Bromfenac Ophthalmic Solution 0.09% 1.035 mg/mL
Bromfenac Ophthalmic Solution 0.09% · SOLUTION/ DROPS · Alembic Pharmaceuticals Inc.
Bromfenac ophthalmic solution is an anti-inflammatory eye drop used to reduce inflammation and pain after eye surgery. It is applied directly to the eye as prescribed by your doctor.
Key Facts
- Brand Name
- Bromfenac Ophthalmic Solution 0.09%
- Generic Name
- Bromfenac Ophthalmic Solution 0.09%
- NDC Code (Product)
62332-508- Manufacturer
- Alembic Pharmaceuticals Inc.
- Strength
- 1.035 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA210560
- Marketing Start
- 06/21/2019
Recall History
Bausch & Lomb, Inc.
Lack of Assurance of Sterility: Failed preservative effectiveness testing.
Mayne Pharma Usa
Lack of Assurance of Sterility: Failed preservative effectiveness test
Apotex Inc.
Lack of Assurance of Sterility: Failed preservative effectiveness testing
Alembic Pharmaceuticals Limited
Failed Impurities/Degradation Specifications
Apotex Inc.
CGMP Deviations: Product excipient was not re-tested at the appropriate date.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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 0.09% 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 extraction.
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 Dosing For the treatment of postoperative inflammation in patients who have undergone cataract extraction, 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.
Contraindications
4 CONTRAINDICATIONS None.
Adverse Reactions
6 ADVERSE REACTIONS The most commonly reported adverse reactions in 2-7% of patients were abnormal sensation in eye, conjunctival hyperemia and eye irritation (including burning/stinging) ( 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 The most commonly reported adverse experiences reported following use of bromfenac after cataract surgery include: abnormal sensation in eye, conjunctival hyperemia, eye irritation (including burning/stinging), eye pain, eye pruritus, eye redness, headache, and iritis. These events were reported in 2-7% of patients. 6.2 Post-Marketing Experience The following events have been identified during post-marketing use of bromfenac ophthalmic solution 0.09% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to topical bromfenac ophthalmic solution 0.09% or a combination of these factors, include corneal erosion, c…
Frequently Asked Questions
What is Bromfenac Ophthalmic Solution 0.09% used for?
Bromfenac ophthalmic solution is an anti-inflammatory eye drop used to reduce inflammation and pain after eye surgery. It is applied directly to the eye as prescribed by your doctor.
Is Bromfenac Ophthalmic Solution 0.09% a controlled substance?
Bromfenac Ophthalmic Solution 0.09% is not classified as a controlled substance by the DEA.
What is the generic name for Bromfenac Ophthalmic Solution 0.09%?
The generic name for Bromfenac Ophthalmic Solution 0.09% is Bromfenac Ophthalmic Solution 0.09%. There are no other listed brand versions of Bromfenac Ophthalmic Solution 0.09%.
What is the NDC code for Bromfenac Ophthalmic Solution 0.09% 1.035 mg/mL?
The NDC (National Drug Code) for Bromfenac Ophthalmic Solution 0.09% 1.035 mg/mL is 62332-508, listed by Alembic Pharmaceuticals Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)