Mucolytic treatment of wet cough associated with acute and chronic diseases of the bronchi and lungs.
Composition:
1 tabl contains 30 mg Ambroxol hydrochloride; tablets contain lactose. 1 tabl Effervescent contains 60 mg ambroxol hydrochloride; tablets contain lactose, sorbitol and sodium. 5 ml of syrup contains 15 mg, the syrup contains sorbitol. 5 ml oral solution contains 30 mg ambroxol hydrochloride; the solution contains sorbitol.
Action:
Drug with secretolytic and secretomotor action. It increases the amount of serous bronchial secretion and stimulates the secretion and transport of surfactant in the alveoli. After oral administration, almost completely absorbed from the gastrointestinal tract. Cmax blood reaches about 1-3 h. In 80-90% it is bound to plasma proteins. It is metabolised in the liver and excreted in 90% with urine in the form of metabolites, and 10% in unchanged form. T0,5 is 7-12 hours.
Contraindications:
Hypersensitivity to the active substance or any of the excipients. Tablets: do not give to children <6 years. Effervescent tablets: do not give to children <12 years. 15 mg / 5 ml syrup: for children <2 years only use under medical supervision. 30 mg / 5 ml oral solution: do not give to children <2 years.
Precautions:
If new lesions appear on the skin or mucous membranes, ambroxol should be discontinued and the patient should report to a physician (severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been very rarely reported). Caution should be exercised when using the drug in patients with impaired mucociliary transport in the bronchi and a large amount of secretion (eg in the primary ciliary dyskinesia) due to the possibility of bronchial secretions accumulating. Use with caution in patients with impaired renal function or severe liver disease (maintaining longer dosing intervals or lower doses) and in patients with a history of gastric and duodenal ulcer (mucolytics may damage the gastric mucosa). In severe renal insufficiency, the possibility of accumulation of ambroxol metabolites that were formed in the liver should be considered. Caution should be exercised in patients with histamine intolerance (long-term treatment should be avoided in these patients); drug affects the metabolism of histamine and can lead to the onset of intolerance (eg headache, runny nose, itching). The effervescent tablets and tablets contain lactose; patients with rare hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose should not take these forms of the drug. Effervescent tablets, syrup and oral solution contain sorbitol; patients with rare hereditary problems of fructose intolerance should not use these forms of the drug. Effervescent tablets contain sodium (5.5 mmol, ie 126.5 mg of sodium in 1 tablet), this should be taken into account in patients who control the sodium content of the diet.
Pregnancy and lactation:
Preparations may be used during pregnancy only if clearly necessary, only after careful assessment of the risk / benefit ratio, especially during the first trimester of pregnancy. The use of preparations during breastfeeding is not recommended. Ambroxol passes through the placenta barrier and into breast milk.
Side effects:
Common: nausea, dysgeusia (eg altered taste), hypoaesthesia of the mouth and throat. Uncommon: abdominal pain, vomiting, diarrhea, indigestion, dry mouth, fever, hypersensitivity reactions (skin rash, swollen face, respiratory disorders, pruritus). Rare: rash, urticaria. Very rare: severe skin reactions (such as Stevens-Johnson syndrome and necrotic epidermal separation). Very rare: anaphylactic reactions (including anaphylactic shock, angioedema, pruritus and other hypersensitivity reactions), dry throat.
Dosage:
Orally.tablets. Adults and children> 12 years: 1 tabl. 3 times a day for the first 2-3 days, then 1 tablet. 2 times a day; children: 6-12 years: 1/2 tabl. 2-3 times a day.In adults, the dose can be increased to 60 mg 2 times a day. The tablets should be swallowed whole with a sufficient amount of liquid.Effervescent tablets. Adults and children> 12 years: 1/2 tabl. effervescent 3 times a day for the first 2-3 days, then 1/2 tabl. effervescent 2 times a day. In adults, the dose can be increased to 60 mg 2 times a day. Effervescent tablets should be dissolved in a glass of water.Syrup 15 mg / 5ml. Adults and children> 12 years: 10 ml 2-3 times daily for 2-3 days, then 10 ml twice daily; children 6-12 years: 5 ml 2-3 times a day; children 2-5 years: 2.5 ml 3 times a day; children 1-2 years: 2.5 ml twice a day.Oral solution 30 mg / 5ml. Adults and children> 12 years: 5 ml 3 times daily for 2-3 days, then 5 ml twice daily; children 6-12 years: 2.5 ml 2-3 times a day; children 2-5 years: 1.25 ml 3 times a day. In adults, the dose can be increased to 60 mg 2 times a day. Do not take more than 4-5 days without medical advice. The preparations should be taken after a meal. Do not use immediately before bedtime.
(C)
