Allergodil C - 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 0.137 mg;

Excipients: 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:Transparent colorless or almost colorless solution.

Pharmacotherapeutic group:Antiallergic - H1 histamine receptor blocker

ATX: & nbsp

R.01.A. C.03 Azelastine

Pharmacodynamics:

Azelastine is a long-acting antiallergic drug, a phthalazinone derivative. Azelastine is selective H₁-gistaminoblocker, has 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, factor, activating, platelets, etc.) that cause bronchospasm and promote the development of early and late stage of allergic reactions and inflammation. With local application, the systemic effect is negligible.Allergodil® C is distinguished by the presence in its composition of sucralose - an auxiliary substance that disguises an unpleasant taste in the mouth.

With intranasal administration, it reduces itching and nasal congestion, 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 and more.

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

Pharmacokinetics:

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

When administered intranasally in an adult recommended daily dose of 1.12 mg (i.e., 2 injections into each nasal passage twice a day), the average concentration of azelastine in the plasma in the equilibrium state is about 1.09 ng / ml. The systemic effect of azelastine after nasal administration in approximately 6 times less than the intake of azelastine hydrochloride in a daily dose of 4.4 mg, which is a therapeutic dose.

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

Metabolized in the liver by oxidation, involving the cytochrome P system450 with the formation of an active metabolite N/ RTI & gt; 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, of its therapeutically active metabolite N-desmethylazelastine - about 45 hours.

Indications:

For symptomatic treatment of allergic rhinitis.

Contraindications:

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

- Childrens age up to 6 years.

Carefully:

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

Pregnancy and lactation:

When testing doses many times exceeding the therapeutic range, no evidence of teratogenic action was obtained on animals, but since there is no experience with the use of azelastine in pregnant women and during breastfeeding,It is not recommended to use nasal spray azelastine during pregnancy, as well as during lactation.

Dosing and Administration:

Intranasally.

In the absence of other recommendations, children aged 6 years 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 have 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. Allergodyl® C is used until 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 2-3 times.

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

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).

Disorders from the gastrointestinal tract:

Rarely: nausea.

Disturbances from the respiratory system:

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

Immune system disorders:

Very rarely: hypersensitivity, anaphylactoid reactions.

Disturbances from the skin and subcutaneous tissues:

Rarely: rash, itching, hives.

Complications of a general nature:

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

Overdose:At the moment, cases of drug overdose with intranasal applicationis unknown. In case of an overdose as a result of accidental ingestion, there may be disturbances from the nervous system (drowsiness, confusion, tachycardia and hypotension). Therapy of these disorders is symptomatic.

Interaction:

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

Special instructions:

Nasal Spray Azelastin® C as a preservative contains benzalkonium chloride, which has irritating effect, and can cause skin reactions.

During treatment, it is necessary to avoid the use of ethanol and the use of drugs that depress the nervous system; the possibility dizziness and drowsiness. 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 result from the disease itself can develop with the use of the Azelastin® C preparation. In these cases, you should avoid driving the machine and working with complex mechanisms.

Form release / dosage:Spray nasal dosed with 137 μg / dose.

Packaging:

4 ml (25 doses) or 30 ml solution (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.

Storage conditions:

At a temperature of 8 to 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years. Opened vials - 3 months.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-001673