ked studies which enrolled a total of 238 subjects with dendritic herpetic keratitis, acyclovirophthalmic ointment, 3% was either superior or as effective as idoxuridine ophthalmic ointment 0.5% or 1% in subjects withdendritic ulcers. Clinical resolution (healed ulcers) at Day 7 averaged 83% for acyclovir and 50% for idoxuridine
16 HOW SUPPLIED/STORAGE AND HANDLING
AVACLYR is available in a 3.5 g tin tube with a black low density polyethylene cap as a clear, colorless, sterile ophthalmicointment for topical use containing 3% acyclovir active drug. Each tube is packaged in an individual carton.
3.5 g tube (NDC 48102-026-35)
Store at 20°C to 25°C (68°F to 77°F).
17 PATIENT COUNSELING INFORMATION
Advise patients to read the FDA-approved patient labelling.
Administration
Advise patients to wash hands well and pull down lower lid of the affected eye to form a pocket. Instruct the patient to apply a 1cm (1/2 inch) ribbon of ointment in the pocket formed by the lower lid 5 times per day (approximately every 3 hours while awake).
After application of the ointment, the patient should be advised to close their eye for 1-2 minutes. Excess ointment can be wipedaway. Continue this dosing 5 times per day until the patient is advised by their physician that the corneal ulcer is healed. Oncehealed, instruct the patient to continue use of a 1 cm (1/2 inch) ribbon of ointment 3 times per day for 7 more days. [see Dosageand Administration (2)].
Manufactured for Fera Pharmaceuticals LLC, 134 Birch Hill Road, Locust Valley, NY 11560
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