Properties
What is it?
International Nonproprietary Name - ambroxol hydrochloride Clinical-pharmacological group: Pulmonology → Mucolytics and antitussives → Mucolytics and expectorants Composition Active substance: ambroxol hydrochloride; 5 ml of syrup contains 15 mg of ambroxol hydrochloride; Excipients: hydroxyethylcellulose, sorbitol, saccharin sodium, citric acid, glycerin, propylene glycol, sodium benzoate, apricot food flavoring, orange food flavoring, menthol, purified water. Pharmacotherapeutic group Mucolytic preparation. Ambroxol is a synthetic secretolytic and secretomotoric preparation. The preparation stimulates the formation of mucus in the bronchi, helps to thin it, and improves its excretion by increasing the activity of the ciliated epithelium. Ambroxol increases surfactant concentration in the lungs and prevents its breakdown. It has a minor antitussive effect. Ambroxol has an anti-inflammatory effect, antioxidant properties, and stimulates local immunity. Indications Ambroxol 15 is used in adults and children over 2 years of age for the treatment of acute and chronic respiratory diseases accompanied by the formation of viscous, difficult-to-remove mucus: acute and obstructive bronchitis, bronchiectatic disease, tracheitis, laryngitis, pharyngitis, sinusitis, rhinitis, pneumonia, bronchial asthma with difficult-to-remove mucus; for the treatment and prevention of postoperative complications in the lungs; during preparation for bronchoscopy and after the procedure; in cystic fibrosis of the lungs. Contraindications The preparation is contraindicated in case of hypersensitivity (allergy) to ambroxol, as well as in patients with peptic ulcer disease of the stomach and duodenum. Precautions for use In case of impaired kidney function, the preparation can be used only on the recommendation of a doctor. Interaction with medicinal products Ambroxol 15 increases the therapeutic efficacy of doxycycline, cefuroxime, and amoxicillin by increasing the concentration of antibiotics in lung tissues. The preparation increases the effective concentration of rifampicin in the lungs. Combination of ambroxol with theophylline is therapeutically justified; simultaneous use of the preparation with cardiac glycosides and diuretics is possible. It is not recommended for use with antitussives that complicate mucus excretion or thicken it. Special instructions Patients with diabetes mellitus can use the preparation. Dosage and administration Ambroxol 15 is taken orally with a measuring spoon after meals: Children aged 6-12 years 1 tbsp 2-3 times a day Children aged 2-6 years 1/2 tbsp 3 times a day Children aged 1-2 years 1/2 tbsp 2 times a day Children under 1 year 1/4-1/2 tbsp 2 times a day If necessary, the dose of the preparation can be doubled during the first 2-3 days of treatment. The course of treatment is 4-14 days. Overdose. Cases of overdose have not been described, but digestive disorders, discomfort or pain in the epigastric region, feeling of fullness in the stomach, vomiting, nausea are possible. In case of overdose, the intake of the preparation should be stopped. Side effects Ambroxol 15 is well tolerated, but with prolonged use or high doses, heartburn, dyspepsia, feeling of fullness in the stomach, vomiting, nausea may occur; rarely – allergic reactions in the form of skin rash, urticaria, angioneurotic edema. Increased salivation and secretion of the nasal mucosa, hyperthermia, dysuria are possible. In case of any negative reactions, it is necessary to stop taking the preparation and consult a doctor.