Mucosol solution for infusions 7.5 mg/ml. 2 ml. ampoules №10

Description

Mucosol composition
active substance: ambroxol hydrochloride;
1 ampoule contains ambroxol hydrochloride 15 mg;
excipients: citric acid, monohydrate (E 330); sodium hydrogen phosphate, dihydrate; sodium chloride; water for injections.

Dosage form
Solution for infusion.

Pharmacological properties
Ambroxol hydrochloride increases the secretion in the respiratory tract. It also enhances the release of pulmonary surfactant and stimulates the activity of the ciliary epithelium. These actions lead to improved mucus secretion and excretion (mucociliary clearance). Improvement in mucociliary clearance has been demonstrated in clinical pharmacological studies. Activating fluid secretion and increasing mucociliary clearance facilitate mucus excretion and relieve coughing.
In vitro studies have shown that under the influence of ambroxol hydrochloride, the number of cytokines, as well as the number of circulating and tissue-bound mononuclear cells and polymorphonuclear cells, decreases.
The antioxidant effects of Ambroxol have also been observed in many preclinical studies.
After the use of ambroxol hydrochloride, the concentration of antibiotics (amoxicillin, cefuroxime, erythromycin) in bronchopulmonary secretions and in sputum increases.

Indications
To enhance the production of pulmonary surfactant in premature infants and newborns with respiratory distress syndrome.

Contraindications
Known hypersensitivity to ambroxol or other components of the drug.

Children
Apply to premature babies and newborns according to indications.

Application during pregnancy or lactation
Apply to premature babies and newborns.

Method of administration and dosage
It has been proven that a total daily dose of 30 mg of ambroxol hydrochloride per 1 kg of body weight is effective.
The dose of Mucosol should be administered in 4 divided doses by slow intravenous infusion; it is recommended to administer each separate dose by intravenous infusion using a pump infusion device for at least 5 minutes.
The duration of treatment is 5 days.
The content of 1-6 ampoules should be diluted in 250-500 ml of saline or Ringer’s solution. A solution diluted with physiological saline or Ringer’s solution, stable from a physico-chemical point of view for 24 hours at a temperature of 15-25 ° C. From a microbiological point of view, if opening the ampoules and diluting there is a risk of microbiological contamination, the solution should be used immediately after cooking. If this does not happen, the user is responsible for the conditions and storage period. If none of these solvents are available, 5% glucose solution can be used as an alternative. When using a 5% glucose solution, the contents of the ampoules should be diluted immediately before use. If the solution was not used immediately after preparation, it must be disposed of.

Overdose
There are no reports of specific overdose symptoms yet. Symptoms that occur with accidental overdose or medical error are similar to known adverse reactions that occur when used at recommended doses and may require symptomatic treatment.

Side effects:

• On the part of the immune system / on the part of the skin and subcutaneous fatty tissue: erythema; anaphylactic reactions (including shock), angioedema, skin rash, urticaria, itching and other hypersensitivity reactions, severe skin lesions: Stevens-Johnson syndrome, Lyell’s syndrome.
• From the gastrointestinal tract: dry mouth, constipation, salivation, dry throat, nausea, vomiting, diarrhea, dyspepsia, abdominal pain.
• From the respiratory system, chest and mediastinal organs: rhinorrhea, shortness of breath (as a symptom of a hypersensitivity reaction).
• On the part of the kidneys and urinary system: urinary disorders.
• General nature and pathological phenomena at the injection site: increased body temperature and chills, reactions from the mucous membrane.

Shelf life
2 years.

Storage conditions
Keep Mucosol out of the reach of children.
Store in its original packaging at a temperature not exceeding 25 ° C.