Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Trifluridine Ophthalmic Solution, 1% in a 7.5 mL fill packaged in a natural plastic bottle with a natural plastic flat tip and a white plastic closure. 7.5mL- NDC 61314-044-75 Store under refrigeration 2-8°C (36-46°F).; PRINCIPAL DISPLAY PANEL NDC 61314-044-75 Trifluridine Ophthalmic Solution 1% FOR EYE USE ONLY Rx Only STERILE 7.5 mL SANDOZ carton
- HOW SUPPLIED: Trifluridine Ophthalmic Solution, 1% in a 7.5 mL fill packaged in a natural plastic bottle with a natural plastic flat tip and a white plastic closure. 7.5mL- NDC 61314-044-75 Store under refrigeration 2-8°C (36-46°F).
- PRINCIPAL DISPLAY PANEL NDC 61314-044-75 Trifluridine Ophthalmic Solution 1% FOR EYE USE ONLY Rx Only STERILE 7.5 mL SANDOZ carton
Overview
Trifluridine Ophthalmic Solution (also known as trifluorothymidine, F 3 TdR, F 3 T), an antiviral drug for topical treatment of epithelial keratitis caused by herpes simplex virus. The chemical name of trifluridine is α,α,α-trifluorothymidine. Trifluridine has the following structural formula. Trifluridine sterile ophthalmic solution contains 1% trifluridine in an aqueous solution with acetic acid and sodium acetate (buffers), sodium chloride, and thimerosal 0.001% (added as a preservative). The pH range is 5.5 to 6.0 and osmolality is approximately 283 mOsm. chemical
Indications & Usage
: Trifluridine Ophthalmic Solution is indicated for the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex virus, types 1 and 2.
Dosage & Administration
: Instill one drop of Trifluridine Ophthalmic Solution onto the cornea of the affected eye every 2 hours while awake for a maximum daily dosage of nine drops until the cornea ulcer has completely re-epithelialized. Following re-epithelialization, treatment for an additional 7 days of one drop every 4 hours while awake for a minimum daily dosage of five drops 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 trifluridine for periods exceeding 21 days should be avoided because of potential ocular toxicity.
Warnings & Precautions
WARNINGS: The recommended dosage and frequency of administration should not be exceeded (See DOSAGE AND ADMINISTRATION ).
Contraindications
: Trifluridine Ophthalmic Solution is contraindicated for patients who develop hypersensitivity reactions or chemical intolerance to trifluridine.
Adverse Reactions
The most frequent adverse reactions reported during controlled clinical trials were mild, transient burning or stinging upon instillation (4.6%) and palpebral edema (2.8%). 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.
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