Flixotid Nebuli (fluticasone propionate) suspension 2 mg/2 ml. №10

Description

Flixotid Nebuli 2 mg Composition
active substance: fluticasone propionate (micronized);

1 nebula (2 ml of suspension) contains fluticasone propionate (micronized) 0.5 mg or 2 mg;

Flixotid Nebuli 0.5 mg excipients: polysorbate 20, sorbitan laurate, sodium dihydrogen phosphate dihydrate, sodium phosphate anhydrous, sodium chloride, water for injection.

Flixotid Nebuli 2 mg Dosage form
Suspension for inhalation.

Basic physical and chemical properties: white, opaque suspension is easily dispersed, without visible impurities.

Pharmacotherapeutic group
Anti-asthma drugs for inhalation use. Glucocorticoids. ATX code R03B A05.

Pharmacodynamics
The glucocorticosteroid fluticasone propionate in the recommended doses for inhalation exhibits a potent anti-inflammatory effect on the lungs, which leads to a decrease in the symptoms and frequency of asthma attacks.

Pharmacokinetics
As a result of inhaled use, the systemic availability of nebulized fluticasone propionate in healthy volunteers is expected to be 8%, compared with 26% for that when using the drug in the form of a metered-dose inhaler. Systemic absorption is carried out mainly through the respiratory system, first quickly, then over a long time. The remainder of the inhalation dose may be swallowed in the mouth.

The absolute oral bioavailability is very low (<1%) due to the combination of incomplete absorption from the digestive tract with extensive first pass metabolism. 87-100% of the oral dose is excreted in the feces, 75% – in the form of the original component, as well as the inactive main metabolite.

Product safety data

Toxicological studies have shown the presence of effects typical of strong GCS, but at doses that are many times higher than those indicated for therapeutic use. In studies on the effect of the drug on reproductive function and the presence of teratogenic properties of the drug, no new data were found. Fluticasone propionate has no mutagenic activity in vitro and in vivo. In experiments on animals, it was shown that there is no carcinogenic potential in the preparation, as well as irritating and sensitizing properties.

Indications
Adults and adolescents over 16 years of age

Prophylactic use in severe asthma in patients requiring high doses of inhaled or oral corticosteroids. For patients who are being treated with high doses of oral corticosteroids, to reduce or eliminate the use of oral corticosteroids.

Children and adolescents from 4 to 16 years old

Treatment of exacerbations of asthma. Appropriate supportive therapy can be complemented by the use of a metered-dose aerosol or powder inhaler.

Inhaled fluticasone propionate has a potent glucocorticoid anti-inflammatory effect in the lungs. It reduces symptoms and exacerbation of asthma in patients who have previously been treated with bronchodilators alone or in combination with other prophylactic drugs. Short, symptomatic flare-ups may generally be relieved with fast-acting bronchodilators, but long-term flare-ups require additional corticosteroid use as early as possible to control inflammation.

Contraindications
History of hypersensitivity to any component of the drug.