Sinecode drops for oral administration, 20ml

Symptomatic treatment of dry cough of various etiologies: suppression of cough in the pre- and postoperative period, during surgical interventions, bronchoscopy, with whooping cough.

The drug is taken orally before meals.

If the cough persists for more than 7 days, you should see a doctor.

Dosage regimen

Children from 2 months to 1 year, 10 drops 4 times / day

Children from 1 to 3 years old, 15 drops 4 times / day

Children 3 and older, 25 drops 4 times / day

Before using the drug in children under 2 years of age, consult a doctor.

Per 100 ml:
Active ingredient: butamirate citrate 1.5 mg.
Excipients: sorbitol solution 70% m / m - 40.5% m / v., Glycerol - 29% m / v., Sodium saccharinate - 0.06% m / v., Benzoic acid - 1.115% m / v., Vanillin - 0.06 % m / v, ethanol 96% v / v - 0.25% m / v., Sodium hydroxide 30% m / m - 0.031% m / v., Water - up to 100 ml. '

• Hypersensitivity to the components of the drug;

• children's age up to 2 months (for drops);

• I trimester of pregnancy;

• lactation period;

• intolerance to fructose (the drug contains sorbitol);

With care: II and III trimesters of pregnancy. Due to the presence of ethyl alcohol in the composition of the drug, use with caution in patients with a tendency to develop drug dependence, with liver diseases, alcoholism, epilepsy, brain diseases, in pregnant women (II and III trimesters) and children.

Sinekod drops for dry cough, made in Switzerland, are convenient to dose and give even to the smallest children who suffer from dry cough.
Х Approved for use in children from 2 months of age.
Х Sinekod facilitates breathing, selectively affecting the cough center
Х Suppresses cough, having a direct effect on the cough center
Х Has a bronchodilating effect (expands the bronchi).
Х Reduces the intensity of nocturnal cough from the first day of treatment

Pharmacokinetics

Suction

Based on the available data, it is assumed that the butamirate ester is rapidly and completely absorbed and hydrolyzed in plasma, converting to 2-phenylbutyric acid and diethylaminoethoxyethanol. The effect of food on absorption has not been studied. The change in the concentration of 2-phenylbutyric acid and diethylaminoethoxyethanol occurs in proportion to the dose taken in the range of 22.5-90 mg.

Butamirate is rapidly and completely absorbed when taken orally, measured concentrations are found in the blood 5-10 minutes after ingestion at doses of 22.5 mg, 45 mg, 67.5 mg and 90 mg. Cmax in blood plasma is achieved within 1 hour when taken in all 4 doses, the average is 16.1 ng / ml when taken orally at a dose of 90 mg.

After taking 150 mg of butamirate, Cmax in the plasma of the main metabolite (2-phenylbutyric acid) is reached after about 1.5 hours and is 6.4 ?g / ml. When the drug is reappointed, its concentration in the blood remains linear, no cumulation is observed

Average plasma concentrations of 2-phenylbutyric acid are reached within 1.5 hours; Cmax was observed at a dose of 90 mg (3052 ng / ml); average plasma concentrations of dithylaminoethoxyethanol are reached within 0.67 hours; Cmax is observed after taking a dose of 90 mg (160 ng / ml).

Distribution

Butamirate has a large Vd in the range of 81-112 L (corrected for body weight in kg), as well as a high degree of binding to plasma proteins. 2-phenylbutyric acid has a high degree of binding to plasma proteins at all doses (22.5-90 mg) and averages 89.3-91.6%. Also, the ability of diethylaminoethoxyethanol to bind to plasma proteins is found, the average values ??vary in the range of 28.8-45.7%. It is not known whether butamirate crosses the placental barrier, whether it is excreted in breast milk.

Metabolism

Hydrolysis of butamirate, which results in the formation of 2-phenylbutyric acid and diethylaminoethoxyethanol, which have an antitussive effect, occurs very quickly. 2-phenylbutyric acid undergoes further partial metabolism by hydroxylation in the para-position.

Withdrawal

Excretion of the three metabolites occurs mainly by the kidneys; after conjugation in the liver, acidic metabolites are largely bound to glucuronic acid. Conjugates of 2-phenylbutyric acid are detected in urine at significantly higher concentrations than in blood plasma. Butamirate is detected in urine within 48 hours, butamirate excreted in urine during the 96-hour sampling period accounts for about 0.02, 0.02, 0.03 and 0.03% of the doses taken 22.5 mg, 45 mg, 67.5 mg and 90 mg, respectively ... As a percentage, butamirate is excreted in the urine in greater amounts and in the form of diethylaminoethoxyethanol than unchanged butamirate or unconjugated 2-phenylbutyric acid. The measured T1 / 2 of 2-phenylbutyric acid, butamirate and diethylaminoethoxyethanol is 23.26-24.42, 1.48-1.93 and 2.72-2.90 h, respectively.

Side effect

From the nervous system: rarely - drowsiness.

From the digestive system: rarely - nausea, diarrhea.

Allergic reactions: rarely - urticaria; other manifestations are possible.

Application during pregnancy and lactation

There have been no controlled clinical studies in pregnant women. In this regard, SinekodЃ should not be used in the first trimester of pregnancy. In the II and III trimesters, the use of SinecodЃ is possible taking into account the benefits to the mother and the potential risk to the fetus.

Given the lack of data on the excretion of butamirate in breast milk, prescribing the drug during lactation is not recommended.

In studies conducted on animals, no adverse effects on the fetus were noted.

special instructions

The syrup and drops for oral administration contain saccharinate and sorbitol as sweeteners, so the drug can be prescribed to patients with diabetes mellitus.

The drug contains a small amount of ethanol: syrup - 11.73 mg / 5 ml, oral drops - 2.81 mg / ml. Therefore, the drug should be used with caution in patients with a tendency to develop drug dependence, with liver diseases, alcoholism, epilepsy, brain diseases, in pregnant women (II and III trimesters) and in children.

This should be taken into account when applicable.

Influence on the ability to drive vehicles and use mechanisms

SinekodЃ can cause drowsiness, therefore, care should be taken when driving vehicles and when performing work that requires concentration of attention (for example, when working with mechanisms) after taking the drug.

Overdose

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

Treatment: gastric lavage, intake of activated carbon, maintenance of vital body functions. There is no specific antidote.

Drug interactions

The drug interaction of butamirate has not been described.

Due to the fact that butamirate suppresses the cough effect, the simultaneous use of expectorants should be avoided in order to avoid the accumulation of sputum in the respiratory tract with the risk of bronchospasm and respiratory tract infection.