(BROME fen ak)
- Bromfenac Sodium
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Bromday: 0.09% (1.7 mL [DSC]) [contains benzalkonium chloride, edetate disodium, polysorbate 80, sodium sulfite]
Prolensa: 0.07% (1.6 mL [DSC], 3 mL) [contains benzalkonium chloride, edetate disodium, sodium sulfite]
Generic: 0.09% (1.7 mL, 2.5 mL, 5 mL [DSC])
Brand Names: U.S.
- Bromday [DSC]
- Nonsteroidal Anti-inflammatory Drug (NSAID), Ophthalmic
Inhibits prostaglandin synthesis by decreasing the activity of the enzyme, cyclooxygenase, which results in decreased formation of prostaglandin precursors.
Theoretically, systemic absorption may occur following ophthalmic use (not characterized); anticipated levels are below the limits of assay detection
0.5 to 4 hours (following oral administration)
Use: Labeled Indications
Treatment of postoperative inflammation and reduction in ocular pain following cataract removal
There are no contraindications listed in the manufacturer’s prescribing information.
Ophthalmic (0.07%, 0.09%): Adults: Instill 1 drop into affected eye(s) once daily beginning 1 day prior to surgery and continuing on the day of surgery and for 2 weeks postoperatively
Dosage adjustment in renal impairment: There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
Dosage adjustment in hepatic impairment: There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
Remove contact lenses prior to administration and wait 10 minutes before reinserting. May be used with other eye drops. If using more than 1 ophthalmic product, wait at least 5 minutes between application of each medication. Minimize contamination by not touching the eyelids or surrounding areas with the dropper tip; keep bottle tightly closed when not in use. Also, to minimize the risk of infection following surgery of both eyes, two separate bottles of eye drops (one for each eye) should be used; instruct patients not to use the same bottle for both eyes.
Store at 15°C to 25°C (59°F to 77°F).
Corticosteroids (Ophthalmic): NSAID (Ophthalmic) may enhance the adverse/toxic effect of Corticosteroids (Ophthalmic). Healing of ophthalmic tissue during concomitant administration of ophthalmic products may be delayed. Exceptions: Loteprednol. Monitor therapy
2% to 7%:
Central nervous system: Headache
Ocular: Abnormal sensation, conjunctival hyperemia, iritis, irritation (burning/stinging), pain, pruritus, redness
Postmarketing and/or case reports: Corneal erosion, corneal perforation, corneal thinning, corneal ulceration, epithelial breakdown
Concerns related to adverse effects:
• Aspirin/NSAID sensitivity: Use with caution in patients with previous sensitivity to acetylsalicylic acid and phenylacetic acid derivatives, including patients who experience bronchospasm, asthma, rhinitis, or urticaria following NSAID or aspirin therapy.
• Keratitis: May cause keratitis; continued use in a patient with keratitis may cause severe corneal adverse reactions, potentially resulting in loss of vision. Immediately discontinue use in patients with evidence of corneal epithelial damage.
• Bleeding disorders: Use with caution in patients with a predisposition to bleeding (bleeding tendencies or medications which interfere with coagulation).
• Diabetes: Use with caution in patients with diabetes mellitus; may be at risk of corneal adverse events, potentially resulting in loss of vision.
• Ocular disease: Use with caution in patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, ocular surface disease, or repeat ocular surgeries (within a short timeframe); may be at risk of corneal adverse events, potentially resulting in loss of vision.
• Rheumatoid arthritis: Use with caution in patients with rheumatoid arthritis; may be at risk of corneal adverse events, potentially resulting in loss of vision.
• Surgery patients: May slow/delay healing or prolong bleeding time following surgery. Also, to minimize the risk of infection following surgery of both eyes, two separate bottles of eye drops (one for each eye) should be used; instruct patients not to use the same bottle for both eyes.
Dosage form specific issues:
• Benzalkonium chloride: Contains benzalkonium chloride as a preservative.
• Sulfites: Contains sulfites, which may cause allergic reactions.
• Contact lenses: Contact lenses should be removed prior to instillation (bromfenac drops contain benzalkonium chloride which may be adsorbed by contact lens); may be reinserted after 10 minutes.
• Duration of therapy: Use for more than 1 day prior to surgery or for 14 days beyond surgery may increase risk and severity of corneal adverse events.
Pregnancy Risk Factor
In animal reproduction studies, at exposures much higher than those which would result from ophthalmic use, embryo-fetal lethality and increased postimplantation loss occurred. Exposure to nonsteroidal anti-inflammatory drugs late in pregnancy may lead to premature closure of the ductus arteriosus and may inhibit uterine contractions.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience headache. Have patient report immediately to prescriber vision changes, ophthalmalgia, severe eye irritation, or subconjunctival hemorrhage (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.