Codelac Neo, drops 5 mg/ml 20 ml

Pharmacodynamics

Butamirate, the active ingredient of Codelac® Neo, is an anti-cough agent of central action. It is neither chemically nor pharmacologically related to opium alkaloids. It is not addictive or addictive.

It suppresses cough having a direct effect on the coughing center. It has a bronchodilator effect (dilates the bronchi). Helps ease breathing by improving spirometry (reduces airway resistance) and blood oxygenation (saturates blood with oxygen).

Pharmacokinetics

Intake

After oral administration, butamirate is quickly and completely absorbed from the gastrointestinal tract. After taking 150 mg of butamirate, the maximum concentration of the main metabolite (2-phenyl butyric acid) in blood plasma is reached after about 1.5 hours and is 6.4 µg/ml.

Distribution and metabolism

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

There is no cumulation if the drug is taken repeatedly.

Elimation

The elimination half-life of butamirate is 6 hours. The metabolites are eliminated mainly by the kidneys. And 2-phenyl butyric acid is excreted mainly in the form bound to glucuronic acid.

Indications

Dry cough of any aetiology, including whooping cough; to suppress cough in preoperative and postoperative periods, surgical procedures and bronchoscopy.

Active ingredient

Butamirate

Composition

Composition per vial:

the active substance:

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

auxiliary substances:

sorbitol (Neosorb 70/70 B, sorbitol syrup) – 8100.0 mg,

Glycerol (glycerin) – 5800,0 mg,

Ethanol 95% (ethyl alcohol, 95%) – 61,0 mg,

Sodium saccharinate – 23.0 mg,

benzoic acid – 23.0 mg,

vanillin – 23.0 mg,

sodium hydroxide solution 30% – 10.0 mg,

purified water – up to 20 ml.

How to take, the dosage

Internal, before meals.

In children aged 2 to 12 months – 10 drops 4 times a day; from 1 to 3 years – 15 drops 4 times a day; over 3 years – 25 drops 4 times a day.

Consult a doctor before using the drug in children under 2 years of age.

The oral drops are 5 mg/ml (1 ml contains 22 drops).

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

Interaction

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

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

Special Instructions

The drops contain sodium saccharinate and sorbitol as sweeteners, so it can be used by patients with diabetes.

To account for the presence of ethyl alcohol in the drug, there is a danger when using the drug in patients with predisposition to the development of drug addiction, with liver disease, alcoholism, epilepsy, brain disease, pregnant women and children.

Impact on the ability to drive vehicles, mechanisms

It is recommended to refrain from driving vehicles and engaging in other potentially dangerous activities requiring increased concentration and rapid psychomotor reactions, since the drug may cause dizziness and somnolence.

Contraindications

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

With caution

Pregnancy (II and III trimesters).

Because of the presence of ethyl alcohol in the drug, caution should be exercised when using in patients with predisposition to drug addiction, liver diseases, alcoholism, epilepsy, brain diseases, pregnant women and children.

Side effects

Classification of the incidence of adverse reactions: very common (≥1/10); common (≥1/100, <1/10); infrequent (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (<1/10000), including individual reports.

Nervous system disorders:

Rarely: drowsiness, dizziness, which subsides when the drug is withdrawn or the dose is reduced.

Gastrointestinal tract disorders:

Rarely: nausea, diarrhea.

Skin and subcutaneous tissue disorders:

Rare: urticaria, possibly allergic reactions.

Overdose

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

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

Pregnancy use

There are no data on the safety of using the drug during pregnancy and its passage through the placental barrier. Administration of the drug in the first trimester of pregnancy is contraindicated. In II and III trimesters of pregnancy the drug may be used taking into account the ratio of benefit to the mother and potential risk to the fetus.

Perfusion of the drug into the breast milk has not been studied, therefore it is not recommended to use the drug during breast-feeding.

Similarities

Sinekod, Omnitus, For cough and runny nose