Выберите категорию:

Bronchirem ®- tablets

INSTRUCTIONS FOR MEDICAL USE

BRONCHIREM®

Trade name of the drug: Bronchirem®.

Active substance (INN): Ambroxol hydrochloride.

Dosage form: Tablets of 30 mg

Contents:

1 tablet contains:

active substance: ambroxol hydrochloride – 30 mg.

Excipients: lactose, corn starch, microcrystalline cellulose, polyvinylpyrrolidone, magnesium stearate, aerosil.

Description: White or almost white, flat-cylindrical, beveled tablets.

Pharmacotherapeutic group: Expectorants.

ATX code: R05CB06

Pharmacological properties

Mucolytic drug with strong expectorant action. The drug thins sputum and reduces its viscosity as a result of depolymerization of mucopolysaccharides in sputum and at the expense of stimulation of serous cells of glands of bronchial mucosa. Ambroxol increases motility activity of the atomizing epithelium, improves mucociliary transport and normalizes the ratio of serous and mucous components of sputum. In addition, the drug, by activating hydrolyzing enzymes and increasing production of lysosomes by Clark cells, reduces the viscosity of sputum, thereby facilitating expectoration of sputum from the airways. Ambroxol increases synthesis and secretion of surfactant in alveoli. 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 the tissues rapidly, and the highest concentration is found in the lungs. Passes through the blood-brain barrier (BBB) and placental barrier, excreted with breast milk.

Metabolized in the liver by conjugation to form pharmacologically inactive metabolites.

The plasma elimination half-life (T½ ) 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 (acute and chronic bronchitis, pneumonia, obstructive bronchitis, bronchial asthma with impaired secretion, bronchiectatic disease, and to improve mucus dilution in inflammation of the throat).

Prevention and treatment of complications after lung surgery, before and after bronchoscopy, with cystic fibrosis of the lungs.

Dosage and administration

Tablets are taken orally after a meal, swallowed whole with plenty of fluid. In adults and children over 12 years of age, 30 mg 2-3 times daily for the first 2-3 days and then 30 mg 2 times daily or 15 mg 3 times daily. Children from 5 to 12 years of age are usually prescribed 15 mg 2-3 times a day.

The duration of use depends on the indication and the course of the disease and is determined by the attending physician individually.

Without the physician’s recommendation, we should not take the drug more than 4-5 days.

Side effects

The drug is usually well tolerated.

Central nervous system: 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,
  • Period of 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 case of impaired bronchial motility and increased secretion (e.g. in malignant ciliated syndrome), the syrup may only be taken after consulting the physician and under medical supervision, due to the danger of mucus accumulation in the bronchi.

In case of severe renal or hepatic impairment it is necessary to increase the interval between doses of the drug.

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

In patients with bronchial asthma, ambroxol may increase coughing. Ambroxol should not be taken immediately before going to bed.

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 stopped.

If the next dose is missed, the dose of the drug should not be exceeded when taking the next dose.

Keep the drug out of reach of children and do not use it after expiration date.

Overdose

Symptoms: so far no cases of poisoning have been observed in case of overdose. However, sometimes it is possible: short-term restlessness and diarrhea, at severe overdose decrease of blood pressure, vomiting, increased 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

Tablets 30 mg in a tightly closed cellular pack.

Storage conditions

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

Shelf life

3 years. Do not use after the expiration date.

Conditions for dispensing from pharmacies

Released without a prescription.

    ×