Abrol (ambroxol) syrup 30 mg/5 ml. 100 ml.

active ingredient: ambroxol hydrochloride (ambroxol hydrochloride);

5 ml syrup contains ambroxol hydrochloride 30 mg;

excipients: hydroxyethylcellulose, sorbitol solution (sorbitol E 420), glycerin, sodium saccharin, benzoic acid (E 210), propylene glycol, Apricot flavor, Garden mint flavor, purified water.

Syrup.

Basic physical and chemical properties: from colorless to slightly yellow hue, transparent syrup.

Means used for coughs and colds. mucolytic agents.

Code ATX R05C B06.

The active substance of Abrol® syrup – ambroxol hydrochloride – increases the proportion of the serous component of bronchial secretions. Ambroxol enhances the secretion of pulmonary surfactant by direct action on type II pneumocytes in the alveoli and Clara cells in the bronchioles, and also stimulates the activity of the cilia of the ciliary epithelium, resulting in a decrease in the viscosity of sputum and improves its excretion (mucociliary clearance). Improvement in mucociliary has been proven during clinical and pharmacological studies.

Increasing the secretion and reducing the viscosity of the secret and improving the mucociliary contribute to expectoration and facilitate expectoration of sputum.

Long-term use (6 months) of ambroxol hydrochloride (75 mg long-acting capsules) in patients with COPD resulted in a significant reduction in exacerbations after a two-month treatment period. In patients treated with ambroxol hydrochloride, the duration of illness and antibiotic therapy was significantly less. Compared with placebo, treatment with ambroxol hydrochloride, extended-release capsules, showed a statistically significant improvement in symptoms associated with expectoration problems, cough, dyspnea, and auscultatory signs.

The local anesthetic effect of ambroxol hydrochloride, which may be due to sodium channel blocking properties, was observed in a rabbit eye model.

In vitro studies have shown that ambroxol hydrochloride blocks neuronal sodium channels; binding was reversible and concentration dependent.

Ambroxol hydrochloride has been shown to be anti-inflammatory in vitro. Thus, ambroxol hydrochloride significantly reduces the release of cytokines from mononuclear and polymorphonuclear blood cells and tissues.

As a result of clinical trials involving patients with pharyngitis, a significant reduction in pain and redness in the throat was demonstrated when using the drug.

Due to the pharmacological properties of ambroxol, pain was quickly relieved in the treatment of diseases of the upper respiratory tract, which was observed in studies of the clinical efficacy of inhaled forms of ambroxol.

After the use of ambroxol hydrochloride, the concentrations of antibiotics (amoxicillin, cefuroxime, erythromycin and doxycycline) in bronchopulmonary secretions and sputum increase. At present, no clinical significance of this fact has been identified.

Secretolytic therapy for acute and chronic bronchopulmonary diseases associated with a violation of bronchial secretion and a weakening of the passage of mucus.

Abrol®, syrup, should not be used in patients with hypersensitivity to ambroxol hydrochloride or other components of the drug.
Abrol®, syrup, for children under 2 years of age, use as directed by a doctor.

The simultaneous use of the drug Abrol® and cough suppressants may lead to excessive accumulation of mucus due to suppression of the cough reflex. Therefore, such a combination is possible only after a thorough assessment by the doctor of the ratio of expected benefits and possible risks of use.

There have been reports of severe skin lesions: erythema multiforme, Stevens-Johnson syndrome (SSD) / toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (GGEP) associated with the use of ambroxol hydrochloride. If there are signs of progression of the skin rash (sometimes associated with the appearance of blisters or lesions of the mucous membrane), you should immediately stop treatment with ambroxol hydrochloride and seek medical help.

In violation of bronchial motility and increased secretion of mucus (for example, in such a rare disease as primary ciliary dyskinesia), the drug Abrol®, syrup, should be used with caution because of the risk of promoting the accumulation of secretions.

Patients with impaired renal function or severe hepatic insufficiency should take Abrol®, syrup, only after consulting a doctor. In patients with severe renal insufficiency, when using ambroxol, like any active substance that is metabolized in the liver and then excreted by the kidneys, the accumulation of metabolites formed in the liver is possible.

If you have known intolerance to some sugars, you should consult your doctor before taking this medicine.

Pregnancy.

Ambroxol hydrochloride crosses the placental barrier. Animal studies have not revealed direct or indirect harmful effects on pregnancy, embryo/fetal development, childbirth or postnatal development.

As a result of clinical studies of the use of the drug after the 28th week of pregnancy, not a single harmful effect on the fetus was revealed.

However, it is necessary to observe the usual measures regarding the use of drugs during pregnancy. In particular, in the first trimester of pregnancy, it is not recommended to use Abrol®, syrup.

Breastfeeding.

Ambroxol hydrochloride passes into breast milk. Abrol®, syrup, is not recommended for use during lactation.

Fertility.

Preclinical studies do not indicate direct or indirect harmful effects on fertility.

Unless otherwise stated, the recommended dose of Abrol®, syrup, 30 mg/5 ml is as follows:

children under 2 years of age 1.25 * ml 2 times a day (equivalent to 15 mg ambroxol hydrochloride per day)

* To measure a dose of 1.25 ml of syrup, use a plastic disposable syringe without a needle with a capacity of 2 ml.

children 2-5 years: 1.25 * ml 3 times a day (equivalent to 22.5 mg ambroxol hydrochloride per day)

* To measure a dose of 1.25 ml of syrup, use a plastic disposable syringe without a needle with a capacity of 2 ml.

children 6-12 years: 2.5 ml up to 3 times a day (equivalent to 30-45 mg ambroxol hydrochloride per day)

adults and children over 12 years of age: the usual dose is 5 ml 3 times a day (equivalent to 90 mg ambroxol hydrochloride per day) for the first 2-3 days and then 5 ml 2 times a day (equivalent to 60 mg ambroxol hydrochloride per day).

If necessary, the therapeutic effect for adults and children over 12 years of age can be enhanced by increasing the dose to 10 ml 2 times a day (equivalent to 120 mg of ambroxol hydrochloride per day).

Abrol®, syrup, 30 mg/5 ml can be taken with or without food. Measure the dose of Abrol®, syrup, 30 mg/5 ml using the measuring cup supplied.

In general, there are no restrictions on the duration of use, but long-term therapy should be monitored.

Abrol®, syrup, 30 mg/5 ml should not be used for more than 4-5 days without consulting a doctor.

Abrol®, syrup, 30 mg/5 ml suitable for use in patients with diabetes mellitus 5 ml contains 1.225 g of carbohydrates.

Abrol®, syrup, 30 mg/5 ml does not contain alcohol.

The drug can be used in pediatric practice. For children under 2 years of age, use as directed by a doctor.

So far, there are no reports of specific overdose symptoms. The symptoms known from rare overdose reports and/or cases of misuse of drugs correspond to known adverse reactions when using ambroxol hydrochloride, at recommended doses, and require symptomatic treatment.

3 years.

Store at a temperature not exceeding 25 ° C in the original packaging.

Keep out of the reach of children.

After opening the vial, store the drug for no more than 6 months.

100 ml from polyethylene or glass. Each vial is in a carton box along with a measuring cup.