Treatment of respiratory tract diseases associated with improper mucus secretion and impeding transport affecting mucus secretion and removal in adults and children> 2 years.
Composition:
1 ml of the oral solution contains 3 mg or 6 mg of Ambroxol hydrochloride. The drug contains sorbitol.
Action:
Ambroxol, a metabolite of bromohexine, is a mucoactive drug with a number of properties, which include secretolytic and secretomotor effects restoring the physiological activity of airway purification, which is an important element of the body's defense mechanisms, resulting in a more productive cough. The pharmacological effect is manifested by the improvement of mucus quality, cilia activity and the production of pulmonary surfactant. Ambroxol is almost completely absorbed after oral administration. Tmax is 1-3 h. In 90% it is bound to plasma proteins. T0,5 Ambroxol in plasma is 7-12 h. The sum of the half-lives of ambroxol and its metabolites in the plasma is about 22 h. Ambroxol is excreted into amniotic fluid and through the placental barrier, and is excreted into breast milk. Metabolized in the liver. The bioavailability of absorbed ambroxol is reduced by one third as a result of first pass metabolism in the liver. Approx. 90% of the administered dose of ambroxol and its metabolites are excreted through the kidneys. Less than 10% of ambroxol is excreted unchanged by the kidneys.
Contraindications:
Hypersensitivity to the active substance or to any of the excipients. Children up to 2 years old. In patients with rare hereditary fructose intolerance (sorbitol content).
Precautions:
Caution should be exercised when ambroxol is used in patients with impaired bronchial motor function (eg in rare cases of primary ciliary dyskinesia, risk of airway obstruction due to mucus accumulation); with renal dysfunction (the risk of accumulation of metabolites in the liver) or severe hepatic impairment; with history of peptic ulcer and duodenal ulcer and patients with bronchial asthma and severe asthma attacks. Very rare cases of severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome have been reported with temporal association with the use of mucolytic drugs; in the event of new lesions on the skin or mucous membranes, immediately report to a doctor and discontinue ambroxol for precaution. The drug contains 245 mg sorbitol / ml - patients with rare hereditary problems of fructose intolerance should not take the medicine.
Pregnancy and lactation:
There are no adequate data from the use of ambroxol in pregnant women. The usual precautions for use in pregnant women should be taken. Especially in the first trimester of pregnancy, ambroxol is not recommended. There are no adequate data on the use of ambroxol in breastfeeding women, therefore ambroxol should only be prescribed to breastfeeding women after careful benefit-risk assessment.
Side effects:
Common: diarrhea. Uncommon: nausea, vomiting, abdominal pain, taste disturbances, dry throat, hypersensitivity reactions (including rash, mucosal edema, angioneurotic edema, respiratory failure, pruritus), fever. Rarely: heartburn. Very rare: nasal discharge, dry mucous membranes of the airways, constipation, salivation, painful or difficult urination, anaphylactic reactions, including anaphylactic shock. Not known: hyperthyroidism, urticaria.
Dosage:
Orally. Adults and children over the age of 12 years: initially for 2-3 days 90 mg of ambroxol hydrochloride per day - 5 ml of the solution at a dose of 6 mg / ml or 10 ml of solution at a dose of 3 mg / ml, 3 times a day (every 8 hours ), then 60 mg of ambroxol hydrochloride per day - 5 ml of solution at a dose of 6 mg / ml or 10 ml of solution at a dose of 3 mg / ml, 2 times a day (every 12 hours). It is possible to increase the effectiveness by using 10 ml of the solution at a dose of 6 mg / ml twice a day (every 12 hours) (which corresponds to 120 mg of ambroxol hydrochloride per day).Children 6-12 years: 30-45 mg of ambroxol hydrochloride per day - 2.5 ml of the solution at a dose of 6 mg / ml or 5 ml of solution at a dose of 3 mg / ml, 2-3 times a day (every 12-8 h) . Children 2-5 years: 22.5 mg of ambroxol hydrochloride per day - 1.25 ml of the solution at a dose of 6 mg / ml or 2.5 ml of solution at a dose of 3 mg / ml, 3 times a day (every 8 hours). If you do not improve or get worse after 5 days of treatment, contact your doctor. The drug is used after a meal. Take a glass of water after taking the medicine.
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