Producer: LLC Kusum Pharm Ukraine
Code of automatic telephone exchange: R05CB06
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active ingredient: Ambroxol of a hydrochloride of 75 mg.
Excipients: silicon dioxide colloid anhydrous, gidroksipropilmetiltsellyuloza, cellulose microcrystallic, magnesium stearate.
Ambroxol increases secretion of glands of respiratory tracts, strengthens release of pulmonary surfactant and stimulates tsiliarny activity. It leads to improvement of mucifying and its removal (mukotsiliarny clearance). Activation of secretion of liquid and increase in mukotsiliarny clearance facilitate removal of a bronchial secret and reduce cough. Under the influence of drug the amount of cytokines, and also quantity of the mononuklear connected with fabric and polimorfonuklearny cells decreases.
Ambroxol absorption bystry and rather full, with linear dependence in the therapeutic range of doses. The maximum levels in a blood plasma are reached after 6,5±2,2 hours. Bioavailability of Ambroxol makes 95%. In a blood plasma in the therapeutic range about 90% of drug contacts proteins.
At oral administration distribution of Ambroxol from blood to fabrics bystry, with high concentration of active agent in lungs.
At oral administration of nearly 30% of drug it is excreted with a stake. Clinical trials showed that CYP3A4 is dominant isoenzyme which is responsible for Ambroxol metabolism. Ambroxol is metabolized mainly in a liver by conjugation.
Plasma elimination half-life of blood makes 10 hours. The general clearance is in limits of 660 ml/min., the renal clearance makes about 8% of the general clearance.
No proofs that the age and a floor influence Ambroxol pharmacokinetics in clinically powerful limits therefore conclusions concerning any correcting of a dose were not drawn were revealed.
Indications to use:
Sekretolitichesky therapy at the acute and chronic respiratory diseases connected with disturbance of bronchial secretion and decrease in evacuation of slime.
Route of administration and doses:
The adult appoint inside on 1 tablet a day, in the morning or in the evening, after food.
Treatment term – up to 14 days. It is necessary to consult with the doctor if symptoms of a disease last longer than 14 days and/or amplify, despite administration of drug of Abrol® of SR.
Features of use:
Use during pregnancy or feeding by a breast.
Ambroxol gets through a placental barrier.
Drug is not recommended to be used in the I trimester of pregnancy. In II and III trimesters of pregnancy of Abrol® of SR apply only when the expected advantage for mother exceeds potential risk for a fruit.
Ambroxol gets into breast milk therefore it is not recommended to use drug during feeding by a breast. However the adverse effect on children who are fed with breast milk is not expected.
Ability to influence the speed of reactions at control of motor transport or work with other mechanisms. Does not influence.
Children. Do not apply.
As a rule, administration of drug is well transferred by patients.
- From a digestive tract: heartburn, dyspepsia, nausea, vomiting, diarrhea.
- From immune system, skin and hypodermic cellulose: rashes, urticaria, a Quincke's disease, anaphylactic reactions (including an acute anaphylaxis) and allergic reactions.
- When progressing damages of skin or mucous membranes it is necessary to stop immediately treatment by drug and to see a doctor.
- Weakness, a headache, dryness in a mouth and airways, a rhinorrhea and a dysuria can sometimes be observed.
- Extremely seldom – severe damages of skin, such as Stephens-Johnson and Layell's syndromes. As a rule, they can be explained with weight of a basic disease or reception of the accompanying medicines.
Interaction with other medicines:
As a result of use of Ambroxol concentration of antibiotics (amoxicillin, a tsefuroksim, erythromycin) in a bronchopulmonary secret and a phlegm increases.
There are no messages of rather clinical interactions with other medicines.
Appropriate security measures at use.
It is not necessary to combine with antibechics which complicate removal of a phlegm.
With care appoint at a renal, liver failure.
There are no messages concerning overdose symptoms today.
In case of symptoms of overdose at considerable exceeding of a therapeutic dose the symptomatic treatment is necessary.
To store at a temperature not above 25 °C in the dry, protected from light place. To store in the place, unavailable to children.
On 10 tablets in the blister; on 1 or 2 blisters in cardboard packaging.