Sinecod syrup 1,5mg ml 100ml
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Active ingredients
Butamirate
Release form
Syrup
Composition
1 ml of butamirata citrate 1.5 mg.
Pharmacological effect
An antitussive drug of central action, does not belong to the 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 bronchodilatory effect. It contributes to the relief of respiration, improving spirometry indicators (reduces the resistance of the respiratory tract) and oxygenation of the blood.
Pharmacokinetics
Absorption: Based on available data, it is assumed that the ester of butamirate 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-phenylbutyric acid and diethylaminoethoxyethanol occurs in proportion to the dose taken in the range of 22.5-90 mg. Butamirate is quickly 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 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. The average plasma concentrations of 2-phenylbutyric acid are reached within 1.5 h; Cmax was observed at a dose of 90 mg (3052 ng / ml); average plasma concentrations of dithylaminoethoxyethanol are achieved within 0.67 h; Cmax observed after administration in a dose of 90 mg (160 ng / ml). Distribution: Butamirate has a high 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 butamirath penetrates the placental barrier, whether it is excreted in breast milk. Metabolism: The hydrolysis of butamirata, which results in the formation of 2-phenylbutyric acid and diethylaminoethoxyethanol, which have an antitussive effect, occurs very quickly. 2-Phenylbutyric acid is further partially metabolized by hydroxylation at the para position.Excretion: The excretion of three metabolites occurs mainly by the kidneys; after conjugation in the liver, metabolites with an acidic reaction are largely associated with glucuronic acid. Conjugates of 2-phenylbutyric acid are detected in urine at significantly higher concentrations than in plasma. Butamirate is detected in the urine within 48 hours, and the amount of butamirate released in the urine during the 96-hour sampling period is 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 a larger amount and in the form of diethylaminoethoxyethanol than butamirate in unchanged form or unconjugated 2-phenylbutyric acid. The measured T1 / 2 2-phenylbutyric acid, butamiracy and diethylaminoethoxyethanol are 23.26-24.42, 1.48-1.93 and 2.72-2.90 h, respectively.
Contraindications
- hypersensitivity to the components of the drug - children up to 2 months (for drops) - children up to 3 years (for syrup) - I trimester of pregnancy - lactation period - fructose intolerance (the drug contains sorbitol) With caution: II and III trimesters of pregnancy. Due to the presence of ethyl alcohol in the preparation, it is wary to be used in patients with a tendency to develop drug dependence, with liver diseases, alcoholism, epilepsy, brain diseases, pregnant women (II and III trimesters) and children.
Use during pregnancy and lactation
No controlled clinical trials have been conducted in pregnant women. In this regard, Sinecod should not be used in the first trimester of pregnancy. In the II and III trimesters, the use of Sinecod is possible taking into account the benefits to the mother and the potential risk to the fetus. Given the lack of data on the allocation of butamirata with breast milk, the appointment of the drug during lactation is not recommended. In studies conducted on animals, no adverse effects on the fetus were observed.
Dosage and administration
The drug is taken orally before meals. If the cough persists for more than 7 days, you should consult a doctor. Syrup Patients
Dosage and administration
Children from 3 to 6 years old 5 ml 3 times / day Children 6 to 12 years old 10 ml 3 times / day Children 12 years and older 15 ml 3 times / day Adults from 15 ml 4 times / day When taking the syrup, you should use a measuring cap (attached).The measuring cap should be washed and dried after each use. Drops for oral administration PatientsDosage and administration
Children from 2 months to 1 year 10 drops 4 times / day Children from 1 year to 3 years 15 drops 4 times / day Children 3 and over 25 drops 4 times / day Before use of the drug in children under 2 years of age should consult a doctor.Side effects
Determination of the frequency of side effects: very often (1/10), often (1/100 and less than 1/10), infrequently (1/1000 and less than 1/100), rarely (1/10 000 and less than 1/100), very rarely ( less than 1/10 000), including individual messages. On the part of the nervous system: rarely - drowsiness. On the part of the digestive system: rarely - nausea, diarrhea. Allergic reactions: rarely - urticaria, other manifestations are possible.
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.
Interaction with other drugs
Interaction with other drugs butamirata not described. Due to the fact that butamirate suppresses the cough effect, it is necessary to avoid the simultaneous use of expectorant drugs in order to avoid the accumulation of sputum in the airways with the risk of developing bronchospasm and respiratory infections.
special instructions
Syrup and drops for oral administration contain saccharinate and sorbitol as sweeteners, so the drug can be prescribed to patients with diabetes. The drug contains a small amount of ethanol: syrup - 11.73 mg / 5 ml, drops for oral administration - 2.81 mg / ml. Therefore, the drug should be used with caution in patients with a tendency to develop drug dependence, liver disease, alcoholism, epilepsy, brain diseases, pregnant women (II and III trimesters) and in children. This should be considered when you need to use. Impact on the ability to drive vehicles and control mechanisms Sinecod can cause drowsiness, so you should be careful when driving and when performing work that requires concentration (for example, when working with mechanisms) after taking the drug.