Omnitus, 20 mg 10 pcs

Pharmacodynamics
Butamirate, the active ingredient of Omnitus®, is a centrally acting cough suppressant. It is neither chemically nor pharmacologically related to opium alkaloids. It is not addictive or addictive.
It suppresses cough having direct influence on the coughing center. It has a bronchodilator effect (expands the bronchi). Helps ease breathing, improving spirometry (reduces airway resistance) and blood oxygenation (oxygenates blood).

Pharmacokinetics
Absorption is high. After oral administration of the modified-release tablet (50 mg), maximum concentration in plasma of the main metabolite (2-phenyl butyric acid) is observed after 9 hours and is 1.4 µg/ml.
Butamirate is hydrolyzed in plasma to 2-phenyl butyric acid and diethylaminoethoxyethanol. These metabolites also have antitussive activity and, like butamyrate, are largely (about 95%) bound to plasma proteins, which causes their long elimination half-life. 2-phenyl butyric acid is partially metabolized by hydroxylation at the para-position. There is no cumulation when taking the drug again.
Half-life is 13 hours. Excretion of the three metabolites occurs mainly through the kidneys; after conjugation in the liver, acidic metabolites are largely bound to glucuronic acid.

Indications

Dry cough of any etiology (for colds, flu, whooping cough and other conditions).

Suppression of cough in the preoperative and postoperative period, during surgical interventions, bronchoscopy.

Pharmacological effect

Pharmacodynamics
Butamirate, the active substance of the drug Omnitus®, is a centrally acting antitussive agent. It is neither chemically nor pharmacologically related to opium alkaloids. Does not form dependence or addiction.
Suppresses cough, having a direct effect on the cough center. Has a bronchodilator effect (expands the bronchi). Helps make breathing easier by improving spirometry (reduces airway resistance) and blood oxygenation (saturates the blood with oxygen).

Pharmacokinetics
Absorption – high. After oral administration of a modified-release tablet (50 mg), the maximum plasma concentration of the main metabolite (2-phenylbutyric acid) is observed after 9 hours and is 1.4 mcg/ml.
Butamirate is hydrolyzed in blood plasma to 2-phenylbutyric acid and diethylaminoethoxyethanol. These metabolites also have antitussive activity, and, like butamirate, are largely (about 95%) bound to plasma proteins, which determines their long half-life. 2-phenylbutyric acid is partially metabolized by hydroxylation in the para position. With repeated administration of the drug, accumulation is not observed.
The half-life is 13 hours. The three metabolites are eliminated mainly through the kidneys; After conjugation in the liver, acidic metabolites are largely bound to glucuronic acid.

Special instructions

Omnitus® 20 mg tablets are contraindicated in children under 6 years of age. Due to the fact that butamirate suppresses the cough reflex, the simultaneous use of expectorants should be avoided to avoid the accumulation of sputum in the respiratory tract with the risk of developing bronchospasm and respiratory tract infection.

Active ingredient

Butamirat

Active components

Butamirat

Composition

1 modified-release film-coated tablet 20 mg contains: active ingredient – butamirate citrate – 20 mg; excipients: lactose monohydrate, hypromellose, talc, magnesium stearate, colloidal silicon dioxide, povidone; shell composition: hypromellose, talc, ethylcellulose, macrogol, titanium dioxide, sunset yellow dye [E 110].

Pregnancy

Contraindicated during lactation, pregnancy, children and adolescents under 6 years of age.

Contraindications

Hypersensitivity to the components of the drug, pregnancy (first trimester), breastfeeding period, children under 6 years of age – 20 mg tablets, children under 18 years of age – 50 mg tablets. Lactose intolerance, lactase deficiency, glucose-galactose malabsorption (the drug contains lactose).

Side Effects

Classification of the frequency of adverse reactions: very often (≥1/10), often (≥1/100, <1/10), infrequently (≥1/1000, <1/100), rarely (≥1/10000, <1/1000), very rarely (<1/10000), including isolated cases. From the central nervous system: rarely - dizziness, drowsiness. From the digestive system: rarely - nausea, diarrhea. Allergic reactions: rarely - skin rash, itching, urticaria.

Overdose

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

Treatment: orally – activated carbon, saline laxatives, if necessary – symptomatic therapy.

Prescribing

Centrally acting antitussive

Complete set of goods

Modified-release film-coated tablets 20 mg.

10 tablets per PVC/AL blister. 1 blister along with instructions for use is placed in a cardboard box.

Syrup 0.8 mg/ml. 200 ml of the drug in a dark glass bottle of hydrolytic group III, sealed with a plastic cap with first opening control.

On the top side of the cap there is a diagram for opening the bottle. 1 bottle along with a measuring spoon (volume 5 ml, with a line for a volume of 2.5 ml) and instructions for use in a cardboard pack.

Functional features

Absorption is high. After oral administration of a modified-release tablet (50 mg), the maximum plasma concentration of the main metabolite (2-phenylbutyric acid) is observed after 9 hours and is 1.4 mcg/ml.
Butamirate is hydrolyzed in blood plasma to 2-phenylbutyric acid and diethylaminoethoxyethanol. These metabolites also have antitussive activity, and, like butamirate, are largely (about 95%) bound to plasma proteins, which determines their long half-life. 2-phenylbutyric acid is partially metabolized by hydroxylation in the para position. When taking the drug again, no accumulation is observed.
The half-life is 13 hours. The three metabolites are excreted mainly through the kidneys; After conjugation in the liver, acidic metabolites are largely bound to glucuronic acid.

Storage conditions

Tablets: At a temperature not exceeding 25 °C in consumer packaging. Keep out of the reach of children.

Shelf life

Tablets: 2 years. Do not use after the expiration date stated on the package.

Manufacturer

Hemofarm A.D., Serbia