Synecod for dry cough, oral drops 5mg/ml, 20ml

Composition

Auxiliary substances:

sorbitol 70% solution of m/m – 405 mg,

glycerol – 290 mg,

sodium saccharin – 1.15 mg,

benzoic acid – 1.15 mg,

vanilla – 1.15 mg,

ethanol 96% vol. /about. 3 mg,

sodium hydroxide 30% m/m – 0.5 mg,

water – up to 1 ml.

Pharmacological action

Antitussive drug of central action, does not belong to the opium alkaloids either chemically or pharmacologically. It does not form an addiction or addiction. Suppresses cough, having a direct effect on the cough center. It has a bronchodilating effect. Helps facilitate breathing by improving spirometry (reduces airway resistance) and blood oxygenation.

Clinical pharmacology

Absorption Based on the available data, it is assumed that butamirate ether is rapidly and completely absorbed and hydrolyzed in plasma, turning into 2-phenylbutyric acid and diethylaminoethoxyethanol. The effect of food on absorption has not been studied. The change in the concentration of 2-fepylbutyric 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 detected in the blood 5-10 minutes after use at doses of 22.5 mg,45 mg,67.5 mg and 90 mg. Cmax in blood plasma is reached within 1 hour when taken in all 4 doses, the average value is 16.1 ng / ml when taken orally at a dose of 90 mg. Mean plasma concentrations of 2-phenylbutyric acid were reached within 1.5 hours; Cmax was observed at a dose of 90 mg (3052 ng / ml); mean plasma concentrations of dithylaminoethoxyethanol were reached within 0.67 hours; Cmax was observed after use at a dose of 90 mg (160 ng/ml). Distribution Butamirate has a large Vd in the range of 81-112 L (adjusted 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%. The ability of diethylaminoethoxyethanol to bind to plasma proteins is also found, the average values vary in the range of 28.8-45.7%. It is not known whether butamirate penetrates the placental barrier or is excreted in breast milk. Metabolism Hydrolysis of butamirate, resulting 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 at the para-position. Elimination 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 the urine at significantly higher concentrations than in the blood plasma. Butamirate is detected in the urine within 48 hours, and the proportion of butamirate excreted in the urine during the 96-hour sampling period accounts for about 0.02,0.02,0.03, and 0.03% of the 22.5 mg,45 mg,67.5 mg, and 90 mg doses taken, respectively. As a percentage, butamirate is excreted in the urine in a larger amount and in the form of diethylaminoethoxyethanol than butamirate in unchanged form 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.

Indications

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

Use during pregnancy and lactation

No controlled clinical trials have been conducted in pregnant women. Therefore, Synecode® should not be used in the first trimester of pregnancy. In the second and third trimesters, the use of Synecode 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, the use of the drug during lactation is not recommended. In animal studies, no adverse effects on the fetus were observed.

Contraindications

• Hypersensitivity to the components of the drug;
• children under 2 months of age (for drops);
• children under 3 years of age (for syrup);
• I trimester of pregnancy;
• lactation period;
• fructose intolerance (the drug contains sorbitol);

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

Side effects

Determining the frequency of side effects: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10 000 and <1/1000), very rare (Nervous system disorders: rarely-drowsiness. From the digestive system: rarely-nausea, diarrhea. Allergic reactions: rarely-urticaria, other manifestations are possible.

Interaction

The drug interaction of butamirate is not described. Due to the fact that butamirate suppresses the cough effect, the simultaneous use of expectorants should be avoided in order to avoid accumulation of sputum in the respiratory tract with the risk of bronchospasm and respiratory tract infection.

How to take, course of use and dosage

Inside, before eating. Drops: children from 2 months to 1 year — 10 drops 4 times a day,1-3 years-15 drops 4 times a day, older than 3 years-25 drops 4 times a day. If the cough persists for more than 7 days, you should consult a doctor. Before using the drug in children under 2 years of age, you should consult your doctor.

Overdose

Symptoms: drowsiness, nausea, vomiting, diarrhea, dizziness, decreased blood pressure. Treatment: gastric lavage, taking activated charcoal, maintaining vital body functions. There is no specific antidote.

Description

Drops for oral use (for children) in the form of a clear liquid from colorless to colorless with a yellowish tinge of color, with a vanilla smell.

Special instructions

Syrup and drops for oral use 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, drops for oral use-2.81 mg / ml. Therefore, the drug should be used with caution in patients with a tendency to develop drug dependence, liver diseases, alcoholism, epilepsy, brain diseases, pregnant women (II and III trimesters) and children. This should be taken into account when applying it. Effects on the ability to drive motor vehicles and operate Mechanicsmisinecode® may cause drowsiness, so caution should be exercised when driving vehicles and when performing work that requires concentration (for example, when working with mechanisms) after taking the drug.

Form of production

Oral drops [for children] 5 mg / ml. 20 ml each in a dark glass bottle equipped with a low-density polyethylene dropper dispenser and a polypropylene lid equipped with a first opening control system.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 30°C.

Shelf

life is 3 years.

Active ingredient

Butamirate

Dosage form

oral drops