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Ambrobene

Ambrobene (ambroxol hydrochloride) is a drug that facilitates expectoration of sputum and has mucolytic activity. It is used in otorhinolaryngological practice for acute and chronic respiratory tract diseases, accompanied by impaired production and evacuation of sputum. Impaired removal of mucus from the respiratory tract is one of the key factors underlying the pathogenesis of inflammatory diseases of various parts of the respiratory tract. Stagnation of bronchial contents causes a deterioration in the ventilation and respiratory abilities of the lungs and an increased risk of infection. The production of secretions by the bronchi is an essential condition for the proper functioning of the respiratory system. The composition of sputum produced by the bronchi is complex and depends on the coordinated work and proper condition of a number of physiological links. Inflammation of any part of the respiratory tract (trachea, bronchi) through a compensatory mechanism increases mucus production, with which, in turn, the consistency of sputum changes in the direction of increasing viscosity. Accordingly, the more viscous the sputum, the lower the rate of its evacuation from the respiratory tract. The insufficiency of the drainage function of the ciliated epithelium of the bronchi and trachea contributes to the retention of sputum in the respiratory tract, resulting in the development of cough. In this case, taking antitussive medications will not only not improve the situation, but will also worsen it. And here drugs that facilitate sputum discharge come to the fore and, in particular, Ambrobene as one of the most effective and safe representatives of this pharmacological group.

In most clinical situations, this mucolytic agent is the best choice in the treatment of infectious and inflammatory diseases of the respiratory tract, incl. in patients of the younger age group. Ambrobene is a new generation secretolytic, which is a derivative of bromhexine and has a powerful expectorant effect. Ambrobene does not affect the production of bronchial secretions produced by mucosal cells. It thins mucus by destroying acidic mucopolysaccharides and DNA, while facilitating the passage of secretions. In addition, the drug increases the concentration of pulmonary surfactant, which improves lung compliance, which indirectly improves mucociliary transport and gives a pronounced expectorant effect. At the same time, Ambrobene does not cause bronchial obstruction. The effect of taking the drug is noticeable within half an hour. It is dose-dependent and is maintained at a clinically significant level for another 6-12 hours. Ambroxol is also an antioxidant that protects the cells of the respiratory tract from the aggressive effects of free radicals. Simultaneous use of antitussive drugs with Ambrobene is contraindicated, because in this case, the cough reflex will be suppressed, which will lead to stagnation of sputum in the respiratory tract.

Ambrobene solution for oral administration and inhalation 7.5 mg/ml, 100 ml

Registration Certificate Holder

Teva Pharmaceutical Industries (Israel)

Dosage form

Medicine - Ambrobene

Description

Solution for oral administration and inhalation

transparent, colorless to light yellow with a brown tint, odorless.

1 ml

ambroxol hydrochloride 7.5 mg

Excipients

: potassium sorbate - 1 mg, hydrochloric acid - 0.6 mg, purified water - 991.9 mg.

40 ml - dark glass bottles with a dropper stopper (1) complete with a measuring cup - cardboard boxes. 100 ml - dark glass bottles with a dropper stopper (1) complete with a measuring cup - cardboard boxes.

Indications

Injection

used for diseases of the respiratory tract with the release of viscous sputum and with difficulty in sputum discharge in cases where it is necessary to obtain a quick therapeutic effect or it is impossible to take the drug orally:

acute and chronic bronchitis;
pneumonia;
bronchial asthma;
bronchiectasis;
stimulation of surfactant synthesis during respiratory distress syndrome in premature infants and newborns (as part of complex therapy).

The solution for oral administration and inhalation
is used for diseases of the respiratory tract with the production of viscous sputum and difficulty in sputum discharge:

acute and chronic bronchitis;
pneumonia;
bronchial asthma;
bronchiectasis.

Contraindications for use

peptic ulcer of the stomach and duodenum;
epileptic syndrome;
hypersensitivity to ambroxol and/or other components of the drug.

with caution
in case of impaired renal function and/or severe liver disease, reducing the dose and increasing the time between doses of the drug (treatment in such cases should be carried out under the supervision of a physician).

With extreme caution

and only under the supervision of a physician should Ambrobene be used in cases of impaired bronchial motility and large volumes of secreted secretions in order to avoid the danger of stagnation of secretions in the bronchi.

pharmachologic effect

Mucolytic and expectorant drug.

Ambroxol, an active metabolite of bromhexine, improves the rheological properties of sputum, reduces its viscosity and adhesive properties, facilitating its removal from the respiratory tract.

Ambroxol stimulates the activity of the serous cells of the bronchial lining glands, the production of enzymes that break down the bonds between sputum polysaccharides, the formation of surfactant and the direct activity of the bronchial cilia, preventing their adhesion.

After oral administration, the therapeutic effect occurs within 30 minutes and lasts for 6-12 hours (depending on the dose taken).

When administered parenterally, the effect of the drug occurs quickly and lasts for 6-10 hours.

Drug interactions

The simultaneous use of Ambrobene with drugs that have antitussive activity (for example, containing codeine) is not recommended due to the difficulty of removing sputum from the bronchi while reducing cough.

The simultaneous use of Ambrobene with antibiotics (including amoxicillin, cefuroxime, erythromycin, doxycycline) improves the flow of antibiotics into the pulmonary tract. This interaction with doxycycline is widely used for therapeutic purposes.

Ambrobene mixture cannot be used for injection with solutions having a pH higher than 6.3.

