Omnitus

General characteristics. Structure:

Active agent: butamirata citrate of 20 mg

Excipients: lactoses monohydrate - 218.5 mg, a gipromelloza - 70 mg, talc - 10 mg, magnesium stearate - 8 mg, silicon dioxide colloid anhydrous - 2 mg, povidone - 1.5 mg.

Structure of a cover: a gipromelloza - 5.105 mg, talc - 4.7 mg, ethyl cellulose - 3.14 mg, a macrogoal - 1.253 mg, titanium dioxide - 1.041 mg, dye a sunset yellow (E110) (11%) - 1.261 mg.

Active agent: butamirata citrate of 50 mg

Excipients: lactoses monohydrate - 230.5 mg, a gipromelloza - 85 mg, talc - 10 mg, magnesium stearate - 12 mg, silicon dioxide colloid anhydrous - 6 mg, povidone - 1.5 mg.

Structure of a cover: a gipromelloza - 5.305 mg, talc - 4.95 mg, ethyl cellulose - 3.183 mg, a macrogoal - 1.273 mg, titanium dioxide - 1.061 mg, dye crimson Ponso 4R (E124) - 2.122 of mg, a brown varnish (dye a sunset yellow (E110), dye an azoruby (E122), dye black (E151)) - 106 mkg.

Pharmacological properties:

Antibechic drug of the central action. Butamirata citrate is not neither chemically, nor pharmacological related with opium alkaloids. Has a direct impact on the tussive center. Renders expectorant, moderate bronkhodilatiruyushchy and antiinflammatory action. Improves indicators of spirometry and oxygenation of blood.

Pharmacokinetics. Absorption. After intake absorption high. After intake of drug in the form of syrup in a dose of 150 mg of Cmax in plasma of the main metabolite (2-phenyl-butyric acid) it is observed in 1.5 h and makes 6.4 mkg/ml, at reception of a tablet with the modified release (50 mg) respectively 9 h and 1.4 mkg/ml.

Distribution and metabolism. Butamirata citrate is quickly hydrolyzed in plasma in 2-fenilmaslyanuto acid and diethylaminoethoxyethanol. Both of these metabolites possessing also antibechic action substantially contact proteins of plasma that explains their long stay in plasma. Further the main metabolite 2-phenyl-butyric acid is oxidized to 14C-r-hydroxy-2-phenyl-butyric acid. Does not kumulirut.

Removal. T1/2 of a butamirat at administration of drug in the form of syrup makes 6 h, in the form of tablets of-13 h. All three metabolites are removed by kidneys, and acid metabolites generally in the form of glucuronides.

Indications to use:

— dry cough of any etiology (at catarrhal diseases, flu, whooping cough and other states);
— for suppression of cough in the preoperative and postoperative period, during surgical interventions, a bronkhoskopiya.

Route of administration and doses:

Drug is appointed inside.
Tablets of 20 mg
The adult appoint 2 tablets of 2-3 times/days; to children 12 years - on 1 tablets of 3 times/days are more senior; to children aged from 6 up to 12 years - on 1 tablets of 2 times/days.
Tablets of 50 mg
Each 8-12 h appoint the adult 1 tablet.
Pill is taken before food, without chewing.

Features of use:

During treatment it is not recommended to appoint drugs, the oppressing TsNS (including somnolent, antipsychotic means, tranquilizers), patients should not take alcohol.

Patients with a diabetes mellitus can appoint drug since as sweetener in syrup sorbitol and saccharin are used, tablets contain lactose.

Side effects:

From the alimentary system: nausea, diarrhea.
Others: dieback, dizziness, allergic reactions.

Interaction with other medicines:

Medicinal interaction of a butamirat is not described.

Contraindications:

— lactation period;
— hypersensitivity to drug components.
— pregnancy;
— children's age up to 6 years (a tablet of 20 mg);
— children's and teenage age up to 18 years (a tablet of 50 mg).

Use of drug OMNITUS at pregnancy and feeding by a breast
Use of drug in the form of syrup at pregnancy is contraindicated, in the form of tablets - in the I trimester of pregnancy.
In need of use of drug in the period of a lactation it is necessary to resolve an issue of the breastfeeding termination.

Use for children
Contraindication: children's age up to 6 years (a tablet of 20 mg); children's and teenage age up to 18 years (a tablet of 50 mg), for syrup - children's age up to 3 years.

Overdose:

Symptoms: nausea, vomiting, drowsiness, diarrhea, dizziness, decrease in the ABP.
Treatment: inside - absorbent carbon, salt laxatives, if necessary - performing symptomatic therapy.

Storage conditions:

Drug in the form of tablets should be stored in the dry, protected from light place at a temperature from 15 °C to 25 °C.

Issue conditions:

Without recipe

Packaging:

Tablets with модиф. release, покр. film cover, 20 mg: 10 pieces.

Tablets with модиф. release, покр. film cover, 50 mg: 10 pieces.