Амбровикс

General characteristics. Structure:

Active ingredient: 0,015 g (15 mg) or 0,03 g (30 mg) of hydrochloride Ambroxol.

Excipients: methylparahydroxybenzoate, пропилпарагидроксибензоат, sorbitol solution uncrystallizable, propylene glycol, alcohol, Acidum hydrochloricum concentrated additive vkusoaromatichesky Aromatik AE 111 Pineapple or additive vkusoaromatichesky Aromatik AE 210 Banana, the water purified.

The medicine liquefying a bronchial secret, facilitating process of expectoration and not stimulating a tussive reflex.

Pharmacological properties:

Pharmacodynamics. Active ingredient of Ambroviks® syrup Ambroxol 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.

Pharmacokinetics. Absorption. 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 hours at oral administration of dosage forms of bystry release.

Distribution. At oral administration distribution of Ambroxol from blood in fabric bystry and sharply expressed, with high concentration of active agent in lungs. Distribution volume at oral administration was determined as 552 l. In a blood plasma in the therapeutic range about 90% of drug contacts proteins.

Metabolism. About 30% of a dose after oral administration are removed through presistemny metabolism.

Ambroxol is metabolized, mainly, in a liver by a glyukokuronization and splitting to dibromantranilovy acid (about 10% of a dose), except some insignificant metabolites. Clinical trials on microsomes of a liver of the person showed that CYP3A4 is responsible for metabolism of Ambroxol to dibromantranilovy acid.

Removal. In 3 days of oral administration about 6% of a dose are in a free form whereas 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.

Special groups of patients. At patients with an abnormal liver function removal of Ambroxol is reduced that leads to increase in its concentration in a blood plasma by 1,3-2 times. As the therapeutic range of Ambroxol rather wide, it is not necessary to change a dosage.

The age and floor have no clinically significant influence on Ambroxol pharmacokinetics therefore dose adjustment is not required. Meal does not influence bioavailability of Ambroxol.

Indications to use:

Sekretolitichesky 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:

Drug can be accepted irrespective of meal.

 Амбровикс® 15 mg / 5 ml:
adults and children are more senior than 12 years: 10 ml (2 teaspoons) 3 times a day;
children of 6-12 years: 5 ml (1 teaspoon) 2-3 times a day;
children at the age of 2-6 years: 2,5 ml (1/2 teaspoons) 3 times a day.

 Амбровикс® 30 mg / 5 ml:
adults and children are more senior than 12 years: 10 ml (2 teaspoons) twice a day.

The term of treatment of acute respiratory diseases and initial treatment of chronicities – up to 14 days. It is necessary to consult with the doctor if symptoms last more than 14 days and/or symptoms amplify, despite Ambroviks® syrup reception.

The dosing mode with a high dose should be applied at initial treatment, the dose can be reduced twice after 14 days of administration of drug.

At acute diseases it is necessary to consult with the doctor if symptoms do not disappear and/or amplify, despite Ambroviks® syrup reception.

Features of use:

Extremely weakened patients sick with anatomic narrowing of bronchial tubes and the increased secretion of slime at use of Ambroxol can have difficulties of evacuation of a bronchial secret. In these cases it is necessary to take measures for suction of a secret.

It is necessary to appoint drug with care at a peptic ulcer of a stomach and duodenum.

For patients with a diabetes mellitus it is necessary to consider the content in syrup of solution of sorbitol of 70%.

At the admission of administration of drug it is not necessary to double a dose.

At a heavy renal failure and a liver it is necessary to use lower concentration or to increase an interval between administrations of drug.

It was reported about several cases of strong injury of skin, including Stephens-Johnson's syndrome and a toxic epidermal necrolysis associated with reception of such expectorants as Ambroxol. This state can be explained, as a rule, with severity of an associated disease or a concomitant use of other drugs. Besides, at an early stage of a syndrome of Stephens-Johnson and a toxic epidermal necrolysis patients can have nonspecific signs of the beginning of the disease reminding flu: fervescence, all body pain, rhinitis, cough and pharyngalgia. Emergence of these signs can lead to an unnecessary symptomatic treatment anti-cold drugs.

Therefore at emergence of injuries of skin or mucous it is necessary to see immediately a doctor, and treatment by Ambroxol should be stopped for precaution.

Pregnancy and lactation. Use in II and the III trimester of pregnancy is possible if the expected effect of therapy exceeds potential risk for a fruit. For the period of treatment it is necessary to stop breastfeeding.

Influence on ability to drive the car or other moving mechanisms. It is not known of cases of influence of drug on ability to drive the car and mechanisms. The corresponding researches were not conducted.

Side effects:

Assessment of undesirable effects is based on the following data on emergence frequency: very often (≥1/10), it is frequent (≥1/100 to <1/10), infrequently (≥1/1000 to <1/100), is rare (≥1/10 000 to <1/1000), is very rare (<1/10 000), it is unknown (it cannot be estimated on the basis of the available data).

From immune system, skin and hypodermic cellulose. Seldom: rash, urticaria. It is unknown: a Quincke's disease, an itch, anaphylactic reactions, including shock, other reactions of hypersensitivity.

From a nervous system. Often: dysgeusia.

From digestive tract. Often: nausea, numbness of a mouth. Infrequently: vomiting, diarrhea, dyspepsia, an abdominal pain, dryness in a mouth. Very seldom: lock, hypersalivation. It is unknown: dryness in a throat.

From respiratory organs, a thorax and mediastinum. Often: numbness in a throat. Very seldom: rhinorrhea. It is unknown: asthma (as hypersensitivity reaction symptom).

From kidneys and urinary tract. Very seldom: dysurias.

Others. Infrequently: fever, reactions of skin and mucous membranes.

Interaction with other medicines:

Амбровикс® do not appoint along with antibechics (for example, containing codeine) as it complicates an otkhozhdeniye of the liquefied phlegm from bronchial tubes against the background of suppression of a tussive reflex.

Ambroxol promotes penetration of antibiotics (amoxicillin, tsefuroksy, Oxytetracyclinum, doxycycline, erythromycin) in a bronchial secret.

Contraindications:

- hypersensitivity to drug components;
- children up to 2 years;
- pregnancy (I trimester);
- lactation period.

Overdose:

Symptoms: nausea, vomiting, diarrhea, dispeptic frustration, falling of arterial pressure.

Treatment: Artificial vomiting, a gastric lavage (in the first 1-2 h after administration of drug); reception of fat-containing products. If necessary to carry out symptomatic therapy.

Storage conditions:

To store in the place protected from light at a temperature not over 25 ºС. To store in the place, unavailable to children.

Issue conditions:

Without recipe

Packaging:

On 100 ml and 150 ml of syrup in the bottles placed together with a leaf insert in packs from a cardboard.