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

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 is 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 (maybe an increase of up to 24 hours). It is excreted by the kidneys in form of metabolites. Completely removed from the blood during hemodialysis.

Indications:

Spasm of smooth muscles, 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 antrioventricular (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 those in shock.

Pregnancy and lactation:

In pregnancy and lactation, the safety and efficacy of the drug is not established. The purpose 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 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 first diluting the 20 mg / ml solution of the drug with 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 of body weight.

In children from 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 the drug should not be isolated, and rotate and separate the valve with rotating movements.

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 - 0.01-0.1%; 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, infrequent - increased hepatic transaminases.

From the nervous system: often - drowsiness.

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

From the side of the hemostasis system: very rarely - eosinophilia.

With rapid intravenous administration, as well as with the use of high doses, it is possible to develop an antrioventricular block, disturbances 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, 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:

Intravenously, the drug should be administered slowly and under the supervision of a doctor.

During the treatment period, alcohol intake should be excluded.

It should be borne in mind that 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 administering motor vehicles and occupations with potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions, since the following side effects are possible: lowering of arterial pressure, drowsiness, disturbance of heart rhythm.

Form release / dosage:

Solution for injection 20 mg / ml.

Packaging:

2 or 5 ml each in polymeric ampoules manufactured using the technology "blow-fill-seal" "blow-fill-seal".

For 5 or 10 polymer ampoules, along with the instructions for medical use, put in a pack of cardboard.

Storage conditions:

In the 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 expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-002300

Date of registration:08.11.2013

The owner of the registration certificate:SLAVYANSKAYA APTEKA, LLC SLAVYANSKAYA APTEKA, LLC Russia

Manufacturer: & nbsp

SLAVYANSKAYA APTEKA, LLC Russia

Information update date: & nbsp21.08.2015

Illustrated instructions

Instructions

Papaverine hydrochloride (Papaverini hydrochloridum)