Trifluridine Sterile Eye Drops is indicated for the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis caused by herpes simplex virus type 1 and type 2.

Trifluridine is a fluorinated pyrimidine nucleoside analog that interferes with DNA synthesis of herpes simplex virus type 1 and type 2 as well as vaccinia virus. It inhibits viral DNA replication through three mechanisms:

• Competitive inhibition of viral DNA polymerase
• Incorporation into and termination of the growing viral DNA chain
• Inactivation of viral DNA polymerase

Children above 6 years of age & adults: Instill 1 drop every 2 hrs. while awake; maximum 9 drops/day until the corneal ulcer has completely re-epithelialized.

After re-epithelialization: Instill 1 drop every 4 hrs. or at least 5 drops/day for 7 days is recommended.

If there are no signs of improvement after 7 days of therapy or complete re-epithelialization has not occurred after 14 days of therapy, other forms of therapy should be considered. Continuous administration of Fludin eye drops for periods exceeding 21 days should be avoided because of potential ocular toxicity.

Use in children: Safety and effectiveness in pediatric patients below 6 years of age have not been established.

Use in elderly patients: No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.

Trifluridine is contraindicated in patients who develop hypersensitivity reactions or chemical intolerance to the medication.

Reported side effects are usually mild and temporary burning or stinging sensation after instillation. Other adverse effects may include superficial punctate keratopathy, epithelial keratopathy, hypersensitivity reactions, stromal edema, irritation, keratitis sicca, hyperemia, and increased intraocular pressure.

Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Trifluridine should be used during pregnancy only if the expected benefit justifies the potential risk to the fetus.

Use in lactation: It is unlikely that Trifluridine is excreted in human milk after ophthalmic administration because of the relatively low dose. However, it should not be prescribed to nursing mothers unless the potential benefit outweighs the possible risk.

Trifluridine should only be prescribed in patients with a confirmed clinical diagnosis of herpetic keratitis.

Ophthalmic Anti-viral Products

Store at 2° to 8°C. Do not use for more than 30 days after first opening. Keep out of reach of children.