Sinecode - instructions for use, doses, side effects, contraindications

Excipients: sorbitol solution 70% m / m 40.50, glycerol 29.00, sodium saccharinate 0.06, benzoic acid 0.115, vanillin 0.06, ethanol 96% v / v. 0.25, sodium hydroxide 30% m / m 0.031, water to 100 ml.

Description:Colorless transparent liquid with a vanilla smell.

Pharmacotherapeutic group:Antitussive remedy of central action

ATX: & nbsp

R.05.D.B.13 Butamate

Pharmacodynamics:

Butamirate, the active substance of the preparation Sinekod® is a central antitussive drug. Does not apply to opium alkaloids either chemically or pharmacologically.Does not form addiction or addiction.

Suppresses cough, having direct influence on the cough center. Has bronchodilator effect (enlarges the bronchi). It facilitates breathing, improving the spirometry (reduces the resistance of the respiratory tract) and oxygenation of the blood (oxygenates the blood).

Pharmacokinetics:

Suction

Based on the available data, it is assumed that butyrate ether quickly 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-phenylbutyric acid and diethylaminoethoxyethanol is proportional to the value of the received dose in the range of 22.5 mg to 90 mg.

Butamirate is rapidly and completely absorbed when taken orally, measurable concentrations are detected in the blood through 5-10 minutes after taking the doses of 22.5 mg, 45 mg, 67.5 mg and 90 mg. The maximum plasma concentrations are achieved within 1 hour when taking the dosage at all 4 levels, the average is 16.1 ng / ml with oral administration of a dose of 90 mg.

Average plasma concentrations of 2-phenylbutyric acid are achieved within 1.5 hours; maximum concentrationwas observed after a dose of 90 mg (3052 ng / ml); average plasma concentrations of diethylaminoethoxyethanol are reached within 0.67 h; FROM_maxis observed after taking a dose of 90 mg (160 ng / ml).

Distribution

Butamirate has a large volume of distribution in the range of 81 - 112 liters (corrected for body weight in kg), and high degree of binding to plasma proteins. 2-phenylbutyric acid has a high degree of binding to plasma proteins at all dosage levels (22.5 to 90 mg), and averages 89.3% to 91.6%. Also, the ability of diethylaminoethoxyethanol to bind to plasma proteins is detected, the average values vary between 28.8% and 45.7%. It is not known whether the butamate through the placenta or excreted with human milk.

Metabolism

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

Excretion

The excretion of three metabolites occurs mainly through the kidneys; after conjugation in the liver, metabolites with acid reaction are largely bound to glucuronic acid.Conjugates of 2-phenylbutyric acid are detected in urine at much higher concentrations than in blood plasma. Butamate is found in the urine within 48 hours, the fraction of butramate released in the urine during a 96-hour period sampling, accounted for about 0.02, 0.02, 0.03 and 0.03% of the accepted doses of 22.5 mg, 45 mg, 67.5 mg and 90 mg respectively.

As a percentage butamate excreted in urine in a larger amount in the form of diethylaminoethoxyethanol than butamirate in unaltered form or unconjugated 2-phenylbutyric acid.

The measured half-life of 2-phenylbutyric acid, butamate 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 in preoperative and postoperative period, during surgical interventions, bronchoscopy, with whooping cough.

Contraindications:

Hypersensitivity to the components of the drug, children up to 3 years of age (for children up to 3 years can use Sinekod® drops for taking inside for children), pregnancy (I trimester), lactation period, fructose intolerance (the drug contains sorbitol).

Carefully:

Pregnancy (II and III trimesters). In connection with the presence of ethyl alcohol in the formulation with caution to use in patients with a propensity to develop drug dependence, with liver diseases, alcoholism, epilepsy, brain diseases, pregnant and children.

Pregnancy and lactation:

In studies conducted in animals, there were no undesirable effects on the fetus. Controlled studies in pregnant women were not conducted. In this regard, Sinecode® should not be used in the first trimester of pregnancy. In the II and III trimesters, the use of Sinecode® is possible in view of the benefits to the mother and the potential risk to the fetus.

Given the lack of data on the isolation of butramate with mother's milk, the appointment of the Sinekod® preparation during lactation is not recommended.

Dosing and Administration:

Inside, before eating.

Children from 3 to 6 years - 5 ml 3 times a day; from 6 to 12 years - 10 ml 3 times a day; 12 years and older - 15 ml 3 times a day; adults - 15 ml 4 times a day.

Use the graduated cap (supplied).

The measuring cap should be washed and dried after each use.

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

Side effects:

Classification of incidence 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 individual messages.

From the nervous system:

Rarely: drowsy

From the gastrointestinal tract:

Rarely: nausea, diarrhea.

From the skin and subcutaneous tissues:

Rarely: urticaria, possibly the development of allergic reactions.

Overdose:

Symptoms: drowsiness, nausea, vomiting, diarrhea, dizziness and depression blood pressure. Treatment: gastric lavage, reception of activated charcoal, maintenance of vital body functions. There is no special antidote.

Interaction:

No drug interactions for butamir are described. Due to the fact that butamate suppresses the cough reflex, simultaneous use of expectorants should be avoided in order to avoid congestion of sputum in the respiratory tract with the risk of bronchospasm and respiratory tract infection.

Special instructions:

The syrup contains, as sweeteners, saccharinate and sorbitol, so it can be prescribed to patients with diabetes mellitus.The preparation contains a small amount of ethyl alcohol (11.73 mg / 5 ml), less than 100 mg per dose. In connection with the presence of ethyl alcohol in the formulation with caution to use in patients with a propensity to develop drug dependence, with liver diseases, alcoholism, epilepsy, brain diseases, pregnant and children.

Effect on the ability to drive transp. cf. and fur:

Sinecod® can cause drowsiness, so caution should be exercised when driving vehicles and performing work that requires attention (for example, when working with mechanisms) after taking the drug.

Form release / dosage:Syrup (vanilla) 1.5 mg / ml.

Packaging:

100 ml or 200 ml in a bottle of dark glass, with a lid of polyethylene and polypropylene, equipped with a system from unauthorized opening of children, and with a measuring cap made of polypropylene. The bottle together with the instruction for use is placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life:

3 years. Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:П N011631 / 01

Date of registration:01.04.2011

The owner of the registration certificate:Новартис Консьюмер Хелс САНовартис Консьюмер Хелс СА Switzerland

Manufacturer: & nbsp

NOVARTIS CONSUMER HEALTH, S.A. Switzerland

Information update date: & nbsp13.01.2016

Illustrated instructions

Instructions

Synecode® (Sinecod®)