Allergodyl (azelastine hydrochloride) nasal spray 10 ml.

active substances: azelastine hydrochloride;

1 ml of solution contains azelastine hydrochloride 1 mg;

excipients: hypromellose, disodium edetate, anhydrous citric acid, sodium hydrogen phosphate, dodecahydrate, sodium chloride, purified water.

Dosage nasal spray.

Main physical and chemical properties: transparent colorless solution.

Drugs used in diseases of the nasal cavity. Antiallergic drugs, with the exception of corticosteroids. ATX code R01A C03.

Azelastine hydrochloride is an antagonist of H1 receptors and as a result is an antiallergic substance with a relatively long half-life (t1/2 20 hours).

In addition, research data indicates suppression of bronchial spasm induced by leukotrienes and platelet-activating factor (PAF) inhibitors.

Because of these properties, azelastine hydrochloride is also able to suppress inflammation in the airways caused by hypersensitivity reactions.

Azelastine is rapidly and almost completely absorbed after oral administration and is mainly distributed in peripheral organs, primarily in the lungs, skin, muscles, liver and kidneys, and only to a small extent in the brain. Dose-dependent linear kinetics were demonstrated. Azelastine hydrochloride and its metabolites are eliminated approximately 75% with feces and approximately 25% through the kidneys. The most important metabolic pathways are ring hydroxylation, N-dimethylation and oxidative opening of the azepine ring.

In patients with allergic rhinitis, the steady-state average concentration of azelastine hydrochloride in blood plasma observed 2 hours after the use of a total daily dose of 0.56 mg of azelastine hydrochloride (1 injection in each nostril 2 times a day) was approximately 0.65 ng/ml , but it did not lead to clinically significant systemic side effects.

As a consequence of the dose-dependent linear effect, an increase in mean plasma levels can be expected with an increase in the daily dose.

Symptomatic treatment of seasonal allergic rhinitis (hay fever) and non-seasonal (year-round) allergic rhinitis.

Hypersensitivity to the active substance, ethylenediaminetetraacetic acid (EDTA) or any other component of the drug.

There are no clinical data on the use of azelastine hydrochloride in women during pregnancy or breastfeeding. Animal studies of high oral doses of azelastine resulted in embryonic lethality, developmental delay, and skeletal malformations.

Therefore, it is not recommended to use the drug during pregnancy or breastfeeding.

For nasal use.

If not prescribed otherwise, spray 1 dose in each nostril 2 times a day (morning and evening; corresponds to a daily dose of azelastine hydrochloride 0.56 mg/day).

When using the spray, the head of the bottle must be kept straight.

The duration of therapy depends on the type, severity, development of symptoms and is determined by the doctor individually.

The drug can be used for long-term therapy.