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Active ingredients
Ambroxol
Release form
Pills
Composition
1 tablet contains: Active ingredient: Ambroxol hydrochloride 30.0 mg. Excipients: Lactose monohydrate, corn starch, magnesium stearate, anhydrous colloidal silicon dioxide.
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 6-12 hours (depending on the dose taken). 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 was proved. Ambroxol when combined with antibiotics (amoxicillin, cefuroxime, erythromycin and doxycycline) increases their concentration in sputum and bronchial secretions.
Pharmacokinetics
When ingested Ambroxol is almost completely absorbed from the gastrointestinal tract. The maximum concentration is reached within 1-3 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%). The half-life of plasma ranges from 7 to 12 hours. The total half-life of ambroxol and its metabolites is approximately 22 hours; Excreted mainly by the kidneys in the form of metabolites - 90%,less than 10% is displayed unchanged .; Given the high association with plasma proteins, a large volume of distribution and a slow redistribution from tissues into the blood, ambroxol is not significantly eliminated during dialysis or forced diuresis .; In patients with severe liver disease, the clearance of ambroxol is reduced by 20-40%. In patients with severely impaired renal function, the elimination half-life of ambroxol metabolites increases. Ambroxol penetrates into the cerebrospinal fluid and through the placental barrier, and is excreted in breast milk.
Indications
Acute and chronic diseases of the respiratory tract, accompanied by a violation of the formation and discharge of sputum.
Contraindications
hypersensitivity to Ambroxol or to one of the excipients; use in children under 6 years; ; pregnancy (I term); ; lactose intolerance, lactase deficiency or glucose-galactose malabsorption .; With caution: Impaired motor function of the bronchi and increased formation of sputum (with fixed cilia syndrome), peptic ulcer and 12 duodenal ulcer during the exacerbation period, pregnancy (II-III trimester), lactation period .; Patients with impaired renal function or severe liver disease should take Ambrobene with extreme caution, observing large intervals between doses or taking the drug in a smaller dose.
Use during pregnancy and lactation
Pregnancy: Not enough data on the use of ambroxol during pregnancy. In particular, this applies to the first 28 weeks of pregnancy. Studies conducted on animals did not reveal a teratogenic effect .; The use of Ambrobene in pregnancy (II-III trimester) is possible only on prescription, after a thorough assessment of the risk / benefit ratio .; Lactation period: Animal studies have shown that Ambroxol passes into breast milk. Due to insufficient study of the use of the drug in women during lactation, Ambrobene can only be used by a doctor, after careful assessment of the risk / benefit ratio.
Dosage and administration
Tablets should be swallowed whole, without chewing, after eating, washing down with plenty of liquid .; Children from 6 to 12 years old should take 1/2 tablet 2-3 times a day (15 mg of ambroxol 2-3 times a day) .; Adults and children over 12 years old in the first 2-3 days of treatment should take 1 tablet 3 times a day (30 mg ambroxol 3 times a day).With the ineffectiveness of therapy, adults can increase the dose to 2 pills 2 times a day (120 mg ambroxol per day). In the following days, take 1 tablet 2 times a day (30 mg of ambroxol 2 times a day) .; The duration of treatment is selected 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.
Side effects
General disorders: Rarely (from more than 0.1% to less than 1%): allergic reactions (urticaria, skin rash, angioedema of the face, shortness of breath, itching), fever, weakness, headache .; Very rare (less than 0.01%): anaphylactic reactions, including anaphylactic shock .; On the part of the gastrointestinal tract: Rarely (from more than 0.1% to less than 1%): nausea, abdominal pain, vomiting, diarrhea, constipation .; Other: Rarely (from more than 0.1% to less than 1%): dryness of the mucous membrane of the oral cavity and respiratory tract, exanthema, rhinorrhea, dysuria.
Overdose
Symptoms: Signs of intoxication with ambroxol overdose were not detected. There is information about nervous agitation and diarrhea .; Ambroxol is well tolerated when taken orally at a dose of up to 25 mg / kg / day. In case of severe overdose, increased salivation, nausea, vomiting, lowering blood pressure are possible .; Treatment: Intensive care methods, such as induction of vomiting, gastric lavage, should be used only in cases of severe overdose, in the first 1-2 hours after taking the drug. Symptomatic treatment is indicated.
Interaction with other drugs
With simultaneous use of ambroxol and antitussives due to the suppression of the cough reflex, secretion stagnation may occur. Therefore, such combinations should be selected with caution .; When ambroxol and antibiotics of amoxicillin, cefuroxime, erythromycin and doxycycline are taken together, the concentration of the latter in sputum and bronchial secretions increases.
special instructions
It should not be combined with antitussive drugs that impede the excretion of sputum .; Very rarely, severe skin reactions such as Stevens-Johnson syndrome and Lyell's syndrome have been observed with Ambrobene.When you change the skin or mucous membranes, it is necessary to urgently consult a doctor and stop taking the drug. The impact on the ability to drive vehicles and to drive machines and mechanisms is still not known.