Ambroxol 15 mg 5 ml Syrup

AMBROXOL, syrup

Ambroxol composition

Active ingredient:  In 5 ml of syrup there is 15 mg of ambroxol hydrochloride. Excipients: propylene glycol, methylparaben (E 218), propylparaben (E 216), 96% ethanol,  sorbitol (E 420), raspberry flavoring, purified water.

Indications:

 For acute and chronic bronchopulmonary diseases associated with a decrease in bronchial secretion and the elimination of phlegm, for secretolytic therapy.

Contraindications:

 High sensitivity to any component of the product, peptic ulcer disease of the stomach and duodenum, convulsive syndrome, intolerance to the product’s excipients, rare hereditary conditions (see the “Special instructions and precautions” section).

Use during pregnancy and lactation:

 Ambroxol hydrochloride crosses the placental barrier. In animal studies, no direct or indirect harmful effects of ambroxol hydrochloride on the course of pregnancy, embryonic/fetal development, labor, or postnatal development were found. In clinical studies, use of the product after the 28th week of pregnancy revealed no negative effects on the fetus. However, during pregnancy, standard precautions regarding the use of the product must be followed. In particular, ambroxol is not recommended during the first trimester of pregnancy. Ambroxol passes into breast milk; therefore, its use is not recommended during lactation.  

How to use Ambroxol, dosage

 Unless otherwise prescribed by the doctor regarding dosing of the Ambroxol medicine, 15 mg/5 ml syrup is dosed as follows: Children under 2 years: 2 times per day (equivalent to 15 mg ambroxol hydrochloride per day) 2.5 ml (1/2 teaspoon). Children aged 2–6 years: 3 times per day (equivalent to 22.5 mg ambroxol hydrochloride per day) 2.5 ml (1/2 teaspoon). Children aged 6–12 years: 2–3 times per day (equivalent to 30–45 mg ambroxol hydrochloride per day) 5 ml (1 teaspoon). Adults and children over 12 years: for the first 2–3 days, the dose is 3 times per day (equivalent to 90 mg ambroxol hydrochloride per day) 10 ml (2 teaspoons), then 2 times per day (equivalent to 60 mg ambroxol hydrochloride per day) 10 ml (2 teaspoons). If necessary, in adults and children over 12 years, the therapeutic effect can be enhanced by increasing the dose to 20 ml twice daily (equivalent to 120 mg ambroxol hydrochloride per day). The 15 mg/ml Ambroxol syrup can be used regardless of food intake. The dose of 15 mg/ml Ambroxol syrup can be measured using the measuring spoon included in the package. There are no restrictions depending on the duration of use, but long-term therapy should be carried out under medical supervision. The 15 mg/ml Ambroxol syrup should not be used for more than 4–5 days without a doctor’s advice. The 15 mg/ml Ambroxol syrup can be used in patients with diabetes; 5 ml of solution contains 2.0 carbohydrates.