BROMFENAC .75 mg/mL Solution/ Drops
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Nonsteroidal Anti-inflammatory Drug class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
Bromfenac ophthalmic is used to treat eye swelling and redness (inflammation) and pain that can occur after cataract surgery. Bromfenac ophthalmic is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by stopping the release of certain natural substances that cause pain and swelling.
Read the full MedlinePlus article ↗- Bromfenac eye drops are used specifically around the time of cataract surgery. They help reduce inflammation — the swelling and irritation inside your eye — and ease eye pain durin...
- Tilt your head back, pull down your lower eyelid gently, and place one drop into the affected eye once a day. The most important things to remember: don't let the dropper tip touch...
- How do I use the drops correctly without causing problems?
- No — take your contact lenses out before you put the drops in. The preservative in bromfenac eye drops can be absorbed by soft contact lenses, which isn't good for your eyes or you...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Bromfenac Sodium — tap one for details:
Bromfenac Sodium may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII XF417D3PSL
Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
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UNII F5UM2KM3W7
Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
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UNII R57ZHV85D4
Boric acid is a weak acid derived from boron. In medicines, it typically serves as a buffer to help maintain the product's pH level and may act as a preservative in certain formulations.
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UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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UNII TUF2IVW3M2
Poloxamer 407 is a synthetic polymer made from ethylene oxide and propylene oxide. In medicines, it acts as a thickener, emulsifier, and solubilizer to help mix ingredients and create the right texture.
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UNII W25LM17A4W
Polycarbophil is a synthetic polymer that absorbs water and swells. It's used as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the digestive system.
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UNII 91MBZ8H3QO
Sodium borate is an inorganic salt compound used in medicines as a buffer to help maintain a stable pH level, and sometimes as a mild preservative or cleansing agent in topical formulations.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII B22547B95K
A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
11 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $24.098 | $120.49 / 5 ml |
| Medicaid paysCMS SDUD · 12 mo | $26.55 | $132.75 / 5 ml |
| Medicare drug plans payPart D · Q2 2026 | $29.83 | $149.16 / 5 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| bromfenac 0.075% .76 mg/mL 49708-0755-41 | Sun | 1 pouch | $24.098 | AB | Availability likely | — |
| Bromfenac .75 mg/mLthis 68180-0434-01 | Lupin | 1 bottle | $24.098 | AB | Availability likely | — |
| Bromsite 0.075% .76 mg/mL 49708-0754-41 | Sun | 1 pouch | $49.548 | AB | Availability likely | +106% |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 68180-0434-01 You're viewing this | 1 BOTTLE in 1 CARTON (68180-434-01) / 5 mL in 1 BOTTLE | 2024-02-12 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Bromfenac ophthalmic solution, 0.075% is indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery. Bromfenac ophthalmic solution is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Instill one drop of bromfenac ophthalmic solution to the affected eye twice daily (morning and evening) beginning 1 day prior to surgery, the day of surgery, and 14 days postsurgery. ( 2.1 )
2.1Recommended Dosing One drop of bromfenac ophthalmic solution should be applied to the affected eye twice daily (morning and evening) 1 day prior to surgery, the day of surgery, and 14 days postsurgery.
2.2Use with Other Topical Ophthalmic Medications Bromfenac ophthalmic solution, 0.075% should be administered at least 5 minutes after instillation of other topical medications. Bromfenac ophthalmic solution, 0.075% may be administered in conjunction with other topical ophthalmic medications such as alpha-agonists, beta-blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Topical ophthalmic solution: bromfenac 0.075%. Topical ophthalmic solution: bromfenac, 0.075%. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Slow or Delayed Healing ( 5.1 ) Potential for Cross-Sensitivity ( 5.2 ) Increased Bleeding Time of Ocular Tissue ( 5.3 ) Keratitis and Corneal Effects ( 5.4 ) Contact Lens Wear ( 5.5 )
5.1Slow or Delayed Healing All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including bromfenac ophthalmic solution, 0.075%, may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.
