Branzol (ambroxol)

Overdose

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Specific symptoms of overdose in humans are not described. There have been reports of accidental overdose and / or medical error, resulting in symptoms of known side effects of the drug Lazolvan®: nausea, dyspepsia, vomiting, diarrhea, abdominal pain.

Treatment: induction of vomiting, gastric lavage in the first 1-2 hours after taking the drug, symptomatic therapy.

Specific symptoms of overdose in humans are not described. There have been reports of accidental overdose and / or medical error resulting in symptoms of known side effects of Branzol (Ambroxol)®: nausea, dyspepsia, vomiting, diarrhea, abdominal pain.

Treatment: induction of vomiting, gastric lavage in the first 1-2 hours after taking the drug, symptomatic therapy.

Contraindications

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Hypersensitivity, gastric and duodenal ulcer, convulsive syndrome, pregnancy (first trimester), breastfeeding.

Hypersensitivity, peptic ulcer of the stomach and duodenum, convulsions of any etiology.

Incompatibilities

Increases the penetration of amoxicillin, cefuroxime, erythromycin and doxycycline into the bronchial secretions. Simultaneous use with antitussive agents leads to difficulty in the discharge of sputum. It is compatible with drugs that inhibit labor activity.

Undesirable effects

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From the gastrointestinal tract: with prolonged use in high doses — gastralgia, nausea, vomiting.

Allergic reactions: skin rash, urticaria, angioedema, in some cases — allergic contact dermatitis, anaphylactic shock.

Nausea, vomiting, epigastric pain (with prolonged use), allergic reactions: skin rash, urticaria, angioedema.

Therapeutic indications

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Acute and chronic respiratory diseases with the release of viscous sputum:

acute and chronic bronchitis,

pneumonia,

chronic obstructive pulmonary disease,

bronchial asthma with difficulty in expectorating sputum,

bronchiectatic disease.

Acute and chronic bronchitis, bronchial asthma (with difficult sputum discharge), bronchiectatic disease.

Acute and chronic respiratory diseases with the release of viscous sputum:

acute and chronic bronchitis,

pneumonia,

chronic obstructive pulmonary disease,

bronchial asthma with difficulty in expectorating sputum,

bronchiectatic disease.

Respiratory tract diseases accompanied by the release of viscous sputum: acute and chronic bronchitis, pneumonia, chronic obstructive pulmonary diseases (including bronchial asthma with difficulty in expelling sputum), bronchiectatic disease.

Bronchitis (acute, chronic, asthmatic), bronchial asthma, accompanied by difficulty in expectorating sputum, bronchiectatic disease, laryngitis, sinusitis, dry rhinitis, in the pre-and postoperative period and in intensive care (for the prevention and elimination of complications from the respiratory system).

Pharmacotherapeutic group

  • Secretolytics and stimulants of motor function of the respiratory tract

Pharmacodynamic properties

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Studies have shown that ambroxol is the active ingredient of the drug Lazolvan® - increases the 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). Increased mucociliary clearance improves sputum discharge and relieves cough. In patients with COPD, long-term therapy with Lazolvan® (for at least 2 months) led to a significant reduction in the number of exacerbations. There was a significant decrease in the duration of exacerbations and the number of days of antibiotic therapy.

Studies have shown that ambroxol is the active ingredient of Branzol (Ambroxol)® - increases the 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). Increased mucociliary clearance improves sputum discharge and relieves cough. In patients with COPD, long-term therapy with Branzol (Ambroxol)® (for at least 2 months) led to a significant reduction in the number of exacerbations. There was a significant decrease in the duration of exacerbations and the number of days of antibiotic therapy.

The effect occurs 30 minutes after administration and lasts 6-12 hours.

Increasing the content of mucosal secretions, changes the disturbed ratio of serous and mucosal components of sputum, increases the release of lysosomes (from Clark cells), leading to a decrease in the viscosity of sputum, increases the content of surfactant in the lungs, stimulating its formation and disrupting its decay. Normalizes bronchopulmonary secretion, improves rheological parameters of sputum. Increases mucociliary transport of sputum (secretomotor action).

Pharmacokinetic properties

All immediate-release ambroxol dosage forms are characterized by rapid and almost complete absorption with a linear dose dependence in the therapeutic concentration range. Cmax with oral administration, it is achieved in 1-2. 5 hours.

Vd — 552 l. In the therapeutic range of concentrations, binding to plasma proteins is approximately 90%.

The transition of ambroxol from the blood to the tissues with oral administration is rapid. The highest concentrations of the active component of the drug are observed in the lungs.

Approximately 30% of the oral dose is exposed to the effect of primary passage through the liver. Studies on human liver microsomes have shown that the CYP3A4 isoenzyme is the predominant isoform responsible for the metabolism of ambroxol to dibromantranilic acid. The remaining part of ambroxol is metabolized in the liver, mainly by glucuronidation and partial cleavage to dibromantranilic acid (approximately 10% of the administered dose), as well as a small amount of additional metabolites.

