Flavamed (ambroxol hydrochloride) solution against cough 15 mg/5 ml. 100 ml.

Description

Flavamed solution Storage
active substance: ambroxol hydrochloride;

1 ml of oral solution contains ambroxol hydrochloride 3 mg; 1 measuring spoon of 5 ml contains ambroxol hydrochloride 15 mg;

Excipients: glycerin (85%), benzoic acid (E 210), sorbitol, non-crystallizing solution 70% (E 420), hydroxyethylcellulose, aromatic concentrate with the smell of raspberries, purified water.

Flavamed solution Dosage form
The solution is oral.

Main physical and chemical properties: transparent colorless, slightly brownish liquid with the smell of raspberries.

Flavamed solution Pharmacotherapeutic group
Remedies used for coughs and colds. Mucolytics.

ATX code R05C B06.

Pharmacological properties

Pharmacodynamics.

The active substance of the drug Flavamed® cough solution – ambroxol hydrochloride – increases the proportion of the serous component of bronchial secretions. Ambroxol enhances pulmonary surfactant secretion by directly affecting type II pneumocytes in alveoli and Clara cells in bronchioles, and stimulates ciliary activity. This reduces the viscosity of the sputum and improves its excretion (mucociliary clearance).

Activation of secretion and reduction of sputum viscosity and improvement of mucociliary clearance promote expectoration of sputum and relieve productive cough.

On average, the effect of the drug after oral administration is manifested in 30 minutes after application and persists for 6-12 hours depending on the single dose.

Ambroxol hydrochloride has been shown to have anti-inflammatory effects in vitro. Thus, ambroxol hydrochloride significantly reduces the release of cytokines from mononuclear and polymorphonuclear cells in blood and tissues.

Concentrations of antibiotics (amoxicillin, cefuroxime, erythromycin and doxycycline) in bronchopulmonary secretion and sputum increase after administration of ambroxol hydrochloride. To date, no clinical significance of this fact has been identified.

Pharmacokinetics.

Absorption. Absorption of ambroxol hydrochloride is rapid and fairly complete, with a linear relationship in the therapeutic range. Peak plasma concentrations are reached within 1-2 hours after ingestion.

Distribution. When taken orally, the distribution of ambroxol hydrochloride from blood to tissues is rapid and pronounced, with the highest concentration of active substance in the lungs. The volume of distribution when taken orally is 552 liters. In plasma, approximately 90% of the drug is bound to blood proteins in the therapeutic range.

Metabolism and excretion. Approximately 30% of the orally administered dose is excreted by the first passage through the liver. Ambroxol hydrochloride is metabolized mainly in the liver by glucuronidation and cleavage to dibromoanthranilic acid (approximately 10% of the dose). Clinical studies on human liver microsomes have shown that CYP3A4 is responsible for the metabolism of ambroxol hydrochloride to dibromoanthranilic acid.

Within 3 days of oral administration, about 6% of the dose is excreted unchanged, while approximately 26% of the dose is excreted in the urine.

The half-life from blood plasma is about 10 hours. The total clearance is approximately 660 ml / min. Renal clearance is approximately 8% of the total. After 5 days, approximately 83% of the total dose is excreted in the urine.

Pharmacokinetics in special groups of patients. In patients with impaired liver function, the excretion of ambroxol hydrochloride is reduced, which leads to 1.3-2 times higher levels in blood plasma. Because the therapeutic range of ambroxol hydrochloride is quite wide, no dosage adjustment is required.

Age and sex do not have a clinically relevant effect on the pharmacokinetics of ambroxol hydrochloride, therefore no dose adjustment is required.

Food intake does not affect the bioavailability of ambroxol hydrochloride.

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