Sinekod syrup 1.5mg / mL vial with 100ml measured cap

$5.07

Sinekod syrup 1.5mg / mL vial with 100ml measured cap

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SKU: 01347041651 Categories: , , Tags: ,

Description

Composition
Active substance:
Per 100 ml: 1.5 mg butamirata citrate.
Excipients:
Sorbitol solution 70% m / m – 40.5% w / v glycerol -. 29% w / v, sodium saccharin -. 0.06% w / v, benzoic acid -. 1.115% w / v, vanillin -. 0.06% m / vol., ethanol 96% vol. / vol. – 0.25% w / v sodium hydroxide 30% m / m -. 0.031% w / v Water -. 100 ml.
Description:
Syrup (vanilla) as a colorless transparent liquid with a smell of vanilla.
Product form:
100 ml vial of dark glass, with polyethylene and polypropylene cap provided with a tamper-evident system by children and with a measured cap of polypropylene. The vial together with instructions for use placed in a cardboard box.
Contraindications
– increased sensitivity to the drug; – Children up to age 2 months (drip); – Children up to age 3 years (syrup); – I trimester of pregnancy; – lactation; – fructose intolerance (preparation comprises sorbitol);
Dosage
1.5 mg / ml
Indications
– symptomatic treatment of dry cough of various etiologies: cough suppression in the pre- and postoperative period, during surgery, bronchoscopy, whooping cough.
Interaction with other drugs
Drug interaction butamirata not described. Due to the fact that butamirata suppresses the cough effect, should avoid the simultaneous use of expectorants to avoid accumulation of mucus in the airways of the risk of bronchospasm and respiratory tract infections.
Overdose
Symptoms: drowsiness, nausea, vomiting, diarrhea, dizziness, decreased blood pressure. Treatment: gastric lavage, activated charcoal, support of vital functions of the body. No specific antidote.
pharmachologic effect
Pharmacological group:
R05DB13
Pharmacodynamics:
Centrally acting antitussive drug, does not refer to the opium alkaloids do not chemically or pharmacologically. It does not produce dependence or addiction. Suppresses cough, having a direct effect on the cough center. It has a bronchodilatory effect. It helps ease breathing, improving spirometry (reduces airway resistance) and blood oxygenation.
Pharmacokinetics:
Absorption Based on available data, it is assumed that the ether butamirata rapidly and completely absorbed and hydrolyzed in plasma, turning into a 2-phenylbutyric acid and dietilaminoetoksietanol. The influence of food on the absorption has not been studied. Changes in the concentration of 2-fepilmaslyanoy acid dietilaminoetoksietanola is proportional to the magnitude of the received dose in the range of 22.5-90 mg. Butamirata rapidly and completely absorbed after ingestion as measured by the concentration found in the blood after 5-10 min after administration in doses of 22.5 mg, 45 mg, 67.5 mg and 90 mg. Cmax is reached within 1 hour at admission in all 4 doses, the median plasma levels of 16.1 ng / ml when administered at a dose of 90 mg. Mean 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 ditgilaminoetoksietanola achieved within 0.67 hours; Cmax observed after taking a dose of 90 mg (160 ng / ml). The distribution has a large butamirata Vd in the range 81-112 l (adjusted for body weight in kg), and also 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) with an average of 89.3-91.6%. Also found dietilaminoetoksietanola ability to bind to plasma proteins, averages vary within 28.8-45.7%. It is unknown whether butamirata crosses the placental barrier, excreted in breast milk there. Metabolism butamirata hydrolysis, resulting in the formation of 2-phenylbutyric acid and dietilaminoetoksietanol having antitussive action is very fast. 2-phenylbutyric acid undergoes further partial metabolized by hydroxylation at the para-position. Excretion three excretion of metabolites occurs in the kidneys; after conjugation in the liver, with acidic metabolites largely linked to glucuronic acid. Conjugates 2-phenylbutyric acid determined in urine at significantly higher concentrations than in plasma. Butamirata detected in the urine within 48 hours, at a fraction butamirata excreted in the urine for 96-hour sampling period, for about 0.02, 0.02, 0.03 and 0.03% on the received doses of 22.5 mg, 45 mg, 67.5 mg and 90 mg, respectively . The percentage butamirata excreted in the urine in a greater amount and type dietilaminoetoksietanola than butamirata in unmodified form or unconjugated 2-phenylbutyric acid. The measured T1 / February 2-phenylbutyric acid and butamirata dietilaminoetoksietanola is 23.26-24.42, 1.48-1.93 and 2.72-2.90 h, respectively.
Pregnancy and breast-feeding
Controlled clinical studies in pregnant women have been conducted. In this regard Sinekod® should not be used in the I trimester of pregnancy. In II and III trimester use Sinekoda possible given the benefits to the mother and the potential risk to the fetus. Given the lack of data on the allocation of butamirata in breast milk, the appointment during lactation is not recommended. In studies conducted on animals, not observed undesirable effects on the fetus.
Conditions of supply of pharmacies
Without recipe
side effects
Determining the frequency of side effects: very common (> 1/10), common (> 1/100 and
special instructions
The syrup and drops for oral administration contain as sweeteners saccharin and sorbitol, and the drug may be administered to patients with diabetes. The preparation 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 propensity for the development of drug dependency, with liver disease, alcoholism, epilepsy, brain diseases in pregnant (II and III trimester) and children. This should be considered if necessary application. The effect on the ability to drive and control mechanisms Sinekod® can cause drowsiness, so caution should be exercised when driving and when the work requiring attention span (e.g., when operating mechanisms) after ingestion.
Storage conditions
The drug should be kept out of reach of children at a temperature not higher than 30 ° C.
Dosing and Administration
Inside, the food. Syrup (metered measured cap): children from 3 to 6 years – 5 ml 3 times per day, 6-12 years – 10 ml 3 times per day, or over 12 years – 15 ml 3 times per day; adults – 15 ml 4 times per day. Use a measuring cup (included). Measuring cap should be washed and dried after each use. If cough persists for more than 7 days, you should consult your doctor.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

GlaxoSmithKline Helsker

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