Codelac Neo, 100 mg+100 mg 10 pcs

Pharmacotherapeutic group: central antitussive.

The ATX code: R05DB13

Pharmacological properties

Pharmacodynamics

Butamirate, the active ingredient of Codelac^® Neo, is an anti-cough medicine of central action. It is not chemically or 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

The absorption is high. After oral administration of sustained-release tablet, maximum plasma concentration of the main metabolite (2-phenyl butyric acid) is observed after 9 h and is 1.4 µg/ml.

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. No cumulation is observed when taking the drug again.

Indications

Dry cough of any etiology (with “colds”, flu, whooping cough and other conditions). To suppress cough in preoperative and postoperative period, during surgery and bronchoscopy.

Active ingredient

Butamirate

Composition

Active ingredient:

butamirate citrate – 50.00 mg.

Excipients: lactose monohydrate (milk sugar) – 241.00 mg, hypromellose – 85.00 mg, talc – 4.00 mg, magnesium stearate – 4.00 mg, colloidal silica (aerosil) – 6.00 mg, povidone low molecular weight (polyvinylpyrrolidone low molecular weight) – 5.00 mg.

Coating: opadray white (opadray II white 57M280000) (as a powder containing hypromellose (15 cP) – 5.58 mg, titanium dioxide – 4.86 mg, polydextrose – 4.68 mg, talc – 1.26 mg, maltodextrin or dextrin – 0.90 mg, glycerin or glycerol – 0.72 mg) – 18.00 mg.

How to take, the dosage

Ingestion.

The tablets are taken before meals, without chewing.

1 tablet every 8-12 hours.

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

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

Each tablet contains 241 mg of lactose. The drug is contraindicated in patients with lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

Influence on driving and operating ability

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 drowsiness and dizziness.

Contraindications

High sensitivity to the drug components, pregnancy (I trimester), breastfeeding, lactose intolerance, lactase deficiency, glucose-galactose malabsorption. Childhood under 18 years of age.

With caution

Pregnancy (II and III trimesters).

Side effects

Classification of the incidence of adverse reactions: very frequently (≥1/10), frequently (≥1/100, < 1/10), infrequently (≥1/1000, < 1/100), rarely (≥1/10000, < 1/1000), very rarely (< 1/10000), including individual reports.

Nervous system disorders: rare – drowsiness, dizziness, which disappears when the drug is withdrawn or the dose is reduced.

Gastrointestinal tract: rarely – nausea, diarrhea.

Skin and subcutaneous tissues: rarely – urticaria, possibly allergic reactions.

Overdose

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

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

Pregnancy use

There are no data on 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 administration is possible taking into account the ratio of benefit to the mother and potential risk to the fetus. Penetration of the drug into 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