FDA

Bromfenac Sodium

Approved 29 Jul 2024EyeSolution/drops

The FDA lists this product in 16 strengths and forms.

Indications

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 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 )

Contraindications

None. None. ( 4 )

Warnings and precautions

Sulfite Allergic Reactions. (5.1) Slow or Delayed Healing. (5.2) Potential for Cross-Sensitivity. (5.3) Increased Bleeding Time. (5.4) Keratitis and Corneal Reactions. (5.5)

5.1Sulfite Allergic Reactions

Bromfenac ophthalmic solution contains sodium sulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

5.2Slow or Delayed Healing

All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including bromfenac, may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.

5.3Potential for Cross-Sensitivity

There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs, including bromfenac. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.

5.4Increased Bleeding Time

With some NSAIDs, including bromfenac, there exists the potential for increased bleeding time due to interference with platelet aggregation. There have been reports that ocularly applied NSAIDs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. It is recommended that bromfenac ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.

At a glance

Brand name: Bromfenac Sodium
Route: Eye
Dosage form: Solution/drops
Applicant: Amneal
Status: Prescription
FDA approval: 29 Jul 2024
Application: ANDA210962-001

Indications

Warnings and precautions

Sulfite Allergic Reactions. (5.1) Slow or Delayed Healing. (5.2) Potential for Cross-Sensitivity. (5.3) Increased Bleeding Time. (5.4) Keratitis and Corneal Reactions. (5.5)

5.1Sulfite Allergic Reactions

5.2Slow or Delayed Healing

5.3Potential for Cross-Sensitivity

5.4Increased Bleeding Time

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

There are no available data on bromfenac use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. The systemic exposure to bromfenac following topical ocular administration is low [see Clinical Pharmacology ( 12.3 ) ]. Consequently, the systemic exposure of a pregnant woman to bromfenac is expected to be minimal following topical ocular administration.

However, because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of bromfenac during late pregnancy should be avoided. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Premature closure of the ductus arteriosus in the fetus has occurred with third trimester use of oral and injectable NSAIDs. Measurable maternal and fetal plasma drug levels are available with oral and injectable routes of NSAID administration. The maternal plasma level of bromfenac following ocular administration is unknown [see Clinical Pharmacology ( 12.3 ) ] . Data Animal Data Embryo-fetal lethality and maternal toxicity were produced in rats and rabbits treated with bromfenac during the period of organogenesis at oral doses up to 0.9 mg/kg/day and 7.5 mg/kg/day, respectively.

These doses corresponded to a C max 90- and 150- times the predicted C max at the recommended human ophthalmic dose (RHOD), respectively. In rats, bromfenac treatment caused delayed parturition at 0.3 mg/kg/day (30 times the predicted human C max at the RHOD), and caused dystocia, increased neonatal mortality, and reduced postnatal growth at 0.9 mg/kg/day (90 times the predicted human C max at the RHOD).

Bromfenac Sodium

Indications

Contraindications

Warnings and precautions

5.1Sulfite Allergic Reactions

5.2Slow or Delayed Healing

5.3Potential for Cross-Sensitivity

5.4Increased Bleeding Time

At a glance

Two medicines in one question?

Bromfenac Sodium

Indications

Contraindications

Warnings and precautions

5.1Sulfite Allergic Reactions

5.2Slow or Delayed Healing

5.3Potential for Cross-Sensitivity

5.4Increased Bleeding Time

At a glance

Two medicines in one question?

5.5Keratitis and Corneal Reactions Use

5.6Risk of Contamination Do

5.7Contact Lens Wear

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

Composition

Strengths and forms

Official product information