ZIRGAN

The estimated maximum daily dose of ganciclovir administered as 1 drop, 5 times per day is 0.375 mg. Compared to maintenance doses of systemically administered ganciclovir of 900 mg (oral valganciclovir) and 5 mg/kg (IV ganciclovir), the ophthalmically administered daily dose is approximately 0.04% and 0.1% of the oral dose and IV doses, respectively, thus minimal systemic exposure is expected.

In one open-label, randomized, controlled, multicenter clinical trial which enrolled 164 patients with herpetic keratitis, ZIRGAN was non-inferior to acyclovir ophthalmic ointment, 3% in patients with dendritic ulcers. Clinical resolution (healed ulcers) at Day 7 was achieved in 77% (55/71) for ZIRGAN versus 72% (48/67) for acyclovir, 3% (difference 5.8%, 95% CI - 9.6%-18.3%). In three randomized, single-masked, controlled, multicenter clinical trials which enrolled 213 total patients, ZIRGAN was non-inferior to acyclovir ophthalmic ointment, 3% in patients with dendritic ulcers. Clinical reso...

Most common adverse reactions reported in patients were blurred vision (60%), eye irritation (20%), punctate keratitis (5%), and conjunctival hyperemia (5%). Most common adverse reactions were blurred vision (60%), eye irritation (20%), punctate keratitis (5%), and conjunctival hyperemia (5%). ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated, at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

None. None.

ZIRGAN is indicated for topical ophthalmic use only. ( 5.1 ) Patients should not wear contact lenses if they have signs or symptoms of herpetic keratitis or during the course of therapy with ZIRGAN. ( 5.2 ) 5.1 Topical Ophthalmic Use Only ZIRGAN is indicated for topical ophthalmic use only. 5.2 Avoidance of Contact Lenses Patients should not wear contact lenses if they have signs or symptoms of herpetic keratitis or during the course of therapy with ZIRGAN. 5.3 Risk of Contamination Do not allow...