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Active ingredients
Ambroxol
Release form
Pills
Composition
Ambroxol hydrochloride 30 mg. Auxiliary substances: lactose monohydrate - 40 mg, corn starch - 30 mg, microcrystalline cellulose - 30 mg, croscarmellose sodium - 5.3 mg, povidone (K-30) - 4 mg, magnesium stearate - 0.7 mg.
Pharmacological effect
Expectorant mucolytic agent. Ambroxol is an active N-demethylated metabolite of bromhexine. Possesses sekretomotorny, sekretolitichesky and expectorant action. Stimulates the serous cells of the glands of the mucous membrane of the bronchi, increasing the content of mucous secretion and, thus, alters the disturbed ratio of serous and mucous components of sputum. Ambroxol increases the content of mucous secretion and the release of a surfactant (surfactant) in the alveoli and bronchi. Increases motor activity of the ciliated epithelium, increases mucociliary transport of sputum. On average, when taken orally, the effect occurs after 30 minutes, the duration of action is 6-12 hours, depending on the size of a single dose.
Pharmacokinetics
Absorption: After oral administration, Ambroxol is rapidly and almost completely absorbed from the gastrointestinal tract. Cmax is reached in approximately 1-3 hours. The absolute bioavailability of ambroxol when administered orally as a result of metabolism associated with the effect of the first passage through the liver decreases by approximately 1/3. The resulting metabolites (such as dibromantranilic acid, gyukuronidy) excreted by the kidneys. Distribution: Plasma protein binding is about 85% (80-90%). Ambroxol penetrates the BBB and placental barriers, as well as excreted in breast milk. Metabolism: Ambroxol is metabolized in the liver by conjugation to form pharmacologically inactive metabolites. Withdrawal: T1 / 2 is 7–12 hours. T1 / 2 of ambroxol and its metabolites (in total) is about 22 hours. It is mainly excreted by the kidneys - 90% in the form of metabolites formed in the liver. Less than 10% of the amount excreted through the kidneys accounts for ambroxol in unchanged form. Pharmacokinetics in special clinical situations: In severe impaired renal function, the T1 / 2 metabolites of Ambroxol increase, but do not change in severe liver diseases.Due to the high degree of binding to plasma proteins and a large volume of distribution, as well as a slow reverse distribution from the tissues to the blood, no significant elimination of ambroxol by dialysis or forced diuresis is expected.
Indications
Acute and chronic diseases of the respiratory tract, accompanied by impaired secretion and transport of sputum: - Acute and chronic bronchitis; - Pneumonia; - Chronic obstructive pulmonary disease; - Bronchial asthma with obstructed sputum discharge; - Bronchiectasis.
Contraindications
- congenital fructose intolerance (for solution); - children's age up to 6 years (for pills); - hypersensitivity to ambroxol or other components of the drug.; Precautions should be prescribed when bronchial motility is violated and secretions are formed in significant quantities (for example, rare syndrome of fixed cilia), with renal or hepatic failure, with gastric ulcer and duodenal ulcer, as well as children under 2 years of age (solution).
Dosage and administration
Adults and children over 12 years old within the first 2-3 days should be prescribed 3 times / day, 30 mg (1 tablet or 2 scoops (10 ml) of the solution, which corresponds to 90 mg of ambroxol hydrochloride / day, then 2 times / 30 mg per day (1 tab. or 2 measuring spoons), (which corresponds to 60 mg of ambroxol hydrochloride / day. If necessary, 60 mg (2 pills or 4 measuring spoons (20 ml) of solution) can be administered to enhance the therapeutic effect. ) 2 times / day (which corresponds to 120 mg of ambroxol hydrochloride / day). For children aged 6 to 12 years: 2-3 times / day for 15 mg (1/2 tab. Or 1 scoop spoonful of solution), which corresponds Ambroxol hydrochloride / day is 30–45 mg / day. For children aged 2 to 6 years, the drug is prescribed only as a solution 3 times / day in 1/2 tsp (2.5 ml), which corresponds to 22.5 mg ambroxol hydrochloride / day. at the age of 2 years: 2 times / day for ½ measuring spoons (2.5 ml) of the solution, which corresponds to 15 mg of ambroxol hydrochloride / day. In case of renal insufficiency or severe liver damage, the interval between doses or reduce the dose should be increased. The drug is taken after a meal: pills - not chewed and squeezed with a sufficient amount of liquid, solution - using a measuring spoon. The duration of use is determined individually, depending on the evidence and the course of the disease.Without prescription, Flavamed; Do not take more than 4-5 days.