Abrol syrup of 15 mg
Producer: LLC Kusum Pharm Ukraine
Code of automatic telephone exchange: R05CB06
Release form: Liquid dosage forms. Syrup.
General characteristics. Structure:
The operating substance – Ambroxol a hydrochloride.
Active ingredient of Abrol – Ambroxol a hydrochloride – increases secretion of glands of respiratory tracts.
Ambroxol strengthens release of pulmonary surfactant and stimulates tsiliarny activity owing to what department of slime and its removal (mukotsiliarny clearance) is facilitated. Activation of secretion of liquid and increase in mukotsiliarny clearance facilitate removal of slime and reduce cough.
The local anesthetizing effect of Ambroxol of a hydrochloride is explained by its properties of blocking of natrium channels. The researches in vitro showed that Ambroxol the hydrochloride blocks neural natrium channels. In the researches in vitro it is established that Ambroxol the hydrochloride substantially reduces release of cytokine from blood and quantity of fabric mononuclear and polymorphonuclear cells.
Considerable reduction of pain and reddening in a throat at patients at drug use is proved.
Pharmacological properties which lead to bystry easing of pain and the discomfort connected with pain in a nasal cavity, in an ear and a trachea at air inhalation, at treatment of upper parts of respiratory tracts are revealed.
After use of Ambroxol of a hydrochloride concentration of antibiotics (amoxicillin, a tsefuroksim, erythromycin) in a bronchopulmonary secret and a phlegm increases.
Hydrochloride Ambroxol absorption bystry and rather full, with linear dependence in the therapeutic range. The maximum levels in a blood plasma are reached in 1 - 2,5 hour at oral administration of dosage forms of bystry release.
At oral administration hydrochloride Ambroxol distribution bystry and sharply expressed, with the highest concentration of active agent in lungs. Distribution volume at oral administration makes about 552 l. In a blood plasma in the therapeutic range about 90% of drug contacts proteins.
Ambroxol the hydrochloride is metabolized mainly in a liver by a glyukuronization and splitting in dibromantranilovy acid (about 10% of a dose), except some insignificant metabolites. Clinical trials showed that CYP3A4 is responsible for hydrochloride Ambroxol metabolism in dibromantranilovy acid.
In 3 days of oral administration about 6% of a dose are in a free form while about 26% of a dose – in the conjugated form in urine.
Plasma elimination half-life of blood makes about 10 hours. The general clearance is in limits of 660 ml/min. together with renal clearance that makes about 8% of the general clearance.
At patients with an abnormal liver function removal of Ambroxol of a hydrochloride is lowered that causes increase in its level in a blood plasma by 1,3 - 2 times.
As the therapeutic amplitude of Ambroxol of a hydrochloride rather wide, it is not necessary to change a dosage.
The age and floor have no clinically significant influence on hydrochloride Ambroxol pharmacokinetics therefore any dose adjustment is not required.
Meal does not influence bioavailability of Ambroxol of a hydrochloride.
Indications to use:
Secretory therapy at the acute and chronic bronchopulmonary diseases connected with disturbance of bronchial secretion and weakening of advance of slime.
Route of administration and doses:
Abrol® syrup is appointed inside:
Adults and children, are more senior than 12 years: 10 ml 3 times a day;
children at the age of 6 - 12 years: 5 ml 2-3 times a day;
children at the age of 2 - 6 years: 2,5 ml 3 times a day;
children under 2 years of 2,5 ml 2 times a day.
At acute diseases it is necessary to consult with the doctor if symptoms do not disappear and/or amplify, despite Abrol® syrup reception.
Drug can be used irrespective of meal.
Features of use:
Several messages on the severe damages of skin (Stephens-Johnson's syndrome), toxic epidermal necrolysis (Lyell's disease) connected using expectorants such as Ambroxol a hydrochloride were received. Generally they could be explained with weight of a current of a basic disease and/or simultaneous use of other drug. Also at an initial stage of a syndrome of Stephens-Johnson or a Lyell's disease at patients nonspecific grippopodobny symptoms, such as fever, rhinitis, cough and a pharyngalgia can be observed. Mistakenly at such symptoms it is possible to appoint a symptomatic treatment drugs against cough and cold. Therefore at emergence of new damages of skin or mucous membranes it is necessary to ask immediately for medical care and to stop Ambroxol treatment by a hydrochloride.
Patients with an impaired renal function of Abrol® should accept only after consultation with the doctor.
Abrol® syrup contains sorbite therefore patients with rare hereditary intolerance of fructose should not accept this drug. It can also have insignificant laxative effect.
Abrol® syrup does not contain sugar therefore it can be applied sick diabetes.
Does not contain alcohol.
Use during pregnancy or feeding by a breast.
As a result of clinical trials of use of drug after the 28th week of pregnancy any harmful effects of drug on a fruit are not revealed, thus, in the I trimester of pregnancy it is not recommended to apply Abrol®. In the II-III trimesters of pregnancy drug is used only when the expected advantage for mother exceeds potential risk for a fruit or the child.
Ambroxol gets into breast milk therefore during treatment of Abrolom® it is necessary to stop feeding by a breast.
Ability to influence speed of response at control of motor transport or work with other mechanisms.
There are no data on influence on speed of response at control of motor transport or work with other mechanisms. Researches of influence on speed of response at control of motor transport or work with other mechanisms were not conducted.
Children. Drug can be used in pediatric practice.
- From immune system: anaphylactic reactions, including an acute anaphylaxis, a Quincke's disease, skin rash, a small tortoiseshell, an itch and other allergic reactions. It was very seldom reported about severe damages of skin, such as Stephens-Johnson's syndrome and Lyell's disease (toxic epidermal necrolysis). Generally they could be explained with weight of a current of a basic disease or simultaneous use of other drug.
- From a nervous system: dysgeusia (disorder of taste).
- Other: nausea, vomiting, diarrhea, dyspepsia, heartburn, diarrhea, an abdominal pain, decrease in sensitivity in an oral cavity and a drink, dryness in a mouth and a throat.
- As a rule, Abrol® syrup is well transferred by patients.
- At emergence of any side reactions it is necessary to ask immediately for medical care and to stop treatment by Ambroxol.
Interaction with other medicines:
At simultaneous use with Ambroxol concentration of antibiotics (amoxicillin, a tsefuroksim, erythromycin) in a bronchopulmonary secret and a phlegm increase.
There are no messages on clinical undesirable interactions with other medical supplies.
Hypersensitivity to Ambroxol or other components of drug. At rare inborn states because of which the intolerance of excipient is possible (see the section "Special Instructions") administration of drug is contraindicated.
Now people have no messages on cases of overdose of drug. In case of use of the doses exceeding recommended it is necessary to see a doctor. Symptomatic treatment.
To store at a temperature not above 25 °C in protected from light and the place, unavailable to children.
After the first opening of a bottle to store drug no more than 4 weeks.
On 100 ml in bottles. Each bottle in a cardboard box together with a measured glass.