Allergodil nasal spray 0.14mg / dose, 10ml

Treatment of seasonal and perennial allergic rhinitis (including hay fever) and rhinoconjunctivitis.

- Treatment of symptoms of vasomotor (perennial non-allergic) rhinitis, such as nasal congestion, rhinorrhea, sneezing, postnasal syndrome.

Intranasally.

Allergic rhinitis and rhinoconjunctivitis

In the absence of other recommendations for adults and children 6 years of age 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 old - two doses (280 ?g / 0.28 ml) in each nasal passage twice a day, morning and evening.

Allergodil is used until symptoms stop and is suitable for long-term use, but not more than 6 months of continuous treatment.

Vasomotor rhinitis

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

Allergodil is used until symptoms stop and is suitable for long-term use, but not more than 8 weeks of continuous treatment.

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

1 bottle (10 ml) contains:

active substance : azelastine hydrochloride 0.01 g;

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

• Hypersensitivity to azelastine and / or other components of the drug;

• For allergic rhinitis and rhinoconjunctivitis - children under 6 years of age;

• With vasomotor rhinitis - children under 12 years of age

  Application during pregnancy and lactation

  When testing doses that exceed the therapeutic range many times in animals, no evidence of teratogenic effect has been obtained, but since there is no experience with the use of azelastine in pregnant women and lactating, the use of azelastine nasal spray during pregnancy and lactation is not recommended.

Trade name: ALLERGODILЃ

International non-proprietary name:

azelastine

Dosage form:

metered dose nasal spray

Composition:

1 bottle (10 ml) contains:

active substance : azelastine hydrochloride 0.01 g;

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

Description: transparent colorless or almost colorless solution

Pharmacotherapeutic group:

antiallergic agent - H1 histamine receptor blocker.

pharmachologic effect

Azelastine is a long-acting antiallergic agent, a phthalazinone derivative. Azelastine is a selective H1-histamine blocker, has an antihistamine, antiallergic and membrane stabilizing effect, reduces capillary permeability and exudation, stabilizes the membrane of mast cells and prevents the release of biologically active substances from them (histamine, serotonin, leukotrienes, a factor and other activators). bronchospasm and contributing to the development of early and late stages of allergic reactions and inflammation. When applied topically, the systemic effect is insignificant.

When administered intranasally, it reduces itching and nasal congestion, sneezing and rhinorrhea. Relief of symptoms of allergic rhinitis is noted starting from 15 minutes after application and lasts up to 12 hours or more.

There is no clinically significant effect on the QT (QTc) interval even with long-term use of high doses of azelastine.

Pharmacokinetics.

Bioavailability after intranasal administration is about 40%. The maximum concentration (Cmax) in the blood after intranasal administration is achieved in 2-3 hours. When used intranasally at the recommended daily dose of 1.1 mg, the equilibrium blood concentration is less than 1% of the dose (1 ng / ml).

The concentration of the drug in the blood serum after intranasal administration 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 have been studied for oral administration.

The connection with blood proteins is 80-90%.

It is metabolized in the liver by oxidation with the participation of the cytochrome P450 system with the formation of an active metabolite of 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 for use

- Treatment of seasonal and perennial allergic rhinitis (including hay fever) and rhinoconjunctivitis.

- Treatment of symptoms of vasomotor (perennial non-allergic) rhinitis, such as nasal congestion, rhinorrhea, sneezing, postnasal syndrome.

Contraindications

• Hypersensitivity to azelastine and / or other components of the drug;

• For allergic rhinitis and rhinoconjunctivitis - children under 6 years of age;

• With vasomotor rhinitis - children under 12 years of age

Application during pregnancy and lactation

When testing doses that exceed the therapeutic range many times in animals, no evidence of teratogenic effect has been obtained, but since there is no experience with the use of azelastine in pregnant women and lactating, the use of azelastine nasal spray during pregnancy and lactation is not recommended.

Method of administration and dosage

Intranasally.

Allergic rhinitis and rhinoconjunctivitis

In the absence of other recommendations for adults and children 6 years of age 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 old - two doses (280 ?g / 0.28 ml) in each nasal passage twice a day, morning and evening.

Allergodil is used until symptoms stop and is suitable for long-term use, but not more than 6 months of continuous treatment.

Vasomotor rhinitis

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

Allergodil is used until symptoms stop and is suitable for long-term use, but not more than 8 weeks of continuous treatment.

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

Side effect

Rarely - mild, transient irritation of the inflamed nasal mucosa, manifested by burning, itching, sneezing, in rare cases, nosebleeds.

Incorrect administration with the head tilted back may result in a bitter taste in the mouth, which in rare cases can cause nausea.

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

Overdose

At the moment, cases of drug overdose with intranasal use are unknown.

Interaction with other medicinal products

With intranasal use of azelastine, no clinically significant interactions with other drugs have been identified.

special instructions

In some cases, when using a nasal spray, fatigue, of varying severity and weakness, is revealed, which can also be caused by the underlying disease. In these cases, it is not recommended to drive a car and work with dangerous machinery. Drinking alcohol can exacerbate these effects.

Release form

Dosed nasal spray 140 mcg / dose.

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

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

Storage conditions

At a temperature of 8 - 25 ? C, out of the reach of children.

Shelf life

3 years. Opened vials - 6 months.

Do not use after the expiration date.

Conditions of dispensing from pharmacies

Without recipe