bromfenac ophthalmic (Rx)

Frequency Not Defined

Abnormal sensation in eye

Conjunctival hyperemia

Eye irriation (burning/stinging)

Eye pain

Eye pruritus

Eye redness

Headache

Iritis

Corneal erosion

Contraindications

None listed by manufacturer

Cautions

Contains sodium sulfite which may cause allergic reactions in susceptible individuals

Topical nonsteroidal 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 potential for healing problems

Potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs; use caution when treating individuals who have previously exhibited sensitivities to these drugs

Interferes 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; recommended that the drug be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time

Remove contact lenses before application, may reinsert 10 minutes after instilling drops

Corneal adverse reactions may occur in patients with keratitis after continued use that may result in loss of vision; discontinue use in patients with evidence of corneal epithelial damage

Use caution in patients with diabetes (may be at risk of corneal adverse effects that may result in loss of vision)

Use caution in patients with complicated ocular surgeries, corneal denervation, repeat ocular surface disease, or corneal epithelial defects

Use caution in patients with rheumatoid arthritis

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 this drug, 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 (eg, 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

Pregnancy

There are no adequate and well-controlled studies in pregnant women to inform any drug-associated risks

Because of known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of this drug during late pregnancy should be avoided

Animal data

• Treatment of pregnant rats and rabbits with oral bromfenac did not produce teratogenic effects at clinically relevant doses

Lactation

There are no data on presence of bromfenac in human milk, effects on breastfed infant, or on milk production; however, systemic exposure to this drug from ocular administration is low

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 breastfed child from bromfenac or from the underlying maternal condition

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Nonsteroidal anti-inflammatory agent; inhibits COX-1 and COX-2, which results in decreased formation of prostaglandin precursors

Absorption

Negligible systemic absorption

Half-life: 0.5-4 hr