Zirgan Drug Information
Generic name: GANCICLOVIR
Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC] Nucleoside Analog Antiviral [EPC]
Uses of Zirgan
ZIRGAN is indicated for the treatment of acute herpetic keratitis (dendritic ulcers) in adults and pediatric patients aged 2 years and older.
Side Effects of Zirgan
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.
Warnings & Cautions for Zirgan
Topical Ophthalmic Use Only ZIRGAN is indicated for topical ophthalmic use only.
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.
Risk of Contamination
Do not allow the tip of the container to touch any surface, as this may contaminate the ointment. If pain develops, or if redness, itching, or inflammation becomes aggravated, the patient should be advised to consult a physician.
Pregnancy Safety for Zirgan
Pregnancy Risk Summary There are no available human data on use of ZIRGAN or ganciclovir during pregnancy to inform any drug-associated risk. Intravenous administration of ganciclovir to pregnant mice or rabbits during organogenesis or during the pre/postnatal period did not produce adverse embryofetal or offspring effects at clinically relevant doses ( see Data ). Data Animal Data Daily intravenous doses of ganciclovir were administered to pregnant mice and rabbits, and also to female mice prior to mating, during gestation, and during lactation.
Fetal resorptions were present in at least 85% of rabbits and mice. Additional 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.
A maternal no observed adverse effect level (NOAEL) was observed at 36 mg/kg/day (approximately 470 times higher than the maximum RHOD, based on body surface area) in mice and at 6 mg/kg/day (approximately 240 times higher than the maximum RHOD, based on body surface area) in rabbits. In pre/postnatal development studies in mice, there were maternal/fetal toxicity and embryolethality which included fetal effects of hypoplasia of the testes and seminal vesicles in the male offspring, as well as pathologic changes in the nonglandular region of the stomach.
Pediatric Use of Zirgan
Pediatric Use The safety and effectiveness of ZIRGAN for the treatment of acute herpetic keratitis (dendritic ulcers) have been established in pediatric patients aged 2 years and older. Use of ZIRGAN for this indication is supported by evidence from adequate and well-controlled studies. The safety and effectiveness of ZIRGAN have not been established in pediatric patients below the age of 2 years.
Clinical Studies of Zirgan
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. 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.
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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