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

Composition:Each tablet contains drotaverina hydrochloride 40.0 mg.
Excipients: lactose (milk sugar) - 53.8 mg, potato starch - 42.0 mg, talc - 2.8 mg, stearic acid - 1.4 mg.

Description:Tablets from yellow to yellow with a greenish shade of color, flat-cylindrical, with a bevel.

Pharmacotherapeutic group:Spasmolytic agent

ATX: & nbsp

A.03.A.D.02 Drotaverine

Pharmacodynamics:

Myotropic antispasmodic, isoquinoline derivative. Inhibits PDE IV (phosphodiesterase IV), which leads to the accumulation of intracellular cAMP (cyclic adenosine monophosphate) and as a consequence to the 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 digestive tract (gastrointestinal tract), biliary, genito-urinary and vascular systems.In the myocardium and vessels, the enzyme hydrolyzing cAMP is PDE III (phosphodiesterase III), which explains the absence of serious side effects from CVS (cardiovascular system) and unexplained therapeutic effect with CCC.

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. TSmah -2 h. The connection with plasma proteins is 95-98%. Mostly excreted by the kidneys, to a lesser extent - with bile. Does not penetrate the BBB.

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, ureterolithiasis, pyelitis, cystitis, bladder spasm.

As an auxiliary therapy: with spasms of smooth muscles of the digestive tract: peptic ulcer of stomach and duodenum, gastritis, spasm of cardia and pylorus, enteritis, colitis, spastic colitis with constipation and irritable bowel syndrome with flatulence; tensor headache; dysmenorrhea.

In carrying out some instrumental Studies, including cholecystography.

Contraindications:

Hypersensitivity, expressed hepatic and renal failure, the period of childbirth, lactation period, children under 12 years of age, lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

Carefully:

Arterial hypotension, pregnancy.

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:

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

On the part of the CAS: a decrease in blood pressure (BP), a feeling of palpitation, tachycardia.
From the digestive system: nausea, constipation.
Allergic reactions: angioedema, urticaria, rash, itching.

Overdose:

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

Treatment: symptomatic therapy.

Interaction:

With simultaneous application drotaverine can weaken antiparkinsonian effect of levodopa.

Strengthens the effect of other antispasmodics (including m-holinoblokatorov), arterial hypotension caused by tricyclic antidepressants, quinidine, procainamide. Reduces the spasmogenic activity of morphine. Phenobarbital increases the severity of spasmolytic action of drotaverine.

Special instructions:In the treatment of peptic ulcer and duodenal ulcer are used in combination with other antiulcer drugs.

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 other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:Tablets of 40 mg.

Packaging:

10 tablets in a planar cell package;

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

Storage conditions:AT dry, protected from light, 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 expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LS-000547

Date of registration:23.07.2010

The owner of the registration certificate:BORISOVSKIY FACTORY OF MEDPREPARATES, OJSC BORISOVSKIY FACTORY OF MEDPREPARATES, OJSC Republic of Belarus

Manufacturer: & nbsp

BORISOVSKIY FACTORY OF MEDPREPARATES, OJSC Republic of Belarus

Information update date: & nbsp16.02.2016

Illustrated instructions

Instructions

Drotaverine (Drotaverine)