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Substance · official US FDA label

Trifluridine (trifluridine)

1 medicine listed on Vimpia contains it, alone or combined. Below, the official US FDA label for trifluridine, unchanged.

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This is a US label.

The official US FDA label for trifluridine, effective August 1, 2024, describes products sold in the United States. The medicine sold in DR Congo may differ in strength, form or approved uses: ask a pharmacist or a doctor.

Official US FDA label for trifluridine

Data provided by the U.S. Food and Drug Administration (openFDA), unchanged. The full label on DailyMed.

Uses

INDICATIONS AND 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

US dosage, for products sold in the United States. For a medicine bought in DR Congo, follow its box, its leaflet or your pharmacist.

DOSAGE AND 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 and precautions

WARNINGS: The recommended dosage and frequency of administration should not be exceeded (See DOSAGE AND ADMINISTRATION ).

Side effects

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.

Medicines that contain it

Names as they are sold. A medicine without an English page links to its French page.

Sources

  • ●Labels: U.S. Food and Drug Administration, openFDA (public domain). Data provided by the U.S. Food and Drug Administration (openFDA), unchanged. DailyMed.
  • ●English names of substances: RxNorm, U.S. National Library of Medicine.
  • ●Marketing authorizations: register of the ACOREP, DR Congo.
  • ●Essential medicines: national list of essential medicines of DR Congo (LNME).
  • ●Composition: public medicines database of France (BDPM), ANSM, open licence.

Public information, for reference only: it does not replace the advice of a pharmacist or a doctor. Vimpia writes nothing about how to use a medicine and translates nothing: the label is the US FDA's, unchanged; names, composition and authorizations come from the official sources above.