Flavamed Max (ambroxol hydrochloride) effervescent tablets 60 mg. №10 tube

Description

Flavamed Max Storage:

active substance: ambroxol hydrochloride;

1 effervescent tablet contains 60 mg of ambroxol hydrochloride;

excipients: citric acid, anhydrous; sodium bicarbonate; sodium carbonate anhydrous; sodium saccharin; sodium cyclamate; sodium chloride; sodium citrate; lactose anhydrous; mannitol (E421); sorbitol (E420); cherry flavor “ALH” (code 801); simethicone.

Flavamed Max Dosage form.

Effervescent tablets.

Basic physical and chemical properties: round white tablets with a line for division on one side.

Flavamed Max Pharmacotherapeutic group.

Medications used in cough and catarrhal diseases. Mucolytics. ATX code R05C B06.

Pharmacological properties.

Pharmacodynamics.

Ambroxol, a derivative of benzylamine, is a metabolite of bromhexine. It differs from bromhexine by the absence of a methyl group and the presence of a hydroxyl group in the trans position of the cyclohexyl ring. Despite the fact that the mechanism of action of this substance is not yet fully understood, its secretolytic and secretomotor action has been revealed in various studies.

On average, when administered orally, the effect of the drug begins 30 minutes after ingestion and lasts from 6 to 12 hours, depending on the size of a single dose.

In preclinical studies, ambroxol has been shown to increase the proportion of serous secretions. Acceleration of secretion is probably due to a decrease in its viscosity and activation of the ciliated epithelium.

Ambroxol increases surfactant production by acting directly on type II alveolar pneumocytes and Claire cells in the small airway.

This promotes the formation and release of surfactants in the alveoli and bronchi. The presence of these effects has been proven in cell cultures and in various animal species.

When used with ambroxol, the concentrations of antibiotics in bronchopulmonary secretions and sputum increase. To date, the clinical significance of this effect has not been established.

Pharmacokinetics.

Ambroxol is almost completely absorbed after oral administration. Tmax after oral administration is from 1 to 3 hours. The absolute bioavailability of ambroxol when administered orally is reduced by approximately one third after the first passage through the liver. During this process, metabolites are formed (for example, dibromosubstituted orthoaminobenzoic (dibromanthronic) acid, glucuronides), which are then excreted by the kidneys. Plasma protein binding is approximately 85% (80-90%). The terminal half-life of plasma is 7-12 hours. The plasma half-life for ambroxol and its metabolites is approximately 22 hours.

Ambroxol crosses the placental barrier, penetrates the cerebrospinal fluid and breast milk.

90% of the substance is excreted by the kidneys in the form of metabolites formed in the liver. The amount of unchanged ambroxol excreted by the kidneys is less than 10%.

Due to the high level of protein binding and high volume of distribution, as well as the slow re-redistribution of ambroxol from tissues into the blood, the excretion of large amounts of ambroxol by dialysis or forced diuresis should not be expected.

In severe liver disease, the clearance of ambroxol is reduced by 20-40%. In case of severe renal insufficiency, accumulation of ambroxol metabolites should be expected.

Clinical characteristics.

Indication.

Secretolytic therapy for acute and chronic bronchopulmonary diseases associated with impaired bronchial secretion and impaired mucus.