Acute and chronic respiratory diseases, with difficulty in coughing up sticky bronchial secretions, such as: acute and chronic bronchitis, bronchial asthma, cystic fibrosis, emphysema, bronchiectasis.
Composition:
5 ml of syrup contains 15 mg or 30 mg ambroxol; the syrup contains sorbitol, methyl and propyl p-hydroxybenzoates and propylene glycol.
Action:
Bromhexine metabolite exhibiting expectorant and mucolytic activity. It increases the secretion of mucus in the airways. As a result of hydrolytic depolymerization of mucoprotein and mucosaccharide fibers, the drug reduces the viscosity of mucus, thereby improving the activity of the bronchial epithelial cilia and accelerates the transport of secretions in the airways, which facilitates expectoration and relieves cough. Ambroxol is rapidly and almost completely absorbed from the gastrointestinal tract. The maximum concentration of ambroxol in the blood occurs approximately 2 hours after oral administration. The bioavailability is 70-80%. Approximately 90% bound to plasma proteins Metabolized mainly in the liver. About 90% of the dose is excreted in the urine, including about 5-6% in the unchanged form. The elimination of the drug is two-phase, T0,5 phase α is 1.3 h, phase β - 8.8 h.
Contraindications:
Hypersensitivity to Ambroxol, Bromhexine or any of the excipients. Hereditary, rare conditions of intolerance to excipients.
Precautions:
Particular caution should be exercised in patients with impaired renal function (risk of accumulation of liver metabolites in ambroxol) or severe hepatic impairment; in patients with peptic ulcer of the stomach or duodenum (due to unfavorable influence of ambroxol on the gastric mucosa); in patients with weakened cough reflexes or impaired ciliary purification of the bronchi (the possibility of secretion). The liquefaction of large amounts of secretions in immobilized and severe patients as well as in young children must be associated with suctioning. In patients with bronchial asthma, ambroxol may initially cough. If new lesions occur within the skin or mucous membranes during treatment, ambroxol should be discontinued and the lesions should be diagnosed because of the risk of severe skin changes such as Stevens-Johnson syndrome or Lyell's syndrome. Due to the content of methyl and propyl p-hydroxybenzoates and propylene glycol, syrup can cause allergic reactions (possible late-type reactions). Due to the sorbitol content, syrup should not be used in patients with rare hereditary fructose intolerance; sorbitol may have a slight laxative effect.
Pregnancy and lactation:
Ambroxol passes through the placental barrier. Animal studies do not indicate harmful effects with respect to pregnancy, embryonal / fetal development, parturition or postnatal development. Based on the extensive clinical experience in pregnant women after the 28th week of pregnancy, no adverse effects on the health of the fetus have been demonstrated. Despite this, ordinary precautions should be taken when using the drug in pregnant women. Especially in the first trimester of pregnancy, use is not recommended. Ambroxol is excreted in human milk. Although this should not be harmful to breastfed newborn babies, it is not recommended for women who are breastfeeding.
Side effects:
Common: taste disorders (eg change of taste), nausea, hypoaesthesia, hypophysis. Uncommon: vomiting, diarrhea, abdominal pain, dyspepsia, dry mouth. Rarely: heartburn, rash, urticaria. Not known: pruritus and other hypersensitivity reactions, anaphylactic reactions (including anaphylactic shock, angioneurotic edema), dry throat. Much rare cases of severe skin lesions, such as Stevens-Johnson Syndrome and toxic epidermal necrolysis, have been reported with the use of mucolytic substances, e.g. ambroxol; the majority of cases could be explained by the severity of the underlying disease and / or the concurrent use of other drugs.
Dosage:
Orally.Adults and children aged> 12 years: for the first 2-3 days 30 mg of ambroxol hydrochloride 3 times a day; then the dose should be reduced to 30 mg 2 times a day. Children from 6 to 12 years: 15 mg 2-3 times a day. Children from 2 to 6 years: 7.5 mg 3 times a day. Children from 1 to 2 years: 7.5 mg 2 times a day. If the treatment lasts longer than 7-14 days, the dose should be reduced. Take it after a meal. Do not use immediately before bedtime.