Codelac Neo modified-release pills 50mg, 10pcs

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 silicon dioxide (aerosil) – 6.00 mg, low-molecular povidone (polyvinylpyrrolidone low-molecular) – 5.00 mg.

Shell: opadray white (opadray II white 57 M 280000) (in powder form containing hypromellose (15 sP) – 5.58 mg, titanium dioxide-4.86 mg, polydextrose-4.68 mg, talc-1.26 mg, maltodextrin or dextrin-0.90 mg, glycerol or glycerol-0.72 mg) – 18.00 mg.

Pharmacological action

Pharmacotherapeutic group: antitussive agent of central action.

ATX code: R05DB13

Pharmacological properties

Pharmacodynamics

Butamirate, the Active ingredient of Codelac® Neo, is a centrally acting antitussive agent. 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

Absorption is high. After oral use of a prolonged-release tablet, the maximum plasma concentration 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 diethylaminoethoxy-ethanol, 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-phenyl-butyric acid is partially metabolized by hydroxylation. With repeated use of the drug, accumulation is not observed.

The half-life of butamirate is 13 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 (with “colds”, flu, whooping cough and other conditions). 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 benefit to the mother and potential risk to the fetus. The 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, pregnancy (I trimester), breast-feeding, lactose intolerance, lactase deficiency, glucose-galactose malabsorption. Children under 18 years of age.

With caution

Pregnancy (II and III trimesters).

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 (

From the nervous system: rarely-drowsiness, dizziness, which passes when the drug is discontinued or the dose is reduced.

From the gastrointestinal tract: rarely-nausea, diarrhea.

From the skin and subcutaneous tissues: rarely-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.

Tablets are taken before meals, without chewing.

Take 1 tablet every 8-12 hours.

If the cough persists for more than 5 days after starting treatment, then you should contact your doctor.

Overdose

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

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

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 the ability to drive vehicles and mechanisms

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

Storage conditions

Store at a temperature not exceeding 25 ° C.

Keep out of reach of children!

Shelf life

2 years

Active ingredient

Butamirate

Dosage form

long-acting tablets