Each gram gel contains ganciclovir 1.5 mg.
Pharmacology: Ganciclovir, a guanosine derivative, is transformed by viral and cellular thymidine kinases (TK) to ganciclovir triphosphate, which works as an antiviral agent by inhibiting the synthesis of viral DNA in 2 ways: Competitive inhibition of viral DNA-polymerase and direct incorporation into viral primer strand DNA, resulting in DNA chain termination and prevention of replication.
Treatment of acute herpetic keratitis (dendritic ulcers).
Instill 1 drop in the affected eye 5 times daily (approximately every 3 hrs while awake) until the corneal ulcer heals and then 1 drop 3 times daily for 7 days.
Ganciclovir is indicated for topical ophthalmic use only. Patients should not wear contact lenses if they have signs or symptoms of herpetic keratitis or during the course of therapy with ganciclovir. Patients should be advised not to allow the dropper tip to touch any surface, as this may contaminate the gel.
Use in pregnancy: Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Ganciclovir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: It is not known whether topical ophthalmic ganciclovir administration could result in sufficient systemic absorption to produce detectable quantities in breast milk. Caution should be exercised when ganciclovir is administered to nursing mothers.
Use in children: Safety and efficacy in pediatric patients be <2 years have not been established.
Use in the elderly: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Use in pregnancy: Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Ganciclovir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: It is not known whether topical ophthalmic ganciclovir administration could result in sufficient systemic absorption to produce detectable quantities in breast milk. Caution should be exercised when ganciclovir is administered to nursing mothers.
Most common adverse reactions reported in patients are blurred vision, eye irritation, punctate keratitis and conjunctival hyperemia.
Store below 30°C. Protect from light.
Not to be used 1 month after opening.
S01AD09 - ganciclovir ; Belongs to the class of antiinfectives, antivirals. Used in the treatment of eye infections.
Ophth gel 0.15% x 3 g x 1's. 4.5 g x 1's. 5 g x 1's.
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