A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Ocufen Warnings, Precautions, Pregnancy, Nursing, Abuse - Flurbiprofen
Ocufen Warnings, Precautions, Pregnancy, Nursing, Abuse - Flurbiprofen
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® 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®.
It is recommended that OCUFEN® (flurbiprofen sodium ophthalmic solution) 0.03%
be used with caution in surgical patients with known bleeding tendencies or
who are receiving other medications which may prolong bleeding time.
Drug Interactions: see (DRUG INTERACTIONS) section.
Carcinogenesis, mutagenesis, impairment of fertility: Long-term
studies in mice and/or rats have shown no evidence of carcinogenicity or impairment
of fertility 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.
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