Beraksol-SOLOpharm (Solution) Instructions for Use

Marketing Authorization Holder

Grotex, LLC (Russia)

ATC Code

R05CB06 (Ambroxol)

Active Substance

Ambroxol (Rec.INN registered by WHO)

Dosage Form

Beraksol-SOLOpharm

Oral and inhalation solution 7.5 mg/1 ml: dropper tubes/ampoules 2 ml 20 pcs.; 100 ml bottle 1 pc. with a measuring cup

Dosage Form, Packaging, and Composition

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

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 for injections – up to 1 ml.

Solvent composition (per 1 ml): sodium chloride – 9 mg, water for injections – up to 1 ml.

2 ml – polyethylene dropper tubes/ampoules A (10) – foil film bags (2) – cardboard packs.
100 ml – glass bottles with a dropper cap (1) complete with a measuring cup – cardboard packs.

Clinical-Pharmacological Group

Mucolytic and expectorant drug

Pharmacotherapeutic Group

Mucolytic expectorant

Pharmacological Action

Mucolytic agent with expectorant action. It stimulates the serous cells of the bronchial mucosal glands, increasing the content of mucous secretion and thus changing the disturbed ratio of the serous and mucous components of sputum.

This activates hydrolyzing enzymes and enhances the release of lysosomes from Clara cells, which leads to a decrease in sputum viscosity.

Ambroxol increases the content of surfactant in the lungs, which is associated with an increase in its synthesis and secretion in alveolar pneumocytes, as well as with a disruption of its breakdown. It increases mucociliary transport of sputum. It slightly suppresses cough.

Pharmacokinetics

After oral administration, Ambroxol is almost completely absorbed from the gastrointestinal tract. C_max in blood plasma is reached in approximately 0.5-3 hours. It does not accumulate. Plasma protein binding is about 90%.

After oral administration and parenteral administration, Ambroxol is rapidly distributed in the body tissues, with the highest concentration found in the lungs.

It penetrates the blood-brain barrier and the placental barrier, and is excreted in breast milk.

It is metabolized in the liver by conjugation to form pharmacologically inactive metabolites.

T_1/2 is 7-12 hours. It is excreted mainly by the kidneys as metabolites – 90%, unchanged – 5%.

T_1/2 increases in severe chronic renal failure.

Indications

Acute and chronic respiratory diseases accompanied by the release of viscous sputum (chronic bronchitis with broncho-obstructive syndrome, bronchial asthma, bronchiectasis). Respiratory distress syndrome in newborns and premature infants.

ICD codes

Dosage Regimen

Orally for adults and children over 12 years old – 30 mg 2-3 times/day.

Orally for children aged 5 to 12 years – 15 mg 2-3 times/day; aged 2 to 5 years – 7.5 mg 3 times/day; aged under 2 years – 7.5 mg 2 times/day.

As inhalations for adults and children over 5 years old – 15-22.5 mg 1-2 times/day.

Parenterally for adults (IM, IV) – 15 mg, in severe cases – 30 mg 2-3 times/day.

For children IM – 1.2-1.6 mg/kg 3 times/day; IV – 1.2-1.6 mg/kg/day.

For children under 2 years old IV – 15 mg/day, frequency of administration – 2 times/day.

For children from 2 to 5 years old IV – 22.5 mg/day, frequency of administration – 3 times/day.

For children over 5 years old IV – 30-45 mg/day, frequency of administration – 2-3 times/day.

For the treatment of respiratory distress syndrome in premature and newborn infants, Ambroxol is administered IV or IM at a dose of 10 mg/kg/day, frequency of administration – 3-4 times/day, if necessary the dose can be gradually increased to 30 mg/kg/day.

Adverse Reactions

From the digestive system rarely – nausea, vomiting, diarrhea, abdominal pain.

Allergic reactions skin rash, urticaria, angioedema.

Other rarely – weakness, headache.

Contraindications

First trimester of pregnancy, hypersensitivity to ambroxol.

With caution

Second and third trimester of pregnancy, renal and/or hepatic insufficiency, impaired bronchial motor function and increased mucus secretion (for example, in the rare syndrome of primary ciliary dyskinesia), gastric and duodenal ulcer (including history).

Use in Pregnancy and Lactation

Ambroxol is contraindicated in the first trimester of pregnancy. If necessary to use in the second and third trimesters, the potential benefit of therapy for the mother and the possible risk to the fetus should be assessed.

If it is necessary to use ambroxol during lactation, the issue of discontinuing breastfeeding should be decided.

Use in Hepatic Impairment

Use with caution in patients with impaired liver function.

Use in Renal Impairment

Use with caution in patients with impaired renal function.

Pediatric Use

Use is possible according to the dosage regimen and the pediatric dosage form.

Geriatric Use

Use is possible according to the dosage regimen.

Special Precautions

In patients suffering from bronchial asthma, to avoid non-specific irritation of the respiratory tract and their spasm, bronchodilators can be used before inhalation of ambroxol.

Drug Interactions

With simultaneous use with antitussive agents, sputum discharge is difficult against the background of reduced cough; with amoxicillin, doxycycline, cefuroxime, erythromycin – their penetration into the bronchial secretion is enhanced.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.