Bromfenac
FDA Drug Information • Also known as: Bromfenac, Bromfenac 0.075%, Bromsite 0.075%
- Brand Names
- Bromfenac, Bromfenac 0.075%, Bromsite 0.075%
- Route
- OPHTHALMIC
- Dosage Form
- SOLUTION/ DROPS
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 DESCRIPTION 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
What Is Bromfenac Used For?
1 INDICATIONS AND USAGE BromSite (bromfenac ophthalmic solution) 0.075% is indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery. BromSite 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 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 (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 1-8% 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.
Contraindications
4 CONTRAINDICATIONS None None (4)
Pregnancy and Breastfeeding
8.1 Pregnancy 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 BromSite 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.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING BromSite (bromfenac ophthalmic solution) 0.075% is supplied in white opaque low density polyethylene (LDPE) plastic bottles and translucent dropper tips, and gray high density polyethylene (HDPE) eyedropper caps. A white tamper evident overcap is provided. Each bottle is provided in a sealed foil laminated pouch. 5 mL in a 7.5 mL bottle (NDC No. 49708-754-41) STORAGE Store at 15°C to 25°C (59°F to 77°F). After opening, BromSite can be used until the expiration date on the bottle. Discard after treatment completion.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.