Version May 2024
Postoperative ocular inflammation/pain:
Ophthalmic (0.07%): Instill 1 drop into affected eye(s) once daily beginning 1 day prior to cataract surgery and continue on the day of surgery and for 14 days postoperatively.
Ophthalmic (0.075%): Instill 1 drop into affected eye(s) twice daily beginning 1 day prior to cataract surgery and continue on the day of surgery and for 14 days postoperatively.
Ophthalmic (0.09% once-daily formulation): Instill 1 drop into affected eye(s) once daily beginning 1 day prior to cataract surgery and continue on the day of surgery and for 14 days postoperatively
Ophthalmic (0.09% twice-daily formulation): Instill 1 drop into affected eye(s) twice daily beginning 24 hours after cataract surgery and continue through the first 14 days postoperatively.
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Nervous system: Headache (1% to 8%)
Ophthalmic: Anterior chamber inflammation (1% to 8%), blurred vision (3% to 8%), eye pain (1% to 8%), foreign body sensation of eye (3% to 8%), iritis (1% to 8%), ocular hypertension (1% to 8%), photophobia (3% to 8%), vitreous opacity (1% to 8%)
Postmarketing: Ophthalmic: Corneal perforation (corneal melt) (Asai 2006), keratitis (neurotrophic) (Raj 2022)
There are no contraindications listed in the US manufacturer's labeling.
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to bromfenac, or any component of the formulation.
Concerns related to adverse effects:
• Aspirin/NSAID sensitivity: Use with caution in patients with previous sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs, including patients who experience bronchospasm, asthma, rhinitis, or urticaria following NSAID or aspirin therapy.
• Corneal effects: May cause keratitis. Continued use may cause severe corneal adverse effects, including corneal thinning, erosion, perforation, or ulceration; may result in loss of vision. Discontinue use in patients with evidence of corneal epithelial damage.
• Delayed healing: Healing time may be slowed or delayed. Use with caution in patients receiving concomitant topical steroid therapy due to an increased risk for healing problems.
Disease-related concerns:
• Bleeding disorders: Use with caution in patients with a predisposition to bleeding (bleeding tendencies or medications which interfere with coagulation). Increased intraocular bleeding (including hyphema) has been reported following surgery.
• 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.
Special populations:
• Postsurgical patients: 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: May contain benzalkonium chloride as a preservative.
• Sulfites: May contain sulfites, which may cause allergic-type reactions in susceptible individuals.
Other warnings/precautions:
• 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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Ophthalmic:
BromSite: 0.075% (5 mL) [contains benzalkonium chloride, edetate (edta) disodium dihydrate]
Prolensa: 0.07% (3 mL) [contains benzalkonium chloride, edetate (edta) disodium, sodium sulfite]
Generic: 0.07% (3 mL); 0.09% (1.7 mL)
Yes
Solution (Bromfenac Sodium (Once-Daily) Ophthalmic)
0.09% (per mL): $100.56 - $125.69
Solution (Bromfenac Sodium Ophthalmic)
0.07% (per mL): $128.33 - $128.47
Solution (BromSite Ophthalmic)
0.075% (per mL): $64.80
Solution (Prolensa Ophthalmic)
0.07% (per mL): $142.75
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Ophthalmic:
Prolensa: 0.07% (0.6 mL, 1.6 mL, 3 mL) [contains benzalkonium chloride, edetate (edta) disodium, sodium sulfite]
Generic: 0.07% (1.6 mL, 3 mL)
For topical ophthalmic use only; wash hands prior to use. 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.
Postoperative ocular inflammation/pain: Treatment of postoperative inflammation and reduction of ocular pain following cataract surgery.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Anticoagulants: Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy
Corticosteroids (Ophthalmic): Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may enhance the adverse/toxic effect of Corticosteroids (Ophthalmic). Healing of ophthalmic tissue during concomitant administration of ophthalmic products may be delayed. Risk C: Monitor therapy
Prostaglandins (Ophthalmic): Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may diminish the therapeutic effect of Prostaglandins (Ophthalmic). Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may enhance the therapeutic effect of Prostaglandins (Ophthalmic). Risk C: Monitor therapy
Adverse events have been observed in animal reproduction studies. Exposure to nonsteroidal anti-inflammatory drugs late in pregnancy may lead to premature closure of the ductus arteriosus and may inhibit uterine contractions; some manufacturers recommend avoiding use in late pregnancy.
It is not known if bromfenac is excreted in breast milk. The manufacturer recommends that caution be exercised when administering bromfenac to nursing women. According to one manufacturer, the decision to breast-feed during therapy should take into account the risk of exposure to the infant and the benefits of treatment to the mother.
Inhibits prostaglandin synthesis by decreasing the activity of the enzyme, cyclooxygenase 1 and 2, which results in decreased formation of prostaglandin precursors.
Absorption: Theoretically, systemic absorption may occur following ophthalmic use (not characterized); anticipated levels are below the limits of assay detection
Half-life elimination: 0.5 to 4 hours (following oral administration)
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