Pregnancy Cat

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

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.

Overdose Effects

Overdose through local or accidental oral administration is not likely.

Drug Classes

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.

Composition

n/a

Mode Of Action

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.

Reconstitution

n/a