Allergodil drops Ch. 0.05% 6 ml vial

Description

Composition
Active substance:
1 vial formulation comprises azelastine hydrochloride 3.000 mg.
Excipients:
Hypromellose 6.000 mg Disodium edetate 3.000 mg benzalkonium chloride 0.750 mg sorbitol 399.996 mg Sodium hydroxide to pH 6,0, Water for injections up to 6 ml (6, 090 mg).
Description:
Colorless, clear or almost clear solution.
Product form:
Eye drops 0.05%.
6 ml or 10 ml high density low density dropper cap with a white high-density polyethylene, polyethylene vial translucent polyethylene. 1 vial together with instructions for use placed in a cardboard box.
Contraindications
Hypersensitivity for the active substance or other components of the formulation;
Age 4 years; I trimester of pregnancy.
Dosage
0.05%
Indications
Prevention and treatment of seasonal allergic conjunctivitis;
Treatment of non-seasonal (year) allergic conjunctivitis.
Interaction with other drugs
Not found. In the case of other concomitant therapy eye drops should be instilled in the eye of at least 15 minutes intervals.
Overdose
Data on overdose of the drug available.
pharmachologic effect
Pharmacological group:
Antiallergic agent – H1 histamine receptor blocker.
Pharmacological properties:
Azelastine, phthalazinone derivative, a long-acting anti-allergic agent that selectively blocks the H1-receptors. When applied to mucosal eyes manifested additional antiinflammatory and membrane stabilizing effects of azelastine: azelastine inhibits the release of mediators of early and late phase allergic reactions, e.g., (Leukotriene, histamine, platelet activating factor, reduces the amount of ICAM-1 (intercellular adhesion molecule 1) and eosinophil cells.
Clinically significant effects on QT (QTc) interval is not detected even after prolonged use of high doses of azelastine.
Pharmacokinetics:
Even when used repeatedly allergodil eye drops (1 drop in each eye four times a day) azelastine maximal concentration in plasma is very low, and detected at the limit or below the detection limit.
Pregnancy and breast-feeding
In tests in animals it has been found undesirable effects on the fetus when administering the drug orally in doses many times exceeding the therapeutic one, and therefore the use of the drug in the I trimester of pregnancy is not recommended, as in II and III trimestetrah and during lactation is possible only in case of emergency, if the potential benefit to the mother outweighs risk to the fetus / baby.
Conditions of supply of pharmacies
Without recipe.
side effects
The incidence of side effects is defined as follows:
Very common:> 1/10;
Often: 1/100;
Uncommon: 1/1000;
Rare: 1/10000;
Very rarely:
Often – transient blurred vision, conjunctivitis;
Seldom – a burning sensation in the eye.
Are common:
Infrequently – a sense of bitterness in the mouth;
Very rare – allergic reactions, headache, asthma, dyspnoea, fatigue, flu-like symptoms, sore throat, itching, rhinitis.
special instructions
When applying eye drops is not recommended to wear contact lenses.
Effect on the ability to drive.
In the case of blurred vision immediately after instillation of the drug, should refrain from driving and class activities that require increased attention to its recovery.
Storage conditions
Store at a temperature not higher than 25 ° C.
Keep out of the reach of children.
Dosing and Administration
Seasonal allergic conjunctivitis:
In the absence of any other recommendations of a doctor for adults and children from 4 years to dig in 2 meals a day (morning and evening) 1 drop in each eye. If necessary, increase the dose up to 4 times a day by one drop in each eye. The drug is used until symptoms disappear, but no more than 6 weeks. In the case of a suspected allergen exposure the drug is used as a prophylactic measure.
Non-seasonal (perennial) allergic conjunctivitis:
In the absence of any other recommendations of a doctor for adults and children from 4 years to dig in 2 meals a day (morning and evening) 1 drop in each eye. If necessary, increase the dose up to 4 times a day by one drop in each eye. Duration of treatment – no more than 6 weeks.
The order of application of drops: 1. Remove the protective cap. 2. Before first use, click on the vial 1-2 times upside down. 3. drip one drop in each eye, holding his head thrown back.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist