BROMFENAC SODIUM
Clinical safety rating: caution
Comprehensive clinical and safety monograph for BROMFENAC SODIUM (BROMFENAC SODIUM).
Nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), thereby reducing prostaglandin synthesis, leading to decreased inflammation, pain, and fever. Specifically, bromfenac is a potent inhibitor of COX-2.
| Metabolism | Primarily hepatic metabolism via CYP2C9; minor pathways include glucuronidation. The active moiety is bromfenac, and its metabolites are excreted in urine and feces. |
| Excretion | Renal: ~80% (primarily as unchanged drug and glucuronide conjugate); Biliary/Fecal: ~20% |
| Half-life | Terminal elimination half-life: 1.5-2.5 hours (prolonged in renal impairment; clinical context: short half-life supports twice-daily dosing in ophthalmic use) |
| Protein binding | ~99% (bound to albumin) |
| Volume of Distribution | 0.3 L/kg (clinical meaning: indicates distribution primarily into extracellular fluid; limited tissue penetration) |
| Bioavailability | Ophthalmic: minimal systemic absorption (<5% of ocular dose); Oral: not clinically used; intravenous: 100% |
| Onset of Action | Ophthalmic: 30 minutes to 1 hour for analgesic effect following cataract surgery |
| Duration of Action | Ophthalmic: 12-24 hours (clinical notes: sustained anti-inflammatory effect; dosing every 12 hours for postoperative inflammation) |
One drop (0.1 mL) of 0.09% ophthalmic solution (bromfenac 0.9 mg/mL) instilled into the affected eye(s) twice daily beginning 24 hours before cataract surgery and continuing on the day of surgery and for 14 days postoperatively.
| Dosage form | SOLUTION/DROPS |
| Renal impairment | No dose adjustment required for systemic administration; however, ophthalmic use is not significantly absorbed, and no specific renal adjustment guidelines exist. Use with caution in severe renal impairment (CrCl <30 mL/min) due to potential accumulation of preservatives. |
| Liver impairment | No formal dose adjustment guidelines for ophthalmic use. For systemic NSAIDs, avoid use in severe hepatic impairment (Child-Pugh class C). Bromfenac ophthalmic is not contraindicated but use with caution in hepatic disease. |
| Pediatric use | Safety and efficacy in pediatric patients (<18 years) have not been established; no recommended dosing. |
| Geriatric use | No specific dose adjustment required in elderly patients. Use the same dose as in younger adults. Monitor for increased risk of adverse effects (e.g., corneal complications) due to age-related ocular surface changes. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for BROMFENAC SODIUM (BROMFENAC SODIUM).
| Breastfeeding | Bromfenac is excreted into breast milk in low amounts. M/P ratio not reported. Due to limited data and potential for adverse effects in neonates (e.g., renal impairment, gastrointestinal bleeding), avoid use during breastfeeding or use with caution after assessing risk-benefit. |
| Teratogenic Risk | Bromfenac sodium is an NSAID. First trimester: Limited data, but NSAIDs are associated with a small increased risk of miscarriage and cardiac defects. Avoid if possible. Second trimester: Generally considered safer, but should be used with caution. Third trimester: Contraindicated due to risk of premature closure of the ductus arteriosus, oligohydramnios, and neonatal renal impairment. |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to bromfenac or any component of the formulation.","Prior history of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.","In patients with active peptic ulcer disease or gastrointestinal bleeding."]
| Precautions | ["Increased risk of bleeding due to platelet inhibition; use with caution in patients with known bleeding tendencies or who are on anticoagulants.","Potential for cross-sensitivity to aspirin or other NSAIDs; avoid in patients with prior hypersensitivity reactions.","Delayed healing of ocular tissues; use cautiously after ocular surgery.","Possible corneal adverse effects including keratitis, corneal thinning, or corneal melt; discontinue if corneal epithelial breakdown occurs."] |
| Food/Dietary | No significant food interactions for ophthalmic bromfenac. |
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| Fetal Monitoring | Monitor fetal ultrasound for ductus arteriosus constriction and oligohydramnios in third trimester. Assess maternal renal function and gastrointestinal symptoms. For prolonged use, monitor for signs of premature labor or growth restriction. |
| Fertility Effects | NSAIDs, including bromfenac, may impair female fertility by inhibiting prostaglandin synthesis required for ovulation. Effects are reversible upon discontinuation. No studies on male fertility with bromfenac specifically. |
| Clinical Pearls | Monitor for corneal adverse events; use with caution in patients with risk factors for corneal erosion or perforation. Avoid concurrent use of other NSAIDs including topical ophthalmic preparations. Discontinue if corneal epithelial breakdown occurs. |
| Patient Advice | Do not wear contact lenses during treatment for ophthalmic use. · Report any eye pain, redness, vision changes, or light sensitivity immediately. · Do not touch the dropper tip to any surface to avoid contamination. · Remove contact lenses before instilling drops and wait at least 10 minutes before reinserting. · Keep bottle tightly closed when not in use. |