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Pharmacologic Category
Nonsteroidal Anti-inflammatory Drug (NSAID), Ophthalmic
Dosing: Adult
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.
* See Dosage and Administration in AHFS Essentials for additional information.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Renal Impairment: Adult
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
Dosing: Hepatic Impairment: Adult
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
Use: Labeled Indications
Postoperative ocular inflammation/pain: Treatment of postoperative inflammation and reduction of ocular pain following cataract surgery.
* See Uses in AHFS Essentials for additional information.
Class and Related Monographs
Ophthalmic Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
Comparative Efficacy
Administration: Ophthalmic
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.
Storage/Stability
Store at 15°C to 25°C (59°F to 77°F).
Medication Patient Education with HCAHPS Considerations
What is this drug used for?
• It is used to treat swelling and pain after cataract surgery.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
• Headache
• Burning
• Stinging
• Foreign body sensation in eye
• Redness
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• Vision changes
• Eye pain
• Severe eye irritation
• Bleeding in the eye
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.
Contraindications
There are no contraindications listed in the manufacturer’s labeling.
Documentation of allergenic cross-reactivity for nonsteroidal anti-inflammatory drugs (NSAIDs) is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to bromfenac, or any component of the formulation.
Warnings/Precautions
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.
* See Cautions in AHFS Essentials for additional information.
Geriatric Considerations
No differences in safety and efficacy noted between elderly and younger adults. No dosage adjustment necessary. Elderly may be taking other medications that will increase bleeding.
Pregnancy Risk Factor
C
Pregnancy Considerations
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.
Breast-Feeding Considerations
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.
Briggs' Drugs in Pregnancy & Lactation
Adverse Reactions
1% to 10%:
Central nervous system: Headache (≥1% to ≤8%)
Ophthalmic: Anterior chamber inflammation (1% to 8%), iritis (1% to 8%), ocular hypertension (1% to 8%), vitreous opacity (1% to 8%), eye pain (≤1% to ≤8%), abnormal sensation in eyes (2% to 7%), conjunctival hyperemia (2% to 7%), eye irritation (burning/stinging; 2% to 7%), eye pruritus (2% to 7%), eye redness (2% to 7%)
Frequency not defined:
Hematologic & oncologic: Prolonged bleeding time
Miscellaneous: Wound healing impairment
<1%, postmarketing and/or case reports: Corneal erosion, corneal perforation, corneal thinning, epithelial keratopathy
* See Cautions in AHFS Essentials for additional information.
Allergy and Idiosyncratic Reactions
Toxicology
Metabolism/Transport Effects
None known.
Drug Interactions Open Interactions
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. Exceptions: Loteprednol. 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
Advanced Practitioners Physical Assessment/Monitoring
Assess for intraocular bleeding. Evaluate allergy history with aspirin or other NSAIDs.
Nursing Physical Assessment/Monitoring
Monitor for intraocular bleeding. Check allergy history with aspirin or other NSAIDs. Instruct patient on proper administration technique.
Dosage Forms: US
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Ophthalmic:
BromSite: 0.075% (5 mL) [contains benzalkonium chloride, edetate (edta) disodium dihydrate]
Prolensa: 0.07% (3 mL) [contains benzalkonium chloride, edetate disodium, sodium sulfite]
Generic: 0.09% (1.7 mL, 2.5 mL [DSC])
Dosage Forms: Canada
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 disodium, sodium sulfite]
Anatomic Therapeutic Chemical (ATC) Classification
- S01BC11
Generic Available (US)
Yes
Pricing: US
Solution (Bromfenac Sodium (Once-Daily) Ophthalmic)
0.09% (per mL): $100.56 - $125.70
Solution (BromSite Ophthalmic)
0.075% (per mL): $64.80
Solution (Prolensa Ophthalmic)
0.07% (per mL): $113.07
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.
Mechanism of Action
Inhibits prostaglandin synthesis by decreasing the activity of the enzyme, cyclooxygenase 1 and 2, which results in decreased formation of prostaglandin precursors.
Pharmacodynamics/Kinetics
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)
Local Anesthetic/Vasoconstrictor Precautions
No information available to require special precautions
Effects on Dental Treatment
The dentist should be aware of the potential of abnormal coagulation. Caution should also be exercised in the use of NSAIDs in patients already on anticoagulant therapy with drugs such as warfarin (Coumadin®). See Effects on Bleeding.
Effects on Bleeding
Bromfenac is marketed in the U.S. only as an ophthalmic drop. It is a nonselective NSAID which is known to reversibly inhibit platelet aggregation. However, there is no scientific evidence to warrant discontinuation of topical NSAIDs prior to dental surgery.
Index Terms
Bromfenac Sodium; BromSite
FDA Approval Date
March 24, 2005
References
Bromfenac 0.09% [prescribing information]. Weston, FL: Apotex; February 2014.
Bromfenac 0.09% twice-daily formulation [prescribing information]. Weston, FL: Apotex; February 2014.
BromSite (bromfenac) [prescribing information]. Cranbury, NJ: Sun Pharmaceutical Industries Inc; April 2016.
Henderson BA, Gayton JL, Chandler SP, et al, "Safety and Efficacy of Bromfenac Ophthalmic Solution (Bromday) Dosed Once Daily for Postoperative Ocular Inflammation and Pain," Ophthalmology, 2011, 118(11):2120-7.[PubMed 21762992]
Prolensa (bromfenac) [prescribing information]. Bridgewater, NJ: Bausch & Lomb; April 2020.
Prolensa (bromfenac) [product monograph]. Laval, QC, Canada: Valeant Canada; February 2017.
Silverstein SM, Cable MG, Sadri E, et al, "Once Daily Dosing of Bromfenac Ophthalmic Solution 0.09% for Postoperative Ocular Inflammation and Pain," Curr Med Res Opin, 2011, 27(9):1693-703.[PubMed 21751945]
Brand Names: International
Artofenac (EG); Berlofen (AR); Bromoflam (EG); Bronac (KR); Bronuck (CN, JP, VN); Brosur (IN); Brovis (BD); Broxinac (RU); Fenac (AR); Natax (AR); Relye (BD); Rotarac (BD); Xirofen (BD); Yellox (AT, CH, CZ, DK, EE, ES, FI, FR, GB, HR, HU, IE, LT, MT, NL, NO, PL, PT, RO, SE, SI, SK)
Last Updated 9/11/20
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