Bromday Information
Bromday (Bromfenac) Indications And Usage
Bromday (Bromfenac) ™ (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.
Bromday (Bromfenac) Dosage Forms And Strengths
Topical ophthalmic solution: bromfenac 0.09%.
Bromday (Bromfenac) Contraindications
Bromday (Bromfenac) Warnings And Precautions
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 Bromday (Bromfenac) ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.
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.
Bromday (Bromfenac) Use In Specific Populations
Teratogenic Effects: Pregnancy Category C.
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 Bromday (Bromfenac) ophthalmic solution during late pregnancy should be avoided.
Bromday (Bromfenac) Description
Bromday (Bromfenac) ™ (bromfenac ophthalmic solution) 0.09% is a sterile, topical, nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use. Each mL of Bromday (Bromfenac) 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 CHBrNNaO• 1½HO. The structural formula for bromfenac sodium is:
Bromfenac sodium is a yellow to orange crystalline powder. The molecular weight of bromfenac sodium is 383.17. Bromday (Bromfenac) ophthalmic solution is supplied as a sterile aqueous 0.09% solution, with a pH of 8.3. The osmolality of Bromday (Bromfenac) ophthalmic solution is approximately 300 mOsmol/kg.
Bromday (Bromfenac) Clinical Pharmacology
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.
Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed in animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis, and increased intraocular pressure.
Bromday (Bromfenac) How Supplied/storage And Handling
Bromday (Bromfenac) (bromfenac ophthalmic solution) 0.09% is supplied in a white LDPE plastic squeeze bottle with a 15 mm LDPE white dropper-tip and 15 mm polypropylene gray cap as follows:
1.7 mL in 7.5 mL container (NDC 67425-999-17)
Store at 15º – 25ºC (59º – 77ºF).
Bromday (Bromfenac) Patient Counseling Information
If more than one topical ophthalmic medication is being used, the medicines should be administered at least 5 minutes apart.
Rx Only
©ISTA Pharmaceuticals, Inc.
Manufactured for: ISTA Pharmaceuticals, Inc.Irvine, CA 92618
By: Bausch & Lomb IncorporatedTampa, FL 33637
Under license from:Senju Pharmaceuticals Co., Ltd.Osaka, Japan 541-0046
Bromday (Bromfenac) Package/label Principal Display Panel
Bromday (Bromfenac) ™
(bromfenac ophthalmic solution) 0.09%
Each mL of Bromday (Bromfenac) ophthalmic solution contains:
This product is sterile when manufactured and should be dispensed in the original unopened container. Instruct patient on precautions to avoid contamination.
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.
See accompanying prescribing information.
Store at 15-25°C (59-77°F).
