Drotaverin-Ellara

General characteristics. Structure:

Active agent: at the rate on 1 ml - Drotaverinum of a hydrochloride in terms of anhydrous substance - 20,0 g.

Excipients: sodium metabisulphite, alcohol, water for injections.

Pharmacological properties:

Pharmacodynamics. Myotropic spasmolysant. Reduces receipt of calcium ions in smooth muscle cells (inhibits phosphodiesterase, leads to accumulation of intracellular tsAMF). Reduces a tone of unstriated muscles of internals and a peristaltics of intestines, expands blood vessels. Does not influence the autonomic nervous system, does not get into the central nervous system. Existence of direct influence on smooth muscles allows to use as a spasmolysant in cases when drugs from the M-holinoblokatorov group are contraindicated (closed-angle glaucoma, a prostate hyperplasia).

At parenteral administration effect of drug is shown in 2-4 min. The maximum effect occurs in 30 min.

Pharmacokinetics. It is evenly distributed on fabrics, gets into smooth muscle cells. Communication with proteins of a blood plasma - 95-98%. Elimination half-life 2-4 hours. It is generally removed by kidneys, to a lesser extent with bile. Does not get through a blood-brain barrier.

Indications to use:

Spasms of smooth muscles at diseases of biliary tract: cholecystolithiasis, cholangiolithiasis, cholecystitis, pericholecystitis, cholangitis.

Spasms of smooth muscles at diseases of urinary tract: nephrolithiasis, ureterolithiasis, pyelitis, cystitis, bladder tenesmus.

As auxiliary therapy (when the form of tablets cannot be applied):

- at spasms of smooth muscles of a gastrointestinal origin: peptic ulcer of a stomach and 12-perstny gut, gastritis, spasm of the cardia and gatekeeper, enteritis, colitis;

- at gynecologic diseases: dysmenorrhea.

Route of administration and doses:

Intravenously, intramusculary.

Adults: the daily average dose sosotavlyat 40-240 mg of Drotaverinum of a hydrochloride (divided into 1-3 doses a day) intramusculary. At acute gripes (renal or cholelithic) - 40-80 mg intravenously (duration of introduction about 30 seconds).

Features of use:

At intravenous administration the patient has to be in horizontal position (risk of a collapse).

During treatment it is necessary to abstain from control of vehicles and occupations other potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions (during 1 h after parenteral, especially intravenous administration).

Side effects:

From the central nervony system: headache, dizziness, sleeplessness, feeling of heat, perspiration.

From cardiovascular system: infrequently - tachycardia, a lowering of arterial pressure, a collapse (at intravenous administration introduction).

From the alimentary system: infrequently - nausea, vomiting (at bystry intravenous administration), locks.

Allergic reactions: infrequently - a Quincke's disease, a small tortoiseshell, rash, an itch.

Interaction with other medicines:

Weakens protivoparkinsonichesky effect of a levodopa (strengthening of rigidity and a tremor).

Strengthens spasmolytic action of a papaverine, Bendazolum, etc. spasmolysants, including m-holinoblokatory.

Reduces spazmogenny activity of morphine.

Phenobarbital strengthens spasmolytic action of Drotaverinum.

Contraindications:

- hypersensitivity;

- the expressed liver or renal failure;

- heavy chronic heart failure;

- lactation period;

- children's age;

- period of childbirth;

- feeding period breast.

Overdose:

In high doses breaks an auricle - ventricular conductivity, reduces excitability of a cardiac muscle, can cause a cardiac standstill and paralysis of a respiratory center. In case of overdose patients have to be under careful medical observation and they should carry out symptomatic therapy and treatment, directionally on maintenance of the main functions of an organism.

Storage conditions:

To store in the place protected from light at a temperature from 15 °C to 20 °C.

To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Solution for intravenous and intramuscular administration of 20 mg/ml on 2 or 5 ml in ampoules of light-protective glass.

5 ampoules place in a blister strip packaging from a film polyvinyl chloride.

1 or 2 blister strip packagings together with the application instruction and the scarificator ampoule place in a pack from a cardboard.

10 ampoules together with the application instruction and the scarificator ampoule place in a box from a cardboard with a corrugated insert

When packaging ampoules with a point or a ring of a separation the scarificator is not put.