OMNITUS

Active material: Butamirat
When ATH: R05DB13
CCF: Cold preparations
ICD-10 codes (testimony): A37, J06.9, J10, R05
When CSF: 12.03.01
Manufacturer: HEMOFARM A.D. (Serbia)

DOSAGE FORM, COMPOSITION AND PACKAGING

◊ The modified-release tablet, Film-coated from yellow to orange, round, lenticular.

Excipients: lactose monohydrate, gipromelloza, talc, magnesium stearate, Colloidal anhydrous silica, povidone.

The composition of the shell: gipromelloza, talc, ethyl cellulose, macrogol, Titanium dioxide, colorant sunset yellow (E110).

10 PC. – blisters (1) – packs cardboard.

◊ The modified-release tablet, Film-coated dark red, round, lenticular.

Excipients: lactose monohydrate, gipromelloza, talc, magnesium stearate, Colloidal anhydrous silica, povidone.

The composition of the shell: gipromelloza, talc, ethyl cellulose, macrogol, Titanium dioxide, carmine dye Ponceau 4R (E124) and brown varnish (colorant sunset yellow (E110), dye azorubin (E122), Black dye (E151)).

10 PC. – blisters (1) – packs cardboard.

◊ Syrup in the form of a transparent, colorless, viscous fluid vanilla.

Excipients: sorbitol 70% (noncrystallizing), glycerol, saccharin sodium, benzoic acid, vanillin, anise oil, ethanol 96%, Sodium hydroxide, Purified water.

200 ml – vials of dark glass (1) complete with a measured spoon in volume 5 ml and the risks to the volume 2.5 ml – packs cardboard.

Pharmacological action

Centrally acting antitussive. Butamirate citrate not yavlyaetsya our chemical, or pharmacologically related to the opium alkaloids. It has a direct effect on the cough center. It has expectorant, moderate bronchodilatory and anti-inflammatory. It improves spirometry and blood oxygenation.

Pharmacokinetics

Absorption

After oral administration, absorption is high. After oral administration of the drug in the form of syrup in a dose of 150 mg C_max major metabolite in plasma (2-phenylbutyric acid) observed through 1.5 h and is 6.4 ug / ml, upon receipt of the modified-release tablets (50 mg) respectively 9 and h 1.4 ug / ml.

Distribution and metabolism

Butamirata citrate is rapidly hydrolyzed in plasma in 2 fenilmaslyanuto acid and dietilaminoetoksietanol. Both metabolite, also has antitussive action, largely bound to plasma proteins, which explains their long presence in the plasma. In the future, the main metabolite of 2-phenylbutyric acid is oxidized to ¹⁴C-p-hydroxy-2-phenylbutyric acid. Not accumulates.

Deduction

T_1/2 butamirata while taking the drug in the form of a syrup 6 no, in the form of tablets -13 no. All three metabolites are excreted by the kidneys, and acidic metabolites mainly in the form of glucuronides.

Testimony

- A dry cough of any etiology (for colds, Flu, whooping cough and other conditions);

- A cough suppressant in the preoperative and postoperative, during surgery, bronchoscopy.

Dosage regimen

The drug is prescribed inside.

Pills 20 mg

Adults appoint 2 tab. 2-3 times / day; older children 12 years – by 1 tab. 3 times / day; children aged 6 to 12 years – by 1 tab. 2 times / day.

Pills 50 mg

Adults appoint 1 tab. every 8-12 no.

Tablets are taken before a meal, without chewing.

Syrup

Adults appoint 6 scoops (30 ml) 3 times / day; older children 9 years (by weight 40 kg) – by 3 measuring spoons (15 ml) 4 times / day; children aged 6 to 9 years (weight 22-30 kg) – by 3 measuring spoons (15 ml) 3 times / day; children aged 3 to 6 years (weight 15-22 kg) – by 2 measuring spoons (10 ml) 3 times / day.

Side effect

From the digestive system: nausea, diarrhea.

Other: rash, dizziness, allergic reactions.

Contraindications

- Lactation;

- Hypersensitivity to the drug.

Pill:

- Pregnancy;

- Children up to age 6 years (tablets 20 mg);

- Childhood and adolescence up 18 years (tablets 50 mg).

Syrup:

- I trimester of pregnancy;

- Children up to age 3 years.

Pregnancy and lactation

Do not use this drug in the form of a syrup during pregnancy, in the form of tablets – I trimester of pregnancy.

If necessary, use during lactation should decide the issue of termination of breastfeeding.

Cautions

During the period of treatment is not recommended to prescribe drugs, CNS depressants (incl. hypnotics, antipsychotics, trankvilizatorы), Patients should not drink alcohol.

Patients with diabetes can be prescribed the drug, tk. as a sweetener in the syrup used sorbitol and saccharin, tablets contain lactose.

IN 1 ml syrup contains 0.003 ml ethanol. When receiving the recommended single dose a patient gets into 10 ml syrup 0.03 ml ethanol. It should be taken into account, it presents a danger to patients with liver disease, alcoholism, epilepsy, brain diseases, as well as for children and pregnant.

Overdose

Symptoms: nausea, vomiting, drowsiness, diarrhea, dizziness, decrease in blood pressure.

Treatment: inside – Activated carbon, saline laxatives, if necessary – symptomatic therapy.

Drug Interactions

Drug interactions are not described butamirata.

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

Conditions and terms

A preparation in the form of tablets should be stored in dry, dark place at a temperature of 15 ° to 25 ° C. Shelf life – 2 year.

The drug is in the form of syrup should be stored in a dark place at a temperature between 15 ° and 25 ° C. Shelf life – 5 years.

The drug should be stored out of reach of children.