Bromfenac Sodium

Description

11 DESCRIPTION Bromfenac ophthalmic solution 0.07% is a sterile, topical, nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use. Each mL of bromfenac ophthalmic solution contains 0.805 mg bromfenac sodium sesquihydrate (equivalent to 0.7 mg bromfenac free acid). The USAN name for bromfenac sodium sesquihydrate is bromfenac sodium. 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 . 1.5 H 2 O. The chemical structure for bromfenac sodium sesquihydrate is: Bromfenac sodium is a bright orange to yellow powder. The molecular weight of bromfenac sodium is 383.17. Bromfenac ophthalmic solution is supplied as a sterile aqueous 0.07% solution, with a pH of 7.8. The osmolality of Bromfenac ophthalmic solution is approximately 300 mOsmol/kg. Each mL of bromfenac ophthalmic solution contains : Active: Each mL contains bromfenac sodium sesquihydrate 0.0805%, which is equivalent to bromfenac free acid 0.07%. Preservative: benzalkonium chloride 0.005% Inactives: boric acid, edetate disodium, povidone, sodium borate, sodium sulfite, tyloxapol, sodium hydroxide to adjust pH and water for injection, USP. bromfenac-structure

What Is Bromfenac Sodium Used For?

1 INDICATIONS AND USAGE Bromfenac ophthalmic solution 0.07% 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 surgery. (1) .

Dosage and Administration

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 post-surgery. ( 2.1 ). 2.1 Recommended Dosing One drop of Bromfenac ophthalmic solution should be applied 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 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.

Side Effects (Adverse Reactions)

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 vision blurred. ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals, Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial 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 following use of bromfenac ophthalmic solution 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.

Contraindications

4 CONTRAINDICATIONS None. None

Pregnancy and Breastfeeding

8.1 Pregnancy Treatment of rats at oral doses up to 0.9 mg/kg/day (systemic exposure 90 times the systemic exposure predicted from the recommended human ophthalmic dose [RHOD] assuming the human systemic concentration is at the limit of quantification) and rabbits at oral doses up to 7.5 mg/kg/day (150 times the predicted human systemic exposure) produced no treatment-related malformations in reproduction studies. However, embryo-fetal lethality and maternal toxicity were produced in rats and rabbits at 0.9 mg/kg/day and 7.5 mg/kg/day, respectively. In rats, bromfenac treatment caused delayed parturition at 0.3 mg/kg/day (30 times the predicted human exposure) and caused dystocia, increased neonatal mortality, and reduced postnatal growth at 0.9 mg/kg/day. 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. 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 ophthalmic solution is administered to a nursing woman.

How Supplied

16 HOW SUPPLIED/STORAGE AND HANDLING Bromfenac ophthalmic solution 0.07% is supplied in a white Opaque LDPE bottle with White Opaque LDPE nozzle and gray HDPE cap as follows: