Drotaverinum

General characteristics. Structure:

Active ingredient: 40 mg of a drotaverinagidrokhlorid (in terms of 100% dry matter).

Excipients: potato starch, talc, magnesium stearate, lactose.

Effective remedy of first aid at gripes: renal, bilious, intestinal, besides, drug broadens bilious channels; it is applied at the cholecystitises, cystitis, spasms caused by a peptic ulcer of a stomach and intestines

Pharmacological properties:

Pharmacodynamics. Drotaverinum is quickly and fully soaked up, both after oral administration, and after introduction in oil. It highly contacts proteins of human plasma, especially albumine, alpha and beta globulins.

Drotaverinum is metabolized in a liver, its biological half-life makes 16-22 h Cmax in a blood plasma is reached in 45 and 60 minutes after intake. After metabolism of "first pass" of 65% of a dose are in blood circulation in not changed look. For 72 h Drotaverinum is almost completely brought out of an organism, more than 50% are removed with urine and about 30% - with a stake. Drotaverinum is removed generally in the form of metabolites, parent connection in urine is not found.

Indications to use:

- the spasms of smooth muscles connected with diseases of a biliary path: cholecystolithiasis, cholangiolithiasis, cholecystitis, pericholecystitis, cholangitis, papillitis;
- spasms of smooth muscles of an uric path: nephrolithiasis, ureterolithiasis, pyelitis, cystitis, bladder tenesmus.

As auxiliary therapy:

- at spasms of smooth muscles of a gastrointestinal origin: a peptic ulcer of a stomach and duodenum, gastritis, spasms of the cardia and the gatekeeper, enteritis, colitis, a spastic colitis with a lock and meteoristichesky forms of mucous colitis;
- headaches of tenzionny type;
- at gynecologic diseases: dysmenorrhea.

Route of administration and doses:

Adults: the usual daily dose makes 120-240 mg (3-6 tablets) a day which should be accepted in 2-3 receptions. The single dose for adults makes 40-80 mg (1-2 tablets).

Children of 6-12 years: the recommended daily dose for children over 6 years makes 80 mg (2 tablets) a day which should be accepted in 2 receptions. A single dose - 40 mg (1 tablet). Children are more senior than 12 years: the recommended daily dose for children over 12 years makes 160 mg (4 tablets) a day which should be accepted in 2-4 receptions. A single dose - 40-80 mg (1-2 tablets).

This dosage form is not intended for use for children 6 years are younger.

Features of use:

Use of drug at hypotension demands the increased care.

Tablets of Drotaverinum contain lactose. It can cause gastrointestinal frustration in the persons having a lactose intolerance.

This form is unacceptable for the patients suffering from deficit of lactose, a galactosemia or a syndrome of the broken absorption of a glucose/galactose. To apply with care at children of 1 year to years.

With care use drug at patients with the expressed atherosclerosis of coronary arteries, prostate adenoma, glaucoma, during pregnancy and a lactation.

Patients should be informed that at display of dizziness they have to avoid potentially dangerous actions, such as management of transport and potentially dangerous mechanisms

Oral administration of Drotaverinum during pregnancy does not lead to teratogenic and embriotoksichesky actions. However, at purpose of drug during pregnancy care is necessary.

Due to the lack of necessary clinical data in the period of a lactation it is not recommended to appoint.

Side effects:

— gastrointestinal disturbances: seldom (> 1/10000, <1/1000): nausea, lock;

— disturbances of a nervous system: seldom (> 1/10000, <1/1000): headache, dizziness, sleeplessness;

— cardiovascular disturbances: seldom (> 1/10000, <1/1000): tachycardia, hypotension.

Interaction with other medicines:

Strengthens effect of other spasmolysants (including m-holinoblokatorov), the hypotension caused by tricyclic antidepressants, quinidine, novokainamidy.

Reliability of elimination of a spasm raises phenobarbital.

Reduces spazmogenny activity of morphine, antiparkinsonichesky properties of a levodopa.

Use in a combination with nitrates, beta adrenoblockers, sedatives is possible.

Contraindications:

Individual portability; the expressed liver, renal, heart failure, an atrioventricular block of II-Sh of degree.

Overdose:

Disturbance of atrioventricular conductivity, decrease in excitability of a cardiac muscle, cardiac standstill and paralysis of a respiratory center.

Storage conditions:

In the place protected from moisture and light at a temperature not above 25 °C. To store in the places protected from children. Period of storage 3 years.

Issue conditions:

Without recipe

Packaging:

On 10 or 20 tablets in blister strip packagings. On 1, 2 or 3 blister strip packagings on 10 tablets in a cardboard pack together with the application instruction. On 1, 2 or 3 blister strip packagings on 20 tablets in a cardboard pack together with the application instruction.