With some nonsteroidal
anti-inflammatory drugs, there exists the potential for increased bleeding time
due to interference with thrombocyte aggregation. There have been reports that OCUFEN® ophthalmic
solution may cause increased bleeding of ocular tissues (including hyphemas) in
conjunction with ocular surgery.
There is the potential for
cross-sensitivity to acetylsalicylic acid and other non-steroidal
anti-inflammatory drugs. Therefore, caution should be used when treating
individuals who have previously exhibited sensitivities to these drugs.
anti-inflammatory drugs (NSAIDs) may slow or delay healing. Topical
corticosteroids are also known to slow or delay healing. Concomitant use of
topical NSAIDs and topical steroids may increase the potential for healing
It is recommended that OCUFEN® ophthalmic
solution be used with caution in surgical patients with known bleeding
tendencies or who are receiving other medications which may prolong bleeding
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in mice
and/or rats have shown no evidence of carcinogenicity with flurbiprofen.
Long-term mutagenicity studies in animals have not been performed.
Pregnancy Category C
Flurbiprofen has been shown
to be embryocidal, delay parturition, prolong gestation, reduce weight, and/or
slightly retard growth of fetuses when given to rats in daily oral doses of 0.4
mg/kg (approximately 300 times the human daily topical dose) and above.
There are no adequate and
well-controlled studies in pregnant women. OCUFEN® ophthalmic
solution should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus.
It is not known whether this
drug is excreted in human milk. Because many drugs are excreted in human milk
and because of the potential for serious adverse reactions in nursing infants
from flurbiprofen sodium, a decision should be made whether to discontinue
nursing or to discontinue the drug, taking into account the importance of the
drug to the mother.
Safety and effectiveness in
pediatric patients have not been established.
No overall differences in
safety or effectiveness have been observed between elderly and younger