Sinecode for dry cough, syrup 1.5 mg/ml 200 ml
A country
Switzerland
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Active substance
Butamirat
Description
Sinekod syrup for dry coughs with a pleasant vanilla flavor.
• Helps cope with dry coughs and reduce the intensity of night coughs from the first use*. • Butamirate, the active substance of the drug "Sinekod", is a centrally acting antitussive agent. It is not classified as an opium alkaloid either chemically or pharmacologically. Does not form dependence or addiction. • Sinekod facilitates breathing, selectively affecting the cough center • Suppresses cough, having a direct effect on the cough center • Has a bronchodilator effect (dilates the bronchi).** • Duration of the antitussive effect is up to 6 hours.* * Materazzi F. et al. Gatz. honey. It. Arch.S.Med. 1984; 143: 229-232. ** Instructions for medical use, RU P N011631/01 dated 04/01/2011
Compound
(weight-volume percentage): Active substance – butamirate citrate – 0.150 (1.5 mg/ml). 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 up to 100 ml.
Product description
Colorless transparent liquid with a vanilla odor.
pharmachologic effect
Butamirate, the active substance of the drug Sinecod®, is a centrally acting antitussive agent.
It is not classified as an opium alkaloid either chemically or pharmacologically. Does not form dependence or addiction. Suppresses cough, having a direct effect on the cough center. Has a bronchodilator effect (expands the bronchi). Helps make breathing easier by improving spirometry (reduces airway resistance) and blood oxygenation (saturates the blood with oxygen). Absorption Based on available data, it is assumed that butamirate ester is rapidly and completely absorbed and hydrolyzed in plasma 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 mg - 90 mg. Butamirate is rapidly and completely absorbed when taken orally, measured concentrations are detected in the blood 5 to 10 minutes after taking doses of 22.5 mg, 45 mg, 67.5 mg and 90 mg. Maximum plasma concentrations are achieved within 1 hour when taking dosages at all 4 levels, the average is 16.1 ng/ml when taking an oral dose of 90 mg. Average plasma concentrations of 2-phenylbutyric acid are achieved within 1.5 hours; the maximum concentration was observed after a dose of 90 mg (3052 ng/ml); average plasma concentrations of diethylaminoethoxyethanol are reached within 0.67 hours; Cmax is 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 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 dosage levels (22.5 - 90 mg), averaging 89.3% - 91.6%. The ability of diethylaminoethoxyethanol to bind to plasma proteins is also detected, the average values vary between 28.8% and 45.7%. It is unknown whether butamirate crosses the placenta or 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. Excretion Excretion of the three metabolites occurs primarily through the kidneys; After conjugation in the liver, the acidic metabolites are largely bound to glucuronic acid. Conjugates of 2-phenylbutyric acid are determined in urine in significantly higher concentrations than in blood plasma. Butamirate is detectable in urine within 48 hours, and butamirate excreted in urine during the 96-hour sampling period accounts for approximately 0.02, 0.02, 0.03, and 0.03% of 22.5 mg doses. , 45 mg, 67.5 mg and 90 mg, respectively. As a percentage, butamirate is excreted in the urine in greater quantities in the form of diethylaminoethoxyethanol than unchanged butamirate or unconjugated 2-phenylbutyric acid. The measured half-lives of 2-phenylbutyric acid, butamirate, and diethylaminoethoxyethanol are 23.26–24.42, 1.48–1.93, and 2.72–2.90 hours, respectively.
Indications for use
Symptomatic treatment of dry cough of various etiologies: cough in the preoperative and postoperative period, during surgical interventions, bronchoscopy, and whooping cough.
Contraindications
Hypersensitivity to the components of the drug, children under 3 years of age (for children under 3 years of age, you can use Sinekod® oral drops for children), pregnancy (first trimester), lactation period, fructose intolerance (the drug contains sorbitol).
Carefully
Pregnancy (II and III trimesters). Due to the presence of ethyl alcohol in the drug, use with caution in patients with a tendency to develop drug dependence, with liver diseases, alcoholism, epilepsy, brain diseases, pregnant women and children.
Use during pregnancy and lactation
In animal studies, no adverse effects on the fetus were observed. There have been no controlled studies in pregnant women. In this regard, Sinekod® should not be used in the first trimester of pregnancy. In the second and third trimesters, the use of Sinecod® is possible, taking into account the benefits for the mother and the potential risk for the fetus. Given the lack of data on the excretion of butamirate in breast milk, the use of Sinecod® during lactation is not recommended.
