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

Acute and chronic diseases of the respiratory tract with the production of viscous sputum:

• acute and chronic bronchitis;

• pneumonia;

• chronic obstructive pulmonary disease;

• bronchial asthma with difficulty in sputum discharge;

• bronchiectasis.

The mucolytic effect of the drug is manifested when a large amount of liquid is taken. Therefore, during treatment, it is recommended to drink plenty of fluids.

Internal use

Inside, the drug is used from a dropper tube / ampoule A or a bottle (1 ml = 20 drops from a bottle dropper) after a meal, adding to water, tea, milk or fruit juice.

Adults and children over 12 years old: the first 2-3 days, 4 ml (80 drops) 3 times / day (which corresponds to 90 mg of ambroxol per day), then 4 ml (80 drops) 2 times / day (which corresponds to 60 mg of ambroxol per day).

Children from 6 to 12 years old: 2 ml (40 drops) 2-3 times / day (which corresponds to 30 or 45 mg of ambroxol per day).

Children from 2 to 6 years old: 1 ml (20 drops) 3 times / day (which corresponds to 22.5 mg of ambroxol per day).

Children under 2 years of age: 1 ml (20 drops) 2 times / day (which corresponds to 15 mg of ambroxol per day). For children under 2 years of age, the drug is prescribed only under the supervision of a physician.

The maximum daily dose for oral administration: for adults - 90 mg, for children 6-12 years old - 45 mg, for children 2-6 years old - 22.5 mg, for children under 2 years old - 15 mg.

Inhalation use

The drug can be used using any modern inhalation equipment (except for steam inhalers).

Before inhalation, the amount of the drug corresponding to the required dosage is mixed with a solvent (0.9% sodium chloride solution) (for optimal air humidification - in a 1: 1 ratio).

Before inhalation, it is recommended to warm the inhalation solution to body temperature.

Since during inhalation therapy, a deep breath can provoke a cough, inhalations should be carried out in a normal breathing mode.

Patients with bronchial asthma are advised to carry out inhalation after taking bronchodilators in order to avoid nonspecific irritation of the respiratory tract and their spasm.

The procedure for working with the kit (tube-dropper / ampoule A + tube-dropper / ampoule B):

1. Prepare equipment for inhalation according to the manufacturer's instructions.

2. Separate the dropper tube / ampoule A.

3. Open the dropper tube / ampoule A, making sure that the solution is in the lower part of the dropper tube / ampoule, rotate and separate the valve with rotating movements.

4. Place the contents of the dropper tube / ampoule A into the reservoir of the inhalation equipment in the required dose.

5. Following the same steps with the dropper tube / ampoule B, add its contents before inhalation to the reservoir of the inhalation equipment (for optimal air humidification - in a 1: 1 ratio).

6. Follow the instructions for use of the inhalation equipment.

In the case of using the drug in a vial, a measuring cup is attached to accurately measure the dose of the drug.

Doses for inhalation

Adults and children over 6 years old: 1-2 inhalations / day, 2-3 ml (40-60 drops) of solution (which corresponds to 15-45 mg of ambroxol per day).

Children under 6 years of age: 1-2 inhalations / day, 2 ml (40 drops) of solution (which corresponds to 15-30 mg of ambroxol per day).

Taking the drug for more than 4-5 days is possible only on the recommendation of a doctor.

Solution for oral administration and inhalation (bottle or tube-dropper / ampoule A) in the form of a clear, colorless or slightly colored liquid; solvent (dropper tube / ampoule B) - transparent, colorless liquid; the prepared solution (preparation + solvent) is a clear, colorless or slightly colored liquid.

1 ml

ambroxol hydrochloride 7.5 mg

Excipients: sodium chloride - 6.22 mg, sodium hydrogen phosphate dihydrate - 4.35 mg, anhydrous citric acid - 1.83 mg, benzalkonium chloride - 0.225 mg, water d / i - up to 1 ml.

• Hypersensitivity to ambroxol or other components of the drug;

• I trimester of pregnancy;

• period of breastfeeding.

  Carefully

• Violation of the motor function of the bronchi and increased production of sputum (with immobile cilia syndrome), gastric ulcer and duodenal ulcer in the acute phase, II-III trimesters of pregnancy. Patients with impaired renal function or severe liver disease should take ambroxol with extreme caution, observing long intervals between doses of the drug or taking the drug at a lower dose.

pharmachologic effect

Studies have shown that ambroxol increases secretion in the respiratory tract. It enhances the production of pulmonary surfactant and stimulates ciliary activity. These effects lead to increased mucus flow and transport (mucociliary clearance). Enhancing mucociliary clearance improves sputum flow and relieves coughing.

In patients with chronic obstructive pulmonary disease, long-term therapy with ambroxol (for at least 2 months) led to a significant decrease in the number of exacerbations. There was a significant decrease in the duration of exacerbations and the number of days of antibiotic therapy.

