Mucolytic drug. Ambroxol increases the secretion of mucus in the airways, increases the production of the pulmonary surfactant and improves the function of the cilia of the respiratory epithelium. The effect of the action is to facilitate the expectoration and coughing relief. Absorption of all immediate-release forms of ambroxol is rapid and almost complete. The maximum concentration in the blood is reached within 0.5-3 h. Ambroxol is bound to plasma proteins in about 90%. It passes through the placental barrier and into breast milk. About 30% of the orally administered dose is eliminated during the first pass through the liver (first pass effect). CYP3A4 is an isozyme responsible for the metabolism of ambroxol. Ambroxol is also metabolised by conjugation in the liver. It is excreted through the kidneys. T0,5 in the final phase of elimination is 10 hours.
Contraindications:
Hypersensitivity to ambroxol or to 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 aggregates of the ambroxol) or with severe hepatic impairment. 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 lactose content, tablets should not be used in patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose. Ambroksol in the form of tablets should not be used in children <12 years of age (use a pharmaceutical form appropriate for the child's age, eg syrup).
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: nausea. Uncommon: vomiting, diarrhea, indigestion, abdominal pain. Rare: rash, urticaria. Not known: angioneurotic edema, pruritus, anaphylactic reactions (including anaphylactic shock) and other hypersensitivity reactions. 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 1 tabl. Three times a day; The dose can be increased to 2 tablets twice a day. In long-term treatment (over 10 days) the dose may be reduced to 1 tablet twice daily. The drug should be taken with a meal, washed down with plenty of water.
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