Uses
Trifluridine Ophthalmic Solution is indicated for the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex virus, types 1 and 2.
Source: US FDA prescribing information
- Presentations
- 1
- Brands
- 0
- Manufacturers
- 0
- Available from stock
- 0
Trifluridine is a nucleoside analog antiviral indicated for the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex virus, types 1 and 2. It is available as ophthalmic solution. MedsAcross supplies Trifluridine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- Pharmacological class
- Nucleoside Analog, Nucleoside Analog Antiviral, Nucleoside Metabolic Inhibitor, Nucleic Acid Synthesis Inhibitors
- ATC classification
- S01AD02 Trifluridine · Eye medicines, subgroup S01A, subgroup S01AD
- US FDA first approval
- 10 April 1980
- EU status
- Not recorded
- Orphan designation
- Not recorded
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Ophthalmic
- Dosage forms
- Ophthalmic solution
- Identifiers
- UNII RMW9V5RW38RxCUI 10803CAS 70-00-8DrugBank DB00432Q2359590
Clinical information
From the regulator-approved product information. Each section names its source.
How it works
is not completely known. In vitro perfusion studies on excised rabbit corneas have shown that trifluridine penetrates the intact cornea as evidenced by recovery of parental drug and its major metabolite, 5-carboxy-2´-deoxyuridine, on the endothelial side of the cornea. Absence of the corneal epithelium enhances the penetration of trifluridine approximately two-fold. Intraocular penetration of trifluridine occurs after topical instillation of trifluridine into human eyes. Decreased corneal integrity or stromal or uveal inflammation may enhance the penetration of trifluridine into the aqueous humor. Unlike the results of ocular penetration of trifluridine in vitro, 5-carboxy-2´-deoxyuridine was not found in detectable concentrations within the aqueous humor of the human eye. Systemic absorption of trifluridine following therapeutic dosing with trifluridine appears to be negligible.
Source: US FDA prescribing information
Dosing overview
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.
Source: US FDA prescribing information
Contraindications
Trifluridine Ophthalmic Solution is contraindicated for patients who develop hypersensitivity reactions or chemical intolerance to trifluridine.
Source: US FDA prescribing information
Warnings and precautions
The recommended dosage and frequency of administration should not be exceeded.
Source: US FDA prescribing information
Side effects
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.
Source: US FDA prescribing information
Storage
Store under refrigeration 2-8°C (36-46°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
All presentations
1 presentations of Trifluridine, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Trifluridine 10 mg/mL ophthalmic solutionOphthalmic Cold chainGeneric name | — | US FDA | Available on request |
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 10 April 1980 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions
Conditions linked to Trifluridine in public data. This is not a list of approved uses, see the clinical information.
Questions and answers
Is Trifluridine available for export from India?
Yes, on request. MedsAcross lists 1 presentations of Trifluridine and sources them for licensed hospitals, importers and physicians against valid import documents.
Is Trifluridine approved by the US FDA?
Yes. The US FDA first approved Trifluridine on 10 April 1980, according to Drugs@FDA.
Does Trifluridine need cold chain shipping?
At least one listed presentation of Trifluridine must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Which ATC class is Trifluridine in?
Trifluridine is classified under ATC code S01AD02 (Trifluridine).
References
- Trifluridine prescribing information (Sandoz). U.S. National Library of Medicine, DailyMed. Retrieved 1 August 2024
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