Acute and chronic lung and bronchial diseases with mucus disorder and impaired transport.
Composition:
1 soft tablet contains 15 mg Ambroxol hydrochloride; the pellets contain sorbitol. 1 tabl contains 30 mg ambroxol hydrochloride; tablets contain lactose. 5 ml of syrup contains 30 mg of ambroxol hydrochloride, 5 ml of mini syrup contains 15 mg of ambroxol hydrochloride; syrups contain sorbitol.
Action:
Mucolytic drug. It increases the secretion of mucus in the airways, which increases the production of the pulmonary surfactant and improves the function of the cilia of the respiratory epithelium. 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. Cmax it is achieved 1-2.5 h after administration. Ambroxol binds approximately 90% of plasma proteins. After oral administration, about 30% of the dose is eliminated as a result of first-pass metabolism. Ambroxol is mainly metabolised in the liver in the glucuronidation process and partly, via CYP3A4, also in dibromoanthranilic acid (approximately 10% of the dose). T0,5 is 10 hours.
Contraindications:
Hypersensitivity to ambroxol hydrochloride or to any of the excipients. Hereditary, rare intolerance to any of the excipients.
Precautions:
Caution should be exercised in patients with renal insufficiency or severe hepatic impairment (risk of accumulation of ambroxol metabolites in the body). Due to the risk of severe skin changes, if a new lesion occurs in the skin or mucous membranes, a precautionary discontinuation of ambroxol is necessary. Due to the sorbitol content, soft lozenges and syrup should not be used in patients with rare hereditary fructose intolerance. Due to the lactose content, tablets should not be used in patients with rare, hereditary galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.
Pregnancy and lactation:
Based on the extensive clinical experience in pregnant women after the 28th week of pregnancy, ambroxol has not been shown to affect the health of the fetus. Despite this, ordinary precautions should be taken when using the drug in pregnant women. Especially in the first trimester of pregnancy, ambroxol is not recommended. Ambroxol is excreted in human milk - it is not expected to have an adverse effect on breastfed babies, but it is not recommended for breastfeeding.
Orally.Soft pills. Adults and children> 12 years: 2 lozenges 3 times a day; action can be increased by using 2 lozenges 4 times a day. Children 6-12 years: 1 pill 2-3 times a day; action can be increased by using one lozenge 4-6 times a day. The lozenges can be taken with or without food; suck or chew slowly until completely dissolved.tablets. Adults: 1 tabl. 3 times a day, the effect of the drug can be increased by using 2 tablets. 2 times a day. The tablets can be taken with or without food, with liquid.30 mg / 5 ml syrup. Adults and children> 12 years: 10 ml of syrup twice a day, the dose recommended for acute inflammation of the airways and in the initial period of chronic treatment, in the first 14 days of treatment. Children 6-12 years: 5 ml of syrup 2-3 times a day; 2-6 years: 2.5 ml syrup 3 times a day; 1-2 years: 2.5 ml of syrup twice a day.Mini syrup 15 mg / 5 ml. Adults and children> 12 years: 20 ml of syrup twice a day, the dose recommended for acute inflammation of the airways and in the initial period of chronic treatment, in the first 14 days of treatment. Children 6-12 years: 10 ml of syrup 2-3 times a day; 2-6 years: 5 ml of syrup 3 times a day; 1-2 years: 5 ml of syrup twice a day. Dosage can be reduced by half after 14 days of treatment. Take syrup regardless of meals.