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AZELASTINE

- Azelastine HCL 0.05 g / 100 ml

- Pharmaceutical form: Sterile eye drops

- Therapeutic category: Antihistamine

 

 

Properties:

Azelastine hydrochloride is an antihistamine with mast-cell stabilizer and an inhibitor of the release of histamine and other mediators.
The unique characteristics of Azelastine allow this product to have a rapid onset of action (within three minutes) and a long duration of effect (approximately eight hours) with a twice daily dosing.
Azelastine has been proven to be safe in patients three years of age and older.

 

Pharmokineticks:

Absorption of azelastine following ocular administration was relatively low.
plasma concentrations of azelastine hydrochloride is between 0.02 and 0.25 ng/mL after 56 days of treatment, the elimination half-life, steady-state volume of distribution and plasma clearance were 22 hours, 14.5 L/kg and 0.5 L/h/kg, respectively.

 

Indications:

Azelastine (Azelastine HCL Ophthalmic Solution) 0.05% is indicated for the treatment of itching of the eye associated with allergic conjunctivitis in adults and children three years of age and older.

 

Contraindications:

Azelastine is contraindicated in persons with known or suspected hypersensitivity to any of its components.
The most frequently reported adverse reactions were transient eye burning/stinging (approximately 30%), headaches (approximately 15%) and bitter taste (approximately 10%). The occurrence of these events was generally mild.
The following events were reported in 1-10% of patients:, conjunctivitis, dyspnea, eye pain, fatigue, pruritus, and temporary blurring.

 

Warnings:

- contact lenses should be removed before using this medicine. Wait at least 10 minutes after using Azelastine before inserting contact lenses back.
- To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface. keep the container tightly closed. Serious problems may result from using contaminated eye drops.
- Azelastine may cause a blurred vision for a short time. Do not drive or do other things that require a good see until you know how you react to this medicine.
- Azelastine should not be used to treat contact lens related irritation.
- Azelastine should be used during pregnancy only if it is clearly needed.
- Azelastine is administered to a nursing woman.
- Pediatric Use: Safety and effectiveness in pediatric patients below the age of 3 have not been established.

 

Dosage:

Adults and children 3 years of age and older: one drop in the affected eye twice a day.
Children younger than 3 years of age: Use and dose must be determined by your doctor.

 

Storage:

Store the medicine between (2 to 25 degrees C).

 

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