Universal reference book for medicines
Product name: OMNITUS (OMNITUS)

Active substance: butamirate

Type: antitussive drug

Manufacturer: HEMOFARM (Serbia)
Composition, form of production and packaging
?
Modified-release tablets coated with a film coat from yellow to orange, round, biconvex.
1 tab.

butamirate citrate 20 mg

Excipients: lactose monohydrate - 218.5 mg, hypromellose - 70 mg, talc - 10 mg, magnesium stearate - 8 mg, silicon dioxide colloidal anhydrous - 2 mg, povidone - 1.5 mg.

The composition of the membrane: hypromellose - 5.105 mg, talc - 4.7 mg, ethyl cellulose - 3.14 mg, macrogol - 1.253 mg, titanium dioxide - 1.041 mg, dye solar sunset yellow (E110) (11%) - 1.261 mg.

10 pieces.
- blisters (1) - packs of cardboard.
?
Tablets with modified release, covered with a film shell of dark red color, round, biconvex.
1 tab.

butamirate citrate 50 mg

Excipients: lactose monohydrate - 230.5 mg, hypromellose - 85 mg, talc - 10 mg, magnesium stearate - 12 mg, silicon dioxide colloidal anhydrous - 6 mg, povidone - 1.5 mg.

The composition of the membrane: hypromellose - 5.305 mg, talc - 4.95 mg, ethyl cellulose - 3.183 mg, macrogol 1.273 mg, titanium dioxide - 1.061 mg, dye Ponso 4R (E124) - 2.122 mg, brown varnish (dye sunset yellow (E110) , dye azorubin (E122), dye black (E151)) - 106 mcg.

10 pieces.
- blisters (1) - packs of cardboard.
?
Syrup in the form of a transparent, colorless, viscous liquid with the smell of vanilla.
1 ml

butamirate citrate 800 μg

Auxiliary substances: sorbitol 70% (non-crystallisable) 405 mg, glycerol 290 mg, sodium saccharin 600 μg, benzoic acid 1.15 mg, vanillin 600 μg, anise oil 150 μg, ethanol 96% 3 μl, sodium hydroxide - 100 mcg, purified water - up to 1 ml.

200 ml - bottles of dark glass (1) complete with a measuring spoon (volume 5 ml, with a risk for a volume of 2.5 ml) - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2011.

PHARMACHOLOGIC EFFECT

Antitussive drug of central action.
Butamirate citrate is neither chemically nor pharmacologically related to opium alkaloids. Has direct influence on the cough center.Has expectorant, moderate bronchodilating and anti-inflammatory effect. Improves spirometry and blood oxygenation.
PHARMACOKINETICS

Suction

After ingestion, absorption is high.
After ingestion of the drug in the form of a syrup in a dose of 150 mg C max in the plasma of the main metabolite (2-phenylbutyric acid) is observed after 1.5 hours and is 6.4 μg / ml, with the modified release tablet (50 mg) 9 hours and 1.4 μg / ml.
Distribution and Metabolism

Butamirate citrate is rapidly hydrolyzed in plasma to 2-phenylbutyric acid and diethylaminoethoxyethanol.
Both these metabolites, which also have antitussive action, largely bind to plasma proteins, which explains their long-term presence in plasma. Subsequently, the main metabolite 2-phenylbutyric acid is oxidized to 14 Cr-hydroxy-2-phenylbutyric acid. Do not cumulate.
Excretion

T 1/2 butamirate when taken in the form of a syrup is 6 hours, in the form of tablets -13 hours. All three metabolites are excreted by the kidneys, and the acid metabolites are mainly in the form of glucuronides.

INDICATIONS

- dry cough of any etiology (for colds, flu, pertussis and other conditions);

- to suppress cough in the preoperative and postoperative period, during surgical interventions, bronchoscopy.

DOSING MODE

The drug is prescribed inside.

Tablets 20 mg

Adults appoint 2 tab.
2-3 times / day; children over 12 years - 1 tab. 3 times / day; children aged 6 to 12 years - 1 tab. 2 times / day.
50 mg tablets

Adults appoint 1 tablet.
every 8-12 hours.
Tablets are taken before meals without chewing.

Syrup

Adults appoint 6 measuring spoons (30 ml) 3 times / day;
children over 9 years old (body weight from 40 kg) - 3 scoops (15 ml) 4 times / day; children aged 6 to 9 years (body weight 22-30 kg) - 3 scoops (15 ml) 3 times / day; children aged 3 to 6 years (body weight 15-22 kg) - 2 scoops (10 ml) 3 times / day.
SIDE EFFECT

From the side of the digestive system: nausea, diarrhea.

Other: exanthema, dizziness, allergic reactions.

CONTRAINDICATIONS

- lactation period;

- Hypersensitivity to the components of the drug.

For tablets:

- Pregnancy;

- Children under 6 years of age (20 mg tablets);

- Children and adolescence under 18 years (tablets 50 mg).

For syrup:

- I trimester of pregnancy;

- Children under 3 years old.

PREGNANCY AND LACTATION

Contraindicated use of the drug in the form of syrup during pregnancy, in the form of tablets - in the I trimester of pregnancy.

If you need to use the drug during lactation, you should decide whether to stop breastfeeding.

APPLICATION FOR CHILDREN

Contraindication : children under 6 years (tablets 20 mg);
children and adolescents under 18 years (tablets 50 mg), for syrup - children under 3 years.
SPECIAL INSTRUCTIONS

During the period of treatment, it is not recommended to prescribe drugs that depress the central nervous system (including sleeping pills, antipsychotics, tranquilizers), patients should not consume alcohol.

Patients with diabetes can be prescribed a drug, because
As a sweetener in syrup, sorbitol and saccharin are used, the tablets contain lactose.
1 ml of syrup contains 0.003 ml of ethanol.
When receiving the recommended single dose, the patient receives 0.03 ml of ethanol in 10 ml of syrup. It should be taken into account that this poses a danger for patients with liver diseases, alcoholism, epilepsy, brain diseases, as well as for pregnant women and children.
OVERDOSE

Symptoms: nausea, vomiting, drowsiness, diarrhea, dizziness, lowering blood pressure.

Treatment: inside - activated charcoal, saline laxatives, if necessary - symptomatic therapy.

DRUG INTERACTION

The drug interaction of butamirate is not described.

TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC.

TERMS AND CONDITIONS OF STORAGE

The drug in the form of tablets should be stored in a dry, dark place at a temperature of 15 ° to 25 ° C.
Shelf life - 2 years.
The drug in the form of a syrup should be stored in a dark place at a temperature of 15 ° to 25 ° C.
Shelf life - 5 years.
The drug should be stored out of the reach of children.

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