Omnitus - instructions for use, dose, side effects, contraindications

active substance butamirate citrate 20 mg; Excipients - lactose monohydrate 218.5 mg, hypromellose 70.0 mg, talc 10.0 mg, magnesium stearate 8.0 mg, silicon dioxide colloid, anhydrous 2.0 mg, povidone 1.5 mg, shell composition: hypromellose - 5,105 mg, talc - 4,700 mg, ethylcellulose - 3,140 mg, macrogol - 1,253 mg, titanium dioxide - 1,041 mg, dye solar sunset yellow [E 110] (11%) - 1.261 mg.

1 modified release tablet coated with a film sheath 50 mg contains:

active substance butamirate citrate 50 mg; Excipients - lactose monohydrate 230.5 mg, hypromellose 85.0 mg, talc 10.0 mg, magnesium stearate 12.0 mg, silicon dioxide colloid, anhydrous 6.0 mg, povidone 1.5 mg, shell composition: hypromellose - 5,305 mg, talc - 4,950 mg, ethyl cellulose - 3,183 mg, macrogol - 1,273 mg, titanium dioxide - 1,061 mg, dye crimson [Ponso 4R] [E 124] - 2,122 mg, brown lacquer (dye sunset yellow [E110], dye azorubin [E122], dye black [E151]) - 0.106 mg.

Description:

Modified-release tablets coated with a film membrane 20 mg: round, biconvex tablets, coated with a coating from yellow to orange. Tablets with modified release, film-coated 50 mg: round, biconvex tablets, covered with a shell of dark red color.

Pharmacotherapeutic group:Antitussive remedy of central action

ATX: & nbsp

R.05.D.B.13 Butamate

Pharmacodynamics:

Antitussive, has expectorant, moderate bronchodilator and anti-inflammatory effect.

Butamirate citrate is neither chemically nor pharmacologically related to opium alkaloids and has a direct effect on the cough center, improves spirometry and blood oxygenation.

Pharmacokinetics:

Absorption is high. After intake of the syrup in a dose containing 150 mg of citrate butramate, the maximum plasma concentration 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), respectively 9 h and 1.4 μg / ml. Period half-life for syrup -6 hours, for tablets -13 hours. No cumulative effect. 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 ¹⁴C -p-hydroxy-2-phenylbutyric acid. All three metabolites are excreted by the kidneys, and acid metabolites are mainly associated with glucuronic acid.

Indications:

Dry cough of any etiology (for colds, flu, pertussis and other conditions). Suppression of cough in the preoperative and postoperative period, during surgical interventions, bronchoscopy.

Contraindications:

Dsensitivity, pregnancy, lactation, children under 6 years - tablets 20 mg, up to 18 years - tablets 50 mg.

Dosing and Administration:

Inside. Tablets are taken before meals without chewing.

Tablets 20 mg

Children: from 6 to 12 years - 1 tablet 2 times a day

over 12 years - 1 tablet 3 times a day

Adults: - 2 tablets 2-3 times a day

50 mg tablets

Adults: - 1 tablet every 8-12 hours.

Side effects:Exanthema, nausea, diarrhea, dizziness, allergic reactions.

Overdose:

Symptoms: nausea, vomiting, drowsiness, diarrhea, dizziness, lowering blood pressure. Treatment: Activated carbon, saline laxatives, symptomatic therapy (according to indications).

Interaction:

What drug interactions for butamirate are not described. During the treatment with the drug, it is not recommended to drink alcoholic beverages, as well as drugs that depress the central nervous system (hypnotics, antipsychotics, tranquilizers and other drugs).

Special instructions:

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

Omnitus contains 3 ml (or 0.003 ml) of ethanol in 1 ml. When the dosage is met, the patient takes a single dose of 0.03 ml of ethanol (in 10 ml of syrup).

There is a danger for people with liver disease, alcoholism, epilepsy, brain diseases, as well as for pregnant women and children.

Form release / dosage:

Modified-release tablets, film-coated 20 mg or 50 mg.

Packaging:

For 10 tablets in a blister of PVC / AL. 1 blister together with instructions for use are placed in a pack of cardboard.

Storage conditions:

Store in a dry, dark place at a temperature of 15 to 25 ° C.

Keep out of the reach of children!

Shelf life:2 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LSR-008118/08

Date of registration:14.10.2008 / 31.08.2009

Expiration Date:Unlimited

The owner of the registration certificate:Hemofarm ADHemofarm AD Serbia

Manufacturer: & nbsp

HEMOFARM, A.D. Serbia

Representation: & nbspNizhpharm, JSCNizhpharm, JSCRussia

Information update date: & nbsp07.06.2017

Illustrated instructions

Instructions

Omnitus (Omnitus)