BROMFENAC solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Fosun Pharma USA 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:

Product summary:

Bromfenac ophthalmic solution 0.09% is supplied in a 5 ml Screw neck bottle (White LDPE) with a Nozzle (White LDPE) Screw cap (Grey color- HDPE) as follows: 1.7 mL in 5 mL container (NDC 72266-142-01) STORAGE Store at 15º to 25ºC (59º to 77ºF).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BROMFENAC- BROMFENAC SOLUTION/ DROPS
FOSUN PHARMA USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BROMFENAC OPHTHALMIC SOLUTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BROMFENAC
OPHTHALMIC SOLUTION
BROMFENAC OPHTHALMIC SOLUTION
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
Bromfenac ophthalmic solution 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)
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 FOSUN PHARMA USA INC.
AT 1-866-611-3762 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 5/2020
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
6 ADVERSE REACTIONS
6.1 Clinical Trial Experience
6.2 Post-Marketing Experience
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.