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

Excipients: sodium disulfite - 1.0 mg; ethanol 95% (in terms of anhydrous) - 66.0 mg; ammonium acetate - 0.74 mg; acetic acid 30% - 0.61 mg; water for injection up to 1.0 ml.

Description:A clear solution of yellow or greenish-yellow color.

Pharmacotherapeutic group:Spasmolytic agent

ATX: & nbsp

A.03.A.D.02 Drotaverine

Pharmacodynamics:

Myotropic antispasmodic. 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 a direct effect on smooth muscles can be used as an antispasmodic in cases where drugs from the group of m-holinoblokatorov (closed glaucoma, prostatic hyperplasia) are contraindicated.

With parenteral administration, the drug appears in 2-4 minutes. The maximum effect occurs in 30 minutes.

Pharmacokinetics:

Evenly distributed on the tissues, penetrates into the smooth muscle cells. The connection with blood plasma proteins is 95-98%. Half-life is 2-4 hours. It is mainly excreted by the kidneys, to a lesser extent with bile. Does not penetrate the blood-brain barrier.

Indications:Spasms of smooth muscles associated with diseases of the biliary tract: cholecystolithiasis, cholangiolithiasis, cholecystitis, pericholecystitis, cholangitis, papillitis. Spasms of smooth muscles of the urinary tract: nephrolithiasis, urethrolithiasis, pyelitis, cystitis, bladder tenesmus. As an auxiliary therapy (when the form of tablets can not be used): with spasms of smooth muscles of gastrointestinal origin: peptic ulcer of stomach and duodenum, gastritis, spasms of cardia and pylorus, enteritis, colitis,with gynecological diseases: dysmenorrhea.

Contraindications:

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

Carefully:

Use with caution in the presence of an anamnesis of arterial hypotension and during pregnancy.

Pregnancy and lactation:

During lactation it is necessary to refuse breastfeeding. Use with caution during pregnancy.

Dosing and Administration:

Intravenous, intramuscular.

Adults: The daily average dose is 40-240 mg of drotaverine hydrochloride (divided by 1-3 doses per day) by intramuscular injection. In acute colic (renal or cholelithiasis) - 40-80 mg intravenously slowly (duration of administration is approximately 30 seconds).

Side effects:

From the central nervous system and sensory organs: infrequently - headache, dizziness, insomnia, a feeling of heat, sweating.

From the cardiovascular system: infrequently - tachycardia, lowering of arterial pressure, with intravenous injection - collapse, atrioventricular blockade, arrhythmias, oppression of the respiratory center.

On the part of the digestive system: infrequently - nausea, vomiting (with rapid intravenous injection), constipation.

Allergic reactions: infrequently - 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. 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:

Relieves the antiparkinsonian effect of levodopa (increased rigidity and tremor). Enhances the antispasmodic effect of papaverine, bendazole and other antispasmodics, including m-holinoblokatory. Reduction of blood pressure caused by tricyclic antidepressants, quinidine and procainamide.

Reduces the spasmogenic activity of morphine.

Phenobarbital increases the severity of the spasmolytic effect of drotaverine hydrochloride.

Special instructions:

When intravenously administered Drotaverina patient should be in a horizontal position (risk of collapse).

The drug contains disulfite, which can cause the development of allergic reactions, including anaphylactic shock and bronchospasm in persons susceptible to sulfites, especially if there is an anamnesis of bronchial asthma and allergic diseases. In the case of hypersensitivity to disulfite, parenteral use should be avoided.

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

During the period of treatment, it is necessary to refrain from driving vehicles and practicing other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions (within 1 hour after parenteral, especially intravenous administration).

Form release / dosage:A solution for intravenous and intramuscular administration of 20 mg / ml.

Packaging:

A solution for intravenous and intramuscular injection of 20 mg / ml of 2 ml and 5 ml in ampoules of light-protective glass.

5 ampoules are placed in a contour mesh package made of a polyvinylchloride (PFC) film.

1, 2, 3, 4, 5 contour mesh packages together with the instruction for use and the ampoule scarifier are placed in a pack of cardboard.

10 ampoules together with the instruction for use and the ampoule scarifier are placed in a pack of cardboard with corrugated liner.

When packing ampoules with a dot or a ring of fracture, the ampoule scaper is not inserted.

Packing for hospitals. For 50, 100 contour cell packs with ampoules together with an equal number of instructions for use are placed in a box of corrugated cardboard.

Storage conditions:

Protected from light at a temperature of 15 ° C to 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:On prescription

Registration number:LS-001982

Date of registration:01.11.2011

The owner of the registration certificate:ELLARA, LTD. ELLARA, LTD. Russia

Manufacturer: & nbsp

MC ELLARA, LLC Russia

ELLARA, LTD. Russia

Information update date: & nbsp02.12.2015

Illustrated instructions

Instructions

Drotaverine-Ellara (Drotaverine-Allara)