Included as part of the PRECAUTIONS section.
Slow Or Delayed Healing
All topical nonsteroidal
anti-inflammatory drugs (NSAIDs), including BromSite (bromfenac ophthalmic
solution) 0.075%, 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 problems.
Potential For Cross-Sensitivity
There is the potential for
cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and
other NSAIDs, including BromSite (bromfenac ophthalmic solution) 0.075%.
Therefore, caution should be used when treating individuals who have previously
exhibited sensitivities to these drugs.
Increased Bleeding Time Of Ocular
With some NSAIDs, including
BromSite (bromfenac ophthalmic solution) 0.075%, there exists the potential for
increased bleeding time due to interference with platelet aggregation. There
have been reports that ocularly applied NSAIDs may cause increased bleeding of
ocular tissues (including hyphemas) in conjunction with ocular surgery.
It is recommended that BromSite
be used with caution in patients with known bleeding tendencies or who are
receiving other medications which may prolong bleeding time.
Keratitis And Corneal Reactions
Use of topical NSAIDs may
result in keratitis. In some susceptible patients, continued use of topical
NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion,
corneal ulceration or corneal perforation. These events may be sight
threatening. Patients with evidence of corneal epithelial breakdown should
immediately discontinue use of topical NSAIDs, including BromSite (bromfenac
ophthalmic solution) 0.075%, and should be closely monitored for corneal health.
Post-marketing experience with
topical NSAIDs suggests that patients with complicated ocular surgeries,
corneal denervation, corneal epithelial defects, diabetes mellitus, ocular
surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular
surgeries within a short period of time may be at increased risk for corneal
adverse events which may become sight threatening. Topical NSAIDs should be
used with caution in these patients.
Post-marketing experience with
topical NSAIDs also suggests that use more than 24 hours prior to surgery or
use beyond 14 days postsurgery may increase patient risk for the occurrence and
severity of corneal adverse events.
Contact Lens Wear
BromSite should not be
administered while wearing contact lenses. The preservative in
chloride, may be absorbed by soft contact lenses.
Patient Counseling Information
Advise patients to read the FDA-approved
patient labeling (Instructions for Use) .
Slow Or Delayed Healing
Advise patients of the
possibility that slow or delayed healing may occur while using NSAIDs.
Concomitant Topical Ocular
If more than one topical
ophthalmic medication is being used, advise patients to administer BromSite at
least 5 minutes after instillation of other topical medications.
Concomitant Use Of Contact
Advise patients not to wear
contact lenses during administration of BromSite. The preservative in this
product, benzalkonium chloride, may be absorbed by soft contact lenses.
Sterility Of Dropper
Advise patients to replace the
bottle cap after use and do not touch the dropper tip to any surface as this
may contaminate the contents.
Advise patients to thoroughly
wash hands prior to using BromSite.
Carcinogenesis, Mutagenesis and
Impairment Of Fertility
Long-term carcinogenicity studies in rats and mice given
oral doses of bromfenac up to 0.6 mg/kg/day (129 times a unilateral daily dose
assuming 100% absorbed, on a mg/m² basis) and 5 mg/kg/day (540 times a
unilateral daily dose on a mg/m² basis), respectively revealed no significant
increases in tumor incidence.
Bromfenac did not show
mutagenic potential in various mutagenicity studies, including the bacterial
reverse mutation, chromosomal aberration, and micronucleus tests.
Bromfenac did not impair fertility when administered
orally to male and female rats at doses up to 0.9 mg/kg/day and 0.3 mg/kg/day,
respectively (195 and 65 times a unilateral daily dose, respectively, on a mg/m²
Use In Specific Populations
There are no adequate and
well-controlled studies in pregnant women to inform any drug associated risks.
Treatment of pregnant rats and rabbits with oral bromfenac did not produce
teratogenic effects at clinically relevant doses.
Because of the known effects of
prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system
(closure of ductus arteriosus), the use of BromSite during late pregnancy
should be avoided.
Treatment of rats with
bromfenac at oral doses up to 0.9 mg/kg/day (195 times a unilateral daily human
ophthalmic dose on a mg/m² basis, assuming 100% absorbed) and
rabbits at oral doses up to 7.5 mg/kg/day (3243 times a unilateral daily dose
on a mg/m² basis) produced no structural teratogenicity in
reproduction studies. However, embryo-fetal lethality, neonatal mortality and
reduced postnatal growth were produced in rats at 0.9 mg/kg/day, and
embryo-fetal lethality was produced in rabbits at 7.5 mg/kg/day. Because animal
reproduction studies are not always predictive of human response, this drug
should be used during pregnancy only if the potential benefit justifies the
potential risk to the fetus.
There are no data on the presence of bromfenac in human
milk, the effects on the breastfed infant, or the effects on milk production;
however, systemic exposure to bromfenac from ocular administration is low [see CLINICAL
PHARMACOLOGY]. The developmental and health benefits of breastfeeding
should be considered along with the mother's clinical need for bromfenac and
any potential adverse effects on the breast-fed child from bromfenac or from
the underlying maternal condition.
Safety and efficacy in
pediatric patients below the age of 18 years have not been established.
There is no evidence that the
efficacy or safety profiles for BromSite differ in patients 65 years of age and
older compared to younger adult patients.