Terminal T1/2 ambroxol is 10 hours. The total clearance is in the range of 660 ml / min, the renal clearance accounts for approximately 8% of the total clearance. Using a radioactive label, it was estimated that after taking a single dose of the drug for the next 5 days, about 83% of the dose is excreted in the urine. There was no clinically significant effect of age and gender on the pharmacokinetics of ambroxol, so there is no reason to select a dosage based on these signs.

Dosage (Posology) and method of administration

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Inside, regardless of the meal. Oral administration (1 ml = 25 drops).

Adults and children over 12 years: 4 ml (=100 drops) 3 times a day: children from 6 to 12 years: 2 ml (=50 drops) 2-3 times a day, from 2 to 6 years: 1 ml (=25 drops) 3 times a day, up to 2 years: 1 ml (=25 drops) 2 times a day. Drops can be diluted in water, tea, juice or milk.

Inhaled.

Adults and children over 6 years of age: 1-2 inhalations of 2-3 ml of solution per day, children under 6 years of age: 1-2 inhalations of 2 ml of solution per day. Lazolvan®, solution for inhalation, can be used using any modern equipment for inhalation (except steam inhalers). To achieve maximum hydration during inhalation, the drug is mixed with 0.9% sodium chloride solution in a ratio of 1:1. Since inhaling deep breaths can cause coughing during inhalation therapy, inhalation should be performed in normal breathing mode. Before inhalation, it is usually recommended to warm up the inhalation solution to body temperature. Patients with bronchial asthma are recommended to inhale after taking bronchodilators, in order to avoid non-specific irritation of the respiratory tract and their spasm

If the symptoms of the disease persist for 4-5 days from the start of taking the drug, it is recommended to consult a doctor.

Inside, after eating. Adults and children over 12 years of age — in the first 2-3 days - 1 tablet (30 mg) 3 times / day, then-30 mg 2 times or 15 mg 3 times, or 1 capsule retard (75 mg) per day, in the morning. Children from 5 to 12 years — 15 mg (1/2 table) 2-3 times / day.

Solution: dose with the supplied measuring cup. Adults in the first 2-3 days — 4 ml 3 times, then-4 ml 2 times or 2 ml 3 times / day. Children under 2 years — 1 ml 2 times, from 2 to 5 years - 1 ml 3 times, from 5 to 12 years - 2 ml 2-3 times.

Conducting inhalations (using an inhaler). Adults and children over 5 years of age-1-2 inhalations of 2-3 ml per day, children under 5 years of age-1-2 inhalations of 2 ml per day.

Syrup: adults — 10 ml 3 times / day 2-3 days, then-10 ml 2 times or 5 ml 3 times / day, children under 2 years-2.5 ml 2 times a day, from 2 to 5 years-2.5 ml 3 times a day, from 5 to 12 years — 5 ml 2-3 times a day.

Inside, regardless of the meal. Oral administration (1 ml = 25 drops).

Adults and children over 12 years: 4 ml (=100 drops) 3 times a day: children from 6 to 12 years: 2 ml (=50 drops) 2-3 times a day, from 2 to 6 years: 1 ml (=25 drops) 3 times a day, up to 2 years: 1 ml (=25 drops) 2 times a day. Drops can be diluted in water, tea, juice or milk.

Inhaled.

Adults and children over 6 years of age: 1-2 inhalations of 2-3 ml of solution per day, children under 6 years of age: 1-2 inhalations of 2 ml of solution per day. Branzol (Ambroxol)®, solution for inhalation, can be used using any modern equipment for inhalation (except steam inhalers). To achieve maximum hydration during inhalation, the drug is mixed with 0.9% sodium chloride solution in a ratio of 1:1. Since inhaling deep breaths can cause coughing during inhalation therapy, inhalation should be performed in normal breathing mode. Before inhalation, it is usually recommended to warm up the inhalation solution to body temperature. Patients with bronchial asthma are recommended to inhale after taking bronchodilators, in order to avoid non-specific irritation of the respiratory tract and their spasm

If the symptoms of the disease persist for 4-5 days from the start of taking the drug, it is recommended to consult a doctor.

Inside, after eating, first dissolve the tablet in a glass of water.

Effervescent pills: adults — 30 mg 3 times a day, if necessary, the dose is increased to 60 mg 2 times a day.

Syrup: adults and children over 12 years of age in the first 2-3 days-10 ml (2 measuring spoons) 3 times a day, then-10 ml 2 times a day, children from 6 to 12 years - 5 ml (1 measuring spoon) 2-3 times a day, children from 2 to 6 years-2.5 ml 3 times a day, children from 1 to 2 years-2.5 ml 2 times a day.

Taking the drug for more than 4-5 days — only under the supervision of a doctor.

Inside. Pills (after meals) adults — 1 tab. 3 times a day, with long-term therapy-1 tab. 2 times a day.

Drops (during meals) dilute with tea, fruit juice, milk, water. Adults-at first 4 ml 3 times a day, with long-term therapy-2 ml 3 times a day, children under 2 years - 1 ml 2 times a day, 2-5 years — 1 ml 3 times a day, older than 5 years-2 ml 2-3 times a day.