Indication:
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Trifluridine Eye drops 1%w/v 08-12-2011
For the Treatment of primary Keratoconjuntivitis and Recurrent
Epilthelial Keratitis due to Herpes Simplex Viruses Type ! and 2
Ocular viral infections
Adverse Reaction:
Most frequent adverse reactions -were mild -,
transcient burning or stinging upon instillation 4%, palpebral edema 2%,
Other adverse reactions-
superficial punctuate, keratopathy, epithelial keratapathy, hypersensitivity reactions,
stromal edema, irritation, hyperremia, and increased ontraocular pressure
Contra-Indications:
Hyprsensitivity to the drug or the ingredients in the formulation
Special Precautions/ Warnings-
Diagnosis - only prescribe trifluridine solution for patients who have clinical diagnosis of
herpetic keratitis
Irritation- trifluridine may cause mild local irritation of the conjuntiva ad cornea when instilled, but are transcient effects
Resistence - although not well documented, possibility of development of viral resistence on multiple exposure to trifluridine
Pregnancy - trifluridine ophthalmic solution should be used during pregnancy only if the potential benefits justifies the potential risk to the fetus.
Lactation- the drug should be be prescribed for nursing mothers unless the potential benefits outweigh the potential risks.
Children- safety and efficacy in pediatric patients below 6 years of age have not been established
Dosages/ Overdosage Etc:
Indication-
Ocular viral infections
Dosage-
Instil 1 drop of trifluridine ophthalmic solution onto the cornea of the affected eye every 2 hours while awake for a maximum daily dosage of 9 drops until the corneal ulcer has completely re-epithelialized.
Following re-epithelialization treatment for an additional 7 days of 1 drop every 4 hours while awake for a maximum daily dosage of 5 drops is recommended.
If there are no signs of improvement after 7 days of therapy or complete re-epitheliazation
has not occured after 14 days of therapy, other forms of therapy should be considered.
Storage under refrigeration 2 to 8C ( 36 to 46F)
Patient Information:
1. Only prescribe trifluridine solution for patients who have clinical diagnosis of
herpetic keratitis
2. Irritation- trifluridine may cause mild local irritation of the conjuntiva ad cornea when instilled, but are transcient effects
3. Resistence- Although not well documented, possibility of development of viral resistence on multiple erposure to trifluridine
4. Pregnancy - trifluridine ophthalmic solution should be used during pregnancy only if the potential benefits justifies the potential risk to the fetus.
5. Lactation- the drug should be be prescribed for nursing mothers unless the potential benefits outweigh the potential risks.
6. Children- safety and efficacy in pediatric patients below 6 years of age have not been established
Ref - USP PDI Vol II 17th Edition (1997)
TRIFLURIDINE - OPHTHALMIC
1.Allergies-
Tell your doctor if you have ever had any unusual or allergic reaction to
trifluridine. Also tell your healthcare care professional if you are allergic
to any other substances such as foods. preservatives or dyes.
2.Pregnancy-
Studies have not been done in humans. When injected in chick embryos,
trifluridine has been shown to cause birth defects. However, studies in
in rabbits and rats have not shown that that trifluridine causes birth defects
although it did cause delayed bone formation in rats and rabbits and
death in unborn rabbits.
3. Breast-feeding-
It is unlikely that trifluridine used in eyes is absorbed in mothers body and
passes into breast milk. In addition, trifluridine has not been reported to
cause problems in nursing babies
4.Children-
Although there is no specific information comparing use of trifluridine in
children with use in other age groups, this medicine is not expected to
cause different side effects or problems than it does in adults.
5.Older adults-
There is no specific information comparing use of trifluridine in the elderly
with use in other age groups.
6. Other medicines-
Tell your doctor if you are using any other prescription or non-prescription
(Over-the counter) OTC medicine that is used in the eye.
Pregnancy and lactation:
Pregnancy -
Ttrifluridine ophthalmic solution should be used during pregnancy only if the potential
benefits justifies the potential risk to the fetus.
Lactation-
The drug should be be prescribed for nursing mothers unless the potential benefits
outweigh the potential risks.
Children-
Safety and efficacy in pediatric patients below 6 years of age have not been established
Manufacturer Details