BROMFENAC OPHTHALMIC SOLUTION 0.09% solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BROMFENAC SODIUM (UNII: 8ECV571Y37) (BROMFENAC - UNII:864P0921DW)

Available from:

Alembic Pharmaceuticals Inc.

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. None. Teratogenic Effects: Pregnancy Category C . Reproduction studies performed in rats at oral doses up to 0.9 mg/kg/day (1300 times the recommended human ophthalmic dose [RHOD]) and in rabbits at oral doses up to 7.5 mg/kg/day (11,000 times RHOD) revealed no evidence of teratogenicity due to bromfenac. However, 0.9 mg/kg/day in rats caused embryo-fetal lethality, increased neonatal mortality, and reduced postnatal growth. Pregnant rabbits treated with 7.5 mg/kg/day caused increased post implantation loss. 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 p

Product summary:

Bromfenac Ophthalmic Solution 0.09% is supplied in a white LDPE screw neck bottle with a LDPE white nozzle and HDPE gray cap as follows: 1.7 mL in 5 mL container - NDC 62332-508-17 STORAGE: Store at 15º to 25ºC (59º to 77ºF)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BROMFENAC OPHTHALMIC SOLUTION 0.09% - BROMFENAC OPHTHALMIC SOLUTION
0.09% SOLUTION/ DROPS
ALEMBIC PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BROMFENAC
OPHTHALMIC SOLUTION 0.09% SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
BROMFENAC OPHTHALMIC SOLUTION 0.09%.
BROMFENAC OPHTHALMIC SOLUTION 0.09%
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
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. (1)
DOSAGE AND ADMINISTRATION
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 (2.1).
DOSAGE FORMS AND STRENGTHS
Topical ophthalmic solution: bromfenac 0.09% (3)
WARNINGS AND PRECAUTIONS
Sulfite Allergic Reactions (5.1)
Slow or Delayed Healing (5.2)
Potential for cross-sensitivity (5.3)
Increase bleeding of ocular tissues (5.4)
Corneal effects including keratitis (5.5)
Contact Lens Wear (5.6)
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 PHARMACEUTICAL
INC. AT 1-866-
210-9797 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 11/2022
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS & USAGE
2 DOSAGE & ADMINISTRATION
2.1 Recommended Dosing
2.2 Use with Other Topical Ophthalmic Medications
3 DOSAGE FORMS & STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Sulfite Allergic Reactions
5.2 Slow or Delayed Healing
5.3 Potential for Cross-Sensitivity
5.4 Increased Bleeding Time
5.5 Keratitis and Corneal Reactions
5.6 Contact Lens Wear
6 ADVERSE REACTIONS
6.1 Clinical Trail Experience
6.2 Post-Marketing Experi