OMNITUS PILLS WITH A MODIFIED RELEASE 50MG

Pharmaco-therapeutic group:

Antitussive central acting

Mechanism of action

Antitussive drug of central action. Butamirate citrate is neither chemically nor pharmacologically related to opium alkaloids. It has a direct effect on the cough center. It has an expectorant, moderate bronchodilatory 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 at a dose of 150 mg Cmax in the plasma of the main metabolite (2-phenylbutyric acid) is observed after 1.5 hours and amounts to 6.4 μg / ml, while taking a release pill (50 mg), respectively 9 hours and 1.4 μg / ml.

Distribution and metabolism

Butamirate citrate is rapidly hydrolyzed in plasma to 2-phenyl-butylated acid and diethylaminoethoxyethanol. Both of these metabolites, which also have an antitussive effect, are largely associated with plasma proteins, which explains their long-term presence in the plasma. Subsequently, the main metabolite 2-phenylbutyric acid is oxidized to 14Cr-hydroxy-2-phenylbutyric acid. Does not accumulate.

Removal

T1/2 butamiraty when taking the drug in the form of a syrup is 6 hours, in the form of pills -13 hours. All three metabolites are excreted by the kidneys, with acidic metabolites mainly in the form of glucuronides.

Indications

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

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

Dosage and administration

The drug is prescribed inside.

20 mg tablets

For adults appoint 2 tab. 2-3 times / day; children over 12 years old 1 tab. 3 times / day; children aged 6 to 12 years - 1 tab. 2 times / day.

50 mg tablets

For adults appoint 1 tab. every 8-12 hours

Tablets are taken before meals without chewing.

Syrup

For adults designate 6 scoops (30 ml) 3 times / day; children over 9 years old (body weight 40 kg) - on 3 measured spoons (15 ml) 4 times / days; children aged 6 to 9 years (body weight 22-30 kg) - on 3 measured spoons (15 ml) 3 times / days; children aged 3 to 6 years (body weight 15-22 kg) - 2 scoops (10 ml) 3 times / day.

Side effect

Gastrointestinal: nausea, diarrhea.

Other: exanthema, dizziness, allergic reactions.

Contraindications

- lactation period;

- hypersensitivity to the drug.

For tablets:

- pregnancy;

- children's age up to 6 years (tablets of 20 mg);

- children's and teenage age till 18 years (tablets of 50 mg).

For syrup:

- I trimester of pregnancy;

- children's age up to 3 years.

Use during pregnancy and lactation

The drug is contraindicated in the form of a syrup during pregnancy, in the form of pills in the first trimester of pregnancy.

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

Use in children

Contraindication: children's age up to 6 years (tablets of 20 mg); children and adolescents up to 18 years (50 mg tablets), for syrup - children up to 3 years.

Special notes

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

Patients with diabetes can be prescribed the drug, because Sorbitol and saccharin are used as a sweetener in syrup, pills contain lactose.

In 1 ml of syrup contains 0.003 ml of ethanol. When receiving the recommended single dose, the patient receives in 10 ml of syrup 0.03 ml of ethanol. It should be borne in mind that this is a danger for patients with liver diseases, alcoholism, epilepsy, brain diseases, as well as for pregnant women and children.

Overdosage

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

Treatment: inside - Activated carbon, saline laxatives, if necessary - carrying out symptomatic therapy.

Drug interaction

Drug interaction butamirata not described.

Terms and conditions of storage

The drug in pill form 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 kept out of the reach of children.