Prolensa

Prolensa is an FDA-registered drug product whose active ingredient is BROMFENAC SODIUM. It is labelled by Bausch & Lomb Incorporated taken by ophthalmic and marketed as a human prescription drug product. Identifiers on file: NDC 24208-602, application NDA203168, label effective 20260505. It is one of 4 FDA drug label records sharing the active ingredient BROMFENAC SODIUM. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing BROMFENAC SODIUM are most often described in connection with: treatment postoperative, reduction ocular, pain patients, undergone cataract, usage prolensa, nonsteroidal anti-inflammatory, drug nsaid. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE PROLENSA ® is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. PROLENSA is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. ( 1 )

2 DOSAGE AND ADMINISTRATION Instill one drop into the affected eye once daily beginning 1 day prior to surgery, continued on the day of surgery, and through the first 14 days postsurgery. ( 2.1 ) 2.1 Recommended Dosage Apply one drop to the affected eye once daily beginning 1 day prior to cataract surgery, continued on the day of surgery, and through the first 14 days of the postoperative period. 2.2 Use with Other Topical Ophthalmic Medications PROLENSA may be administered in conjunction with other topical ophthalmic medications such as alpha agonists, beta-blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics. Drops should be administered at least 5 minutes apart.

4 CONTRAINDICATIONS None. None. ( 4 )

6 ADVERSE REACTIONS The most commonly reported adverse reactions in 3% to 8% of patients were anterior chamber inflammation, foreign body sensation, eye pain, photophobia, and blurred vision. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated, at 1 ‑ 800-553-5340 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 practice. The most commonly reported adverse reactions following use of PROLENSA following cataract surgery include: anterior chamber inflammation, foreign body sensation, eye pain, photophobia, and vision blurred. These reactions were reported in 3% to 8% of patients.

FDA lists 4 drug label records with BROMFENAC SODIUM as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Prolensa used for?
1 INDICATIONS AND USAGE PROLENSA ® is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. PROLENSA is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. ( 1 )

Who makes Prolensa?
Bausch & Lomb Incorporated is the labeler of record for Prolensa. 4 FDA label records share the active ingredient BROMFENAC SODIUM, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Prolensa come in?
administered by ophthalmic. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Prolensa prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing BROMFENAC SODIUM?
Yes. 4 FDA drug label records list BROMFENAC SODIUM as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Prolensa been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.