Pharmacological properties

Pharmacodynamics. active ingredient of medicine abrol — Ambroxol a hydrochloride — increases secretion of glands of airways. Ambroxol strengthens discharge of pulmonary surfactant by direct impact on type ii pnevmotsita in alveoluses and cages Klara in bronchioles and also stimulates tsiliarny activity. it promotes increase in secretion of slime and improvement of mukotsiliarny clearance. improvement of mukotsiliarny clearance is proved during the kliniko-pharmacological researches.

Activation of secretion of liquid and increase in mukotsiliarny clearance facilitate removal of slime and reduce cough.

Knows that Ambroxol the hydrochloride renders the local anesthetizing effect that can speak its ability to block natrium channels. Blocking of neural natrium channels was characterized by the fact that binding was reversible and depended on concentration.

Ambroxol the hydrochloride has anti-inflammatory effect. The researches in vitro revealed that Ambroxol the hydrochloride considerably reduces release of cytokine from blood and fabric binding of mononuclear and polymorphonuclear cages.

to

as a result of clinical trials with involvement of patients with pharyngitis proved considerable reduction of severity of pain and reddening in a throat at use of medicine. Also during the researches of clinical performance of inhalation forms of Ambroxol it was shown that Ambroxol the hydrochloride is effective at treatment of the upper airways as it promotes fast reduction of severity of pain and the related discomfort in a nasal cavity, in an ear and a trachea at a breath.

After use of Ambroxol of a hydrochloride concentration of antibiotics (amoxicillin, a tsefuroksim, erythromycin) in a bronchopulmonary secret and in a phlegm increase.

Pharmacokinetics. Absorption. Hydrochloride Ambroxol absorption from oral forms of not prolonged action fast and rather full, with linear dependence in the therapeutic range. The C _max in blood plasma is reached in 1-2.5 h at oral administration of dosage forms of fast release and on average in 6.5 h at application of forms of slow release. Relative bioavailability of capsules with the prolonged action — 95%.

Distribution. At oral administration hydrochloride Ambroxol distribution from blood in fabric fast and pronounced, with high concentration of active agent in lungs. Distribution volume at oral administration is 552 l. In blood plasma in the therapeutic range about 90% of medicine contacts proteins.

Metabolism and removal. About 30% of a dose after intake are removed by presistemny metabolism. Ambroxol the hydrochloride is metabolized in a liver by a glyukuronization and splitting to dibromantranilovy acid (about 10% of a dose). It is known what in microsomes of a liver of the person of CYP 3A4 is responsible for hydrochloride Ambroxol metabolism to dibromantranilovy acid.

about 6% of a dose are removed by

In 3 days of oral administration in not changed look whereas about 26% — in the conjugated form with urine.

T _½ plasma is made by about 10 h. The general clearance is in limits of 660 ml/min. together with kidney clearance that makes about 83% of the general clearance.

Pharmacokinetics at special groups of patients. At patients with an abnormal liver function the removal of Ambroxol of a hydrochloride is reduced that causes by 1.3-2 times higher level in blood plasma. As the therapeutic range of Ambroxol of a hydrochloride is rather wide, it is not required to change a dose.

Age and sex have no clinically significant impact on hydrochloride Ambroxol pharmacokinetics therefore dose adjustment is not required.

Meal does not affect bioavailability of Ambroxol of a hydrochloride.

Indication

Sekretolitichesky therapy at the sharp and chronic bronchopulmonary diseases connected with violations of bronchial secretion and weakening of advance of slime.

Use

Abrol of a tablet. if it is not appointed differently, the recommended medicine dose abrol tablets is as follows:

children at the age of 6–12 years: the dose makes ½ tablets 2–3 times a day (30–45 mg of Ambroxol of a hydrochloride a day are equivalent);

adults and children are aged more senior than 12 years: the dose makes 1 tablet 3 times a day during the first 2–3 days (90 mg of Ambroxol of a hydrochloride a day are equivalent). To continue treatment by application of 1 tablet 2 times a day (60 mg of Ambroxol of a hydrochloride a day are equivalent).

