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

Excipients - sorbitol 70% (non-crystallizing) - 405.00 mg, glycerol - 290.00 mg, sodium saccharin - 0.60 mg, benzoic acid -1.15 mg, vanillin - 0.60 mg, anise oil - 0.15 mg , ethanol 96% - 3.00 μl, sodium hydroxide - 0.10 mg, purified water - up to 1.00 ml.

Description:

Transparent, colorless, viscous liquid with the smell of vanilla.

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,not pharmacologically related to opium alkaloids and has a direct effect on the cough center, improves spirometry and oxygenation of the blood.

Pharmacokinetics:

Absorption is high. After ingestion 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 a modified release tablet (50 mg), respectively, 9 hours and 1.4 μg / ml. The half-life for syrup is 6 hours, for tablets -13 hours. There is 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:

Hypersensitivity, pregnancy (I trimester), lactation, children under 3 years.

Dosing and Administration:

Inside.

The syrup contains 1 measuring spoon (5 ml volume):

Children

from 3 to 6 years (15-22 kg) - 2 measuring spoons (10 ml) 3 times a day

from 6 to 9 years (22-30 kg) - 3 measuring spoons (15 ml) 3 times a day

over 9 years (40 kg) - 3 measuring spoons (15 ml) 4 times a day

Adults: - 6 measuring spoons (30 ml) 3 times a day

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:

Syrup 0.8 mg / ml.

Packaging:

For 200 ml of the drug in a bottle of dark glass III hydrolytic group, sealed with a plastic lid with the control of the first opening. On the top side of the lid is a scheme for opening the vial. 1 bottle with a measuring spoon (volume 5 ml, with a risk for volume of 2.5 ml) and instructions for use in a pack of cardboard.

Storage conditions:

Store at a temperature of 15 to 25 ° C, in a place protected from light.

Keep out of the reach of children!

Shelf life:

5 years.

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

Terms of leave from pharmacies:Without recipe

Registration number:P N00959

Date of registration:11.09.2008 / 08.12.2015

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)