Codelac Neo

CODELAC® NEO is a powerful remedy for dry cough in adults and children, a centrally acting antitussive .

Advantages of the drug/molecule

helps suppress dry cough, selectively affecting the cough center;
helps reduce the frequency, strength and intensity of cough impulses during dry cough;
has an antitussive, moderate bronchodilator and anti-inflammatory effect, improves the respiratory function of the lungs;
begins to act within 30 minutes after the first dose*1,2;
has a long-lasting antitussive effect after a single dose: up to 6 hours – for liquid forms3
up to 12 hours – for tablet forms4

retains antitussive effect with long-term use5;
has a favorable safety profile: does not depress breathing;
does not contain addictive components;
approved for use by children from 2 months of age**;
Possibility of use in pregnant women from the 2nd trimester***;
Can be used by people with diabetes - does not contain sucrose or glucose as a sweetener

Advantages of release forms

3 forms of release provide the possibility of using the drug in people of different age groups: drops - for babies from 2 months of age;
syrup – for children from 3 years of age and adults;
tablets - for persons over 18 years of age.

Each of the release forms ensures maximum ease of use of the drug:

drops:

The bottle is equipped with a lid with first opening control

precise dosing for babies thanks to a convenient dropper bottle

the bottle is designed for 440 dose-drops (1 ml = 22 drops)

syrup:

Each bottle is equipped with a two-component polyethylene cap with first opening control, which provides protection against independent use of the drug by children;

the convenience of a liquid dosage form, providing parents with comfortable use of the drug and ease of swallowing for children;

Convenience and ease of administration - the sweetish taste and pleasant vanilla aroma greatly facilitate the process of taking the drug for children;

convenience and accuracy of dosing - the drug packaging is equipped with a convenient double-sided measuring spoon, for 2.5 and 5 ml, respectively;

two packaging options - 100 and 200 ml in a bottle: 100 ml - the optimal volume for the treatment of dry cough in a child 3-6 years old;

200 ml is a rational volume for the treatment of dry cough in an older child (6-12 or 12-18 years old), as well as in adults who prefer liquid dosage forms of drugs for the treatment of cough; Ideally suited for families with a frequently ill child or several children.

pills:

small tablet size, facilitating the process of swallowing the drug;

tablets coated with a film coating, which prevents the appearance of unpleasant taste sensations while taking the drug;

Modified-release tablets provide stable, even maintenance of concentrations of the active substance and the ability to reduce the frequency of dosing to 2 times a day.

Indications for use

dry cough of any origin, with: “colds”;
flu;
whooping cough;
other conditions.

to suppress cough in the preoperative and postoperative periods;

during surgical interventions and bronchoscopy.

The line of over-the-counter cough medications KODELAK® is specially designed taking into account the stages of cough in acute respiratory diseases:

at the beginning of the disease, at the stage of dry cough, CODELAC® NEO can be used.
subsequently, for a wet cough, including a cough with difficult sputum discharge, you can use KODELAK® BRONCHO (for children - KODELAK® BRONCHO with thyme).
during the recovery period, when there is a residual dry or unproductive cough, KODELAK® NEO can be used to alleviate the condition of patients.

Codelac Neo drops vn approx 5 mg/ml 20 ml fl-cap/pack card x1

Codelac Neo drops vn approx 5 mg/ml 20 ml fl-cap/pack card x1 ATXR05DB13 Butamirate

Compound

Drops for oral administration 20 ml

active substance: ,

butamirate citrate (calculated as 100% substance) 100 mg

excipients: sorbitol (Neosorb 70/70 B, sorbitol syrup), - 8100 mg, glycerol (glycerol), - 5800 mg, ethanol 95% (ethyl alcohol 95%), - 61 mg, sodium saccharinate, - 23 mg, benzoin acid - 23 mg, vanillin - 23 mg, sodium hydroxide solution 30% - 10 mg, purified water - up to 20 ml,

Syrup 5 ml

active substance: ,

butamirate citrate (calculated as 100% substance) 7.5 mg

excipients: sorbitol (Neosorb 70/70, sorbitol syrup) - 2025 mg, glycerol (glycerin) - 1450 mg, ethanol 95% (ethyl alcohol 95%) - 12.69 mg, sodium saccharinate - 3 mg, benzoic acid - 5.75 mg, vanillin - 3 mg, sodium hydroxide solution 30% - 1.55 mg, purified water - up to 5 ml,

Modified-release tablets, film-coated 1 tab.

active substance: ,

butamirate citrate (calculated as 100% substance) 50 mg

excipients: lactose monohydrate (milk sugar) - 241 mg, hypromellose (methocel K4M) - 85 mg, talc - 4 mg, magnesium stearate - 4 mg, colloidal silicon dioxide (Aerosil) - 6 mg, low molecular weight povidone (low molecular weight polyvinylpyrrolidone) - 5 mg,

film shell: Opadry II white 57M280000 (in the form of a powder containing hypromellose (15 cP) - 5.58 mg, titanium dioxide - 4.86 mg, polydextrose - 4.68 mg, talc - 1.26 mg, maltodextrin/dextrin, - 0.9 mg, glycerin/glycerol, - 0.72 mg), - 18 mg,

Description of the dosage form

Drops: colorless to colorless liquid with a yellowish tint, transparent or slightly opalescent, with a vanilla odor.

Syrup: colorless liquid with a vanilla odor.

Tablets: round, biconvex, white film-coated. On a cross section, it is white or almost white.