In case of need the therapeutic effect for adults and children can be aged more senior than 12 years is enhanced by application of 2 tablets 2 times a day (120 mg of Ambroxol of a hydrochloride a day are equivalent).

should swallow of

Tablet entirely with enough liquid (for example water, tea or fruit juice) after meal.

generally do not have

restrictions on application duration, but long therapy should be carried out under medical control.

should not apply

Tablet Abrol longer than 4-5 days without consultation with the doctor.

Abrol syrup of 15 mg / 5 ml. If it is not appointed differently, the recommended medicine Abrol dose syrup of 15 mg / 5 ml is as follows:

children under 2 years: 2.5 ml (½ teaspoons) 2 times a day (15 mg of Ambroxol of a hydrochloride a day are equivalent);

children at the age of 2–6 years: 2.5 ml (½ teaspoons) 3 times a day (22.5 mg of Ambroxol of a hydrochloride a day are equivalent);

children at the age of 6–12 years: 5 ml (1 teaspoon) 2–3 times a day (30–45 mg of Ambroxol of a hydrochloride a day are equivalent);

adults and children are aged more senior than 12 years: the dose makes 10 ml (2 teaspoons) 3 times a day (90 mg of Ambroxol of a hydrochloride a day) during the first 2–3 days are equivalent and then 10 ml (2 teaspoons) 2 times a day (60 mg of Ambroxol of a hydrochloride a day are equivalent).

If necessary the therapeutic effect for adults and children can be aged more senior than 12 years is enhanced by increase in a dose to 20 ml 2 times a day (120 mg of Ambroxol of a hydrochloride a day are equivalent).

For adults and children 12 years are aged more senior than

use of syrup with higher concentration is recommended (Abrol syrup of 30 mg / 5 ml).

Abrol syrup of 30 mg / 5 ml. If other is not registered, such mode of administration of medicament Abrol syrup of 30 mg / 5 is recommended to ml:

children under 2 years: 1.25 ml 2 times a day (15 mg of Ambroxol of a hydrochloride a day are equivalent);

children at the age of 2–5 years: 1.25 ml 3 times a day (22.5 mg of Ambroxol of a hydrochloride a day are equivalent);

children at the age of 6–12 years: 2.5 ml up to 3 times a day (30–45 mg of Ambroxol of a hydrochloride a day are equivalent);

adults and children are aged more senior than 12 years: the usual dose makes 5 ml 3 times a day (90 mg of Ambroxol of a hydrochloride a day) during the first 2–3 days are equivalent and then 5 ml 2 times a day (60 mg of Ambroxol of a hydrochloride a day are equivalent).

If necessary the therapeutic effect for adults and children can be aged more senior than 12 years is enhanced by increase in a dose to 10 ml 2 times a day (120 mg of Ambroxol of a hydrochloride a day are equivalent).

Abrol syrup can be applied irrespective of meal. Syrup can be measured by means of a measured glass which is applied. It is necessary to pay attention that the volumetric glass is not intended for dosage measurement of 1.25 ml of syrup (for children at the age of 2–5 years). For measuring off of a dose of 1.25 ml it is possible to use the plastic single syringe without needle with a capacity of 2 ml.

generally do not have

restrictions concerning application duration, but long therapy should be carried out under medical control.

Abrol should not apply syrup longer than 4-5 days without consultation with the doctor.

Abrol syrup can be applied at patients with diabetes; 5 ml contain 1.2 g of carbohydrates.

Abrol syrup does not contain alcohol.

Abrol SR. If it is not appointed differently, such administration of medicament Abrol SR is recommended:

adult: 1 tablet of 1 times a day (75 mg/days of Ambroxol of a hydrochloride are equivalent) in the morning or in the evening after a meal. It is necessary to swallow of tablets entirely, washing down with enough water.

in general do not have

restrictions on application duration, but long therapy should be carried out under medical control.

Abrol SR should not apply

longer than 4-5 days without consultation with the doctor.

