Bromfenac Ophthalmic Solution, 0.07% .7 mg/mL
Bromfenac Sodium · SOLUTION/ DROPS · Apotex Corp.
Bromfenac Ophthalmic Solution, 0.07% is a solution/ drops containing bromfenac sodium at .7 mg/mL, taken ophthalmic. Manufactured by Apotex Corp..
Key Facts
- Brand Name
- Bromfenac Ophthalmic Solution, 0.07%
- Generic Name
- Bromfenac Sodium
- NDC Code (Product)
60505-1006- Manufacturer
- Apotex Corp.
- Strength
- .7 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA207334
- Marketing Start
- 07/11/2024
Recall History
ALEMBIC PHARMACEUTICALS, INC.
Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 Ophthalmic Solution, 0.07% 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 & 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 Dosage Apply one drop 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, 0.07% 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.
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
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 blurred vision ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575, 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 practice. The most commonly reported adverse reactions following use of bromfenac ophthalmic solution, 0.07% 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.
Frequently Asked Questions
What is Bromfenac Ophthalmic Solution, 0.07% used for?
Bromfenac Ophthalmic Solution, 0.07% contains Bromfenac Sodium. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.
Is Bromfenac Ophthalmic Solution, 0.07% a controlled substance?
Bromfenac Ophthalmic Solution, 0.07% is not classified as a controlled substance by the DEA.
What is the generic name for Bromfenac Ophthalmic Solution, 0.07%?
The generic name for Bromfenac Ophthalmic Solution, 0.07% is Bromfenac Sodium. There are 6 other brand versions of Bromfenac Sodium.
What is the NDC code for Bromfenac Ophthalmic Solution, 0.07% .7 mg/mL?
The NDC (National Drug Code) for Bromfenac Ophthalmic Solution, 0.07% .7 mg/mL is 60505-1006, listed by Apotex Corp..