Allergodyl (nasal spray): instructions for use

Please note that before buying the drug Allergoodil (nasal spray), you must carefully read the instructions for use, the methods of application and dosage, as well as other useful information on the drug Alergodyl (nasal spray). On the site "Encyclopaedia of Diseases" you will find all the necessary information: instructions for use, dosage, contraindications, as well as reviews of patients who have already used this medication.

Composition

in 1 dose contains:

- active substance: azelastine hydrochloride 0.137 mg;

- auxiliary substances: hypromellose 0,137 mg; sucralose 0.206 mg; sorbitol 8.831 mg;

- disodium edetate dihydrate 0.069 mg; sodium citrate dihydrate 0.093 mg;

- benzalkonium chloride solution 50% 0.034 mg; purified water 129.548 mg.

Description: Clear, colorless or almost colorless solution.

Pharmacotherapeutic group: antiallergic agent - H1-histamine receptor blocker.

Form of issue

Spray nasal dosed with 137 μg / dose.

4 ml (25 doses) or 30 ml (200 doses) into high-density polyethylene (HDPE) bottles with a screw-on dispenser.

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

Allergodyl (nasal spray) - Pharmacological action

Azelastine is a long-acting antiallergic substance, a derivative of phthalazinone. Azelastine is a selective H1-histamin blocker, has antihistamine, anti-allergic and membrane-stabilizing action, reduces capillary permeability and exudation, stabilizes the membrane of mast cells and prevents the release of biologically active substances (histamine, serotonin, leukotrienes, platelet activating factor, etc.), causing bronchospasm and contributing to the development of early and late stage of allergic reactions and inflammation. With local application, the systemic effect is negligible.

Allergoodil (nasal spray) is distinguished by the presence in its composition of sucralose - an auxiliary substance that disguises an unpleasant taste in the mouth.

With intranasal administration reduces itching and stuffiness of the nose, sneezing and rhinorrhea. Relaxation of symptoms of allergic rhinitis is noted, starting from the first 15 minutes after application, and lasts up to 12 hours or more.

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

Allergodyl (nasal spray) - Pharmacokinetics

Bioavailability after intranasal application is about 40%. The maximum concentration (Cmax) in blood plasma after intranasal administration is achieved in 2-3 hours.

When administered intranasally at the recommended daily dose of 1.12 mg (ie, 2 injections in each nasal passage twice a day), the average equilibrium concentration in plasma of the equilibrium state is about 1.09 ng / ml.

The systemic effect of azelastine after nasal administration is about 6 times less than that of oral azelastine hydrochloride at a daily dose of 4.4 mg, which is a therapeutic dose.

In patients with allergic rhinitis , the concentration in the blood is higher than in healthy people. Relationship with plasma proteins 80-95%.

Metabolised in the liver by oxidation with the participation of the cytochrome P450 system to form the active metabolite N-desmethylazelastine.

It is excreted mainly through the intestine and kidneys in the form of inactive metabolites.

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

Allergodyl (nasal spray) - Indications for use

For symptomatic treatment of allergic rhinitis.

Contraindications

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

- Children under 6 years.

Restrictions on the use of the drug to special groups of patients (elderly persons and patients with renal and hepatic insufficiency ) are absent.

Allergodyl (nasal spray) - during pregnancy and lactation

When testing doses that exceed the therapeutic range many times, no evidence of teratogenicity has been obtained on animals, but since there is no experience with azelastine in pregnant women and during breastfeeding, the use of nasal spray azelastine during pregnancy and during the period lactation.

Allergodyl (nasal spray) - Dosage and administration

Intranasally.

In the absence of other recommendations for children aged 6 to 12 years - one dose (137 mcg / 0.137 ml) in each nasal passage twice a day - in the morning and in the evening.

Adults and children over 12 years of age - 2 doses (274 mcg / 0.274 ml) in each nasal passage twice a day in the morning and in the evening. The recommended dose should not be exceeded.

Allergoodil (nasal spray) is applied until the symptoms stop and is suitable for long-term treatment (up to 12 months).

The solution should be injected with the vertical position of the head in each nostril. The volume of one spray (one dose) is 0.137 ml and contains 137 μg of active substance.

The order of application

1. Remove the protective cap

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

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

4. Replace the protective cap.

Allergodyl (nasal spray) - Side effect

The incidence of side effects is defined as follows:

Very often:> 1/10;

Often: <1/10> / 100;

Infrequently: <1/100> 1/1000;

Rarely: <1/1000> 1/10000;

Very rarely: <1/10000.

• Impaired nervous system:

Often: dysgeusia (unpleasant taste) as a result of improper application, namely, with excessive head deflection back during the injection.

Very rarely: dizziness (can be caused by the disease itself).

• Disturbances from the gastrointestinal tract:

Rarely: nausea.

• Respiratory system disorders:

Infrequent: discomfort in the nasal cavity (burning sensation, itching), sneezing, nosebleeds.

• Immune system disorders:

Very rarely: hypersensitivity, anaphylactoid reactions.

• Impaired skin and subcutaneous tissue:

Very rarely: rash, itchy skin , hives .

• Complications of a general nature:

Very rarely: fatigue, weakness (can be caused by the disease itself).

Allergodyl (nasal spray) - Overdose

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

In case of an overdose as a result of accidental ingestion, there may be disorders of the nervous system (drowsiness, confusion, tachycardia and hypotension).

Therapy of these disorders is symptomatic.

Interaction with medicines

Strengthens the sedative effect of ethanol and other drugs that depress the central nervous system.

Affects the ability to drive vehicles and work with complex mechanisms.

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

special instructions

Nasal Spray Allergoodil as a preservative contains benzalkonium chloride, which is irritating, and can cause skin reactions.

During treatment it is necessary to avoid the use of ethanol and the use of drugs that depress the central nervous system; the possibility of dizziness and drowsiness should be considered. The use of alcohol can exacerbate these phenomena.

Analogues of nasal spray Allergodyl : Tizin; Reactin; Histimet; Rhinital; Ithral.

Storage conditions and shelf life

At a temperature of 8 to 25 ° C.

Keep out of the reach of children for 3 years. Opened vials - 3 months.

Do not use after the expiration date!

Terms of leave from pharmacies: Without a prescription.

We want to pay special attention to the fact that the description of the drug Allergoodil (nasal spray) is presented for informational purposes only! For more accurate and detailed information about the drug Allergoodil (nasal spray), please refer exclusively to the manufacturer's annotation! Do not self-medicate! You should definitely consult a doctor before starting the drug!