Drug Facts
Composition & Profile
Identifiers & Packaging
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.; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Bromfenac Ophthalmic Solution Rx only 0.075% NDC 68180-434-01 5ml bottle label Bromfenac Ophthalmic Solution Rx Only 0.075% NDC 68180-434-01 5ml Carton Label Figure 6 Figure 7
- 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.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Bromfenac Ophthalmic Solution Rx only 0.075% NDC 68180-434-01 5ml bottle label Bromfenac Ophthalmic Solution Rx Only 0.075% NDC 68180-434-01 5ml Carton Label Figure 6 Figure 7
Overview
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
Indications & 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 & 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 ) 2.1 Recommended 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. 2.2 Use 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.
Warnings & 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 ) 5.1 Slow 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. 5.2 Potential 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. 5.3 Increased 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. 5.4 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 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 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.
Contraindications
None. None ( 4 )
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 6.1 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.
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