Lasolvan solution for infusion 15mg/2 ml, 2ml x 10 ampoules — Made in Spain — Free Delivery

Pharmacological properties

Pharmacodynamics. It was confirmed that ambroxol hydrochloride - the active ingredient of the preparation lasolvan - increases the secretion of mucus in the respiratory tract. Ambroxol enhances the synthesis of pulmonary surfactant and stimulates ciliary activity. these effects lead to improved mucus separation and excretion (mucociliary clearance). in the course of clinical studies, the positive effect became evident after 2 days of treatment. improved mucociliary clearance has been observed in clinical pharmacology studies. activation of fluid secretion and increased mucociliary clearance facilitate mucus excretion and reduce coughing.

In vitro studies have shown that the preparation reduces the amount of cytokines, as well as the number of tissue-bound mononuclear cells and polymorphonuclear cells.

After the administration of ambroxol hydrochloride, the concentration of antibiotics (amoxicillin, cefuroxime, erythromycin) in bronchopulmonary secretions and saliva increases.

Pharmacokinetics. Ambroxol hydrochloride binds to plasma proteins by approximately 90% in adults and 60–70% in newborns. Ambroxol hydrochloride crosses the placental barrier and reaches the fetal lungs. A large volume of distribution of 410 L indicates an accumulation of the substance in the tissues; compared with the content in the blood plasma, the concentration in the lung tissue exceeds the corresponding indicator in the blood plasma with a coefficient of ≥17.

Ambroxol hydrochloride is metabolized mainly in the liver by glucuronidation and degradation to dibromantranilic acid (about 10% of the dose), with the exception of some minor metabolites. Studies of human liver microsomes have shown that the CYP 3A4 enzyme is responsible for the metabolism of ambroxol hydrochloride to dibromanthranilic acid.

After 3 days of IV administration, 4.6% of the dose was detected in the unbound form, while 35.6% of the dose was detected in the bound form in the urine.

T½ of ambroxol hydrochloride from blood plasma is about 10 hours.

In newborns, after repeated intravenous administration, T½ increases approximately 2 times, indicating a decrease in clearance.

Indications

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

Application

The daily dose is 30 mg / kg of body weight, divided into 4 injections per day.

The solution should be administered using an infusion pump by intravenous infusion, for at least 5 minutes.

The solution can also be prescribed as a drop infusion with 5% glucose solution, 5% levulose solution, 0.9% sodium chloride solution or Ringer's solution.

Contraindications

Hypersensitivity to ambroxol hydrochloride or other components of the preparation.

Side effects

Gastrointestinal disorders: nausea, diarrhea, vomiting, dyspepsia, abdominal pain;

from the immune system, skin and subcutaneous tissue: anaphylactic reactions (including anaphylactic shock), rash, urticaria, angioedema, itching and other hypersensitivity reactions.

Very rarely, severe skin lesions have been reported - Stevens-Johnson and Lyell syndromes, temporarily associated with the use of mucolytic agents such as ambroxol. Basically, their appearance could be explained by the severity of the underlying disease or taking concomitant medications.

If lesions of the skin or mucous membranes appear, therapy should be revised immediately and the use of Ambroxol hydrochloride should be discontinued.

Special instructions

Patients with impaired renal function should take the preparation with caution. the sodium concentration in one recommended dose is less than 1 mmol (23 mg).

Interactions

There are no reports of pharmacological and clinical interactions with other preparations.

Incompatibility. Should not be mixed with any medicinal products other than those specified in the APPLICATION section. Do not mix with other solutions, as this leads to the formation of mixtures with a pH level of more than 6.3, since Ambroxol hydrochloride may precipitate as a free base due to an increase in the pH level.

Overdose

There are no reports of specific symptoms of overdose in humans. symptoms that are noted in case of accidental overdose and / or medical error are similar to the known adverse reactions of the preparation when used in recommended doses and may require symptomatic treatment.

Storage conditions

In the original packaging to protect from light, at a temperature not exceeding 25 ° C.