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

auxiliary substances: potato starch - 30.1 mg, lactose monohydrate (sugar milk) - 60.1 mg, povidone (polyvinylpyrrolidone) - 5.8 mg, talc - 2.6 mg, magnesium stearate - 1.4 mg.

Description:

Round tablets of yellow with a greenish shade of color, flat-cylindrical shape with a facet and a risk.

Pharmacotherapeutic group:Spasmolytic agent

ATX: & nbsp

A.03.A.D.02 Drotaverine

Pharmacodynamics:

Myotropic antispasmodic, isoquinoline derivative. Inhibits phosphodiesterase (PDE) IV, which leads to the accumulation of intracellular cyclic adenosine monophosphate (cAMP) and, as a consequence, to the inactivation of the light chain of myosin kinase, resulting in a relaxation of smooth muscle. Regardless of the type of vegetative innervation, drotaverine It acts on smooth muscles in the gastrointestinal tract, bile excretory, genitourinary and vascular systems. In the myocardium and vessels, the enzyme hydrolyzing cAMP is PDE III, which explains the absence of serious cardiovascular side effects (CVS) and the unexplained therapeutic effect on CCC.

The presence of a direct effect on smooth muscle can be used as an antispasmodic in cases when drugs from the group of m-holinoblockers are contraindicated (closed-angle glaucoma, prostatic hyperplasia).

Pharmacokinetics:

When taken orally, absorption is high, the half-absorption period is 12 min. Bioavailability is 100%. Evenly distributed in tissues, penetrates 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 of the urine and bile excretory organs (renal colic, pyelitis, tenesmus, biliary colic, intestinal colic, dyskinesia of bile ducts and gallbladder according to hyperkinetic type, cholecystitis, postcholecystectomy syndrome).

- Spasm of smooth muscles of the gastrointestinal tract (usually as part of a combination therapy): pylorirospasm, gastroduodenitis, peptic ulcer of the stomach and duodenum, spastic constipation, spastic colitis, proctitis.

- Tensor headache.

- Dysmenorrhea, threatening miscarriage, threatening premature birth, postpartum labor.

- In carrying out some instrumental studies, cholecystography.

Contraindications:

Hypersensitivity to the drug components, expressed by hepatic and renal failure, severe heart failure (low cardiac output syndrome), lactation period.

This dosage form is not used in children under 3 years of age.

In connection with the presence of lactose monohydrate (milk sugar) in the formulation, its administration is contraindicated in case of congenital lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

Carefully:

Drotaverine should be used with caution in arterial hypotension, severe arteriosclerosis of the coronary arteries, prostatic hyperplasia, closed-angle glaucoma, during pregnancy.

Dosing and Administration:

Adults prescribe inside for 40-80 mg (1-2 tablets) 2-3 times a day. The maximum daily dose is 240 mg.

Children aged 3 to 6 years - in a single dose of 20 mg, the maximum daily dose - 120 mg (2-3 sessions); at the age of 6 to 12 years, single dose - 40 mg, maximum daily dose - 200 mg; multiplicity of application - 2-5 times a day.

Side effects:

Dizziness, headache, insomnia, palpitations, lowering of blood pressure, allergic reactions, nausea, constipation, fever, sweating.

Overdose:

There are no data on overdose in relation to the drug.

Interaction:

With simultaneous application can weaken the antiparkinsonian effect of levodopa.

Strengthens the effect of papaverine, bendazole and other antispasmodics (including m-holinoblokatorov), lowering arterial pressure caused by tricyclic antidepressants, quinidine and procainamide.

Reduces the spasmogenic activity of morphine.

Phenobarbital increases the severity of spasmolytic action of drotaverine.

Special instructions:

When treating gastric ulcer and duodenal ulcer is used in combination with other drugs,usually prescribed for the treatment of this group of diseases of the esophagus, stomach and duodenum.

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

When administered orally in therapeutic doses, drotaverine does not affect the ability to drive and perform work requiring increased attention. If there are any side effects, the question of driving and working on machines requires individual consideration.

Form release / dosage:Tablets of 40 mg.

Packaging:

For 10 tablets in a planar cell package.

1, 2, 3, 4 or 5 contour mesh packages together with instructions for use in a pack of cardboard.

For 100 tablets in a polymer can. Each bank along with the instruction for use is placed in a pack of cardboard.

Storage conditions:

In dry, protected from light and out of reach of children, at a temperature of no more than 25 ° C.

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-000705

Date of registration:30.06.2010

The owner of the registration certificate:ALSI Pharma, ZAO ALSI Pharma, ZAO Russia

Manufacturer: & nbsp

ALSI Pharma, ZAO Russia

Information update date: & nbsp16.02.2016

Illustrated instructions

Instructions

Drotaverine (Drotaverine)