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

Auxiliary substances: lactose monohydrate (sugar milk) - 108.0 mg, potato starch - 77.6 mg, povidone (plasdon) - 2,0 mg, crospovidone (polyplasdone X-El-10) 5.6 mg, talc 4.0 mg, magnesium stearate 2.8 mg.

Description:

Tablets from light yellow to yellow color, flat-cylindrical shape with a facet and a risk. A greenish shade and blotches of white with a yellowish hue of color to yellow or yellow with a greenish hue of color, varying degrees of intensity are allowed.

Pharmacotherapeutic group:Spasmolytic agent

ATX: & nbsp

A.03.A.D.02 Drotaverine

Pharmacodynamics:

Myotropic antispasmodic. The chemical structure and pharmacological properties are close to papaverine, but it has a stronger and longer action.Reduces the flow of calcium ions into smooth muscle cells (inhibits phosphodiesterase IV, leads to the accumulation of intracellular cyclic adenosine monophosphate (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. Regardless offrom the type of autonomic 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 phosphodiesterase III, which explains the absence of serious side effects from the cardiovascular system and the unexplained therapeutic effect on the cardiovascular system. 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 - 100 %. Evenly distributed in tissues, penetrates smooth muscle cells. The time to reach a maximum concentration of 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 bile ducts and gallbladder according to hyperkinetic type, cholecystitis, postcholecystectomy syndrome), spasm of peripheral arterial vessels and cerebral vessels.

In the combination therapy: pylorospasm, gastroduodenitis, peptic ulcer and duodenal ulcer, spastic constipation, spastic colitis, proctitis, tenesmus, pyelitis. Tensor headache. Dysmenorrhea, threatening miscarriage, threatening premature birth, postpartum labor.

When some instrumental research, cholecystography.

Contraindications:

Hypersensitivity to the drug components, lactase deficiency, lactose intolerance, glucose-galactose malabsorption, expressed hepatic, renal, heart failure; atrioventricular block II-III degree, cardiogenic shock; severe chronic heart failure, children under 12 years (for a dosage of 80 mg), the lactation period.

Carefully:

Pronounced atherosclerosis of the coronary arteries, arterial hypotension, prostatic hyperplasia, glaucoma, gestation period.

Pregnancy and lactation:

During pregnancy, the drug should be taken with caution.

In the lactation period, this drug is contraindicated.

Dosing and Administration:

Inside.

Adults appoint 40-80 mg (1 / 2-1 tablet) 2-3 times a day.

Children over 12 years of age are prescribed 40 mg (1/2 tablet) 2-3 times a day.

Side effects:

From the side of the central nervous system: headache, dizziness, insomnia.

From the cardiovascular system: a feeling of palpitation, tachycardia, lowering of the arterial. pressure, sensation of heat, sweating.

From the digestive system: nausea, constipation.

Allergic reactions: angioedema, urticaria, rash, itching.

Overdose:

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

Treatment: In case of an overdose, patients should be under medical supervision, and if necessary, they should receive symptomatic treatment aimed at maintaining the basic functions of the body, including induction of vomiting or gastric lavage.

Interaction:

With simultaneous application can weaken the antiparkinsonian effect of levodopa. Strengthens the action of papaverine, bendazole and other antispasmodics (including m-holinoblokatorov), arterial hypotension caused by tricyclic antidepressants, quinidine and procainamide. Reduces the spasmogenic activity of morphine.

Phenobarbital increases the severity of spasmolytic action of drotaverine.

Special instructions:

In the treatment of peptic ulcer of the stomach and duodenum, drotaverin forte is used in combination with other antiulcer drugs.

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

When administered orally at therapeutic doses, the drug does not affect the ability to drive and other mechanisms and perform work that requires increased attention.

Form release / dosage:Tablets 80 mg.

Packaging:

10 tablets are placed in a contour mesh package made of a polyvinylchloride film and aluminum foil.

1, 2, 3, 4 or 5 contour mesh packages together with the instruction 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:

2 years.

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

Terms of leave from pharmacies:Without recipe

Registration number:P N002677 / 01

Date of registration:07.08.2008

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: & nbsp16.06.2016

Illustrated instructions

Instructions

Drotaverin forte (Drotaverine forte)