bromsite
Bromsite (Bromfenac Sodium) is a nonsteroidal anti-inflammatory drug used to treat Inflammation, Postoperative Pain, Eye Pain.
Bromfenac Sodium · by Sun Pharm
Key facts
- Active ingredient
- Bromfenac Sodium
- Drug class
- Nonsteroidal Anti-Inflammatory Drug
- Form
- Drops
- Strength
- Bromfenac Sodium EQ 0.075% Acid
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- inflammation, postoperative pain, eye pain
- Manufacturer
- Sun Pharm
- What the pharmacy pays
- ~$14.72 per ml — not your price
- FDA application
- NDA206911
What is Bromsite?
From the FDA label:BromSite (bromfenac ophthalmic solution) 0.075% is a sterile aqueous, topical NSAID, formulated in DuraSite ® 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. BromSite is a greenish-yellow to dark yellow viscous liquid with an osmolality of approximately 290 mOsmol/kg. Active: Each mL contains bromfenac sodium sesquihydrate 0.87 mg, which is equivalent to bromfenac free acid 0.76 mg. Preservative: benzalkonium chloride 0.005% Inactives: boric acid, sodium borate, citric acid anhydrous, sodium citrate dihydrate, poloxamer 407, polycarbophil, sodium chloride, edetate disodium dihydrate, sodium hydroxide (to adjust pH to 8.3), and water for injection (USP). spl-bromsite-str
How to use
Instill one drop of BromSite 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) 2.1 Recommended Dosing One drop of BromSite 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. 2.2 Use with Other Topical Ophthalmic Medications BromSite should be administered at least 5 minutes after instillation of other topical medications. BromSite may be administered in conjunction with other topical ophthalmic medications such as alpha-agonists, beta-blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics.
Side effects
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 1-8% of patients were: anterior chamber inflammation, headache, vitreous floaters, iritis, eye pain and ocular hypertension. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-406-7984 (toll free), or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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.
Warnings
Important safety information
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) 5.1 Slow or Delayed Healing All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including BromSite (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. 5.2 Potential for Cross-Sensitivity There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs, including BromSite (bromfenac ophthalmic solution) 0.075%. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs. 5.3 Increased Bleeding Time of Ocular Tissue With some NSAIDs, including BromSite (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 BromSite be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time. 5.4 Keratitis 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 BromSite (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. 5.5 Contact Lens Wear BromSite should not be administered while wearing contact lenses. The preservative in BromSite, benzalkonium chloride, may be absorbed by soft contact lenses.
Who should not take Bromsite
None None (4)
Drug class
How this class works, per Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Bromsite ranks — best-rated nonsteroidal anti-inflammatory drug for:
Dosage forms
Drops
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Bromsite treat?
- Bromsite (Bromfenac Sodium) may be used to treat inflammation, postoperative pain, eye pain, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Bromsite work?
- Bromsite is a nonsteroidal anti-inflammatory drug. NSAIDs block cyclooxygenase (COX) enzymes that your body uses to make prostaglandins, the chemicals behind pain, swelling, and fever. Lowering prostaglandins eases pain and inflammation and brings down a high temperature.
- How much does Bromsite cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $14.72 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Advil — about $0.04 on the same basis.
- Is there a coupon or discount for Bromsite?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Bromsite. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Bromsite?
- Bromsite is marketed by Sun Pharm. You can see Sun Pharm's full profile, rating, and other products on pharmaranks.
- Is Bromsite a brand-name or generic drug?
- Bromsite is a brand-name product with the active ingredient Bromfenac Sodium.
- Is Bromsite available over the counter?
- No. Bromsite is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Bromsite come in?
- Bromsite is currently marketed as drops, per the FDA's National Drug Code Directory.
- What class of drug is Bromsite?
- Bromsite is classified as nonsteroidal anti-inflammatory drug, per the FDA's Established Pharmacologic Class.
- Is Bromsite FDA-registered?
- Bromsite is on record with the U.S. FDA under application number NDA206911. You can verify this on its official FDA label.
- Is Bromsite safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Bromsite. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Bromsite?
- Bromsite's side effects are taken directly from its FDA label. From the label: 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 a… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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