5.2Potential for Cross-Sensitivity There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs, including bromfenac ophthalmic solution, 0.075%. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
5.3Increased Bleeding Time of Ocular Tissue With some NSAIDs, including bromfenac ophthalmic solution, 0.075%, there exists the potential for increased bleeding time due to interference with platelet aggregation. There have been reports that ocularly applied NSAIDs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. It is recommended that bromfenac ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.
5.4Keratitis and Corneal Reactions Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events may be sight threatening.
Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs, including bromfenac ophthalmic solution, 0.075%, and should be closely monitored for corneal health. Postmarketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening.
Topical NSAIDs should be used with caution in these patients. Postmarketing experience with topical NSAIDs also suggests that use more than 24 hours prior to surgery or use beyond 14 days postsurgery may increase patient risk for the occurrence and severity of corneal adverse events.
5.5Contact Lens Wear Bromfenac ophthalmic solution should not be administered while wearing contact lenses. The preservative in Bromfenac ophthalmic solution, benzalkonium chloride, may be absorbed by soft contact lenses.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Slow or Delayed Healing [see Warnings and Precautions ( 5.1 )] Potential for Cross-Sensitivity [see Warnings and Precautions ( 5.2 )] Increased Bleeding Time of Ocular Tissue [see Warnings and Precautions ( 5.3 )] Keratitis and Corneal Reactions [see Warnings and Precautions ( 5.4 )] Contact Lens Wear [see Warnings and Precautions ( 5.5 )] The most commonly reported adverse reactions in 1 to 8% of patients were: anterior chamber inflammation, headache, vitreous floaters, iritis, eye pain and ocular hypertension.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The most commonly reported adverse reactions in 1 to 8% of patients were: anterior chamber inflammation, headache, vitreous floaters, iritis, eye pain and ocular hypertension.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no adequate and well-controlled studies in pregnant women to inform any drug associated risks. Treatment of pregnant rats and rabbits with oral bromfenac did not produce teratogenic effects at clinically relevant doses. Clinical Considerations Because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of bromfenac ophthalmic solution during late pregnancy should be avoided.
Data Animal Data Treatment of rats with bromfenac at oral doses up to 0.9 mg/kg/day (195 times a unilateral daily human ophthalmic dose on a mg/m 2 basis, assuming 100% absorbed) and rabbits at oral doses up to 7.5 mg/kg/day (3243 times a unilateral daily dose on a mg/m 2 basis) produced no structural teratogenicity in reproduction studies. However, embryo-fetal lethality, neonatal mortality and reduced postnatal growth were produced in rats at 0.9 mg/kg/day, and embryo-fetal lethality was produced in rabbits at 7.5 mg/kg/day.
Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
8.2Lactation There are no data on the presence of bromfenac in human milk, the effects on the breastfed infant, or the effects on milk production; however, systemic exposure to bromfenac from ocular administration is low [see Clinical Pharmacology ( 12.3 )]. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for bromfenac and any potential adverse effects on the breast-fed child from bromfenac or from the underlying maternal condition.
8.4Pediatric Use Safety and efficacy in pediatric patients below the age of 18 years have not been established.
8.5Geriatric Use There is no evidence that the efficacy or safety profiles for bromfenac ophthalmic solution differ in patients 65 years of age and older compared to younger adult patients.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no adequate and well-controlled studies in pregnant women to inform any drug associated risks. Treatment of pregnant rats and rabbits with oral bromfenac did not produce teratogenic effects at clinically relevant doses. Clinical Considerations Because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of bromfenac ophthalmic solution during late pregnancy should be avoided.
Data Animal Data Treatment of rats with bromfenac at oral doses up to 0.9 mg/kg/day (195 times a unilateral daily human ophthalmic dose on a mg/m 2 basis, assuming 100% absorbed) and rabbits at oral doses up to 7.5 mg/kg/day (3243 times a unilateral daily dose on a mg/m 2 basis) produced no structural teratogenicity in reproduction studies. However, embryo-fetal lethality, neonatal mortality and reduced postnatal growth were produced in rats at 0.9 mg/kg/day, and embryo-fetal lethality was produced in rabbits at 7.5 mg/kg/day.
Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and efficacy in pediatric patients below the age of 18 years have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use There is no evidence that the efficacy or safety profiles for bromfenac ophthalmic solution differ in patients 65 years of age and older compared to younger adult patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) that has anti-inflammatory activity. The mechanism of its action is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2. Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation.
In studies performed in animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis, and increased intraocular pressure.
12.3Pharmacokinetics Following bilateral topical ocular twice-daily dosing of Bromfenac, 0.075% ophthalmic solution, the plasma concentrations of bromfenac ranged from below the limit of quantification (LOQ = 0.20 ng/mL) to 2.42 ng/mL at 30 to 60 minutes post-dose.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) that has anti-inflammatory activity. The mechanism of its action is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2. Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation.
In studies performed in animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis, and increased intraocular pressure.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Bromfenac ophthalmic solution, 0.075% is supplied in white opaque low density polyethylene (LDPE) bottle closed with natural LDPE Nozzle and sealed with gray colored HDPE Cap. Tamper evidence provided by tamper evident ring. Each bottle is packed in a carton.
5 mL in a 10 mL bottle (NDC No. 68180-434-01) Storage : Store at 15ºC to 25ºC (59ºF to 77 ºF). After opening, bromfenac ophthalmic solution can be used until the expiration date on the bottle.
Discard after treatment completion.
📋 Description ▾
11 DESCRIPTION Bromfenac ophthalmic solution, 0.075% is a sterile aqueous, topical NSAID, for ophthalmic use. The USAN name for bromfenac sodium sesquihydrate is bromfenac sodium. Bromfenac sodium is designated chemically as sodium [2-amino-3-(4-bromobenzoyl) phenyl] acetate sesquihydrate, with an empirical formula of C 15 H 11 BrNNaO 3 • 1½H 2 O.
The structural formula for bromfenac sodium sesquihydrate is: Bromfenac sodium is a bright orange to yellow powder. The molecular weight of bromfenac sodium sesquihydrate is 383.17. Bromfenac ophthalmic solution is a greenish-yellow to dark yellow viscous liquid with an osmolality between 265 and 335 mOsmol per kg.
Active: Each mL contains bromfenac sodium sesquihydrate 0.0863% (0.863 mg) equivalent to bromfenac free acid 0.075% (0.75 mg) Preservative: benzalkonium chloride 0.005% (0.05 mg) Inactives: boric acid, citric acid anhydrous, edetate disodium dihydrate, poloxamer 407, polycarbophil, sodium borate, sodium chloride, sodium citrate dihydrate, sodium hydroxide to adjust pH and water for injection (USP). Figure 1
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Instructions for Use). Slow or Delayed Healing Advise patients of the possibility that slow or delayed healing may occur while using NSAIDs. Concomitant Topical Ocular Therapy If more than one topical ophthalmic medication is being used, advise patients to administer bromfenac ophthalmic solution at least 5 minutes after instillation of other topical medications.
Concomitant Use of Contact Lenses Advise patients not to wear contact lenses during administration of bromfenac ophthalmic solution. The preservative in this product, benzalkonium chloride, may be absorbed by soft contact lenses. Sterility of Dropper Tip/Product Use Advise patients to replace the bottle cap after use and do not touch the dropper tip to any surface as this may contaminate the contents.
Advise patients to thoroughly wash hands prior to using bromfenac ophthalmic solution. LUPIN and the are registered trademarks of Lupin Pharmaceuticals, Inc. Manufactured for: Lupin Pharmaceuticals, Inc.
Naples, FL 34108 United States Manufactured by: Lupin Limited Pithampur (M.P.) - 454 775 India Revised: October 2024 ID #277250 Image