Ambrobene capsules retard 75mg N20
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Active ingredients
Ambroxol
Release form
Capsules
Composition
Ambroxol hydrochloride 75 mg. Auxiliary substances: microcrystalline cellulose (E102) - 135 mg, microcrystalline cellulose (PC 581) - 80 mg, hypromellose (Pharmacoat 603) - 20 mg, methacrylic acid-ethyl acrylate copolymer (1: 1) - 6.5 mg, triethyl citrate - 1.3 mg, colloidal anhydrous silicon dioxide - 0.65 mg. The composition of the capsule shell: cap - gelatin - 20.367 mg, iron dye yellow oxide (E172) - 0.032 mg, iron dye black oxide (E172) - 0.049 mg, iron dye red oxide (E172) - 0.171 mg, titanium dioxide - 0.244 mg; body - gelatin - 31.293 mg.
Pharmacological effect
Mucolytic and expectorant drug. Ambroxol is a benzylamine - a metabolite of bromhexine. It differs from bromhexine in the absence of a methyl group and the presence of a hydroxyl group in the para-trans position of the cyclohexyl ring. Possesses sekretomotorny, sekretolitichesky and expectorant action. After ingestion, the action occurs after 30 minutes and lasts for 24 hours. Preclinical studies have shown that Ambroxol stimulates the serous cells of the glands of the bronchial mucosa. By activating cells of the ciliary epithelium and reducing the viscosity of sputum, improves mucociliary transport. Ambroxol activates the formation of surfactant, having a direct effect on the alveolar pneumocytes of type 2 and Clara cells of the small respiratory tract. Studies on cell cultures and in vivo animal studies have shown that Ambroxol stimulates the formation and secretion of a substance (surfactant) active on the surface of the alveoli and bronchi of the embryo and adult. Also, in preclinical studies, the antioxidant effect of ambroxol has been proven. Ambroxol when combined with antibiotics (amoxicillin, cefuroxime, erythromycin and doxycycline) increases their concentration in sputum and bronchial secretions.
Pharmacokinetics
Absorption, distribution, metabolism: When administered Ambroxol is almost completely absorbed from the gastrointestinal tract. Cmax is approximately 140 ± 54 ng / ml and is reached 4 hours after ingestion. Due to presystemic metabolism, the absolute bioavailability of ambroxol after oral administration is reduced by about 1/3. The resulting metabolites (such as dibromoanthranilic acid, glucuronides) are eliminated in the kidneys. Plasma protein binding is about 85% (80-90%). Ambroxol penetrates into the cerebrospinal fluid and through the placental barrier, and is excreted in breast milk.Withdrawal: T1 / 2 from plasma is about 18 hours. Excreted mainly by the kidneys as metabolites - 90%, less than 10% is excreted unchanged. Considering the high binding to plasma proteins, high Vd and slow redistribution from tissues to blood, ambroxol does not significantly excrete during dialysis or forced diuresis. Pharmacokinetics in special clinical situations In patients with severe liver disease, the clearance of ambroxol is reduced by 20-40%. In patients with severe impaired renal function, the T1 / 2 metabolites of ambroxol are increased.
Indications
- acute and chronic diseases of the respiratory tract, accompanied by a violation of the formation and discharge of sputum.
Contraindications
- I trimester of pregnancy; - children's age up to 12 years; - hypersensitivity to the components of the drug .; The drug should be used with caution in patients with impaired motor function of the bronchi and increased sputum formation (with fixed cilia syndrome), with gastric ulcer and duodenal ulcer in the acute phase, in the second and third trimesters of pregnancy, during lactation .; Patients with impaired renal function or severe liver disease Ambrobene should be prescribed with extreme caution, while patients should observe large intervals between doses or take the drug in a smaller dose.
Dosage and administration
Capsules should be taken after meals, swallowed whole, without chewing, drinking plenty of fluids. Adults and children over 12 years old should take 1 capsule / day (75 mg ambroxol / day). The duration of treatment is determined individually depending on the course of the disease. Do not take Ambrobene without a prescription for more than 4-5 days. The mucolytic effect of the drug is manifested when taking a large amount of fluid. Therefore, during the treatment it is recommended to drink plenty of water.