Sinekod drops for oral administration for children 5mg / ml 20ml dropper bottle

Release form, composition and packaging

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

1 ml

butamirate citrate 5 mg

sorbitol solution 70% m / m - 405 mg, glycerol - 290 mg, sodium saccharinate - 1.15 mg, benzoic acid - 1.15 mg, vanillin - 1.15 mg, ethanol 96% v / v.

- 3 mg, sodium hydroxide 30% m / m - 0.5 mg, water - up to 1 ml.

20 ml - dark glass bottles (1) with a dropper-dispenser and a first opening control system - cardboard packs.

pharmachologic effect

Antitussive drug of central action, does not belong to opium alkaloids, either chemically or pharmacologically.

Does not form addiction or addiction.

Suppresses cough, having a direct effect on the cough center.

It has a bronchodilating effect.

Helps to facilitate breathing, improving spirometry (reduces airway resistance) and blood oxygenation.

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 in 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.

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 at a dose of 90 mg (160 ng / ml).

Distribution

Butamirate has a large Vd in the range 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 within 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

The excretion of three metabolites occurs mainly by the kidneys after conjugation in the liver, acidic metabolites bind largely 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.

Indications for use

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

Name ENG

SINECOD

Clinical and pharmacological group

Antitussive drug

ATX code

Butamirate

Dosage

5mg / ml x 20ml

Structure

Excipients: sorbitol solution 70% m / m - 405 mg, glycerol - 290 mg, sodium saccharinate - 1.15 mg, benzoic acid - 1.15 mg, vanillin - 1.15 mg, ethanol 96% v / v.

- 3 mg, sodium hydroxide 30% m / m - 0.5 mg, water - up to 1 ml.

Indications

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

Storage conditions and periods

At a temperature not higher than 30 degrees.

Expiration date: 3 years

Contraindications

Hypersensitivity to drug components

children up to 2 months old (for drops)

children under 3 years old (for syrup)

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.

INN / Active ingredient

Butamirat

Specifications

Category

Cough

Scope of the medicinal product

General

Release form

Drops

Manufacturer country

Switzerland

Package quantity, pcs

one

Scope of application

Virology

Minimum age from

2 months

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Volume, ml.

20 ml

Brand name

Sinekod

The amount of the dosage form in the primary package

20 ml

Primary packaging type

Bottle

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Central antitussive agent

Anatomical and therapeutic characteristics

R05DB13 Butamirate

Dosage form

Oral drops [for children]

The target audience

Children

Expiration date in days

1095

Dosage (volume) of the substance in the preparation

butamirate citrate 5 mg

Package weight, g

twenty

Mode of application

:

Oral drops and syrup should be taken before meals.

For children under 3 years of age, the drug should be taken in the form of oral drops.

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

< br> Sinekod drops for oral administration for children are prescribed: < br> Children from 2 months to 1 year: 10 drops 4 times / day.

< br> Children from 1 to 3 years old: 15 drops 4 times / day.

< br> Children 3 years and older: 25 drops 4 times / day.

Information on technical characteristics, delivery set, country of manufacture