Allergodil® [Azelastine]

Pharmacological properties

azelastine is a phthalazinone derivative of a new structure, which has a prolonged anti-allergenic effect and has pronounced properties of a selective antagonist of histamine H1 receptors.

Azelastine inhibits the synthesis or release of chemical mediators involved in allergic reactions in the early and late stages, such as leukotrienes, histamine, platelet activating factor inhibitors PAF and serotonin.

Evaluation of the ECG of patients who have been using azelastine in high doses for a long time shows that there is no clinically significant effect on the Q – T interval.

Pharmacokinetics After repeated use of eye drops Allergodil (1 drop in each eye 4 times a day) C_max plasma azelastine was very low and was at the lower limit of quantification (9.2 ng / ml) or did not reach it.

Indications

Eye drops:

• treatment and prevention of seasonal allergic conjunctivitis in adults and children over the age of 4 years;
• treatment and prevention of year-round (non-seasonal) allergic conjunctivitis in adults and children over the age of 12 years.

Nasal spray: treatment of seasonal allergic rhinitis (fever) and non-seasonal year-round allergic rhinitis.

Application

Eye drops

Seasonal allergic conjunctivitis: usually adults and children over 4 years old are instilled 1 drop in each eye 2 times a day (morning and evening), if necessary, the frequency of use is increased to 4 times a day.

For prevention, the drug is used until possible contact with the allergen.

Non-seasonal allergic conjunctivitis: usually adults and children over 12 years old are instilled 1 drop in each eye 2 times a day (morning and evening), if necessary, the frequency of use is increased to 4 times a day.

The duration of treatment is no more than 6 weeks.

Nasal spray

Allergodil injected in a single dose (0.14 mg / 0.14 ml) in each nasal passage 2 times a day, which corresponds to a daily dose of azelastine 0.56 mg.

When injecting a nasal spray, you need to keep your head straight.

Use allergodil until symptoms disappear; prolonged use is possible, but not more than 6 months.

Contraindications

Hypersensitivity to the drug, the period of pregnancy (especially the first trimester) and breastfeeding; for nasal spray - children under 6 years old.

Side effects

Eye drops: possible slight irritation of the eyes, the appearance of a bitter aftertaste in the mouth. in isolated cases, allergic reactions may occur.

Nasal spray: hypersensitivity reactions, anaphylactic reactions.

From the nervous system: vertigo, dysgeusia.

On the part of the respiratory system: irritation of the nasal mucosa, burning, itching and sneezing, nosebleeds.

From the digestive tract: nausea.

On the part of the skin: skin rash, itching, urticaria.

Others: fatigue, feeling tired, weakness.

As a result of improper administration, when the head is tilted back, a bitter aftertaste in the mouth may occur.

special instructions

It is not recommended to wear contact lenses during treatment with allergodil eye drops. do not use to treat infectious eye lesions. benzalkonium chloride can cause irritation to the mucous membrane of the eye.

Alcohol enhances the severity of side effects from the central nervous system.

During pregnancy and breastfeeding. The use of the drug is contraindicated during pregnancy (especially in the first trimester) and breastfeeding. If necessary, use Allergodil should stop breast-feeding.

Children. Allergodil eye drops are used to treat children over the age of 4 (seasonal allergic conjunctivitis) and over 12 years old (non-seasonal (year-round) allergic conjunctivitis). In the form of a nasal spray, Allergodil is used in children over the age of 6 years.

The ability to influence the reaction rate when driving vehicles or working with mechanisms. The drug does not have an adverse effect on the ability to drive vehicles and work with complex mechanisms, however, in the presence of temporary irritation of the mucous membrane of the eye, it is recommended to refrain from driving vehicles or working with complex mechanisms. When applying the nasal spray in isolated cases, fatigue, a feeling of fatigue, weakness, dizziness, which may accompany the disease, can occur. In these cases, the reaction rate when driving vehicles and working with other mechanisms can be reduced.

Interactions

Not identified.

Overdose

Not marked. in case of accidental overdose, rinse eyes with plenty of water.

In case of overdose or intoxication when using the nasal spray, disorders of the central nervous system are possible (drowsiness, dizziness, apathy, tachycardia, arterial hypotension). The treatment is symptomatic. The antidote is unknown.

Storage conditions

In the original packaging at a temperature not exceeding 25 ° C. after opening the bottle, eye drops should be used within 4 weeks, nasal spray - 6 months.