Beraxol-Solopharm oral and inhalation solution 7.5mg/ml, 100ml

Composition

Composition of the drug per 1 ml: Active ingredient: Ambroxol Hydrochloride 7.5 mgm Auxiliary substances: Sodium Chloride 6.22 mg Sodium hydrophosphate dihydrate 4.35 mg Citric acid anhydrous 1.83 mg Benzalkonium chloride 0.225 mg Water for injection up to 1.0 ml

Pharmacological action

Beraxol-Solopharm is an expectorant, mucolytic agent. 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). Increased mucociliary clearance improves sputum discharge and eases coughing. In patients with chronic obstructive pulmonary disease, long-term ambroxol therapy (for at least 2 months) resulted in 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.

Recommendations for use

The mucolytic effect of the drug is manifested when taking a large amount of liquid. Therefore, during treatment, it is recommended to drink plenty of water. Application Inside apply the drug from the dropper tube And after eating, adding it to water, tea, milk or fruit juice. Adults and children over 12 years of age: for the first 2-3 days,4 ml 3 times a day (which corresponds to 90 mg of ambroxol per day), then 4 ml 2 times a day (which corresponds to 60 mg of ambroxol per day). Children from 6 to 12 years: 2 ml 2-3 times a day (which corresponds to 30 or 45 mg of ambroxol per day). Children from 2 to 6 years: 1 ml 3 times a day (which corresponds to 22.5 mg of ambroxol per day). Children under 2 years of age: 1 ml 2 times a 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 doctor. The maximum daily dose when taken orally: for adults-90 mg, for children 6-12 years-45 mg, for children 2-6 years-22.5 mg, for children under 2 years-15 mg. Application in the form of inhalationthe product can be used using any modern equipment for inhalation (except steam inhalers). Before inhalation, the drug from the dropper tube A is mixed with 0.9% sodium chloride solution from the dropper tube B (solvent) (for optimal air humidification – in the ratio of 1: 1). Before inhalation, it is recommended to warm up the inhaled solution to body temperature. Since deep inhalation therapy can trigger coughing, inhalation should be carried out in the mode of normal breathing. Patients with bronchial asthma are recommended to be inhaled after taking bronchodilators, in order to avoid non-specific irritation of the respiratory tract and their spasm. Dosage for inhalation Adults and children over 6 years of age: 1-2 inhalations per day of 2-3 ml of solution (which corresponds to 15-45 mg of ambroxol per day). Children under 6 years of age: 1-2 inhalations per day of 2 ml of the 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.

Contraindications

Hypersensitivity to ambroxol or other components of the drug, pregnancy (I trimester), breast-feeding. With caution: Violation of the motor function of the bronchi and increased sputum formation (with fixed cilia syndrome), peptic ulcer of the stomach and duodenum 12 during exacerbation, pregnancy (II-III trimester). 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.

Side effects

Gastrointestinal disorders: often – nausea, decreased sensitivity in the oral cavity and pharynx; infrequently-dyspepsia, upper abdominal pain, vomiting, diarrhea; rarely-heartburn, dryness of the oral and pharyngeal mucosa, constipation. Respiratory, thoracic and mediastinal disorders: rarely-dryness of the respiratory tract mucosa, rhinorrhea. Disorders of the nervous system: often-dysgeusia (violation of taste sensations). Immune system disorders: rarely-hypersensitivity reactions, skin rash, urticaria, pruritus, angioedema; very rarely-anaphylactic reactions, including anaphylactic shock. Skin and subcutaneous tissue disorders: very rare – Stevens-Johnson syndrome, Lyell’s syndrome. Other: rarely-adynamia, fever.

Interaction

When used with antitussive medications, sputum discharge may be difficult as a result of suppression of the cough reflex. When used concomitantly with amoxicillin, doxycycline, cefuroxime, erythromycin, ambroxol increases their concentration in the bronchial secretions. No clinically significant adverse drug interactions have been reported.

Overdose

Symptoms:  heartburn, dyspepsia, diarrhea, nausea, vomiting, upper abdominal pain. There are reports of short-term anxiety. With a severe 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 products, symptomatic therapy.

Special instructions

Beraxol-Solopharm should not be taken simultaneously with antitussive medications that may inhibit the cough reflex. Beraxol-Solopharm 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 recommended to perform breathing exercises; in patients with a severe course of the disease, aspiration of liquefied sputum should be performed. In patients with asthma, ambroxol may worsen coughing. Recommends taking ambroxol just before bedtime. Patients with severe skin lesions-Stevens-Johnson syndrome or Lyell’s syndrome-may experience fever, body aches, rhinitis, cough, and sore throat in the early phase. During symptomatic treatment, mucolytic agents such as ambroxol may be misapplied. There are isolated reports of detection of Stevens-Johnson syndrome and Lyell’s syndrome, which coincided with the appointment of the drug, but there is no causal relationship with taking the drug. If the above-mentioned syndromes develop, it is recommended to stop treatment and immediately seek medical help. If renal function is impaired, ambroxol should be used only on the recommendation of a doctor. Ambroxol solution is not recommended to be mixed with Cromoglicic acid and alkaline solutions. Patients who follow a hyponatremic 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 of age contains 120 mg of sodium.

Storage conditions

Store at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Shelf

life is 3 years.

Do not use after the expiration date!

Active ingredient

Ambroxol

Dosage form

oral solution