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Ocufen

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WARNINGS

With nonsteroidal anti-inflammatory drugs, there exists the potential for increased bleeding due to interference with thrombocyte aggregation. There have been reports that OCUFEN® (flurbiprofen sodium ophthalmic solution) ophthalmic solution may cause increased bleeding of ocular tissues including hyphemas in conjunction with ocular surgery.

There exists the potential for cross-sensitivity to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.

PRECAUTIONS

General

Wound healing may be delayed with the use of OCUFEN® (flurbiprofen sodium ophthalmic solution, USP) 0.03%.

It is recommended that OCUFEN® (flurbiprofen sodium ophthalmic solution) ophthalmic solution be used with caution in surgical patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.

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

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 333 times the human daily topical dose) and above.

Nursing mothers

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.

Pediatric use

Safety and effectiveness in pediatric patients have not been established.

Geriatric use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Last reviewed on RxList: 12/30/2008
This monograph has been modified to include the generic and brand name in many instances.

Additional Ocufen Information

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