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

Myotropic antispasmodic. The chemical structure and pharmacological properties are close to papaverine, but it has a stronger and longer action. Reduces the flow of Ca²⁺ in smooth muscle cells (inhibits phosphodiesterase (PDE), leads to the accumulation of intracellular 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 (CNS).

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

Pharmacokinetics:When taken orally, the absorption is high, the half-absorption period is 12 minutes. Bioavailability is 100%. Evenly distributed on the tissues, penetrates into the smooth muscle cells. Time to reach the maximum concentration in the blood (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 (BBB).

Indications:

Spasm of smooth muscles in diseases of 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, urethrolithiasis, 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 research, incl. cholecystography.

Contraindications:

Hypersensitivity to the active ingredient or to any of the excipients of the drug. Severe hepatic or renal insufficiency. Severe chronic heart failure. Children under 6 years. Period of delivery. The period of breastfeeding.

Carefully:

Pronounced atherosclerosis of the coronary arteries, prostatic hyperplasia, angle-closure glaucoma. Individual lactose intolerance.

Pregnancy and lactation:

Retrospective studies of clinical data and animal reproductive experiments have shown that the oral administration of drotaverine during pregnancy does not affect the fetus and its development. However, the use of the drug is recommended by the doctor's appointment after a careful weighing of the benefit-risk ratio. It is not recommended to use the drug during lactation due to the lack of necessary clinical data.

Dosing and Administration:

Inside.Adults: 40 - 80 mg (1 - 2 tablets) 2-3 times a day. The maximum single dose is 80 mg, the maximum daily dose is 240 mg.

Children aged 6 to 12 years: 40 mg 1-2 times a day. The maximum single dose is 40 mg, the maximum daily dose is 80 mg.

Side effects:

Rarely: dizziness, headache, insomnia, heart palpitations, nausea, constipation, lowering of blood pressure (BP), a feeling of heat, increased sweating, allergic skin reactions.

Very rarely: hypotension.

If any of the side effects indicated in the instructions appear, or you notice any other side effects not listed in the instructions, inform the doctor about it.

Overdose:

Symptoms: in large doses violates atrioventricular conduction, reduces the excitability of the heart muscle.

Can cause:

- heart failure and paralysis of the respiratory center;

- cardiotoxic effect in the form of pronounced sinus bradycardia with the development of CA blockade III degree and the appearance of ectopic rhythms: a rhythm of AV compounds, polymorphic ventricular extrasystole, as well as the development on their background of the trembling of the ventricles of the heart with the transition to ventricular fibrillation;

- marked depression of the central nervous system (CNS) in the form of a disturbance of consciousness from a mild sopor to a coma III degree, without the development of focal neurological symptoms.

In case of an overdose, patients should be under close medical supervision and should be given symptomatic therapy and treatment aimed at maintaining the basic functions of the body.

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 novocainamide. 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.

The use of the drug in children aged 6 to 12 years is strictly according to the indications and only according to the doctor's prescription, since the use of drotaverine in this group of patients has not been sufficiently studied.

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 per contour cell pack. 2 contour squares with instructions for use in a pack of cardboard. For 30 or 50 tablets in cans of polymeric. Each jar with instructions for use in a pack of cardboard.

Storage conditions:

In a dry place, protected from light.

Keep out of the reach of children.

Shelf life:

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

Terms of leave from pharmacies:Without recipe

Registration number:P N000589 / 01

Date of registration:10.01.2012

The owner of the registration certificate:ROSFARM, CJSC ROSFARM, CJSC Russia

Manufacturer: & nbsp

ROSFARM, LLC Russia

Information update date: & nbsp29.11.2015

Illustrated instructions

Instructions

Drotaverine (Drotaverine)