Codelac Broncho, tablets 10 pcs

Pharmacotherapeutic group: expectorant combination medicine

ATX code: [R05CA10]

Pharmacological properties

Pharmacodynamics

Compound medicine for the treatment of cough, has mucolytic and expectorant effects, as well as anti-inflammatory activity. The action of Codelac ^® Broncho is due to the pharmacological properties of its components:

Ambroxol has secretomotor, secretolytic and expectorant action, normalizes the disturbed ratio of serous and mucous components of sputum, increases the secretion of surfactant in the alveoli. It reduces the viscosity of sputum and promotes its expulsion.

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

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

The extract of Thermopsis has expectorant effect, with moderate irritant effect on the mucous membrane receptors of the stomach, increases by reflex the secretion of bronchial glands.

Sodium bicarbonate shifts index of the environment (pH) of bronchial mucus to the alkaline side, reduces sputum viscosity and stimulates motor function of the scimitar epithelium and bronchioles.

Pharmacokinetics

Ambroxol.

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

Distribution. Transition of ambroxol from the blood to the tissues when administered orally is fast. The highest concentrations of the active component of the drug are observed in the lungs. Passes through the blood-brain barrier, placental barrier, excreted with breast milk.

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

Elimination. The half-life (T ½) of ambroxol is about 10 hours. Excreted by the kidneys: 90% as metabolites, 10% unchanged.

Pharmacokinetics in special groups of patients. No clinically significant effect of age and sex on ambroxol pharmacokinetics has been found, so there is no reason to adjust the dose according to these characteristics.

The ambroxol clearance in patients with severe hepatic impairment is reduced by 20-40%.

In severe renal failure, the T ½ of ambroxol metabolites is increased.

Sodium glycyrrhizinate (trisodium salt of glycyrrhizic acid).

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

Thermopsis lanceolate herb extract.

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

Sodium bicarbonate.

It is well absorbed in the gastrointestinal tract. Maximum effect occurs 30-60 min after oral administration and lasts for 2-6 hours. It is eliminated from the body by the kidneys, respiratory mucosa and bronchial glands.

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Indications

Respiratory diseases with sputum retention: acute and chronic bronchitis, pneumonia, chronic obstructive pulmonary disease (COPD), bronchiectatic disease.

Active ingredient

Ambroxol, Sodium hydrocarbonate, Sodium glycyrrhizinate, Thermopsis extract

Composition

Active ingredients:

Ambroxol hydrochloride (ambroxol) – 20.0 mg,

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

Thermopsis lanceolate herb extract – 10.0 mg,

sodium bicarbonate – 200.0 mg.

Excipients:

potato starch – 84.30 mg, microcrystalline cellulose – 150.10 mg, povidone (polyvinylpyrrolidone, povidone K25) – 26.40 mg, talc – 13.00 mg, stearic acid – 5.20 mg, sodium carboxymethyl starch (sodium starch glycolate) – 11.00 mg.

How to take, the dosage

Internal, with meals.

Adults and children over 12 years old take 1 tablet 3 times a day.

It is not recommended to use without a doctor’s prescription for more than 4-5 days.

Interaction

Combined use with anti-cough medications leads to difficulty of sputum discharge against reduction of coughing.

The drug increases penetration of antibiotics into the bronchial secretion.

Special Instructions

Do not combine with cough suppressants.

Contraindications

Hypersensitivity to the components of the drug, pregnancy, breast-feeding period, children under 12 years of age.

With caution

In case of hepatic and/or renal failure, gastric and 12 duodenal ulcer, bronchial asthma.

Side effects

Allergic reactions.

Rarely – weakness, headache, diarrhea, dry mouth and respiratory tract, exanthema, rhinorrhea, constipation, dysuria. With prolonged use in high doses – gastralgia, nausea, vomiting.

Pregnancy use

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