Papaverine hydrochloride - instructions for use, dose, side effects, contraindications

Excipients: sodium edetate (disodium salt ethylenediaminetetraacetic acid; Trilon B) -0.05 g, methionine - 0.1 g, water for injection - up to 1 liter.

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 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:Absorption is high. Bioavailability is 54%. The connection with plasma proteins is 90%. Well distributed, penetrates through gistogematicheskie barriers. Metabolised in the liver. T1 / 2-0,5-2 h (possibly an increase of up 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 cavity organs (cholecystitis, pilorospasm, spastic colitis, renal colic), spasm of peripheral vessels (endarteritis), spasm of cerebral vessels;

Angina pectoris (as part of complex therapy);

Bronchospasm;

As an auxiliary medicine for premedication.

Contraindications:

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

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 liver and kidney function, hypothyroidism, adrenal insufficiency, prostatic hypertrophy, and patients with supraventricular tachycardia and those in shock .

Pregnancy and lactation:During pregnancy and lactation (breastfeeding), the safety and efficacy of papaverine hydrochloride is not established.

Dosing and Administration:

The drug is administered intramuscularly, subcutaneously or intravenously. A single dose for adults is 0.02-0.04 g (1-2 ml 2 % solution), the interval between administrations is at least 4 hours. Intravenous administration is made by diluting a 2% solution of the drug 10-20 ml isotonic sodium chloride solution. For elderly patients, the initial single dose should not exceed 001 g. For children aged 1 to 12 years, the maximum single dose is 0.2-0.3 g / kg.

Side effects:

Maybe: nausea, constipation, drowsiness, excessive sweating, arterial hypotension, increased activity of hepatic transaminases. With rapid on / in the introduction, as well as when used in high doses: development AV blockade, heart rhythm disturbances.

Overdose:

Symptoms: diplopia, weakness, lowering blood pressure, drowsiness.

Treatment: symptomatic (maintenance of arterial pressure)

Interaction:Interaction with other drugs Papaverine 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. With simultaneous use with anticholinergics, anticholinergic effects may be enhanced. With simultaneous use with alprostadil for intracavernous administration, there is a risk of developing priapism. Reduces the hypotensive effect of methyldopa.

Special instructions:

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 liver and kidney function, hypothyroidism, adrenal insufficiency, prostatic hypertrophy, and patients with supraventricular tachycardia and those in shock . Intravenously, the drug should be administered slowly and under the supervision of a doctor.

During the treatment period, alcohol intake should be excluded.

During pregnancy and lactation (breastfeeding), the safety and efficacy of papaverine hydrochloride is not established.

Form release / dosage:

Solution for injection 20 mg / ml (ampoules).

Packaging:

To 2 ml in the ampoules of neutral glass HC-3.

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

By 5 ampoule into a contour mesh box made of polyvinylchloride film and aluminum foil, or without paper and foil.

2 contour packs with instructions for use in a pack of cardboard.

In each pack insert knife ampoule or scarifier. When you pack the ampoules with a dot or rupture ring, the ampoule knife or scarifier does not insert.

Storage conditions:

Store in a 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 expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N000924 / 01

Date of registration:31.07.2008

The owner of the registration certificate:Armavir Biofactory, FKPArmavir Biofactory, FKP Russia

Manufacturer: & nbsp

Armavir Biofactory, FKP

Information update date: & nbsp22.08.2015

Illustrated instructions

Instructions

Papaverine hydrochloride (Papaverine hydrochloride)