Acute and chronic lung and bronchial diseases with mucus disorder and impaired transport.
Composition:
1 ml of inhalation fluid contains 7.5 mg of Ambroxol hydrochloride.
Action:
Mucolithic facilitating expectoration. It increases the secretion of mucus in the airways, stimulates the production of the pulmonary surfactant and improves the function of the ciliated epithelium of the respiratory system. As a result, the amount of mucus increases and improves its transport (mucociliary clearance), which makes it easier to cough up and relieves cough. Absorption is fast and almost complete. Ambroxol binds approximately 90% of plasma proteins. The highest concentration of active substance was found in the lung tissue. After oral administration, approximately 30% of the dose is eliminated as a result of the first pass through the liver. CYP3A4 is the main isoenzyme responsible for the metabolism of ambroxol. In addition, ambroxol is mainly metabolised in the liver via a coupling mechanism. T0,5 is 10 hours.
Contraindications:
Hypersensitivity to ambroxol hydrochloride or other components of the drug.
Precautions:
The patient should breathe normally during inhalation as the inhalation of the fluid alone may cause a cough reflex. Cases of severe skin changes such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been very rarely observed. In the event of new lesions within the skin or mucous membranes, it is necessary to prevent the ambroxol from being discontinued. The product contains a preservative - benzalkonium chloride, when inhaled in patients with hypersensitivity to the airways, it can cause bronchospasm.
Pregnancy and lactation:
Caution should be used during pregnancy, especially in the first trimester of pregnancy, the use of ambroxol is not recommended. Ambroxol is excreted in human milk, ambroxol is not recommended in breast-feeding women.
Side effects:
Common: taste disorders (eg altered taste), hypophysis, hypophysis, nausea, or hypoaesthesia of the mouth. Uncommon: diarrhea, vomiting, indigestion, dry mouth, abdominal pain. Rare: rash, urticaria. Not known: dry throat, angioneurotic edema, pruritus, hypersensitivity reactions, anaphylactic reactions (including anaphylactic shock).
Dosage:
Adults and children under the age of 6 and above: 1-2 inhalations with 2-3 ml of fluid per day. Children under 6: 1-2 inhalations with 2 ml of liquid daily. The preparation can be mixed with physiological saline in a 1: 1 ratio, in order to optimally humidify the air, especially when using the ventilator. Do not mix with cromoglycanic acid and other solutions with which a solution with a pH higher than 6.3, e.g. Patients with bronchial asthma should start inhalation after taking the usual bronchodilators.