Viroptic®
trifluridine 1.0% · ophthalmic solution
Antiviral
Approved uses
Primary herpetic keratoconjunctivitis and recurrent epithelial keratitis, HSV types 1 and 2
One drop onto the cornea of the affected eye every 2 hours while awake, to a maximum of nine drops daily, until the ulcer re-epithelializes; then one drop every 4 hours for a further 7 days
The 21-day ceiling matters: beyond it the corneal toxicity outweighs the antiviral effect
Contraindications
Trifluridine Ophthalmic Solution is contraindicated for patients who develop hypersensitivity reactions or chemical intolerance to trifluridine.
Available FormsTrifluridine ophthalmic solution 1%, 7.5 mL fill in a plastic bottle with a dropper tip.
Mechanism of ActionTrifluridine interferes with DNA synthesis in cultured mammalian cells. However, its antiviral mechanism of action is not completely known.
Warnings & Precautions
- The recommended dose and frequency should not be exceeded.
- Mild local irritation of the conjunctiva and cornea may occur on instillation.
- If there is no improvement after 7 days, or complete re-epithelialization has not occurred in 14 days, other therapy should be considered; do not continue beyond 21 days.
Common Side Effects
The most frequent adverse reactions reported during controlled clinical trials were mild, transient burning or stinging upon instillation and palpebral edema. Other adverse reactions in decreasing order of reported frequency were superficial punctate keratopathy, epithelial keratopathy, hypersensitivity reaction, stromal edema, irritation, keratitis sicca, hyperemia, and increased intraocular pressure.
Pregnancy & LactationPregnancy: Trifluridine was not teratogenic at subcutaneous doses up to 5 mg/kg/day, about 23 times the estimated human exposure; there are no adequate and well-controlled studies in pregnant women.
Lactation: Not stated on the FDA label.
Pediatric Use≥6 years