Generic

Ganciclovir

Indications

Xoviral Sterile Ophthalmic Gel is indicated for the treatment of acute herpetic keratitis (dendritic ulcers).

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.

Dosage & Administration

Instill 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 not recommended for those who have a history of Ganciclovir hypersensitivity.

Side Effects

Most common adverse reactions reported in patients are blurred vision, eye irritation, punctate keratitis and conjunctival hyperemia.

Pregnancy & Lactation

Pregnancy Classification C. Ganciclovir has been demonstrated to be embryotoxic and teratogenic in rabbits and mice after intravenous injection. If complete absorption was assumed, fetal resorptions were found in at least 85 percent of rabbits and mice given 60 mg/kg/day and 108 mg/kg/day (about 10,000x and 17,000x the human ocular dose of 6.25 mcg/kg/day, respectively).

Nursing Mothers: It’s unclear whether topical ganciclovir application causes enough systemic absorption to produce measurable amounts in breast milk. When it’s given to nursing women, it’s best to be cautious.

Precautions & Warnings

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.

Therapeutic Class

Antiviral Ophthalmic Products

Storage Conditions

Keep at 15°C to 30°C in a dry, light-protected location. It’s best if the contents aren’t used for more than a month after the tube is initially opened.

Pharmaceutical Name

Aristopharma Ltd.