Codelac Broncho, pills, 20pcs

Composition

Active ingredients:  

ambroxol hydrochloride (ambroxol) – 20.0 mg,

sodium glycyrrhizinate (trisodium salt of glycyrrhizic acid) – 30.0 mg,

thermopsis lanceolus herb extract-10.0 mg,

sodium bicarbonate-200.0 mg.

Auxiliary substances:  potato starch-84.30 mg, microcrystalline cellulose-150.10 mg, povidone (polyvinylpyrrolidone, povidone K 25) – 26.40 mg, talc-13.00 mg, stearic acid-5.20 mg, sodium carboxymethyl starch (sodium starch glycolate) – 11.00 mg

Pharmacological action

Pharmacotherapy group: expectorant combined agent

ATX Code: [R05CA10]

Pharmacological properties

Pharmacodynamics

A combined preparation for the treatment of cough, it has mucolytic and expectorant effects, as well as has anti-inflammatory activity. The effect of Codelac ® Broncho is determined by the pharmacological properties of its components:

Ambroxol has secretomotor, secretolytic and expectorant effects, normalizes the disturbed ratio of serous and mucosal components of sputum, increases the secretion of surfactant in the alveoli. Reduces the viscosity of sputum and promotes its discharge.

On average, when taken orally, the effect of ambroxol occurs in 30 minutes, the duration of action is 6-12 hours, depending on the dose taken.

Glycyrrate (glycyrrhizic acid and its salts) has anti-inflammatory and antiviral effects. It has a cytoprotective effect due to its antioxidant and membrane-stabilizing activity. Potentiates the action of endogenous glucocorticosteroids, providing anti-inflammatory and anti-allergic effects. Due to its pronounced anti-inflammatory activity, it helps to reduce the inflammatory process in the respiratory tract.

Thermopsis extract has an expectorant effect, exerting a moderate irritating effect on the receptors of the gastric mucosa, reflexively increases the secretion of bronchial glands.

Sodium bicarbonate shifts the pH of the bronchial mucus medium to the alkaline side, reduces the viscosity of sputum, and stimulates the motor function of the ciliated epithelium and bronchioles.

Pharmacokinetics

of Ambroxol.

Suction. Ambroxol is characterized by rapid and almost complete absorption from the gastrointestinal tract. Bioavailability is 70-80%. The maximum concentration in blood plasma after oral use is reached in 1-3 hours. Binding to plasma proteins is 80-90%.

Distribution. The transfer of ambroxol from the blood to the tissues when taken orally occurs quickly. The highest concentrations of the active component of the drug are observed in the lungs. Penetrates through the blood-brain barrier, placental barrier, is excreted in breast milk.

Metabolism. Approximately 30% of the oral dose is exposed to the effect of” primary passage ” through the liver. Studies on human liver microsomes have shown that the CYP3A4 isoenzyme is the predominant isoenzyme responsible for ambroxol metabolism. The remainder of ambroxol is metabolized in the liver to inactive metabolites.

Output. The half-life (half-life) of ambroxol is about 10 hours. Excreted by the kidneys: 90% in the form of metabolites,10% unchanged.

Pharmacokinetics in special groups of patients. There was no clinically significant effect of age and gender on the pharmacokinetics of ambroxol, so there is no reason to adjust the dose for these signs.

Ambroxol clearance is reduced by 20-40% in patients with severe hepatic insufficiency.

In severe renal insufficiency, the half-life of ambroxol metabolites increases.

Sodium glycyrrhizinate (trisodium salt of glycyrrhizic acid).

After oral use, in the intestine, under the influence of the enzyme β-glucuronidase, produced by bacteria of normal microflora, an active metabolite is formed from glycyrrhizic acid – β-glycyrrhetoic acid, which is absorbed into the systemic circulation. In the blood, beta-glycyrrhetic acid binds to albumin and is almost completely transported to the liver. The release of β-glycyrrhetoic acid occurs mainly with bile, in the residual amount – with urine.

Thermopsis lanceolata herb extract.

The components of the extract are well absorbed in the gastrointestinal tract. The maximum effect occurs 30-60 minutes after ingestion and lasts for 2-6 hours. They are excreted from the body by the kidneys, the mucous membrane of the respiratory tract and the bronchial glands.

Sodium bicarbonate.

It is well absorbed in the gastrointestinal tract. The maximum effect occurs 30-60 minutes after ingestion and lasts for 2-6 hours. They are excreted from the body by the kidneys, the mucous membrane of the respiratory tract and the bronchial glands.

Indications

Respiratory tract diseases with difficulty expectorating: acute and chronic bronchitis, pneumonia, chronic obstructive pulmonary disease (COPD), bronchiectasis.

Use during pregnancy and lactation

The use of the drug during pregnancy is contraindicated. If it is necessary to use the drug during lactation, breastfeeding should be discontinued.

Contraindications

Hypersensitivity to the components of the drug, pregnancy, breastfeeding, children under 12 years of age.

With caution

In case of hepatic and / or renal insufficiency, peptic ulcer of the stomach and duodenum, bronchial asthma.

Side effects

Allergic reactions.

Rarely-weakness, headache, diarrhea, dry mouth and respiratory tract, exanthema, rhinorrhea, constipation, dysuria. Long − term use in high doses-gastralgia, nausea, vomiting.

Interaction

Combined use with antitussive drugs leads to difficulty in sputum discharge against the background of a decrease in cough.

The drug increases the penetration of antibiotics into the bronchial secretions.

How to take, course of use and dosage

Inside, during a meal.

Adults and children over 12 years of age: 1 tablet 3 times a day.

It is not recommended to use without a medical appointment for more than 4-5 days.

Overdose

Symptoms: nausea, vomiting, diarrhea, dyspepsia.

Treatment is symptomatic, gastric lavage is advisable in the first 1-2 hours after taking the drug.

Special instructions

Do not combine with antitussive agents.

Form of production

Tablets

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Ambroxol, Sodium bicarbonate, Sodium glycyrrhizinate, Thermopsis extract

Dosage form

Tablets