Pharmacological action Pharmacological action - anti-inflammatory, bronchodilator, expectorant, antitussive.

Pharmacodynamics

A non-opioid antitussive agent that has a direct effect on the cough center. Butamirate citrate is neither chemically nor pharmacologically related to opium alkaloids. It has an antitussive, expectorant, moderate bronchodilator and anti-inflammatory effect, improves spirometry (reduces airway resistance) and blood oxygenation.

Pharmacokinetics

Oral drops, syrup

Suction. After oral administration, the drug is quickly and completely absorbed from the gastrointestinal tract. After taking 150 mg of butamirate, the Cmax of the main metabolite (2-phenylbutyric acid) in the blood plasma is reached after approximately 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 (about 95%) bound to plasma proteins, which determines their long half-life. 2-phenylbutyric acid is partially metabolized by hydroxylation.

When taking the drug again, cumulation is not observed.

Excretion. T1/2 is 6 hours. All three metabolites are excreted mainly in the urine. Moreover, 2-phenylbutyric acid is mainly excreted in the form associated with glucuronic acid.

Modified-release film-coated tablets

Absorption is high. After oral administration of a modified-release tablet, the plasma Cmax of the main metabolite (2-phenylbutyric acid) is observed after 9 hours and is 1.4 mcg/ml.

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 (about 95%) bound to plasma proteins, which determines their long half-life. 2-phenylbutyric acid is partially metabolized by hydroxylation. When taking the drug again, cumulation is not observed.

T1/2 of butamirate - 13 hours. Metabolites are excreted mainly by the kidneys. Moreover, 2-phenylbutyric acid is mainly excreted in the form associated with glucuronic acid.

Indications for Codelac® Neo

dry cough of any etiology (for colds, flu, whooping cough and other conditions),

suppression of cough in the preoperative and postoperative period, during surgical interventions and bronchoscopy.

Contraindications

hypersensitivity to the components of the drug,

pregnancy (first trimester),

breastfeeding period,

fructose intolerance (oral drops, syrup),

lactose intolerance, lactase deficiency, glucose-galactose malabsorption (modified-release film-coated tablets)

children up to 2 months (oral drops), up to 3 years (syrup), up to 18 years (modified-release film-coated tablets).

Use during pregnancy and breastfeeding

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 second and third trimesters of pregnancy, the use of the drug is possible taking into account the ratio of benefits to the mother and potential risk to the fetus.

The penetration of the drug into breast milk has not been studied, therefore the use of the drug during breastfeeding is not recommended.

Side effects

From the side of the central nervous system: dizziness, which goes away when the drug is discontinued or the dose is reduced, drowsiness.

From the digestive system: nausea, vomiting, diarrhea.

From the skin: exanthema.

Allergic reactions: skin rash, itching.

Interaction

No drug interactions have been reported 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 (including sleeping pills, antipsychotics, tranquilizers).

Directions for use and doses

Inside, before meals.

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

Drops for oral administration

Children from 2 to 12 months - 10 drops 4 times a day, from 1 year to 3 years - 15 drops 4 times a day, over 3 years - 25 drops 4 times a day.

Before using the drug in children under 2 years of age, you should consult your doctor.

Drops for oral administration, 5 mg/ml (1 ml contains 22 drops).

Syrup

Children from 3 to 6 years old - 5 ml 3 times a day, from 6 to 12 years old - 10 ml 3 times a day, 12 years and older - 15 ml 3 times a day, adults - 15 ml 4 times in a day.

When taking the drug, you should use a measuring device.

Modified-release film-coated tablets

Without chewing. 1 table each every 8–12 hours

Overdose

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

Treatment: administration of activated carbon, gastric lavage, saline laxatives, symptomatic therapy (according to indications).

special instructions

There is a danger when using the drug in patients with a tendency to develop drug dependence, with liver diseases, alcoholism, epilepsy, and brain diseases.

Drops for oral administration, syrup. The drug can be used by patients with diabetes mellitus, because No sucrose or glucose is used as a sweetener.

Modified-release film-coated tablets. Each tablet contains 241 mg of lactose. The drug is contraindicated in patients with lactose intolerance, lactase deficiency, and glucose-galactose malabsorption.

Impact on the ability to drive vehicles and operate machinery. It is recommended to refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions, because the drug may cause drowsiness and dizziness.

Release form

Drops for oral administration, 5 mg/ml. In a dropper bottle made of dark (amber) glass, 20 ml. 1 bottle in a cardboard pack.

Syrup, 1.5 mg/ml. In a dark (amber) glass bottle, 100 and 200 ml. 1 bottle with a measuring spoon in a cardboard pack.

Modified-release film-coated tablets, 50 mg. In a blister pack made of PVC film and a printed varnished aluminum blank, 10 pcs. In a polymer jar, 30 or 50 pcs. 1, 2 blister packs or a jar in a cardboard pack.

Manufacturer

Drops for oral administration, syrup. OJSC Pharmstandard-Leksredstva. 305022, Kursk, st. 2nd Aggregatnaya, 1a/18.

Tel/fax

Modified-release film-coated tablets. JSC Pharmstandard-UfaVITA. 450077, Russia, Ufa, st. Khudayberdina, 28.

Tel/fax

Conditions for dispensing from pharmacies

Over the counter.

Storage conditions for Codelac® Neo: At a temperature not exceeding 25°C.

Keep out of the reach of children.

The shelf life of Codelac® Neo is 2 years.

Do not use after the expiration date stated on the package.