Brand Name

Zirgan

Generic Name
Ganciclovir
View Brand Information
FDA approval date: April 30, 2010
Classification: Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor
Form: Injection, Gel

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ZIRGAN ®
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Brand Information

ZIRGAN (ganciclovir)
1INDICATIONS AND USAGE
ZIRGAN
2DOSAGE AND ADMINISTRATION
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.
3DOSAGE FORMS AND STRENGTHS
ZIRGAN contains 0.15% of ganciclovir in a sterile preserved topical ophthalmic gel.
4CONTRAINDICATIONS
None.
5ADVERSE REACTIONS
Most common adverse reactions reported in patients were blurred vision (60%), eye irritation (20%), punctate keratitis (5%), and conjunctival hyperemia (5%).
6DESCRIPTION
ZIRGAN
ChemStructure
Ganciclovir has a molecular weight of 255.23, and the empirical formula is C
Each gram of gel contains:Active:ganciclovir 1.5 mg (0.15%). Inactives:carbomer homopolymer, water for injection, sodium hydroxide (to adjust the pH to 7.2-7.6), mannitol. Preservative:benzalkonium chloride 0.075 mg (0.0075%).
7CLINICAL STUDIES
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 noninferior to acyclovir ophthalmic ointment 3% in patients with dendritic ulcers. Clinical resolution at Day 7 was achieved in 72% (41/57) for ZIRGAN versus 69% (34/49) for acyclovir (difference 2.5%, 95% CI - 15.6%-20.9%).
8HOW SUPPLIED/STORAGE AND HANDLING
ZIRGAN
Storage
Store at 15°C to 25°C (59°F to 77°F). Do not freeze.
9PATIENT COUNSELING INFORMATION
This product is sterile when packaged. Patients should be advised not to allow the dropper tip to touch any surface, as this may contaminate the gel. If pain develops, or if redness, itching, or inflammation becomes aggravated, the patient should be advised to consult a physician. Patients should be advised not to wear contact lenses when using ZIRGAN.
Distributed by: Bausch & Lomb Americas Inc.
Bridgewater, NJ 08807 USA

Manufactured by:
Bausch & Lomb Incorporated
Tampa, FL 33637 USA
Zirgan is a trademark of Laboratoires Théa Corporation used under license.
© 2023 Bausch & Lomb Incorporated or its affiliates
9224805 (folded)
10PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC24208-535-35
BAUSCH + LOMB
Zirgan
(ganciclovir
ophthalmic gel)
0.15%
Sterile
FOR TOPICAL
OPHTHALMIC
USE ONLY
Rx only
5 g
AB48835
9691901