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

1 tablet contains drotaverina hydrochloride in terms of 100% substance 40 mg, excipients: magnesium stearate, microcrystalline cellulose, lactose (milk sugar), potato starch, talc, sodium croscarmellose (impellosis).

Description:

Tablets are 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. The chemical structure and pharmacological properties of the drug is close to papaverine, but it has a stronger and longer action. Reduces the intake of calcium ions in smooth muscle cells (inhibits phosphodiesterase, leads to the accumulation of intracellular cyclic adenosine monophosphate).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. The presence of direct influence on smooth muscles 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 minutes. Bioavailability is 100%. Evenly distributed in tissues, penetrates smooth muscle cells. Time to reach the maximum concentration of the drug in the blood plasma (TSmoh) -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 (dyskinesia of bile ducts and gall bladder by hyperkinetic type, cholecystitis, postcholecystectomy syndrome); pyelitis; spastic constipation, spastic colitis, proctitis, tenesmus; pilorospazm, gastroduodenitis,peptic ulcer of stomach and duodenum (in the phase of exacerbation, as part of complex therapy - to relieve the pain syndrome of a spastic nature). Spasm of peripheral, cerebral arteries. Algodismenorea.

Contraindications:

Hypersensitivity, marked hepatic and renal insufficiency; chronic heart failure, atrioventricular blockade of II-III degree, cardiogenic shock, arterial hypotension, lactation period, galactose intolerance, lactase deficiency or glucose-galactose malabsorption, children under 12 years.

Carefully:

Pronounced atherosclerosis of the coronary arteries, angle-closure glaucoma, prostatic hyperplasia, pregnancy.

Dosing and Administration:

Inside, children over 12 years - 40 mg 3 times a day, adults - 40-80 mg 3 times a day. The maximum daily intake for adults is 240 mg.

Side effects:

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

Overdose:

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

Interaction:

With simultaneous application drotaverine can weaken the antiparkinsonian effect of levodopa. Strengthens the effect of papaverine, bendazole and other antispasmodics (including m-holinoblokatorov), increases the reduction in blood pressure caused by tricyclic antidepressants, quinidine and procainamide. Reduces the spasmogenic activity of morphine. Phenobarbital increases the severity of spasmolytic action of drotaverine.

Special instructions:

When treating peptic ulcer and duodenum drotaverine apply in combination with other antiulcer drugs.

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

During the treatment period 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 (within 1 h after taking).

Form release / dosage:

Tablets of 40 mg.

Packaging:

For 10 or 20 tablets in a contour mesh box made of polyvinyl chloride or imported film and aluminum foil printed lacquered or imported.

By 1, 2, 3, or 5 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

Storage conditions:

Store in a dry, dark place at a temperature of no higher than 25 ° C. Keep out of reach of children!

Shelf life:

3 years.

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

Terms of leave from pharmacies:Without recipe

Registration number:P N001557 / 01

Date of registration:30.10.2008 / 11.09.2012

The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Manufacturer: & nbsp

OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Information update date: & nbsp16.06.2016

Illustrated instructions

Instructions

Drotaverine-OBL (Drotaverine-OBL)