BROMFENAC solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lupin 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 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. Caution should be exercised when bromfenac ophthalmic solution is administered to a nursing woman. Safety and efficacy in pediatric patients below the age of 18 have not been established. There is no evidence that the efficacy or safety profiles for bromfenac ophthalmic solution differ in patients 65 years of age and older compared to younger adult patients.

Product summary:

Bromfenac Ophthalmic Solution, 0.09% is supplied in a sterile 5 mL white low density polyethylene bottle fitted with a white low density polyethylene nozzle and sealed with gray colored high density polyethylene cap as follows: 1.7 mL in 5 mL bottle (NDC 68180-436-01) Storage Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BROMFENAC- BROMFENAC SOLUTION
LUPIN 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 ophthalmic solution, 0.09% 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 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 to 7% of patients
were abnormal sensation in eye,
conjunctival hyperemia and eye irritation (including burning/stinging)
(6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT LUPIN PHARMACEUTICALS,
INC. AT 1-800-
399-2561 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 3/2024
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
2.2 Use with Other Topical Ophthalmic Medications
3 DOSAGE FORMS AND 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 Trial Experience
6.2 Post-Marketing Experience
8 USE IN SPECIFIC POP