Pharmacokinetics

Suction

All dosage forms of immediate release ambroxol are characterized by rapid and almost complete absorption from the gastrointestinal tract with a linear dose dependence in the therapeutic concentration range. Cmax in blood plasma after oral administration is achieved after 1-2.5 hours.

Distribution

Vd is 552 liters. In the therapeutic concentration range, plasma protein binding is approximately 90%.

The transition of ambroxol from blood to tissue with oral administration occurs quickly. The highest concentrations of the active ingredient of the drug are observed in the lungs.

Metabolism

Approximately 30% of the taken oral dose undergoes a 'first pass' effect through the liver. Studies on human liver microsomes have shown that the isoenzyme CYP3A4 is the predominant isoform responsible for the metabolism of ambroxol to dibromantranilic acid. The remainder of ambroxol is metabolized in the liver, mainly by glucuronidation and by partial degradation to dibromantranilic acid (approximately 10% of the administered dose), as well as a small amount of additional metabolites.

Withdrawal

The terminal T1 / 2 of ambroxol is 10 hours. The total clearance is within 660 ml / min, renal clearance accounts for approximately 8% of the total clearance. Using the method of radioactive labeling, it was calculated that after taking a single single dose of the drug over the next 5 days, about 83% of the dose taken is excreted in the urine.

Side effect

From the gastrointestinal tract: often - nausea, decreased sensitivity in the mouth and pharynx; infrequently - dyspepsia, pain in the upper abdomen, vomiting, diarrhea; rarely - heartburn, dryness of the oral mucosa and pharynx, constipation.

From the respiratory system: rarely - dryness of the mucous membrane of the respiratory tract, rhinorrhea.

From the nervous system: often - dysgeusia (violation of taste).

From the immune system: rarely - hypersensitivity reactions, skin rash, urticaria, itching, angioedema; very rarely - anaphylactic reactions, incl. anaphylactic shock.

On the part of the skin and subcutaneous tissues: very rarely - Stevens-Johnson syndrome, Lyell's syndrome.

Others: rarely - weakness, fever.

Application during pregnancy and lactation

The drug is contraindicated for use during the first trimester of pregnancy. If it is necessary to use Ambroxol in the II-III trimesters of pregnancy, the potential benefit to the mother and the possible risk to the fetus should be assessed.

During breastfeeding, the drug is contraindicated, since it is excreted in breast milk.

Application for violations of liver function

Patients with severe liver disease should take ambroxol with extreme caution, observing long intervals between doses of the drug or taking the drug at a lower dose.

Application for impaired renal function

Patients with impaired renal function should take ambroxol with extreme caution, observing long intervals between doses of the drug or taking the drug at a lower dose.

Application in children

It is used in children according to indications.

Use in elderly patients

Use with caution in elderly patients in order to avoid the risk of exacerbation of chronic diseases.

special instructions

Beraxol-SOLOfarm should not be taken simultaneously with antitussive drugs, which can inhibit the cough reflex.

Beraxol-SOLOfarm should be used with caution in patients with a weakened cough reflex or impaired mucociliary transport due to the possibility of sputum accumulation.

Patients taking ambroxol should not be advised to perform breathing exercises; in patients with severe disease, aspiration of liquefied sputum should be performed.

In patients with bronchial asthma, ambroxol may aggravate the cough.

You should not take Ambroxol just before bed.

Patients with severe skin lesions - Stevens-Johnson syndrome or Lyell's syndrome - may develop fever, body pain, rhinitis, cough, and sore throat in the early phase. With symptomatic treatment, it is possible that mucolytic agents such as ambroxol are mistakenly prescribed. There are isolated reports of the identification of Stevens-Johnson syndrome and Lyell's syndrome, which coincided with the appointment of the drug, but there is no causal relationship with the intake of the drug.

With the development of the above syndromes, it is recommended to stop treatment and immediately seek medical attention.

In case of impaired renal function, Ambroxol should be used only on the advice of a doctor.

Ambroxol solution is not recommended to be mixed with cromoglycic acid and alkaline solutions.

Patients following a hyponatric diet should keep in mind that 1 ml of ambroxol solution contains 10 mg of sodium. The maximum daily dose for adults and children over 12 years old contains 120 mg of sodium.

Influence on the ability to drive vehicles and mechanisms

Cases of the effect of the drug on the ability to drive vehicles and mechanisms have not been identified so far.

Overdose

Symptoms: heartburn, indigestion, diarrhea, nausea, vomiting, pain in the upper abdomen. There are reports of short-term anxiety. With a pronounced overdose, a significant decrease in blood pressure is possible.

Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug; taking fat-containing foods, symptomatic therapy.

Drug interactions

When used with antitussive drugs, it may be difficult to discharge sputum as a result of suppression of the cough reflex.

When used simultaneously with amoxicillin, doxycycline, cefuroxime, erythromycin, ambroxol increases their concentration in bronchial secretions.

No clinically significant adverse drug interactions have been reported.