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

Excipients: disodium edetate dihydrate (disodium dihydrate of ethylenediaminetetraacetic acid) 0.05 mg; methionine (L-methionine) 0.1 mg; water for injection - up to 1.0 ml.

Description:Pa solution with a greenish-yellow hue.

Pharmacotherapeutic group:antispasmodic

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, the drug reduces the excitability of the heart muscle and slows intracardiac conduction.

Pharmacokinetics:

Bioavailability - 54%. The connection with plasma proteins is 90%. Well distributed, penetrates through the histohematological barriers. Metabolised in the liver. Half-life T_1/2- 0,5-2 hours (possible increase 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 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 impaired 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:

Intramuscularly, subcutaneously or intravenously.

Single dose for adults 20-40 mg (1-2 ml of a 20 mg / ml solution); the interval between administrations is not less than 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 body weight.

Children aged 12 to 18 years The dosing regimen corresponds to the dosing regimen in adults.

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 - itchy skin, rarely - excessive sweating.

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

From the nervous system: often - drowsiness.

From the side of the cardiovascular system: often - lowering blood pressure; infrequently - ventricular extrasystole.

On the part of the blood system: very rarely - eosinophilia.

With rapid intravenous administration, as well as with the use of high doses, it is possible to develop an antrioventricular blockade, a violation of the heart rhythm.

Overdose:

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

Treatment: symptomatic (maintaining blood pressure).

Interaction:

Papaverin reduces the antiparksonic effect of levodopa.

In combination with barbiturates, the spasmolytic effect 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 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.

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 practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions, since the following side effects are possible: lowering of arterial pressure, drowsiness, disturbances of heart rhythm.

Form release / dosage:

Solution for injection, 20 mg / ml.

Packaging:

2 ml per ampoule of neutral glass.

5 ampoules are placed in a contour mesh package made of a polyvinylchloride film (PVC) or a polyethylene terephthalate (PET) film.

For 1 or 2 contour mesh packages together with the instruction for use and the ampoule scarifier are placed in a pack of cardboard.

For 5 or 10 ampoules, together with the instructions for use and the ampoule scarifier, they are placed in a pack of cardboard with a corrugated liner.

When using ampoules with a dot or a ring of fracture, the ampoule scaper is not inserted.

Packing for hospitals

For 4 or 5 or 10 out-of-round cell packs with ampoules together with instructions for use in an amount equal to the number of contoured cell packs, into a cardboard pack.

For 50 or 100 contour cell packs with ampoules, together with instructions for use in an amount equal to the number of contiguous cell packs, are placed in a box of corrugated paperboard.

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-003459

Date of registration:16.02.2016

Expiration Date:16.02.2021

The owner of the registration certificate:ELLARA, LTD. ELLARA, LTD. Russia

Manufacturer: & nbsp

ELLARA, LTD. Russia

Information update date: & nbsp31.07.2016

Illustrated instructions

Instructions

Papaverine (Papaverine )