Ambrosan

General characteristics. Structure:

Active agent: Ambroxol hydrochloride of 7,5 mg/ml.

Pharmacological properties:

Ambrosan — mucolytic (sekretolitichesky), expectorant medicine. Active ingredient of drug — Ambroxol — stimulates secretion of glands of a mucous membrane of respiratory tracts, increases release of pulmonary surfactant and stimulates activity of a tsiliarny epithelium. It leads to simplification of department of a phlegm and its removal (mukotsiliarny clearance). Stimulation of secretion of liquid and increase in mukotsiliarny clearance facilitate evacuation of a phlegm and reduce expressiveness of cough.
The local anesthetizing effect of Ambroxol is connected with blocking of natrium channels. In the researches in vitro it is shown that Ambroxol blocks natrium channels of neurons; binding had reversible character and depended on concentration of drug.
In the researches in vitro it is established that Ambroxol the hydrochloride considerably reduces release of cytokine from blood and fabric binding of mononuclear and polymorphonuclear cells.
As a result of clinical tests with involvement of patients with pharyngitis considerable reduction of expressiveness of pain and a hyperemia in a throat at drug use is proved.
These pharmacological properties leading to bystry easing of pain and the discomfort connected with pain in a nasal cavity in an ear and a trachea at inhalation, correspond to data of additional observation of symptoms in clinical trials of efficiency of Ambroxol at treatment of upper respiratory tracts.
After use of Ambroxol of a hydrochloride concentration of antibiotics (amoxicillin, a tsefuroksim, erythromycin) in a bronchopulmonary secret and a phlegm increase.
Ambroxol absorption bystry and rather full, with linear dependence in the therapeutic range. Cmax in a blood plasma is reached in 0,5–3 h. In the therapeutic range about 90% of drug contacts proteins of a blood plasma.
At oral administration distribution of Ambroxol from blood in fabric bystry and sharply expressed, with high concentration of active agent in lungs.
Ambroxol is metabolized in a liver by conjugation.
T½ makes 10 h of a blood plasma. The general clearance is in limits of 660 ml/min., the renal clearance makes about 8% of the general clearance. About 90% of a dose are allocated from an organism with kidneys.
At patients with an abnormal liver function removal of Ambroxol of a hydrochloride is reduced that leads to increase by 1,3–2 times of level of concentration in a blood plasma. As the therapeutic range of Ambroxol of a hydrochloride rather wide, is not required to dose adjustment.
The age and floor do not exert clinically significant impact on Ambroxol pharmacokinetics therefore dose adjustment is not required.
Meal does not influence bioavailability of Ambroxol of a hydrochloride.

Indications to use:

Sekretolitichesky therapy at the acute and chronic bronkhopulmonalny diseases connected with disturbance of bronchial secretion and difficulty of an otkhozhdeniye of a phlegm.

Route of administration and doses:

Apply inside after food.
To adults and children 12 years — on 30 mg (4 ml of solution or 140 drops) 3 times a day are aged more senior;
to children at the age of 6–12 years — on 15 mg (2 ml of solution or 70 drops) 2–3 times a day;
to children at the age of 2–6 years — on 7,5 mg (1 ml of solution or 35 drops) 3 times a day;
to children 2 years — on 7,5 mg (1 ml of solution or 35 drops) 2 times a day are aged younger.
Course of treatment — no more than 14 days. Consultation of the doctor is necessary if after 7 days of therapy against the background of Ambrosan's use symptoms do not disappear and/or their expressiveness increases.

Features of use:

Patients with an abnormal liver function or kidneys need to accept drug with extra care under constant control of the doctor.
Drug does not contain sugar therefore it can be applied at patients with a diabetes mellitus.
1 ml of solution contains 0,3 g of sorbite that there correspond 0,025 GU (grain units).
Does not contain alcohol.
Not to use on an empty stomach.
Use of drug should not be combined with alcohol intake.
Use during pregnancy and feeding by a breast. At use of drug in the form of tablets the patient needs to inform the doctor on pregnancy approach. It is not necessary to use drug during pregnancy and feeding by a breast.
Ambroxol gets through a placental barrier. Researches on animals did not reveal a direct or indirect negative impact on the course of pregnancy, development of an embryo/fruit, childbirth or post-natal development of the child.
As a result of clinical trials of use of drug after the 28th week of pregnancy any negative impact on a fruit is not revealed, however in the I trimester of pregnancy Ambrosan's use is not recommended. In II and the III trimester of pregnancy drug is used after careful assessment of a ratio the expected advantage for mother / potential risk for a fruit or the child.
Ambroxol gets into breast milk therefore its use during feeding is not recommended by a breast.
Children. Drug in the form of drops is used in pediatric practice.

Side effects:

As a rule, Ambrosan is well had by patients.
From a GIT: heartburn, dyspepsia, nausea, vomiting, diarrhea.
From immune system: skin rash, a small tortoiseshell, a Quincke's disease, anaphylactic reactions (including an acute anaphylaxis) and allergic reactions.

Interaction with other medicines:

At simultaneous use Ambroxol can increase efficiency of antibacterial agents (ampicillin, amoxicillin, tsefuroksy, erythromycin, doxycycline), increasing their concentration in a bronchopulmonary secret and a phlegm. This effect can be used at therapy by Ambroxol.
Simultaneous use with antibechic drugs can cause accumulation of a significant amount of slime in respiratory tracts and increase stagnation of a phlegm because of suppression of a tussive reflex.
There are no messages on clinical undesirable interactions with other medicines.

Contraindications:

Hypersensitivity to Ambroxol or any of drug components, the I trimester of pregnancy, the feeding period a breast, stomach ulcer and a duodenum in an aggravation stage. Tablets. In case of rare inborn states because of which incompatibility to drug excipients (is possible see. Special INSTRUCTIONS), administration of drug is contraindicated.

Overdose:

 Now the person has no messages on specific symptoms of overdose of Ambroxol. The symptoms known from single messages on overdose and/or cases of wrong use of medicines, answer the known side effects of Ambroxol of a hydrochloride in the recommended doses and demand a symptomatic treatment.
In case of any undesirable phenomena consultation of the doctor is necessary.

Storage conditions:

At a temperature not above 25 °C.

Issue conditions:

Without recipe

Packaging:

50 ml, 100 ml.