Kodelak Neo - instructions for use, dose, side effects, contraindications

Excipients: sorbitol (Neosorb 70/70 V, sorbitol syrup) - 8100 mg, glycerol (glycerin) - 5800 mg, ethanol 95% (ethyl alcohol 95%) - 61 mg, sodium saccharinate - 23 mg, benzoic acid 23 mg, vanillin - 23 mg, sodium hydroxide solution 30% - 10 mg, water purified to 20 ml.

Description:Liquid from colorless to colorless with a yellowish shade, transparent or with a slight opalescence, with the smell of vanilla.

Pharmacotherapeutic group:Antitussive remedy of central action

ATX: & nbsp

R.05.D.B.13 Butamate

Pharmacodynamics:

Butamirate, the active substance of the drug Kodelak® Neo, 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

After oral administration butamate quickly and completely absorbed from the gastrointestinal tract. After taking 150 mg of butamirate, the maximum concentration of the main metabolite (2-phenylbutyric acid) in the blood plasma is reached after approximately 1.5 hours and is 6.4 μg / ml. Distribution and Metabolism The hydrolysis of butamirate, initially to 2-phenylbutyric acid and diethylamino-ethoxyethanol, begins in the blood. These metabolites also have antitussive activity, and, like butamirate, to a large extent (about 95%) bind to plasma proteins, which causes their long half-life. 2-Phenylbutyric acid is partially metabolized by hydroxylation.

When you re-take the drug cumulation is not observed.

Excretion

The half-life of butamirate is 6 hours. Metabolites are excreted mainly by the kidneys. Moreover, 2-phenylbutyric acid is mainly excreted in the glucuronic acid-related form.

Indications:

Dry cough of any etiology, including pertussis; for suppressing cough in the preoperative and postoperative period, with surgical interventions and bronchoscopy.

Contraindications:Hypersensitivity to the components of the drug, intolerance to fructose, pregnancy (I trimester), the period of breastfeeding. Child age is up to 2 months.

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:

There is no data on the safety of the drug during pregnancy and its passage through the placental barrier. The use of the drug in the first trimester of pregnancy is contraindicated. In the II and III trimesters of pregnancy, the use of the drug is possible, taking into account the ratio of benefits to the mother and the potential risk to the fetus.

Penetration of the drug into breast milk has not been studied, so the use of the drug during breastfeeding is not recommended.

Dosing and Administration:

Inside, before eating.

Children aged 2 to 12 months - 10 drops 4 times a day; from 1 year to 3 years - 15 drops 4 times a day; older than 3 years - 25 drops 4 times a day.

Before using the drug in children under 2 years old, consult a doctor. Drops for ingestion 5 mg / ml (1 ml contains 22 drops). If the cough persists for more than 5 days after the start of treatment, then 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 (<1/10 000), including individual messages.

From the nervous system:

Rarely: drowsiness, dizziness, passing with withdrawal of the drug or dose reduction.

From the gastrointestinal tract:

Rarely: nausea, diarrhea.

From the skin and subcutaneous tissues:

Rarely: urticaria, possibly the development of allergic reactions.

Overdose:

Symptoms: nausea, vomiting, drowsiness, diarrhea, dizziness, lowering blood pressure, impaired coordination of movements.

Treatment: Activated carbon, saline laxatives, symptomatic therapy (according to indications).

Interaction:

No drug interactions for butamir are described. During the treatment with the drug is not recommended to drink alcoholic beverages, as well as drugs that depress the central nervous system (hypnotics, neuroleptics, tranquilizers and other drugs).

Due to 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:

Drops contain as a sweetener sodium saccharinate and sorbitol, so it can be used in patients with diabetes mellitus.

In connection with the presence of ethyl alcohol in the composition of the drug, there is a danger when using the drug in patients with a tendency to develop drug dependence, with liver diseases, alcoholism, epilepsy, brain diseases, pregnant women and children.

Effect on the ability to drive transp. cf. and fur:It is recommended to refrain from driving and practicing other potentiallydangerous activities that require an increased concentration of attention and speed of psychomotor reactions, since the drug can cause dizziness, drowsiness.

Form release / dosage:

Drops for ingestion 5 mg / ml.

Packaging:To 20 ml in bottles-droppers from dark (amber) glass. One bottle with instructions for use in a pack of cardboard.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-001808

Date of registration:24.08.2012 / 25.08.2017

Expiration Date:Unlimited

The owner of the registration certificate:OTISIFARM, OJSC OTISIFARM, OJSC Russia

Manufacturer: & nbsp

PHARMSTANDART-FORESTRY, OJSC Russia

Information update date: & nbsp30.01.2018

Illustrated instructions

Instructions

Codelac® Neo (Codelac® Neo)