Cytomegaloviral infections, Prophylaxis of cytomegaloviral infections in immunocompromised patients, Herpes simplex keratitis, CMV (cytomegalovirus) retinitis, Prophylaxis of cytomegaloviral infections in immunocompromised patients.
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.
Ophthalmic- Herpes simplex keratitis: Adult: As 0.15% gel: Apply 1 drop in the inferior conjunctival sac of the affected eye 5 times daily (approx 3 hrly while awake) until corneal healing occurs, then 1 drop tid for 7 days after healing. Intravenous- Cytomegaloviral infections: Adult: Induction: 5 mg/kg 12 hrly for 14-21 days. Maintenance: 5 mg/kg once daily for 7 days per wk or 6 mg/kg once daily for 5 days per wk. Doses to be given by IV infusion over 1 hr. Intravenous- Prophylaxis of cytomegaloviral infections in immunocompromised patients: Adult: Induction: 5 mg/kg 12 hrly for 7-14 days. Maintenance: 5 mg/kg once daily for 7 days per wk or 6 mg/kg once daily for 5 days per wk. Doses to be given by IV infusion over 1 hr.
Hypersensitivity to ganciclovir or valganciclovir and other antivirals (e.g. aciclovir, valaciclovir). 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.
Most common adverse reactions reported in patients are blurred vision, eye irritation, punctate keratitis and conjunctival hyperemia.
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.
Overdose through local or accidental oral administration is not likely.
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.
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