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Ganciclovir (ophthalmic): Pediatric drug information

Ganciclovir (ophthalmic): Pediatric drug information
(For additional information see "Ganciclovir (ophthalmic): Drug information" and see "Ganciclovir (ophthalmic): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Zirgan
Therapeutic Category
  • Antiviral Agent, Ophthalmic
Dosing: Pediatric
Herpetic keratitis

Herpetic keratitis: Children ≥2 years and Adolescents: Ophthalmic gel: Apply 1 drop in affected eye 5 times daily (approximately every 3 hours while awake) until corneal ulcer heals, then 1 drop 3 times daily for 7 days.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.

Dosing: Adult

(For additional information see "Ganciclovir (ophthalmic): Drug information")

Herpetic keratitis

Herpetic keratitis: Ophthalmic: Apply 1 drop in affected eye 5 times daily (approximately every 3 hours while awake) until corneal ulcer heals, then apply 1 drop 3 times daily for 7 days.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Gel, Ophthalmic:

Zirgan: 0.15% (5 g) [contains benzalkonium chloride]

Generic Equivalent Available: US

No

Administration: Pediatric

Ophthalmic gel: Gel is intended for topical ophthalmic use only; avoid touching tip of applicator to eye or other surfaces.

Administration: Adult

For ophthalmic application only; avoid touching tip of applicator to eye or other surfaces.

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2016 [group 2]).

Use appropriate precautions for receiving, handling, administration, and disposal. Gloves (single) should be worn during receiving, unpacking, and placing in storage. NIOSH recommends double gloving and a protective gown for administration (NIOSH 2016). Facilities may perform assessment of some (non-antineoplastic) hazardous drugs to determine if appropriate for alternative containment strategies and handling requirements; assess risk to determine appropriate containment strategy (USP-NF 2017).

Storage/Stability

Store at 15°C to 25°C (59°F to 77°F). Do not freeze.

Use

Treatment of acute herpetic keratitis (dendritic ulcers) (FDA approved in ages ≥2 years and adults)

Medication Safety Issues
Sound-alike/look-alike issues:

Ganciclovir may be confused with acyclovir, valGANciclovir

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%: Ophthalmic: Blurred vision (60%), eye irritation (20%)

1% to 10%: Ophthalmic: Punctate keratitis (5%), conjunctival hyperemia (5%)

Contraindications

There are no contraindications listed in the manufacturer’s labeling.

Warnings/Precautions

Concerns related to adverse effects:

• Ocular adverse events: Blurred vision commonly occurs; may also cause eye irritation.

Special populations:

• Contact lens wearers: Contact lenses should not be worn during the course of therapy or in any patient with signs/symptoms of herpetic keratitis.

Other warnings/precautions:

• Appropriate use: For topical ophthalmic use only.

Warnings: Additional Pediatric Considerations

Use with caution in children; long-term safety has not been determined; the potential long-term carcinogenic and adverse reproductive effects of ganciclovir should be considered.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program

There are no known significant interactions.

Pregnancy Considerations

Adverse events were observed in animal reproduction studies conducted with systemic ganciclovir. The amount of ganciclovir available systemically following topical application of the ophthalmic gel is significantly less in comparison to IV doses (0.1%).

Monitoring Parameters

Ophthalmologic exams

Mechanism of Action

Ganciclovir is phosphorylated to a substrate, which competitively inhibits the binding of deoxyguanosine triphosphate to DNA polymerase resulting in inhibition of DNA replication by herpes simplex viruses.

Pharmacokinetics (Adult data unless noted)

Absorption: Negligible systemic absorption (0.1% in comparison to IV doses and 0.04 % in comparison to oral valganciclovir)

Pricing: US

Gel (Zirgan Ophthalmic)

0.15% (per gram): $100.41

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Ganciclorat (BR);
  • Gansovir (BD);
  • Ganvirax (BR);
  • Gavir (IN);
  • Natclovir (LK);
  • Virgan (CL, ES, GR, HU, PL, PT, RO, TR, UA);
  • Virgangel (MX);
  • Vitrasert (BM);
  • Vitrasert Implant (AT, BE, BG, CH, CZ, DE, DK, EE, FI, FR, GB, GR, HN, IT, MT, NL, NO, PL, PT, RU, SE, SK, TR);
  • Xoviral (BD);
  • Zirgan (BD)


For country code abbreviations (show table)
  1. <800> Hazardous Drugs—Handling in Healthcare Settings. United States Pharmacopeia and National Formulary (USP 40-NF 35). Rockville, MD: United States Pharmacopeia Convention; 2017:83-102.
  2. US Department of Health and Human Services; Centers for Disease Control and Prevention; National Institute for Occupational Safety and Health. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2016. http://www.cdc.gov/niosh/topics/antineoplastic/pdf/hazardous-drugs-list_2016-161.pdf. Updated September 2016. Accessed October 5, 2016.
  3. Zirgan (ganciclovir ophthalmic) [prescribing information]. Bridgewater, NJ: Bausch & Lomb; September 2019.
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