Bronchirem ®- oral solution

INSTRUCTIONS FOR MEDICAL USE

BRONCHIREM®

Trade name of the drug: Bronchirem®

Active substance (INN): Ambroxol hydrochloride.

Dosage form: Oral administration solution.

Contents:

5 ml of the solution contains:

Active ingredients: ambroxol hydrochloride – 15 mg.

Excipients: nipagin, nipazole, glycerin (85%), sorbitol solution 70%, hydroxyethyl cellulose, raspberry flavoring, purified water.

Description: colorless to slightly brown transparent liquid with raspberry scent.

Pharmacotherapeutic group: expectorants.

ATX code: R05CB06

Pharmacological properties

Mucolytic drug with strong expectorant action. The drug liquefies sputum by stimulating the serous cells of the glands of the bronchial mucosa. Decrease of sputum viscosity occurs as a result of depolymerization of mucopolysaccharides in sputum. Depolymerization of mucopolysaccharides is primarily associated with breaking disulfide bonds in their molecule. Ambroxol increases motility activity of the atomizing epithelium, improves mucociliary transport, and normalizes the ratio of serous and mucosal components of sputum. By activating hydrolyzing enzymes and increasing production of lysosomes by Clark cells, it reduces the viscosity of sputum. Facilitates expectoration of sputum from the respiratory tract. Ambroxol by increasing the synthesis and secretion in the alveoli of surfactant, stimulates prenatal lung development. Surfactant synthesis is reduced as a result of chronic diseases of the respiratory system. In addition, the properties of surfactant are altered due to the bonds that are formed between surface-active phospholipids and inflammatory proteins. Due to increased production of surfactant the drug has anti-inflammatory effect, has antioxidant properties and increases local immunity. The action of ambroxol appears within 30 minutes and lasts for 6-12 hours.

Pharmacokinetics

After oral administration ambroxol is almost completely absorbed from the gastrointestinal tract. Maximum concentration (Cmax) in blood plasma is reached after approximately 0.3-0.5 hours. Bioavailability is 70-80%. Cumulation of the drug is not detected. Binding to plasma proteins is about 90%. It penetrates into tissues rapidly and the highest concentration is found in lungs. Passes through the blood-brain barrier (BBB) and placental barrier, excreted with breast milk. It is metabolized in the liver by conjugation to form pharmacologically inactive metabolites. The plasma elimination half-life (T1/2) is 7-12 hours. About 90% of the drug is excreted by the kidneys.

Indications for use

Mucolytic therapy in acute and chronic respiratory tract diseases, accompanied with viscous sputum production (acute and chronic bronchitis, pneumonia, obstructive bronchitis, bronchial asthma with impaired secretion, bronchiectatic disease, and for improvement of mucus dilution in inflammations of the nasopharynx). Prevention and treatment of complications after lung surgery, before and after bronchoscopy, with cystic fibrosis of the lungs.

Dosage and administration

The drug should be taken orally after a meal. During treatment, it is necessary to drink a lot of fluid (juices, tea, water), because it enhances the mucolytic effect of the drug.

In the absence of other prescriptions, the following dosage is recommended:

For children under 2 years of age, 2.5 ml 2 times a day;

2 to 5 years of age, 2.5 ml 3 times a day;

5 to 12 years of age, 5 ml 2-3 times a day;

Over 12 years of age and adults – 10 ml 2 times a day for the first 2-3 days, then continue in the same manner or 5 ml 3 times a day.

Duration of therapy depends on the severity of the disease and is determined by the attending physician. Do not take the drug longer than 4-5 days without physician’s recommendation.

Side effects

The drug is usually well tolerated.

Central nervous system disorders: headache.

Digestive system disorders: dry mouth, heartburn, gastralgia, nausea, vomiting, constipation.

Respiratory system: rhinorrhea, dry mucous membranes of the respiratory tract.

Allergic reactions: skin rash, itching, urticaria, angioedema Quincke’s, in some cases – allergic contact dermatitis, very rare – severe acute anaphylactic reactions (anaphylactic shock, Stevens-Johnson syndrome and Lyell syndrome).

Other: weakness, difficulty in urination.

Contraindications

  • Hypersensitivity to ambroxol or other components of the drug;
  • Pregnancy (first trimester);
  • period of lactation;
  • Gastric and 12 duodenal ulcer;
  • concomitant use of the drug with anti-cough drugs.

Drug interactions

Simultaneous use of the drug and antibacterial agents (amoxicillin, cefuroxime, doxycycline, erythromycin) promotes penetration of antibiotics into the lung tissue. It is compatible with drugs that inhibit labor activity.

When combining the drug with cough suppressants, due to the suppression of the cough reflex, dangerous stasis of liquefied secretion is possible. Therefore, the use of cough suppressants should be performed only when prescribed by the attending physician. Use of non-cardio-selective β-adrenoblockers may worsen sputum secretion due to bronchospasm.

Special indications

In patients with impaired bronchial motility and increased bronchial secretion (e.g. malignant ciliated syndrome), the drug should only be taken after consulting the attending physician and under medical supervision, because of the danger of mucus accumulation in bronchi.

In severe renal or hepatic impairment it is necessary to increase the interval between doses of the drug. When prescribing the drug to patients with diabetes it must be taken into account that 1 level measuring spoon contains 1.75 g sorbitol, which corresponds to 0.15 units.

It is contraindicated during lactation and in the I trimester of pregnancy. In II and III trimester of pregnancy, treatment with ambroxol is possible only upon the recommendation of the attending physician.

The drug does not affect the ability to drive vehicles and service other mechanisms.

If the first signs of allergic reactions develop, the drug should be noted.

In case of skipping the next dose, do not exceed the dose of the drug at the subsequent administration.

Overdose

Symptoms: so far no cases of poisoning have been observed in case of overdose of the drug. However, sometimes there may be: short-term restlessness and diarrhea, at severe overdose decrease of blood pressure, vomiting, excessive salivation are possible.

Treatment: in such cases, especially in severe overdose it is necessary to consult a doctor and on his recommendation gastric lavage, intake of fat-containing products, control of hemodynamic parameters, symptomatic therapy if necessary.

Form of production

Oral solution in 40 ml, 50 ml, 80 ml, 90 ml, 100 ml and 125 ml bottles, with measuring spoon or cup.

Storage conditions

Store in a dry, dark place at a temperature not exceeding 25°C. Keep out of the reach of children!

Shelf life

2 years. Do not use after the expiration date.

Conditions of dispensing from pharmacies

Released without a prescription.

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