Allergodyl - instructions for use, dose, side effects, contraindications

Active substanceAzelastineAzelastine

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Allergodyl®

drops d / eye

Meda Pharma GmbH & Co. KG Germany

Allergodyl®

spray nazal.

Meda Pharma GmbH & Co. KG Germany

Allergodil® C

spray nazal.

Meda Pharma GmbH & Co. KG Germany

Dosage form: & nbspnasal dosing spray

Composition:

1 dose contains:

Active substance: azelastine hydrochloride 0.140 mg

Excipients: hypromellose 0.140 mg; disodium edetate dihydrate 0.700 mg; citric acid 0.061 mg; sodium hydrogen phosphate dodecahydrate 0.907 mg; sodium chloride 0.961 mg, water purified 138.419 mg.

Description:Transparent colorless or almost colorless solution.

Pharmacotherapeutic group:Antiallergic - H1 histamine receptor blocker

ATX: & nbsp

R.01.A. C.03 Azelastine

Pharmacodynamics:

Azelastine, a derivative of phthalazinone, is an antiallergic, long-acting agent. Being selective H₁-gistaminoblocker, has antihistamine, antiallergic and membrane-stabilizing effect, reduces capillary permeability and exudation, stabilizes the membranes of mast cells and prevents the release of biologically active substances (histamine, serotonin, leukotrienes, a factor activating platelets, etc.) that cause bronchospasm and contribute to the development of 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. Relaxation of symptoms of allergic rhinitis is noted from 15 minutes after application and lasts up to 12 hours or more.

Clinically significant effects on QT (QTc) the interval is absent, even with prolonged use of high doses of azelastine.

Pharmacokinetics:

Bioavailability after intranasal application of about 40 %.

Maximum concentration (C_max) in the blood after intranasal application is achieved after 2-3 hours. When intranasally in a daily dose of 0.56 mg azelastine hydrochloride (one injection in each nasal passage twice a day), the average equilibrium concentration of azelastine hydrochloride in plasma through 2 hours after administration are 0.65 ng / ml.

Doubling the total daily dose to 1.12 mg (two injections per nasal twice daily) leads to a steady average plasma azelastin concentration of 1.09 ng / ml.

However, despite the relatively high absorption in patients, the systemic exposure after intranasal application in approximately 8 times lower than after oral intake of a daily dose of 4.4 mg azelastine hydrochloride, which is a therapeutic oral dose for the treatment of allergic rhinitis.

Intranasal use in patients with allergic rhinitis causes an increase in the level of azelastine in blood plasma compared with healthy subjects.

Other pharmacokinetic data were studied when administered orally.

Relationship with 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.

The half-life (T1 / 2) of azelastine is about 20 hours, its active metabolite desmethylazelastine is about 45 hours.

Indications:

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.

Contraindications:

Hypersensitivity to azelastine and / or other components of the drug;
At an allergic rhinitis, and a rhinoconjunctivitis - children's age up to 6 years; with vasomotor rhinitis - children under 12 years.

Pregnancy and lactation:When testing doses many times exceeding the therapeutic range,in animals have not received any evidence of teratogenicity, but because there is no experience of using azelastine in pregnant and breast-feeding is not recommended to use azelastine nasal spray during pregnancy and lactation.

Dosing and Administration:

Intranasally.

Allergic rhinitis and rhinoconjunctivitis

If there are no other recommendations for adults and children 6 years and older - one dose (140 mcg / 0.14 ml) in each nasal passage twice a day in the morning and in the evening.

If necessary, adults and children over 12 years of age - two doses (280 mcg / 0.28 ml) in each nasal passage twice a day in the morning and in the evening.

Allergodyl is used until the symptoms stop and are suitable for prolonged use, but not more than 6 months of continuous treatment.

Vasomotor rhinitis

Adults and children over 12 years of age - two doses (280 mcg / 0.28 ml) in each nasal passage twice a day in the morning and in the evening.

Allergodyl is used until the symptoms stop and are suitable for prolonged use, but not more than 8 weeks of continuous treatment.

The volume of one injection (one dose) is 0.14 ml and contains 140 μg of active substance.

The order of application

1. Remove the protective cap.

2. Before using for the first time, press the sprayer 2-3 times.

3. Depending on the prescribed dose, inject once or twice in each nasal passage, keeping your head straight.

4. Attach the protective cap again.

Side effects:

The incidence of side effects is defined as follows:

Very often:> 1/10;

Often: <1/10> 1/100;
Infrequently: <1/100> 1/1000;
Rarely: <1/1000> 1/10000;
Very rarely: <1/10000.

Often - as a result of the wrong method of administration, when the head is thrown back, there may be a bitter taste in the mouth, which in rare cases can cause nausea.

Infrequent - a mild, transient irritation of the inflamed mucous membrane of the nose, manifested by burning, itching, sneezing, in rare cases, nosebleeds.

Very rarely - allergic reactions (rash, itching, urticaria), weakness, dizziness (can be caused by the disease itself).

Overdose:At present, there are no known cases of drug overdose with intranasal application.

Interaction:In the intranasal application of azelastine, there is no clinically relevant interaction with other drugs.

Special instructions:

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.

Effect on the ability to drive transp. cf. and fur:

In rare cases, fatigue, fatigue, dizziness, or weakness that may be a consequence of the disease itself can develop with the use of azelastine nasal spray. In these cases, you should avoid driving the machine and working with complex mechanisms.

Form release / dosage:

Spray nasal dosed with 140 mcg / dose.

Packaging:

For 10 ml of solution in a glass bottle of brown color with a screw-on dispenser-dispenser.

1 bottle together with the instruction for use is placed in a cardboard box.

Storage conditions:

At a temperature of 8-25 ° C.

Keep out of the reach of children.

Shelf life:

3 years. Opened vials - 6 months.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe