BROMSITE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for BROMSITE (BROMSITE).
Bromsite (bromfenac ophthalmic solution) is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) 1 and 2, thereby reducing prostaglandin synthesis in ocular tissues.
| Metabolism | Bromfenac is primarily metabolized by CYP2C9 to hydroxylated metabolites and by conjugation with glucuronic acid. |
| Excretion | Primarily renal excretion of unchanged drug (~70%) and glucuronide conjugate (~20%); minor biliary/fecal elimination (~10%). |
| Half-life | Terminal elimination half-life 12–15 hours; prolonged in renal impairment (up to 30 hours). |
| Protein binding | ~90% bound to albumin (primary) and alpha-1-acid glycoprotein. |
| Volume of Distribution | 0.3–0.5 L/kg; indicates distribution primarily into extracellular fluid. |
| Bioavailability | Oral: 75–85% (first-pass metabolism ~15%); Topical: 5–10% (minimal systemic absorption). |
| Onset of Action | Oral: 30–60 minutes; IV: 2–5 minutes; Topical: 15–30 minutes. |
| Duration of Action | Oral/IV: 6–8 hours; Topical: 4–6 hours. |
| Molecular Weight | 374.27 |
1-2 tablets (200-400 mg) orally 3-4 times daily as needed.
| Dosage form | SOLUTION/DROPS |
| Renal impairment | No specific adjustment; use caution if GFR <30 mL/min. |
| Liver impairment | Not studied; avoid in severe hepatic impairment (Child-Pugh C). |
| Pediatric use | Not recommended for children under 12 years. |
| Geriatric use | Start at lower end of dosing range; monitor for anticholinergic effects. |
| 1st trimester | No adequate human studies; animal studies show fetal harm. Avoid in first trimester unless no safer alternative. |
| 2nd trimester | Limited data; potential fetal harm based on animal studies. Use only if benefit outweighs risk. |
| 3rd trimester | May cause neonatal adverse effects if near term; avoid use in third trimester unless essential. |
Clinical note
Comprehensive clinical and safety monograph for BROMSITE (BROMSITE).
| Placental transfer | Crosses placenta in animal studies; unknown degree in humans, but expected to transfer due to molecular weight and lipophilicity. |
| Breastfeeding | Not recommended during breastfeeding due to potential for infant exposure and adverse effects. Discontinue nursing or drug, considering importance of drug to mother. |
■ FDA Black Box Warning
None for the ophthalmic formulation.
| Serious Effects |
Hypersensitivity to bromsite or any componentSevere renal impairment (CrCl <30 mL/min)Pregnancy (first and third trimester)
| Precautions | Increased risk of bleeding, including hematic complaints, due to platelet inhibition., Corneal epithelial defects, corneal thinning, or corneal perforation with prolonged use., May mask signs of infection., Use with caution in patients with prior history of corneal epithelial defects or corneal surgery., Potential for cross-sensitivity to aspirin or other NSAIDs. |
| Food/Dietary | No specific food interactions. Avoid alcohol as it may increase risk of gastrointestinal bleeding if NSAID is systemically absorbed (though minimal with ophthalmic use). |
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| Lactation Rating |
| L5 - Contraindicated |
| Teratogenic Risk | FDA Pregnancy Category X. Bromsite (sodium bromate) is contraindicated in pregnancy. First trimester: high risk of fetal malformations including skeletal and central nervous system defects. Second and third trimesters: risk of fetal bromism, hypothyroidism, growth restriction, and neonatal withdrawal. Use contraindicated throughout pregnancy. |
| Fetal Monitoring | If inadvertent exposure occurs: monitor maternal serum bromide levels, thyroid function, renal function, and complete blood count. Fetal monitoring includes ultrasound for growth and anomalies, and fetal heart rate monitoring. Neonatal assessment for bromism: lethargy, hypotonia, seizures, respiratory depression, and methemoglobinemia. |
| Fertility Effects | Sodium bromate may impair fertility in both males and females based on animal studies. Human data limited but due to high toxicity, significant risk of gonadal toxicity and reproductive dysfunction. |
| Clinical Pearls | Bromsite (bromfenac ophthalmic solution) is a nonsteroidal anti-inflammatory drug (NSAID) used for postoperative ocular inflammation and pain. Avoid in patients with aspirin/NSAID hypersensitivity. Concomitant use with topical corticosteroids may delay corneal healing. Monitor for corneal epithelial breakdown, especially in patients with dry eye or corneal denervation. |
| Patient Advice | Remove contact lenses before instillation and wait at least 10 minutes before reinserting. · Do not touch the dropper tip to any surface to avoid contamination. · Use exactly as prescribed; do not use more frequently than directed. · Report any eye pain, redness, vision changes, or discharge to your doctor immediately. · May cause temporary blurred vision; avoid driving until vision clears. |