2010/09/17

Allergodil

Composition, structure and packing

Nasal spray dose

1 dose azelastina hydrochloride 140 mg.

Excipients: disodium salt of EDTA x 2H2O, hydroxypropylmethylcellulose, citric acid, sodium phosphate dibasic dvenadtsativodny, sodium chloride, purified water.

Clinico-pharmacological group: antiallergic drug for local use in ENT practice.

Pharmacological action

Blocker histamine H1-receptor, a derivative ftalazinona. Has a strong and prolonged anti-allergic effect. It inhibits the synthesis or release of mediators involved in the early and late stages of allergic reactions (including leukotrienes, serotonin, platelet activation factor / PAF /), inhibits the release of histamine from mast cells activated by allergen, preventing bronchospasm caused by leukotrienes and PAF, reduces the number of cells and molecular adhesion of eosinophils.

With prolonged use at high doses was not observed clinically significant effect on azelastina interval QT.

Pharmacokinetics

Absorption and distribution

After 2 h after intranasal application in a daily dose of 560 micrograms azelastina concentration in plasma is about 0.65 ng / ml, in a daily dose of 1.12 mg - 1.09 ng / ml. Thus, the concentration azelastina in blood plasma is proportional to the dose of the drug. Despite increasing doses of systemic bioavailability after intranasal application of about 8 times lower than with oral azelastina a daily dose of 4.4 mg (therapeutic dose for treatment of allergic rhinitis).

After repeated intranasal administration of the drug in a daily dose of 560 micrograms Css azelastina in the blood plasma of healthy volunteers at about 0.27 ng / ml.

Repeated use of the drug in patients with allergic rhinitis leads to increased concentrations azelastina in plasma compared with healthy volunteers, suggesting a more pronounced systemic absorption (most likely due to increased permeability of the inflamed mucosa of the nasal cavity).

Metabolism

The concentration of active metabolite N-dismetilatselastina located on the lower limit of quantification of content or does not reach it (0.12 ng / ml).

Statement
seasonal rhinitis, rhinoconjunctivitis.

Dosage regimen

Allergodil inject one dose (140 mkg/0.14 ml) in each nostril 2 times / day, which corresponds to a daily dose of 560 micrograms azelastina. Allergodil apply to the disappearance of symptoms. Perhaps the prolonged use, but not more than 6 months.

Rules of the drug Allergodil
Remove the protective cap.
Before first use, click on the spray 2-3 times.
Vprysnutr 1 time in each nostril, while holding his head straight.
Again, wear the protective cap.

Side effect

Local reactions: in some cases - irritation of inflamed mucous membranes of the nose, dryness, burning, itching, sneezing, and in rare cases - nosebleeds.

Contraindications
Children under 6 years
Hypersensitivity to the drug's components.

Pregnancy and lactation

Allergodil not recommended for use in the I trimester of pregnancy and during lactation. In experimental studies, when used in doses many times higher than the therapeutic range, data on the teratogenicity azelastina not received.

Cautions

Improper use of spray with tilting the head back can cause a bitter taste in the mouth.

Overdose

So far, cases of overdosing Allergodil not reported.

Drug Interactions

Drug Interactions drug Allergodil not revealed.

Terms and Conditions of storage

The drug in the form of nasal spray should not be stored at a temperature below 8 ° C. Shelf life - 3 years.

After opening a bottle of spray should be used for no more than 6 months.