Codelac Neo oral drops 5mg/ml, 20ml

Composition

Composition per bottle:

Active ingredient:  

butamirate citrate (in terms of 100% substance) – 100.0 mg;

excipients: sorbitol (Neosorb 70/70 In, sorbitol syrup) – 8100,0 mg, glycerol (glycerin) – 5800,0 mg, ethanol 95% (ethyl alcohol 95%) – 61,0 mg, sodium saccharin was 23.0 mg, benzoic acid was 23.0 mg, vanillin was 23.0 mg, sodium hydroxide solution 30% – 10.0 mg, vodoochistka – up to 20 ml.

Pharmacological action

Pharmacodynamics

Butamirate, the Active ingredient of Codelac® Neo, is an antitussive agent of central action. It does not belong to opium alkaloids either chemically or pharmacologically. It does not form an addiction or addiction.

Suppresses cough, having a direct effect on the cough center. It has a bronchodilating effect (dilates the bronchi). Helps facilitate breathing by improving spirometry (reduces airway resistance) and blood oxygenation (saturates the blood with oxygen).

Pharmacokinetics

Suction

After oral use, 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 blood plasma is reached in about 1.5 hours and is 6.4 mcg / ml.

Distribution and metabolism

Hydrolysis of butamirate, initially to 2-phenylbutyric acid and diethylaminoethoxyethanol, begins in the blood. These metabolites also have antitussive activity, and, like butamirate, are largely bound to plasma proteins (about 95%), which causes their long half-life. 2-phenylbutyric acid is partially metabolized by hydroxylation.

With repeated use of the drug, accumulation is not observed.

Deduction

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

Indications

Dry cough of any etiology, including whooping cough; for cough suppression in the preoperative and postoperative period, during surgical interventions and bronchoscopy.

Use during pregnancy and lactation

There are no data on the safety of using 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 second and third trimesters of pregnancy, the use of the drug is possible taking into account the ratio of benefits for the mother and 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.

Contraindications

Hypersensitivity to the components of the drug, fructose intolerance, pregnancy (I trimester), breast-feeding. Children under 2 months of age.

With caution

Pregnancy (II and III trimesters).

Due to the presence of ethyl alcohol in the composition of the drug, it should be used with caution in patients with a tendency to develop drug dependence, liver diseases, alcoholism, epilepsy, brain diseases, pregnant women and children.

Side effects

Classification of the frequency of adverse reactions: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (

Nervous system disorders:

Rarely: drowsiness, dizziness that passes when the drug is discontinued or the dose is reduced.

From the gastrointestinal tract:

Rare: nausea, diarrhea.

Skin and subcutaneous tissue disorders:

Rare: urticaria, possible development of allergic reactions.

Interaction

No drug interactions have been described for butamirate. During treatment with the drug, it is not recommended to consume alcoholic beverages, as well as drugs that depress the central nervous system (sleeping pills, antipsychotics, tranquilizers and other drugs).

Due to the fact that butamirate suppresses the cough reflex, simultaneous use of expectorants should be avoided in order to avoid accumulation of sputum in the respiratory tract with the risk of developing bronchospasm and respiratory tract infection.

How to take, course of use and dosage

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 of age, you should consult your doctor.

Oral drops of 5 mg / ml (1 ml contains 22 drops).

If the cough persists for more than 5 days after starting treatment, you should consult a doctor.

Overdose

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

Treatment: activated charcoal, saline laxatives, symptomatic therapy (as indicated).

Special instructions

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

Due to 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, liver diseases, alcoholism, epilepsy, brain diseases, pregnant women and children.

Influence on the ability to drive vehicles, mechanisms

It is recommended to refrain from driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions, as the drug can cause dizziness, drowsiness.

Form of production

Drops for oral use 5 mg / ml.

20 ml of waflakons-droppers made of dark (amber) glass. One bottle together with instructions for use in a cardboard pack.

Storage conditions

At a temperature not exceeding 25 ° C.

Keep out of reach of children.

Shelf

life is 5 years.

Active ingredient

Butamirate