Mucosol solution for infusion 7.5 mg/ml, 2ml x 10 ampoules — Made in Ukraine — Free Delivery

Pharmacological properties.

Pharmacodynamics.

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 decreases, as well as the number of circulating and tissue-bound mononuclear cells and polymorphonuclear cells.

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.

Pharmacokinetics.

Ambroxol hydrochloride binds to plasma proteins by about 90% in adults and 60–70% in newborns. The preparation crosses the placental barrier and reaches the fetal lungs. A high volume of distribution of 410 l indicates a greater accumulation in tissues than in blood plasma, the concentration in lung tissues exceeds the corresponding indicator in plasma by a factor of 17.

Metabolism and excretion.

Ambroxol hydrochloride is metabolized mainly in the liver by glucuronidation and, to a lesser extent, by splitting to dibromantranilic acid (the latter is about 10% of the dose), other minor metabolites are also formed. A study of human liver microsomes showed that the CYP3A4 enzyme is responsible for the metabolism of ambroxol hydrochloride to dibromanthranilic acid.

3 days after administration, 4.6% of the dose is excreted unchanged, while 35.6% of the dose is excreted in the conjugated form in the urine.

The half-life of ambroxol hydrochloride from plasma is approximately 10 hours. In newborns, after repeated intravenous administration, the half-life is approximately doubled, indicating a decrease in clearance.

In severe liver disease, the clearance of ambroxol is reduced by 20-40%. In severe renal impairment, the accumulation of ambroxol metabolites, namely dibromantranilic acid and glucuronides, is possible.

Ambroxol crosses the blood-brain and placental barriers and is excreted in breast milk.

Clinical characteristics.

Indications.

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

Structure:

Active ingredient: ambroxol hydrochloride (ambroxol hydrochloride);

1 ampoule contains ambroxol hydrochloride 15 mg;

excipients: citric acid, monohydrate (E 330); sodium hydrogen phosphate, dihydrate; sodium chloride; water for injections.

Contraindications

Known hypersensitivity to ambroxol or other components of the preparation.

Interaction with other medicinal products and other types of interactions.

To date, no clinically significant interactions with other preparations have been established.

The simultaneous use of the preparation Mucosol and cough suppressants can lead to excessive accumulation of mucus due to inhibition of the cough reflex; such a combination is possible only after a doctor's careful assessment of the ratio of the expected benefit and the possible risk due to the use.

Features of the application.

If intravenous administration is given too quickly, in very rare cases headache, fatigue, exhaustion and a feeling of heaviness in the legs may occur.

Since ambroxol can increase mucus secretion, Mukosol, a solution for infusion, should be used with caution in cases of impaired bronchial motility and increased mucus secretion (for example, in such a rare disease as primary ciliary dyskinesia).

Mucosol should be used with caution in patients with impaired renal function or severe liver disease. When using ambroxol, like any other active substance that is metabolized in the liver and then excreted by the kidneys, the accumulation of metabolites that are formed in the liver is observed in patients with severe renal failure.

Very rarely, severe skin reactions developed, such as Stevens-Johnson syndrome or Lyell's syndrome (toxic epidermal necrolysis), which sometimes occurred during the use of Ambroxol. Most of these cases are associated with an underlying medical condition or with the simultaneous use of another preparation. If any changes appear on the part of the skin or mucous membranes, the use of Ambroxol should be discontinued and immediately consult a doctor.

Mucosol, solution for infusion, contains less than 1 mmol (23 mg) sodium per ampoule.

Application during pregnancy or lactation.

Apply to premature babies and newborns.

The ability to influence the reaction rate when driving or driving other mechanisms.

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 the preparation is 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 contents 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 physicochemical point of view for 24 hours at a temperature of 15-25 ° C. From a microbiological point of view, if opening the ampoule and dilution is associated with 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.

Children.

Apply to premature babies and newborns according to indications.

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.

Adverse reactions.

From the immune system / from 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).

From the kidneys and urinary system: urination disorders.

General and pathological phenomena at the injection site: increased body temperature and chills, reactions from the mucous membrane.

Shelf life.

2 years.

Storage conditions.

Keep out of the reach of children.

Store in its original packaging at a temperature not exceeding 25 ° C.

Incompatibility.

Mucosol should not be mixed with any medicinal products other than those indicated in the section "method of administration and dosage".