Dosage regimen

Solution for oral administration and inhalation

taken orally after meals with a sufficient amount of liquid (water, juice, tea) using a measuring cup.

1 ml of solution contains 7.5 mg of ambroxol.

Children under 2 years of age

prescribe the drug 1 ml of solution 2 times a day (15 mg/day).

Children aged 2 to 6 years

the drug is prescribed 1 ml of solution 3 times/day (22.5 mg/day).

Children aged 6 to 12 years

prescribe the drug 2 ml of solution 2-3 times/day (30-45 mg/day).

Adults and teenagers

in the first 2-3 days, 4 ml of solution is prescribed 3 times a day (90 mg/day). In the following days - 4 ml 2 times / day (60 mg / day).

When using Ambrobene in the form of inhalations

use any modern equipment (except steam inhalation). Before inhalation, the drug should be mixed with a 0.9% sodium chloride solution (for optimal air humidification it can be diluted in a ratio of 1:1) and heated to body temperature. Inhalations should be carried out in normal breathing mode so as not to provoke coughing shocks.

Patients with bronchial asthma should use bronchodilators before inhaling ambroxol to avoid nonspecific irritation of the respiratory tract and their spasm.

Children under 2 years of age

inhale 1 ml of solution 1-2 times/day (7.5-15 mg/day).

Children aged 2 to 6 years

inhale 2 ml of solution 1-2 times/day (15-30 mg/day).

Adults and children over 6 years of age

inhale 2-3 ml of solution 1-2 times/day (15-45 mg/day).

Injection

should be administered intravenously (slow stream or drip). The solvent used is 0.9% sodium chloride solution, 5% dextrose solution, Ringer-Locke solution or other basic solution with a pH not higher than 6.3.

For children

The drug is usually prescribed in a daily dose of 1.2-1.6 mg/kg body weight.

Children under 2 years of age

prescribed 1 ml (1/2 amp.) 2 times/day (15 mg/day).

Children aged 2 to 6 years

prescribed 1 ml (1/2 amp.) 3 times/day (22.5 mg/day).

Children over 6 years of age

Prescribe 2 ml (1 amp.) 2-3 times/day (30-45 mg/day).

For adults

prescribed 1 amp. 2-3 times/day (30-45 mg/day). In severe cases, the dose can be increased to 2 amp. 2-3 times/day (60-90 mg/day).

For respiratory distress syndrome in newborns and premature infants

The daily dose of the drug is 30 mg and, as a rule, is divided into 4 separate injections.

Injections are stopped after the disappearance of acute manifestations of the disease and switched to oral administration of other dosage forms of Ambrobene.

Treatment of children under 2 years of age

should only be carried out under the supervision of a physician.
Drinking plenty of fluids is recommended while using the drug.
The duration of treatment depends on the characteristics of the disease. It is not recommended to use the drug without medical prescription for more than 4-5 days.

Overdose

Ambroxol is well tolerated when taken orally at a dose of up to 25 mg/kg/day.
Symptoms:
increased salivation, nausea, vomiting, decreased blood pressure.

Treatment:

gastric lavage in the first 1-2 hours after taking the drug, taking fat-containing foods. Hemodynamic parameters should be monitored. If necessary, symptomatic therapy should be carried out.

Side effect

From the digestive system:

rarely - salivation, gastralgia, nausea, vomiting, diarrhea, constipation.

From the respiratory system:

rarely - dry mouth and respiratory tract, rhinorrhea.

Allergic reactions:

very rarely - skin rash, angioedema of the face, respiratory failure, temperature reaction with chills;
in some cases - contact dermatitis; One case of anaphylactic shock was recorded. Other:
weakness, headache, dysuria, exanthema.

With rapid intravenous administration:

intense headaches, feeling of fatigue and heaviness in the legs, numbness, increased blood pressure, shortness of breath, hyperthermia, chills.

Storage conditions

The solution for oral administration and inhalation should be stored at a temperature not exceeding 25°C.

Best before date

Shelf life: 5 years.

The solution for injection should be stored under normal conditions. Shelf life: 4 years.

Use during pregnancy and breastfeeding

Restrictions during pregnancy - With caution. Restrictions when breastfeeding - With caution. Since to date there is no reliable data on the negative effects of ambroxol on the fetus and newborn, the use of Ambrobene during pregnancy, especially in the first trimester, and during breastfeeding is only possible if there is an expected benefit for the mother outweighs the potential risk to the fetus.

Use for renal impairment

Restrictions for impaired renal function - With caution.

Carefully _

the drug should be used in case of impaired renal function, reducing the dose and increasing the time between doses of the drug (treatment in such cases should be carried out under the supervision of a doctor).

Use for liver dysfunction

Restrictions for liver dysfunction - With caution.

Carefully _

The drug should be used for severe liver diseases, reducing the dose and increasing the time between doses of the drug (treatment in such cases should be carried out under the supervision of a doctor).

Use in children

Restrictions for children - With caution.

The drug in the form of tablets and injection solution is contraindicated for use in children under 6 years of age. The drug in the form of retard capsules is contraindicated for use in children under 12 years of age.

Treatment
of children under 2 years of age
should be carried out only under the supervision of a physician.

Terms of sale

The drug in the form of a solution for oral administration and inhalation is approved for use as an over-the-counter product.

The drug in the form of an injection solution is available with a prescription.

Contacts for inquiries

TEVA (Israel)

Teva LLC

115054 Moscow Valovaya st. 35 Business Tel.