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

Excipients: potato starch - 30.71 mg, lactose monohydrate (sugar milk) - 57 mg, crospovidone (Polyplasdone XL-10) - 2,923 mg, povidone (low molecular weight polyvinylpyrrolidone) - 5,847 mg, talc - 2.05 mg, magnesium stearate - 1.47 mg.

Description:Tablets from light yellow to yellow color, flat-cylindrical shape with a bevel. A greenish shade and blotches of white with a yellowish hue of color to yellow or yellow with a greenish tint of color are allowed.

Pharmacotherapeutic group:Spasmolytic agent

ATX: & nbsp

A.03.A.D.02 Drotaverine

Pharmacodynamics:Drotaverin is a myotropic antispasmodic. The chemical structure and pharmacological properties are close to papaverine, but it has a stronger and longer action.Reduces the intake of calcium ions Ca²⁺ in smooth muscle cells (inhibits phosphodiesterase, leads to accumulation of intramuscular cAMP). Reduces the tone of the smooth muscles of internal organs and intestinal motility, dilates the blood vessels. Does not affect the autonomic nervous system, does not penetrate the central nervous system. The presence of direct influence on smooth muscles can be used as an antispasmodic in cases where drugs are contraindicated group M-holinoblokatorov (zakratougolnaya glaucoma, prostatic hyperplasia).

Pharmacokinetics:

When taken orally, absorption is high, the half-absorption period is 12 min. Bioavailability is 100%. Evenly distributed on the tissues, penetrates into the smooth muscle cells. The time to reach the maximum concentration in the blood is 2 hours. The connection with plasma proteins is 95-98%. It is mainly excreted by the kidneys, to a lesser extent - with bile. Does not penetrate the blood-brain barrier.

Indications:

Spasm of smooth muscles in diseases of the bile ducts: cholecystolithiasis, cholangiolithiasis, cholecystitis, pericholecystitis, cholangitis, inflammation of the papilla of the duodenum.

Spasm of smooth muscles in diseases of the urinary tract: nephrourolythiasis, urethrolithiasis, pyelitis, cystitis, bladder spasm.

Spasm of peripheral arterial vessels, vessels of the brain.

As an auxiliary therapy: with spasms of smooth muscles of the gastrointestinal tract: stomach ulcer and duodenal ulcer, gastritis, cardia and pyloric spasm, enteritis, colitis, spastic colitis with constipation and irritable bowel syndrome with flatulence; cholelithiasis; postcholecystectomy syndrome; nephrolithiasis; tensor headache; Algodismenorea, threatening miscarriage, threatening premature birth; spasm of the throat of the uterus during labor, prolonged opening of the throat, postnatal fights.

In carrying out some instrumental research, incl. cholecystography.

Contraindications:

Hypersensitivity to the drug components, expressed by hepatic, renal, heart failure; atrioventricular block II-III degree, cardiogenic shock, arterial hypotension. This dosage form is not used in children under 3 years of age.

Carefully:

Pronounced atherosclerosis of the coronary arteries, prostatic hyperplasia, angle-closure glaucoma, pregnancy and lactation.

Pregnancy and lactation:With caution apply the drug during pregnancy and during lactation(breastfeeding).

Dosing and Administration:

Adults prescribe inside for 40 - 80 mg (1 -2 tablets) 2-3 times a day.

Children under the age of 6 years - 40-120 mg (1 - 3 tablets) in 2-3 divided doses, the maximum daily dose - 120 mg; from 6 to 18 years - 80-200 mg (2 - 5 tablets) in 2-5 receptions, the maximum daily dose - 240 mg.

Side effects:

From the side of the central nervous system: infrequently - dizziness.

From the cardiovascular system: infrequently - palpitation, lowering blood pressure.

Feeling hot, sweating.

Allergic skin reactions.

Overdose:

In large doses violates atrioventricular conduction, reduces the excitability of the heart muscle, can cause heart failure and respiratory center paralysis.

Interaction:

With simultaneous application can weaken the antiparkinsonian effect of levodopa.

Strengthens the action of papaverine, bendazole and other antispasmodics (incl.M-holinoblokatorov), lowering arterial pressure caused by tricyclic antidepressants, quinidine and procainamide.

Reduces the spasmogenic activity of morphine.

Phenobarbital increases the severity of the spasmolytic effect of drotaverine hydrochloride.

Effect on the ability to drive transp. cf. and fur:During the period of treatment it is necessary to refrain from driving motor vehicles and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Tablets of 40 mg.

Packaging:

For 10 tablets in a contour mesh package made of PVC and foil.

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

Storage conditions:

In a dry, protected from light place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LS-001440

Date of registration:04.04.2011

The owner of the registration certificate:MOSHIMFARM PREPARATES them. N.А.Semashko, OJSC MOSHIMFARM PREPARATES them. N.А.Semashko, OJSC Russia

Manufacturer: & nbsp

MOSHIMFARM PREPARATES them. NA Semashko OJSC Russia

Information update date: & nbsp18.01.2016

Illustrated instructions

Instructions

Drotaverine (Drotaverine)