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APO-TRIFLURIDINE OPHTHALMIC is a brand name for Trifluridine, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
APO-TRIFLURIDINE (trifluridine) is contraindicated for patients who are known to be hypersensitive or intolerant to trifluridine or any of its non-medicinal ingredients. WARNINGS The recommended dosage and frequency of administration of APO-TRIFLURIDINE should not be exceeded (see DOSAGE AND ADMINISTRATION).
Use in Pregnancy Trifluridine should not be administered to pregnant women or nursing mothers unless the anticipated benefits outweigh the potential risks. The teratogenic potential of this compound in humans is unknown. The topical application of trifluridine to the eyes of rabbits on days 6 to 18 of gestation produced no teratogenic effects.
0 mg/kg/day (see TOXICOLOGY). 1 mg/kg/day, assuming a body weight of 45 kg.
PRECAUTIONS GENERAL:
Trifluridine should be prescribed only for patients who have a clinical diagnosis of herpetic keratitis. Trifluridine may cause mild local irritation of the conjunctiva and cornea when instilled, but these effects are usually transient.
Caution should be exercised in the use of trifluridine in the treatment of infections caused by strains of herpes simplex virus resistant to other antivirals. Conflicting evidence has been presented on the issue of cross-resistance to other antiviral agents.
Resistance of herpes simplex virus type 1 to trifluridine has been produced in vitro and these strains are able to produce trifluridine-resistant infections in vivo. HSV-1 strains insensitive to trifluridine were also resistant to idoxuridine and adenine arabinoside.
On the other hand, it has been shown that virus lacking thymidine kinase and/or DNA polymerase activity may retain complete or reduced sensitivity to trifluridine in vitro and that trifluridine is still of some benefit in rabbit eyes infected with acyclovir- resistant strains of herpes simplex virus type 1.
Early work showed that rabbits infected with HSV-1 strains made resistant to idoxuridine could still be treated successfully with trifluridine. Following re-epithelialization, trifluridine should not be used in an attempt to reduce the rate of recurrence of herpetic keratitis as supporting experimental and clinical data are lacking, and toxicity may occur with prolonged use.
There is no specific experience respecting efficacy and safety of use in children.
Page 4 of 15 Drug Interactions:
Trifluridine should not be applied to the eye simultaneously with other medications. However, the following ophthalmic drugs have been administered topically and concurrently with trifluridine in a limited number of patients without apparent evidence of adverse interaction: antibiotics - chloramphenicol, erythromycin, polymyxin B sulfate, bacitracin, gentamicin sulfate, tetracycline hydrochloride, sodium sulfacetamide, neomycin sulfate; steroids - dexamethasone sodium phosphate, dexamethasone, prednisolone acetate, prednisolone sodium phosphate, hydrocortisone, fluorometholone; and other ophthalmic drugs - atropine sulfate, scopolamine hydrobromide, naphazoline hydrochloride, cyclopentolate hydrochloride, homatropine hydrobromide, pilocarpine, l-epinephrine hydrochloride and sodium chloride.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Trifluridine in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Carcinogenesis and Mutagenesis: (see TOXICOLOGY) Use in Pregnancy:
There are no adequate and well-controlled studies in pregnant women. The product should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus (see TOXICOLOGY). 0 mg/day), its dilution in body fluids and its extremely short half-life (approximately 12 minutes).
The drug should not be prescribed for nursing mothers unless the potential benefit outweighs the potential risk. ADVERSE REACTIONS Fifty-four of 297 (18%) patients experienced adverse reactions. The following adverse reactions were noted in controlled and open studies during the administration of trifluridine: burning upon instillation (12%); superficial punctate keratitis (2%); and eyelid edema, irritation, epithelial keratopathy, allergic reaction, increased intraocular pressure, keratitis sicca, stromal edema, blurred vision and nausea each occurred in less than 1% of the patients.
SYMPTOMS AND TREATMENT OF OVERDOSAGE Overdosage by ocular instillation is unlikely because any excess solution should be quickly expelled from the conjunctival sac. Acute overdosage by accidental oral ingestion of trifluridine has not been reported.
However, should such ingestion occur, the 75 mg of trifluridine in a single bottle of solution would not be expected to produce adverse effects. 5 to 30 mg/kg/day in children and adults with neoplastic disease produce reversible bone marrow depression as the only potentially serious toxic effect and only after at least 5 doses.
The acute oral LD50 in the mouse and rat was 4379 mg/kg or higher. DOSAGE AND ADMINISTRATION Adult Page 5 of 15 Instill one drop of APO-TRIFLURIDINE (trifluridine) Ophthalmic Solution, 1% onto the cornea of the affected eye every two hours while awake.
The maximum daily dosage is nine drops. This therapeutic regimen should be continued until the herpetic lesion has completely re- epithelialized. At this time the dosage APO-TRIFLURIDINE should be reduced to one drop every four hours for a maximum daily dosage of five drops.
This regimen should be continued for seven days post-re- epithelialization. If there are no signs of improvement after seven days of full therapy or complete re- epithelialization has not occurred after 14 days of full therapy, other forms of therapy should be considered.
ADMINISTRATION OF A FULL DOSAGE REGIMEN FOR PERIODS EXCEEDING 21 DAYS SHOULD BE AVOIDED BECAUSE OF POTENTIAL OCULAR TOXICITY. […]