Composition, form of production and packaging
? Spray nasal dosed in the form of a clear, colorless or almost colorless solution.
1 dose of 1 fl.
azelastine hydrochloride 140 Ојg 10 mg
Excipients: hypromellose, disodium edetate dihydrate, citric acid anhydrous, sodium hydrophosphate dodecahydrate, sodium chloride, purified water.
10 ml - bottles of dark glass (1) with a dispenser-sprayer - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
The blocker of histamine H 1 -receptors, a derivative of phthalazinone. It has a long anti-allergic and membrane-stabilizing effect, reduces capillary permeability and exudation, stabilizes the membrane of mast cells and prevents the release of biologically active substances (including histamine, serotonin, leukotrienes, platelet activating factor), causing bronchospasm and promoting early and late stage of allergic reactions and inflammation.
With local application, the systemic effect is negligible.
With intranasal administration reduces itching and stuffiness of the nose, sneezing and rhinorrhea. Attenuation of symptoms of allergic rhinitis is noted from 15 minutes after application and lasts up to 12 hours or more.
With prolonged use in high doses, there was no clinically significant effect of azelastine on the QT interval.
Bioavailability after intranasal application is about 40%. C max in the blood after intranasal use is achieved after 2-3 hours. When administered intranasally in the recommended daily dose of 1.1 mg C ss in the blood is less than 1% of the dose (1 ng / ml). The concentration of the drug in the serum after intranasal use is 8 times lower than after oral administration. In patients with allergic rhinitis, the concentration in the blood is higher than in healthy people.
Other pharmacokinetic data were studied when administered orally .
Binding to blood proteins - 80-90%.
Metabolised in the liver by oxidation with the participation of the cytochrome P450 system with the formation of the active metabolite desmethylazelastine.
It is excreted mainly by the kidneys in the form of inactive metabolites. T 1/2 azelastine - about 20 h, its active metabolite desmethylazelastine - about 45 h.
- treatment of seasonal and year-round allergic rhinitis (including hay fever) and rhinoconjunctivitis;
- Treatment of symptoms of vasomotor (all-the-year non-allergic) rhinitis, such as nasal congestion, rhinorrhea, sneezing, postnatal syndrome.
For allergic rhinitis and rhinoconjunctivitis, adults and children 6 years of age and older are given 1 dose (140 Ојg / 0.14 ml) in each nasal passage 2 times a day in the morning and in the evening. If necessary, adults and children over 12 years of age - 2 doses (280
mkg / 0.28 ml) in each nasal passage 2 times / day in the morning and in the evening. Allergodyl В® is used until the symptoms stop and are suitable for prolonged use, but no more than 6 months of continuous treatment.
With vasomotor rhinitis, adults and children over 12 years of age are prescribed 2 doses (280 Ојg / 0.28 ml) in each nasal passage 2 times / day in the morning and evening. Allergodyl В® is used until the symptoms stop and are suitable for prolonged use, but not more than 8 weeks of continuous treatment.
Rules for the use of the drug Allergodyl В®
1. Remove the protective cap.
2. Before using for the first time, press the spray gun 2-3 times.
3. Depending on the prescribed dose, inject 1 or 2 times into each nostril while holding the head straight.
4. Re-attach the protective cap.
Local reactions: rarely - a weak, transient irritation of the inflamed mucous membrane of the nose, manifested by burning, itching, sneezing, very rarely nosebleeds.
Allergic reactions: very rarely - rash, itching, hives.
Systemic reactions: very rarely - weakness, dizziness (can be caused by the disease itself).
As a result of the wrong method of administration, when the head is thrown back, there may be bitter taste in the mouth, which in rare cases can cause nausea.
- Children under 6 years of age (with allergic rhinitis and rhinoconjunctivitis);
- Children's age under 12 years (with vasomotor rhinitis);
- Hypersensitivity to azelastine and / or other components of the drug.
PREGNANCY AND LACTATION
Allergodil В® is not recommended for use in pregnancy and lactation, as there is no experience with the use of azelastine during these periods.
In experimental studies, when used in doses that exceed the therapeutic range many times over, there is no evidence of teratogenic effects of azelastine.
APPLICATION FOR CHILDREN
Contraindicated: children under 6 years (with allergic rhinitis and rhinoconjunctivitis); children under 12 years (with vasomotor rhinitis).
Impact on the ability to drive vehicles and manage mechanisms
In some cases, the use of nasal spray reveals fatigue, varying degrees of severity and weakness, which can also be caused by the underlying disease. In these cases, it is not recommended to drive and work with dangerous machinery. The use of alcohol can exacerbate these phenomena.
To date, no cases of an overdose of the drug Allergolidil В® have been reported.
In the intranasal application of azelastine, no interaction with other drugs has been identified.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of the reach of children at a temperature of 8 В° to 25 В° C. Shelf life - 3 years. After opening the bottle, the spray should be used for no more than 6 months.