Directions for use and doses
Inside, before meals. Children from 3 to 6 years old – 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 measuring 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 effect
Classification of the frequency of occurrence of adverse reactions: very often (≥1/10); often (≥1/100, Overdose Symptoms: drowsiness, nausea, vomiting, diarrhea, dizziness and decreased blood pressure. Treatment: gastric lavage, taking activated charcoal, maintaining vital body functions. There is no special antidote.
Interaction with other drugs
No drug interactions have been reported for butamirate. Due to the fact that butamirate suppresses the cough reflex, the simultaneous use of expectorants should be avoided to avoid the accumulation of sputum in the respiratory tract with the risk of developing bronchospasm and respiratory tract infection.
special instructions
The syrup contains saccharinate and sorbitol as sweeteners, so it can be prescribed to patients with diabetes. The drug contains a small amount of ethyl alcohol (11.73 mg/5 ml), less than 100 mg per dose. Due to the presence of ethyl alcohol in the drug, use with caution in patients with a tendency to develop drug dependence, with liver diseases, alcoholism, epilepsy, brain diseases, pregnant women and children.
Release form
Syrup (vanilla) 1.5 mg/ml. 200 ml in a bottle made of dark glass, with a lid made of polyethylene and polypropylene, equipped with a child-proof system, and with a measuring cap made of polypropylene. The bottle along with instructions for use is placed in a cardboard box.
Storage conditions
At a temperature not exceeding 30 C. Keep out of the reach of children.
Best before date
3 years. Do not use after expiration date.
Sinecod Sinecod for dry cough, syrup 1.5 mg/ml, 200 ml
Pharmacological group:
Antitussive agent of central action. ATX code R05DB13
Pharmacodynamics:
An antitussive drug of central action, it is not an opium alkaloid either chemically or pharmacologically. Does not form dependence or addiction. Suppresses cough, having a direct effect on the cough center. Has a bronchodilating effect. Promotes easier breathing by improving spirometry (reduces airway resistance) and blood oxygenation.
Pharmacokinetics:
Absorption Based on available data, it is assumed that butamirate ester is rapidly and completely absorbed and hydrolyzed in plasma to 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 administration 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 achieved within 1.5 hours; Cmax was observed at a dose of 90 mg (3052 ng/ml); average plasma concentrations of dighylaminoethoxyethanol 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 (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 detected, the average values vary between 28.8-45.7%. It is not known whether butamirate crosses the placental barrier or 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.
Excretion Excretion of the three metabolites occurs primarily by the kidneys; After conjugation in the liver, the acidic metabolites are largely bound to glucuronic acid. Conjugates of 2-phenylbutyric acid are determined in urine in significantly higher concentrations than in blood plasma. Butamirate is detectable in urine within 48 hours, and butamirate excreted in urine during the 96-hour sampling period accounts for approximately 0.02, 0.02, 0.03, and 0.03% of the 22.5 mg, 45 mg, 67.5 mg, and 90 mg doses, respectively. . As a percentage, butamirate is excreted in the urine in greater quantities 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.
Sinecod Sinecod for dry cough, drops for oral administration, 20ml
Pharmacological group:
Antitussive agent of central action. ATX code R05DB13
Pharmacodynamics:
An antitussive drug of central action, it is not an opium alkaloid either chemically or pharmacologically. Does not form dependence or addiction. Suppresses cough, having a direct effect on the cough center. Has a bronchodilating effect. Promotes easier breathing by improving spirometry (reduces airway resistance) and blood oxygenation.
Pharmacokinetics:
Absorption Based on available data, it is assumed that butamirate ester is rapidly and completely absorbed and hydrolyzed in plasma to 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 administration 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 achieved within 1.5 hours; Cmax was observed at a dose of 90 mg (3052 ng/ml); average plasma concentrations of dighylaminoethoxyethanol 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 (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 detected, the average values vary between 28.8-45.7%. It is not known whether butamirate crosses the placental barrier or 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.
Excretion Excretion of the three metabolites occurs primarily by the kidneys; After conjugation in the liver, the acidic metabolites are largely bound to glucuronic acid. Conjugates of 2-phenylbutyric acid are determined in urine in significantly higher concentrations than in blood plasma. Butamirate is detectable in urine within 48 hours, and butamirate excreted in urine during the 96-hour sampling period accounts for approximately 0.02, 0.02, 0.03, and 0.03% of the 22.5 mg, 45 mg, 67.5 mg, and 90 mg doses, respectively. . As a percentage, butamirate is excreted in the urine in greater quantities 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.
