Bromfenac
1.035 mg/mL · Solution/ Drops
- Prescription only
- Nonsteroidal Anti-inflammatory Drug
- Active substance
- Bromfenac
- Used in
- Muscles, joints and bones
- Made by
- Alembic Pharmaceuticals Limited
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2023-07-27
Nonsteroidal Anti-inflammatory Drug
- Bromfenac Ophthalmic Solution 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.
Sulfite Allergic Reactions ( 5.1 ) Slow or Delayed Healing ( 5.2 ) Potential for cross-sensitivity ( 5.3 ) Increase bleeding of ocular tissues ( 5.4 ) Corneal effects including keratitis ( 5.5 ) Contact Lens Wear ( 5.6 )
All warnings ↓- Prescription only
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
- Bromfenac Ophthalmic Solution 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.
- BROMFENAC 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 extraction.
From the official label · 2023-07-27 · DailyMed
How it works
From this product’s own US prescribing label.
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.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2023-07-27
Do not take it if
None.
Quoted from the official label, section “Contraindications”.
How to take it
These directions are for this exact strength and form. Another one is different.
- Instill one drop into the affected eye(s) once daily beginning 1 day prior to surgery, continued on the day of surgery and through the first 14 days post-surgery ( 2.1 ).
- 2.1 Recommended Dosing For the treatment of postoperative inflammation in patients who have undergone cataract extraction, one drop of bromfenac ophthalmic solution should be applied to the affected eye(s) 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 Bromfenac ophthalmic solution 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.
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- Sulfite Allergic Reactions ( 5.1 ) Slow or Delayed Healing ( 5.2 ) Potential for cross-sensitivity ( 5.3 ) Increase bleeding of ocular tissues ( 5.4 ) Corneal effects including keratitis ( 5.5 ) Contact Lens Wear ( 5.6 )
- 5.1 Sulfite Allergic Reactions Contains sodium sulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.
- The overall prevalence of sulfite sensitivity in the general population is unknown and probably low.
- Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.
- 5.2 Slow or Delayed Healing All topical nonsteroidal anti-inflammatory drugs (NSAIDs) 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.
- 5.3 Potential for Cross-Sensitivity There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs.
- Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
- 5.4 Increased Bleeding Time With some NSAIDs, 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.
- 5.5 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 and should be closely monitored for corneal health.
- Post-marketing 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.
- Post-marketing experience with topical NSAIDs also suggests that use more than 24 hours prior to surgery or use beyond 14 days post surgery may increase patient risk for the occurrence and severity of corneal adverse events.
- 5.6 Contact Lens Wear Bromfenac should not be administered while wearing contact lenses.
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
- Teratogenic Effects: Pregnancy Category C .
- Reproduction studies performed in rats at oral doses up to 0.9 mg/kg/day (1300 times the recommended human ophthalmic dose [RHOD]) and in rabbits at oral doses up to 7.5 mg/kg/day (11,000 times RHOD) revealed no evidence of teratogenicity due to bromfenac.
- However, 0.9 mg/kg/day in rats caused embryo-fetal lethality, increased neonatal mortality, and reduced postnatal growth.
- Pregnant rabbits treated with 7.5 mg/kg/day caused increased post implantation loss.
- There are no adequate and well-controlled studies in pregnant women.
- 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.
- Nonteratogenic Effects:
- 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.
- Caution should be exercised when bromfenac is administered to a nursing woman.
- IN SPECIFIC POPULATIONS
- 8.1 Pregnancy Teratogenic Effects: Pregnancy Category C .
- Reproduction studies performed in rats at oral doses up to 0.9 mg/kg/day (1300 times the recommended human ophthalmic dose [RHOD]) and in rabbits at oral doses up to 7.5 mg/kg/day (11,000 times RHOD) revealed no evidence of teratogenicity due to bromfenac.
- However, 0.9 mg/kg/day in rats caused embryo-fetal lethality, increased neonatal mortality, and reduced postnatal growth.
- Pregnant rabbits treated with 7.5 mg/kg/day caused increased post implantation loss.
- There are no adequate and well-controlled studies in pregnant women.
- 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.
- Nonteratogenic Effects:
- 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.
- 8.3 Nursing Mothers Caution should be exercised when bromfenac is administered to a nursing woman.
- 8.4 Pediatric Use Safety and efficacy in pediatric patients below the age of 18 have not been established.
- 8.5 Geriatric Use There is no evidence that the efficacy or safety profiles for bromfenac differ in patients 65 years of age and older compared to younger adult patients.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
Use in children
Safety and efficacy in pediatric patients below the age of 18 have not been established.
Quoted from the official label, section “Pediatric Use”.
Use in older people
There is no evidence that the efficacy or safety profiles for bromfenac differ in patients 65 years of age and older compared to younger adult patients.
