Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING ZIRGAN (ganciclovir ophthalmic gel) 0.15% is supplied as 5 grams of a sterile, preserved, clear, colorless, topical ophthalmic gel containing 0.15% of ganciclovir in a polycoated aluminum tube with a white polyethylene tip and cap and protective band (NDC 24208-535-35). Storage Store at 15°C to 25°C (59°F to 77°F). Do not freeze.; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 24208-535-35 BAUSCH + LOMB Zirgan (ganciclovir ophthalmic gel) 0.15% Sterile FOR TOPICAL OPHTHALMIC USE ONLY Rx only 5 g AB48835 9691901 Carton
- 16 HOW SUPPLIED/STORAGE AND HANDLING ZIRGAN (ganciclovir ophthalmic gel) 0.15% is supplied as 5 grams of a sterile, preserved, clear, colorless, topical ophthalmic gel containing 0.15% of ganciclovir in a polycoated aluminum tube with a white polyethylene tip and cap and protective band (NDC 24208-535-35). Storage Store at 15°C to 25°C (59°F to 77°F). Do not freeze.
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 24208-535-35 BAUSCH + LOMB Zirgan (ganciclovir ophthalmic gel) 0.15% Sterile FOR TOPICAL OPHTHALMIC USE ONLY Rx only 5 g AB48835 9691901 Carton
Overview
ZIRGAN (ganciclovir ophthalmic gel) 0.15% contains ganciclovir, a nucleoside analog antiviral. ZIRGAN is a sterile, preserved, clear, colorless, ophthalmic gel for topical ophthalmic use. The chemical name is 9-[[2-hydroxy-1-(hydroxymethyl)ethoxy]methyl]guanine (CAS number 82410-32-0). Ganciclovir is represented by the following structural formula: Ganciclovir has a molecular weight of 255.23, and the empirical formula is C 9 H 13 N 5 O 4 . 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%). ChemStructure
Indications & Usage
ZIRGAN is indicated for the treatment of acute herpetic keratitis (dendritic ulcers) in adults and pediatric patients aged 2 years and older. ZIRGAN is a nucleoside analog antiviral indicated for the treatment of acute herpetic keratitis (dendritic ulcers) in adults and pediatric patients aged 2 years and older. ( 1 )
Dosage & Administration
The recommended dosage 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. Apply 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. ( 2 )
Warnings & Precautions
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 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.
Contraindications
None. None.
Adverse Reactions
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.
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