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

Supplementary substances: lactose monohydrate (sugar milk) - 60 mg, potato starch - 32 mg, povidone or povidone low molecular weight - 3 mg, crospovidone type A - 1.6 mg, talc (magnesium hydrosilicate) - 2 mg, magnesium stearate - 1, 4 mg.

Description:Tablets are yellow with a greenish shade of color of flat-cylindrical shape.

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 acts on smooth muscles in the gastrointestinal tract, bile-excreting, genitourinary and vascular systems. In the myocardium and vessels, the enzyme that hydrolyses 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 and duodenal ulcer, 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, renal, chronic heart failure, atrioventricular blockade of II-III degree, cardiogenic shock, arterial hypotension, lactation period. Children up to 3 years.

Carefully:Pronounced atherosclerosis of the coronary arteries, prostatic hyperplasia, angle-closure glaucoma; during pregnancy.

Pregnancy and lactation:

The use of the drug is recommended only if the benefit to the mother exceeds the potential risk to the fetus. Due to the lack of necessary clinical data drotaverine it is not recommended to appoint during lactation (breast-feeding).

Dosing and Administration:

Adults, inside: 40-80 mg 3 times a day.

Children, inside at the age of 3-6 years - 40-120 mg in 2-3 doses, the maximum daily dose - 120 mg; children 6-18 years - 80-200 mg in 2-5 receptions, the maximum daily dose - 240 mg.

Side effects:

Dizziness, palpitation, a feeling of heat, increased sweating, lowering blood pressure, allergic skin reactions.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

Symptoms: in high doses violates atrioventricular conduction, reduces the excitability of the heart muscle, can cause heart failure and respiratory center paralysis.

Interaction:With simultaneous application drotaverine 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. Phenobarbital increases the severity of spasmolytic action of drotaverine. Reduces the spasmogenic activity of morphine.

Special instructions:

In the treatment of gastric ulcer and duodenal ulcer are used in combination with other antiulcer drugs.

Use with caution for the treatment of children, since there has been no research into the effects of drotaverine on children. The tablet contains lactose, so do not prescribe to patients with lactase deficiency, galactoseemia, or glucose / galactose adsorption syndrome.

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

ATperiod of treatment should refrain from driving motor vehicles and, by occupying other potentially dangerous species, activities requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:Tablets of 40 mg.

Packaging:

10 tablets per contour cell packaging made of polyvinylchloride film and aluminum foil. For 2 or 5 contour squares, together with the instructions for use, are placed in a pack of cardboard.

Storage conditions:

Store in a dark place at a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LS-002280

Date of registration:10.02.2011 / 30.12.2013

The owner of the registration certificate:ORGANICS, JSC ORGANICS, JSC Russia

Manufacturer: & nbsp

ORGANICS, JSC Russia

Information update date: & nbsp27.01.2016

Illustrated instructions

Instructions

Drotaverine (Drotaverine)