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Indications

It is a topical eye antiviral that is indicated for the treatment of acute herpetic keratitis (dendritic ulcers)

Pharmacology

This eye gel contains the active ingredient, Ganciclovir, which is a guanosine derivative that, upon phosphorylation, inhibits DNA replication by herpes simplex viruses (HSV). Ganciclovir is transformed by viral and cellular thymidine kinases (TK) to ganciclovir triphosphate, which acts as an antiviral agent by inhibiting the synthesis of viral DNA in two ways: competitive inhibition of viral DNA-polymerase and direct incorporation into viral primer strand DNA, resulting in DNA chain termination and prevention of DNA replication.

Dosage & Administration

The recommended dosing regimen for Ganciclovir eye gel 0.15% 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.

Contraindications

It is contraindicated to the patients with known hypersensitivity to Ganciclovir.

Side Effects

Most common adverse reactions reported in patients were blurred vision (60%), eye irritation (20%), punctate keratitis (5%), and conjunctival hyperemia (5%).

Pregnancy & Lactation

Pregnancy Category C. Ganciclovir has been shown to be embryo toxic 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.

Nursing Mothers: It is not known whether topical eye ganciclovir administration could result in sufficient systemic absorption to produce detectable quantities in breast milk. Caution should be exercised when it is administered to nursing mothers.

Precautions & Warnings

It is indicated for topical eye use only. Patients should not wear contact lenses if they have signs or symptoms of herpetic keratitis or during the course of therapy with it.

Use in Special Populations

Pediatric Use: Safety and efficacy in pediatric patients below the age of 2 years have not been established.

Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Overdose Effects

Overdose through local or accidental oral administration is not likely.

Therapeutic Class

Ophthalmic Anti-viral Products

Storage Conditions

Store at 15°C to 30°C in a dry place protected from light. It is desirable that the contents should not be used more than one month after first opening of the tube.