SINEKOD

Active material: Butamirat
When ATH: R05DB13
CCF: Cold preparations
ICD-10 codes (testimony): A37, R05
When CSF: 12.03.01
Manufacturer: NOVARTIS CONSUMER HEALTH S.A. (Switzerland)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

◊ Drops for intake for children in the form of a transparent, colorless to colorless liquid with a yellowish tinge.

Excipients: sorbitol simply entails 70%, glycerol, sodium saccharin, benzoic acid, vanillin, ethanol 96%, sodium hydroxide solution 30%, Purified water.

20 ml – vials of dark glass (1) with dropper-dispenser and control system of the first opening – packs cardboard.

◊ Syrup in the form of a colorless transparent liquid with a smell of vanilla.

100 ml – vials of dark glass (1) complete with a measured cap – packs cardboard.
200 ml – vials of dark glass (1) complete with a measured cap – packs cardboard.

Pharmacological action

Centrally acting antitussive drugs, It does not refer to the alkaloids of opium. It has antitussive, expectorant, moderate bronchodilatory, anti-inflammatory. Reduces airway resistance, as evidenced by improvements in spirometry.

Pharmacokinetics

Absorption

Once inside butamirata rapidly and completely absorbed from the gastrointestinal tract. Upon reception of the syrup in a dose of, contains 150 butamirata mg citrate, C_max osnovnogo metabolite (2-phenylbutyric acid) plasma is approximately 1.5 h and is 6.4 ug / ml.

Distribution and metabolism

Hydrolysis butamirata, original 2-phenylbutyric acid and ethanol-diethylaminoethoxy, It starts in blood. These metabolites also possess antitussive activity. Like butamirata metabolites have near maximum (about 95%) degree of binding to plasma proteins, What causes high length T_1/2 plasma. 2-phenylbutyric acid is partially metabolized by hydroxylation in the para position.

With the reappointment of the drug concentration in the blood and remains linear cumulation is not observed.

Deduction

T_1/2 is 6 no. All three metabolites are excreted primarily in the urine, and acidic metabolites are largely connected with glucuronic acid.

Testimony

- A dry cough of various etiologies;

- Suppression of the cough before- and postoperative surgical interventions and bronchoscopy;

- Pertussis.

Dosage regimen

Drops for intake for children is prescribed:

The syrup is administered:

When receiving the drug should be used capful (included).

If possible, drops and syrup should be taken before meals.

Side effect

CNS: less 1% – dizziness, passing with dose reduction or discontinuation.

From the digestive system: nausea, diarrhea.

Allergic reactions: possible skin rash, itch.

Contraindications

- Children up to age 3 years (syrup);

- Hypersensitivity to the drug.

Pregnancy and lactation

Adequate and well-controlled clinical studies safety of Sinekoda^® during pregnancy was conducted. Therefore Sinekod^® should not be used in the I trimester of pregnancy. Во II и III триместрах применение Синекода^® possibly in the presence of direct testimony.

Unknown, butamirata stands there in breast milk. Therefore, the appointment during lactation is not recommended.

IN experimental studies There were no adverse effect on the fetus.

Cautions

As sweeteners syrup and drops contain sorbitol and saccharin, so the drug can be prescribed for patients with diabetes.

Overdose

Symptoms: drowsiness, nausea, vomiting, diarrhea, loss of sense of balance, hypotension.

Treatment: Activated carbon, saline laxatives, measures to maintain the function of the cardiovascular and respiratory systems.

Drug Interactions

Drug interaction Sinekoda^® to date there has not been.

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

Conditions and terms

The drug should be stored out of reach of children at or below 30 ° C. Protect from high temperatures. Shelf life – 5 years.