Quoted from the official label, section “Geriatric Use”.
Side effects
- The most commonly reported adverse reactions in 2-7% of patients were abnormal sensation in eye, conjunctival hyperemia and eye irritation (including burning/stinging) ( 6.1 ).
- To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceutical Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
- 6.1 Clinical Trail Experience The most commonly reported adverse experiences reported following use of bromfenac after cataract surgery include:
- abnormal sensation in eye, conjunctival hyperemia, eye irritation (including burning/stinging), eye pain, eye pruritus, eye redness, headache, and iritis.
- These events were reported in 2-7% of patients.
- 6.2 Post-Marketing Experience The following events have been identified during post-marketing use of bromfenac ophthalmic solution 0.09% in clinical practice.
- Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.
- The events, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to topical bromfenac ophthalmic solution 0.09% or a combination of these factors, include corneal erosion, corneal perforation, corneal thinning, and epithelial breakdown. [ see Warnings and Precautions (5) ]
Quoted from the official label, section “Adverse Reactions”.
What to discuss with your doctor
- 17.1 Slowed or Delayed Healing Patients should be advised of the possibility that slow or delayed healing may occur while using NSAIDs.
- 17.2 Sterility of Dropper Tip Patients should be advised to not touch dropper tip to any surface, as this may contaminate the contents.
- 17.3 Concomitant Use of Contact Lenses Contact lenses should not be worn during the use of this product.
- 17.4 Concomitant Topical Ocular Therapy If more than one topical ophthalmic medication is being used, the medicines should be administered at least 5 minutes apart.
- Rx Only Manufactured by:
- Alembic Pharmaceuticals Limited Karkhadi – 391 450 Gujarat, India Revised:
- 11/2022
Quoted from the official label, section “Patient Counseling Information”.
Strengths and forms
- FORMS & STRENGTHS Topical ophthalmic solution:
- bromfenac 0.09%. Topical ophthalmic solution:
- bromfenac 0.09%
Quoted from the official label, section “Dosage Forms & Strengths”.
What it looks like and how it is packed
- Bromfenac Ophthalmic Solution 0.09% is supplied in a white LDPE screw neck bottle with a LDPE white nozzle and HDPE gray cap as follows:
- 1.7 mL in 5 mL container - NDC 46708-508-17 STORAGE:
- Store at 15º to 25ºC (59º to 77ºF)
Quoted from the official label, section “How Supplied”.
What is in it
- Bromfenac ophthalmic solution 0.09% is a sterile, topical, nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use. Each mL of bromfenac ophthalmic solution contains 1.035 mg bromfenac sodium (equivalent to 0.9 mg bromfenac free acid). Bromfenac sodium is designated chemically as sodium 2-amino-3-(4-bromobenzoyl) phenylacetate sesquihydrate, with an empirical formula of C 15 H 11 BrNNaO 3
- 3/2 H 2 O. The structural structure for bromfenac sodium is:
- Bromfenac sodium is a yellow to orange crystalline powder. The molecular weight of bromfenac sodium is 383.16. Bromfenac ophthalmic solution is supplied as a sterile aqueous 0.09% solution, with a pH of 8.3. The osmolality of bromfenac ophthalmic solution is approximately 300 mOsmol/kg. Each mL of bromfenac ophthalmic solution contains:
- Active :
- bromfenac sodium hydrate 0.1035% Preservative :
- benzalkonium chloride (0.05 mg/mL) Inactives :
- boric acid, disodium edetate (0.2 mg/mL), polysorbate 80 (1.5 mg/mL), povidone K-30 (20 mg/mL), sodium borate, and sodium sulfite anhydrous (2 mg/mL). sodium hydroxide may be used to adjust pH and water for injection USP. bromfenac-struc
Quoted from the official label, section “Description”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Every version of this medicine (2)
The same active substance, strength and kind of form, from every company that sells it — with what each label lists.
Showing 2 of 2
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
European UnionNo exact match for this strength and form
Details
| Made by | Alembic Pharmaceuticals Limited |
|---|---|
| Active substance | Bromfenac |
| Used in | Muscles, joints and bones |
| Strength | 1.035 mg/mL |
| Form | Solution/ Drops |
| Route | Ophthalmic |
| Packs | 1 BOTTLE in 1 CARTON / 1.7 mL in 1 BOTTLE |
| NDC | 46708-508 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
8 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Solution/ Drops7 products
- .7 mg/mL
- .75 mg/mL
.9 mg/mL3
.9 mg/mL · 3 companies
1.035 mg/mL2
1.035 mg/mL · 2 companies
- Alembic Pharmaceuticals Limited · this page
- ARMAS PHARMACEUTICALS INC.
- Solution1 products
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.