Children. Abrol tablets are appointed to children aged 6 years which cannot accept syrup are more senior.

Abrol syrup can use Drug in pediatric practice. At children under 2 years to apply on doctor's orders.

Abrol SR is not applied in pediatric practice.

Contraindication

Drug cannot be used at patients with the known hypersensitivity to Ambroxol to a hydrochloride or other components of medicine.

Abrol of a tablet, is not intended for application for children under 6 years in connection with action force. Ambroxol in the corresponding dose is recommended to children under 6 years for application.

Abrol SR is not intended to

for application for children and teenagers.

Side effects

from the immune system, leather and hypodermic cellulose: skin rash, a small tortoiseshell, a Quincke's disease, an itch, anaphylactic reactions (including an acute anaphylaxis), other reactions of hypersensitivity, an erythema, severe damages of skin: Stephens's syndrome — Johnson and a toxic epidermal necrolysis (Lyell's disease).

from nervous system: dysgeusia (disorder of taste).

from digestive system: nausea, decrease in sensitivity in an oral cavity, vomiting, diarrhea, dyspepsia, an abdominal pain, dryness in a mouth, a lock, salivation, dryness in a throat.

from the respiratory system, bodies of a thorax and mediastinum: decrease in sensitivity in a drink, a rhinorrhea, short wind (as a symptom of reaction of hypersensitivity).

from an urinary system: dysuria.

General frustration: fever, reactions from mucous membranes.

Special instructions

only several messages about severe damages of skin Arrived: Stephens's syndrome — Johnson and a toxic epidermal necrolysis (Lyell's disease) — are connected with use of expectorants, such as Ambroxol a hydrochloride. generally they could be explained with weight of a course of a basic disease at patients and/or simultaneous use of other medicine. also at an initial stage of a syndrome of Stephens — Johnson or a Lyell's disease patients can have nonspecific grippopodobny symptoms, such as fever, ache, rhinitis, cough and sore throat. mistakenly at such nonspecific symptoms of the beginning of flu it is possible to perform symptomatic treatment by medicaments 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.

At violation of bronchial motility and the strengthened slime secretion (for example at such rare disease as primary tsiliarny dyskinesia) medicament should be used with care as Ambroxol can strengthen slime secretion.

to Patients with impaired renal function or heavy degree of a liver failure should take the medicament only after consultation with the doctor. At use of Ambroxol, as well as any substance which is metabolized in a liver, and then is allocated with kidneys, there is an accumulation of the metabolites which are formed in a liver at patients with a heavy renal failure.

Abrol syrup, 15 mg/ml and 30 mg / 5 ml, contains 1.225 g of sorbite in 5 ml (9.8 and 4.9 g are equivalent respectively at application of the maximum daily dose). If the intolerance of some sugars is established, it is necessary to consult with the doctor before taking this drug.

Use during pregnancy or feeding by a breast. Pregnancy. Ambroxol the hydrochloride gets through a placental barrier. The adverse effect on a fruit at use of medicine after the 28th week of pregnancy is not revealed. However it is necessary to take usual precautionary measures at medicament intake during pregnancy. In the I trimester of pregnancy it is not recommended to use drug.

Feeding by a breast. Ambroxol the hydrochloride gets into breast milk. Drug is not recommended to be used during feeding by a breast.

Ability to influence speed of response at control of vehicles or other mechanisms. There are no data on influence on ability to steer vehicles or other mechanisms. Researches were not conducted.

Simultaneous use of Ambroxol and the medicines oppressing cough can lead

Interaction

to excess accumulation of slime owing to suppression of a tussive reflex. therefore such combination is possible only after careful assessment by the doctor of a ratio of the expected advantage and possible risk of application.

Overdose

At the moment is not present messages about specific symptoms of overdose. the symptoms known from single messages about overdose and/or cases of wrong use of medicines, correspond to the known side effects of medicine in the recommended doses and demand symptomatic treatment.

Storage conditions

In original packing at a temperature not above 25 °C in the place protected from light. after opening of a bottle medicine to store no more than 4 weeks