SANDOZ TRIFLURIDINE SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TRIFLURIDINE

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

S01AD02

INN (International Name):

TRIFLURIDINE

Dosage:

1%

Pharmaceutical form:

SOLUTION

Composition:

TRIFLURIDINE 1%

Administration route:

OPHTHALMIC

Units in package:

7.5ML

Prescription type:

Prescription

Therapeutic area:

ANTIVIRALS

Product summary:

Active ingredient group (AIG) number: 0115886001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2019-08-01

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
SANDOZ TRIFLURIDINE
TRIFLURIDINE OPHTHALMIC SOLUTION 1%
TOPICAL ANTIVIRAL AGENT
Sandoz Canada Inc.
Date of Preparation: August 02, 2005
145, Jules-Léger
Boucherville, QC, Canada
J4B 7K8
Control No. 099920
1
PRODUCT MONOGRAPH
SANDOZ TRIFLURIDINE
TRIFLURIDINE OPHTHALMIC SOLUTION
1%
THERAPEUTIC CLASSIFICATION
Topical Antiviral Agent
ACTION
AND
CLINICAL
PHARMACOLOGY
Trifluridine is phosphorylated by a cellular thymidine kinase to its
nucleotide monophosphate.
Trifluridine monophosphate is an inhibitor of thymidylate synthetase,
the target enzyme for the
action of monofluorinated pyrimidines. Trifluridine has been
demonstrated to combine slowly
and irreversibly with thymidylate synthetase in a reaction that
requires ATP.
Trifluridine monophosphate is further phosphorylated by cellular
enzymes to the triphosphate
which is incorporated into DNA (but not RNA) by competitively
inhibiting the incorporation of
the natural nucleotide, thymidine triphosphate (dTTP).
The inhibition of viral replication can be reversed by the addition of
thymidine (thymidine
rescue).
Viral DNA polymerase has a higher affinity for trifluridine
triphosphate than does the DNA
polymerase of uninfected cells, resulting in the preferential
incorporation of the analogue into
viral DNA.
INDICATIONS
AND
CLINICAL
USE
Sandoz Trifluridine Ophthalmic Solution, 1% is indicated for the
treatment of primary
keratoconjunctivitis and recurrent epithelial keratitis due to herpes
simplex viruses, types 1 and 2.
Trifluridine is also effective in the treatment of epithelial
keratitis that has not responded
clinically to the topical administration of idoxuridine or when ocular
toxicity or hypersensitivity
to idoxuridine has occurred. In a smaller number of patients found to
be resistant to topical
vidarabine, trifluridine was also effective.
NOTE:
Sandoz Trifluridine is not indicated for the treatment of keratitis
with deep stromal
invasion and uveitis, ocular vaccinia, adenoviral ocular disease,
prophylaxis of
2
keratoconjunctivitis and/or recu