Expiration date: 12/2025
Structure and Composition:
Spray for nasal administration metered dose
1 vial (10 ml) contains: Azelastine hydrochloride 0.01 g
excipients: hypromellose disodium edetate dihydrate, citric acid anhydrous sodium hydrogen phosphate dodecahydrate Sodium chloride Purified water
Patients in dark glasses with a nozzle, spray or in plastic bottles (complete with spray-dosing) of 10 ml in box of 1 vial.
The solution-eye drops 0.05%
1ml contains: azelastine hydrochloride 0.5 mg
excipients: hydroxypropyl methylcellulose (hypromellose) disodium edetate benzalkonium chloride, sorbitol 70% sodium hydroxide, water for injection
in polyethylene bottles with a dropper to 6 or 10 in the box 1 mL vial.
Description pharmaceutical form:
Spray: a transparent colorless solution.
Eye drops: clear, colorless solution.
Characteristic:
Blocker histamine H1-receptor. Phthalazinone derivative.
Pharmacokinetics:
At intranasal and intraocular application of clinically significant systemic effects absent.
Description of the pharmacological actions:
He is a strong long-acting anti-allergic agent. At intranasal and intraocular application except antihistamine effect is pronounced anti-inflammatory and membrane stabilizing effects of azelastine: azelastine inhibits the synthesis and release of mediators of the early and late phase allergic reactions, including leukotrienes, histamine, platelet activating factor (PAF), and reduces serotonin ICAM-1 (molecular adhesion of cells) and eosinophil cells. According to the study, at the doses azelastine calculated per person, leukotrienes and slow PAF induced bronchospasm.
Clinically significant effects on the QT (QTc) interval is not even with prolonged use of high doses of azelastine.
Testimony:
Spray. Treatment of seasonal and perennial allergic rhinitis and rhinoconjunctivitis.
Eye drops:
Seasonal allergic conjunctivitis (prevention and treatment)
non-seasonal (perennial) allergic conjunctivitis (treatment).
Contraindications:
hypersensitivity to azelastine or any other components of the drug
children's age (up to 6 years - for spray and up to 4 years - for eye drops).
Application of pregnancy and breastfeeding:
Despite the fact that when tested doses, many times higher than the therapeutic range is not obtained any evidence of teratogenicity, it is not recommended to use azelastine (eye drops) in the I trimester of pregnancy, as a nasal spray - during pregnancy and lactation .
Side effect:
Spray. Local: irritation of the inflamed nasal mucosa, manifested by burning, itching, sneezing, in rare cases - epistaxis. As a result, the wrong method of administration, when the head is thrown back, may cause a bitter taste in the mouth.
Eye drops. Increasing the sensitivity of the eye, foreign body sensation, conjunctival membrane discoloration, irritation, pain, itching, redness, swelling, increased lacrimation. Rarely - dry eye, blepharitis.
Common symptoms: dyspnea, dysgeusia, dry skin.
Drug Interactions:
Not found. When concomitant therapy with other eyedrops, Bury their eyes at intervals of not less than 15 minutes.
Dosage and administration:
Spray, intranasally. Seasonal and perennial allergic rhinitis and rhinoconjunctivitis. In the absence of any other physician recommendations for adults and children 6 years and older - 1 injection (140 mg / 0.14 ml) in each nostril 2 times a day (morning and evening), which corresponds to a daily dose of 0.56 mg. If necessary, adults and children over 12 years - 2 doses (280 mg / 0.28 ml) in each nostril 2 times a day (morning and evening). The volume of injection is 0.14 ml containing 0.14 mg of active substance.
The solution should be injected in the upright position of the head in each nostril.
Allergodil applied before termination of symptoms and suitable for long-term use, but not more than 6 months.
Eye drops. Seasonal allergic conjunctivitis: in the absence of any other doctor's recommendations for adults and children from 4 years - 1 drop in each eye two times a day (morning and evening). If necessary - 1 drop in each eye up to 4 times a day.
In the case of a suspected allergen exposure the drug is used as a prophylactic measure.
Low season (year-round) allergic conjunctivitis: in the absence of any other recommendations of the doctor, adults and children up to 12 years - 1 drop in each eye two times a day (morning and evening). If necessary - 1 drop in each eye up to 4 times a day.
Overdose:
At present, cases of overdose Allergodil unknown.
Special instructions:
Allergodil (eye drops) may be used for the treatment of infectious eye diseases in the treatment only on the doctor's recommendation.
Storage conditions:
Do not freeze.
Shelf life:
After opening the vial the drug should be used within 6 months.
