn the ampoule over and slowly put the contents into the syringe.

    5. Put the needle on the syringe.

    Side effects:

    The frequency of adverse reactions is presented according to the following classification of the World Health Organization (WHO): often 1-10%, infrequently 0.1-1%, rarely 0.01-1.1%, very rarely less than 0.001%, including individual cases.

    From the skin: often - skin rash (usually erythematous, urticaria), infrequently - itching, rarely - excessive sweating.

    From the digestive system: often - nausea, constipation, infrequently - increased activity of "liver" transaminases.

    From the nervous system: often - drowsiness.

    From the cardiovascular system: often - lowering blood pressure, infrequently - ventricular extrasystole.

    From the side of the blood: very rarely - eosinophilia.

    With rapid intravenous administration, as well as with the use of high doses, it is possible to develop atrioventricular blockade, disorders of the heart rhythm.

    Overdose:

    Symptoms: diplopia (double vision), weakness, lowering of blood pressure, drowsiness.

    Treatment: symptomatic (maintenance of arterial pressure).
    Interaction:

    Papaverin reduces the antiparkinsonian effect of levodopa. In combination with barbiturates spasmolytic action of papaverine is enhanced. When combined with tricyclic antidepressants, novocaineamide, reserpine, quinidine, an increase in the hypotensive effect is possible. With simultaneous use with anticholinergics, anticholinergic effects may be enhanced. With the simultaneous use of alprostadil for intracavernous administration, there is a risk of developing priapism. Reduces the hypotensive effect of methyldopa.

    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.

    The effectiveness of the drug is reduced by smoking.

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

    When using the drug, care must be taken when driving vehicles and engaging in potentially dangerous activities requiring increased concentration and speed of psychomotor reactions, since the following side effects are possible: lowering of blood pressure, drowsiness, disturbance of heart rhythm.

    Form release / dosage:

    Solution for injection 20 mg / ml.

    Packaging:

    2 ml per ampoule of low-density polyethylene or polypropylene.

    For 10 ampoules together with instructions for use in a pack of cardboard.

    Storage conditions:

    Store at a temperature not exceeding 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:LP-002903
    Date of registration:12.03.2015
    The owner of the registration certificate:GROTEKS, LLC GROTEKS, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp21.08.2015
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