Zirgan

ZIRGAN
^®(ganciclovir ophthalmic gel) 0.15% is indicated for the treatment of acute herpetic keratitis (dendritic ulcers).

The recommended dosing regimen for ZIRGAN is 1 drop in the affected eye 5 times per day (approximately every 3 hours while awake) until the corneal ulcer heals, and then 1 drop 3 times per day for 7 days.

ZIRGAN contains 0.15% of ganciclovir in a sterile preserved topical ophthalmic gel.

Ganciclovir has been shown to be embryotoxic in rabbits and mice following intravenous administration and teratogenic in rabbits. Fetal resorptions were present in at least 85% of rabbits and mice administered 60 mg/kg/day and 108 mg/kg/day (approximately 10,000x and 17,000x the human ocular dose of 6.25 mcg/kg/day), respectively, assuming complete absorption. Effects observed in rabbits included: fetal growth retardation, embryolethality, teratogenicity, and/or maternal toxicity. Teratogenic changes included cleft palate, anophthalmia/microphthalmia, aplastic organs (kidney and pancreas), hydrocephaly, and brachygnathia. In mice, effects observed were maternal/fetal toxicity and embryolethality. Daily intravenous doses of 90 mg/kg/day (14,000x the human ocular dose) administered to female mice prior to mating, during gestation, and during lactation caused hypoplasia of the testes and seminal vesicles in the month-old male offspring, as well as pathologic changes in the nonglandular region of the stomach

There are no adequate and well-controlled studies in pregnant women. ZIRGAN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

• 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)