Allergodil

General characteristics. Structure:

Structure                                    solution Volume in a bottle
                                             6                    ml 10 ml
Active agent:
Azelastina hydrochloride        of 3,000              mg 5,000 mg
Excipients:
Gipromelloza                        of 6,000              mg 10,000 mg
Dinatrium эдетат                    3,000              mg 5,000 mg
Benzalkoniya chloride               of 0,750              mg 1,250 mg
Sorbitol                               of 399,996          mg 666,660 mg
Sodium hydroxide                  to рН 6,0             to рН 6,0
Water for injections                To 6 ml                To 10 ml
                                            (6, 090 mg)            (10,150 mg)

Description: Colourless, transparent or almost transparent solution.

Pharmacological properties:

Azelastin, derivative a ftalazinona, is strong antiallergic means of long action, selectively blocks H1 receptors. When drawing on mucous eyes are shown additional antiinflammatory and membrane stabilizing effects of an azelastin: азеластин slows down release of mediators of an early and late phase of allergic reactions, for example, of leukotriene, a histamine, a factor of activation of thrombocytes; reduces quantity of ICAM-1 (a molecule of intercellular adhesion 1) and eosinophial cells.
Clinically significant impact on QT (QTc) an interval it is not revealed even at prolonged use of high doses of an azelastin.

Pharmacokinetics. Even at numerous use of eye drops of Allergodil (on 1 drop in each eye four times a day) the maximum concentration of an azelastin in a blood plasma very low also come to light on a limit or below a limit of measurements.

Indications to use:

- prevention and treatment of seasonal allergic conjunctivitis; - treatment of nonseasonal (year-round) allergic conjunctivitis.

Route of administration and doses:

Seasonal allergic conjunctivitis: in the absence of other recommendations of the doctor to adults and children of 4 years to dig in 2 times a day (in the morning and in the evening) on 1 drop in each eye. If necessary the dose is increased to 4 times a day on one drop in each eye. Drug is used before disappearance of symptoms, but by no more than 6 weeks.
In case of alleged influence of allergen drug is used with the preventive purpose.
Nonseasonal (year-round) allergic conjunctivitis: in the absence of other recommendations of the doctor to adults and children of 4 years to dig in 2 times a day (in the morning and in the evening) on 1 drop in each eye. If necessary the dose is increased to 4-x once a day on one drop in each eye.
 Use duration – no more than 6 weeks.

Features of use:

At use of eye drops it is not recommended to carry contact lenses.

Influence on ability to manage vehicles
In case of misting of sight right after a drug instillation, it is necessary to refrain from driving and occupation the types of activity requiring special attention before its recovery.

Side effects:

Frequency of development of side effects is determined as follows:
Very often:> 1/10;
Often: <1/10> 1/100;
Infrequently: <1/100> 1/1000;
Seldom: <1/1000> 1/10000;
Very seldom: <1/10000.
Local:
often - passing misting of sight, conjunctivitis;
seldom – a burning sensation in an eye.
The general:
infrequently - feeling of bitterness in a mouth;
very seldom - allergic reactions, a headache, asthma, диспноэ, fatigue, grippopodobny symptoms, pharyngitis, an itch, rhinitis.

Interaction with other medicines:

It is not revealed. In case of the accompanying therapy by other eye drops, it is necessary to dig in them in eyes with an interval not less than 15 minutes.

Contraindications:

- Hypersensitivity concerning active agent or other components of drug; - Age up to 4 years; - I trimester of pregnancy

Use at pregnancy and a lactation
At tests for animals undesirable action on a fruit at purpose of drug was revealed orally in the doses which are repeatedly exceeding therapeutic in this connection use of drug in the I trimester of pregnancy is not recommended, and in II and III trimesters and at a lactation it is possible only in urgent cases if the possible advantage for mother exceeds risk for the fruit/child.

Overdose:

Data on overdose of drug are absent.

Storage conditions:

At a temperature not over 25 ºС. To store in the place, unavailable to children. Period of validity 3 years. After opening of a bottle drug should be used within 4 weeks. Not to use after the period of validity specified on packaging.

Issue conditions:

Without recipe

Packaging:

Drops eye 0,05%.
On 6 ml or 10 ml of solution in a bottle from translucent polyethylene of high density with a dropper from polyethylene of low density with a white cap from polyethylene of high density.
1 bottle together with the application instruction is placed in a cardboard pack.