Codelac Neo drops 5mg/ml 20ml

Codelac Neo drops instruction for use

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Composition for 20 ml

Active substance: butamirate citrate (in terms of 100% substance) - 100 mg;
Auxiliary substances: 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 drug of central action
ATX Code: R05DB13

Pharmacological properties

Pharmacodynamics

Butamirate, the active substance of the preparation 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, butamirate is rapidly 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
Hydrolysis of butamate, initially to 2-phenylbutyric acid and diethylaminoethoxyethanol, 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 Codelac Neo drops 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 for use

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

Contraindications for Codelac Neo drops

Hypersensitivity to the components of Codelac Neo drops, 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.

Application of Codelac Neo drops during pregnancy and during breastfeeding

There is no data on the safety of the drug during pregnancy and its passage through the placental barrier. The use of Codelac Neo drops 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 of Codelac Neo drops

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 (<1/10000), 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 with Codelac Neo drops

Symptoms: nausea, vomiting, drowsiness, diarrhea, dizziness, lower blood pressure, impaired coordination of movements.
Treatment: activated charcoal, saline laxatives, symptomatic therapy (according to indications).

Interaction Codelac Neo drops with other drugs

No drug interactions for butamir are described. During the treatment with Codelac Neo drops 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 the fact that butamir suppresses 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 saccharinate and sorbitol as sweeteners, so it can be used in patients with diabetes mellitus.
In connection with the presence of ethyl alcohol in the composition of Codelac Neo drops, 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.

Impact on the ability to drive and work with machinery

It is recommended to refrain from driving vehicles and practicing other potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions, since the drug may cause dizziness, drowsiness.

Form of issue

Drops for ingestion 5 mg / ml.
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 not higher than 25 ° C. Keep out of the reach of children.
Shelf life - 2 years.
Do not use after the expiration date.

Conditions of leave from pharmacies

To buy Codelac Neo drops you don't need a prescription.