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

The tablets are yellow or yellow with a greenish tint of color, flat-cylindrical shape, with a bevel. Marble is allowed on the surface of the tablets.

Pharmacotherapeutic group:Spasmolytic agent

ATX: & nbsp

A.03.A.D.02 Drotaverine

Pharmacodynamics:

Myotropic antispasmodic, isoquinoline derivative. Inhibits phosphodiesterase IV (PDE IV), which leads to the accumulation of intracellular cyclic adenosine monophosphate (cAMP) and, as a consequence, inactivation of a 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, biliary, genito-urinary and vascular systems. In the myocardium and vessels, the enzyme that hydrolyses cAMP is PDE III, which explains the absence of serious side effects from the cardiovascular system (SSS) and the unexplained therapeutic effect on CAS.

Pharmacokinetics:

When taken orally, absorption is high, the half-absorption period is 12 min. Bioavailability is 100%. Evenly distributed in tissues, penetrates into smooth muscle cells. Time to reach the maximum concentration (Tcmah) - 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 internal organs (renal colic, biliary colic, intestinal colic, dyskinesia of biliary tract and gallbladder according to hyperkinetic type, cholecystitis, postcholecystectomy syndrome); pyelitis.

- In the combination therapy: pylorospasm, gastroduodenitis, peptic ulcer and duodenal ulcer, spastic constipation, spastic colitis, proctitis, tenesmus.

- Tensor headache.

- Dysmenorrhea, threatening miscarriage, threatening premature birth.

- At carrying out of some instrumental researches, cholecystographies.

Contraindications:

Hypersensitivity, marked hepatic and renal failure, lactation period, children under 12 years.

The presence of such diseases as galactose intolerance, lactase deficiency, glucose-galactose malabsorption.

Carefully:

With caution apply the drug in patients with severe atherosclerosis of the coronary arteries, prostatic hyperplasia, glaucoma.

Dosing and Administration:

Inside, adults and children over 12 years - 40-80 mg 2 - 3 times a day. The maximum single dose is 80 mg, the maximum daily dose is 240 mg.

Side effects:

Dizziness, headache, insomnia, palpitation, lowering blood pressure, allergic reactions, nausea, constipation.

Overdose:

Symptoms: violation of atrioventricular conduction, decreased excitability of the heart muscle, cardiac arrest and paralysis of the respiratory center.

Treatment: symptomatic therapy.

Interaction:

Strengthens the effect of other antispasmodics (including m-holinoblokatorov), hypotension caused by tricyclic antidepressants, quinidine, procainamide. Phenobarbital increases the severity of spasmolytic effects of drotaverine hydrochloride with simultaneous intake. Reduces spasmogenic activity of morphine, antiparkinsonian properties of levodopa.

Possible application in combination with nitrates, beta-adrenoblockers, sedatives.

Special instructions:

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

Form release / dosage:

Tablets of 40 mg.

Packaging:

For 10 or 20 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil. 2 contour packs of 10 tablets or 1, 2, 3 contour packs of 20 tablets with instructions for use are placed in a cardboard package.

Storage conditions:

In a dry, the dark place at a temperature of no higher than 25 ° C.

In a place inaccessible to children.

Shelf life:

2 years.

Do not use after the time specified on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LSR-005237/09

Date of registration:30.06.2009

The owner of the registration certificate:LEKFARM, SOOO LEKFARM, SOOO Republic of Belarus

Manufacturer: & nbsp

LEKFARM, SOOO Republic of Belarus

Representation: & nbspРомфарма ОООРомфарма ООО

Information update date: & nbsp16.06.2016

Illustrated instructions

Instructions

Drotaverine (Drotaverine)