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Bromfenac Ophthalmic Solution, 0.07%, 0.09%

TABLE OF CONTENTS

1. DESCRIPTION 6. USE IN SPECIFIC POPULATIONS
2. INDICATIONS AND USAGE 7. WARNINGS AND PRECAUTIONS
3. DOSAGE AND ADMINISTRATION 8. ADVERSE REACTIONS
4. CONTRAINDICATIONS 9. PHARMACOKINETICS
5. MECHANISM OF ACTION 10. HOW SUPPLIED/STORAGE AND HANDLING

 

1. DESCRIPTION

Bromfenac ophthalmic solution 0.09% is a sterile, topical, nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use. Bromfenac sodium is designated chemically as sodium 2-amino-3-(4-bromobenzoyl) phenylacetate sesquihydrate, with the structural formula for bromfenac sodium is:

Molecular formula: C15H11BrNNaO3 • 1½H2O - Molecular weight: 383.17

Bromfenac sodium is a yellow to orange crystalline powder.

Bromfenac ophthalmic solution is supplied in two strengths, 0.07% (PROLENSA®) and 0.09% (BROMDAY®).

Bromfenac ophthalmic solution, 0.07% (PROLENSA®):

Bromfenac ophthalmic solution is supplied as a sterile aqueous 0.07% solution, with a pH of 7.8. The osmolality of bromfenac ophthalmic solution is approximately 300 mOsmol/kg.

Each mL of bromfenac ophthalmic solution contains:

Active: Each mL contains bromfenac sodium sesquihydrate 0.0805%, which is equivalent to bromfenac free acid 0.07%.

Preservative: benzalkonium chloride 0.005%.

Inactives: boric acid, edetate disodium, povidone, sodium borate, sodium sulfite, tyloxapol, sodium hydroxide to adjust pH and water for injection, USP.

Bromfenac ophthalmic solution, 0.09% (BROMDAY®):

Bromfenac ophthalmic solution is supplied as a sterile aqueous 0.09% solution, with a pH of 8.3. The osmolality of bromfenac ophthalmic solution is approximately 300 mOsmol/kg.

Each mL of bromfenac ophthalmic solution contains:

Active: 1.035 mg bromfenac sodium (0.1035%, equivalent to 0.9 mg bromfenac free acid).

Preservative: benzalkonium chloride (0.05 mg/mL)

Inactives: boric acid, disodium edetate (0.2 mg/mL), polysorbate 80 (1.5 mg/mL), povidone (20 mg/mL), sodium borate, sodium sulfite anhydrous (2 mg/mL), sodium hydroxide to adjust pH and water for injection, USP.

2. 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.

3. DOSAGE AND ADMINISTRATION

3.1 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(s) 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.

3.2 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.

4. CONTRAINDICATIONS

None.

5. MECHANISM OF ACTION

Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) that has anti-inflammatory activity. The mechanism of its action is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2.

Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed in animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis, and increased intraocular pressure.

6. USE IN SPECIFIC POPULATIONS

6.1 Usage in Pregnancy

Pregnancy Category C

Treatment of rats at oral doses up to 0.9 mg/kg/day (systemic exposure 90 times the systemic exposure predicted from the recommended human ophthalmic dose [RHOD] assuming the human systemic concentration is at the limit of quantification) and rabbits at oral doses up to 7.5 mg/kg/day (150 times the predicted human systemic exposure) produced no treatment-related malformations in reproduction studies. However, embryo-fetal lethality and maternal toxicity were produced in rats and rabbits at 0.9 mg/kg/day and 7.5 mg/kg/day, respectively. In rats, bromfenac treatment caused delayed parturition at 0.3 mg/ kg/day (30 times the predicted human exposure), and caused dystocia, increased neonatal mortality and reduced postnatal growth at 0.9 mg/kg/day.

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.

Because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of PROLENSA ophthalmic solution during late pregnancy should be avoided.

6.2 Nursing Mothers

Caution should be exercised when bromfenac is administered to a nursing woman.

6.3 Pediatric Use

Safety and efficacy in pediatric patients below the age of 18 have not been established.

6.4 Geriatric Use

There is no evidence that the efficacy or safety profiles for bromfenac differ in patients 65 years of age and older compared to younger adult patients.

7. WARNINGS AND PRECAUTIONS

7.1 Sulfite Allergic Reactions

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.

7.2 Slow or Delayed Healing

All topical nonsteroidal anti-inflammatory drugs (NSAIDs) 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

7.3 Potential for Cross-Sensitivity

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

7.4 Increased Bleeding Time

With some NSAIDs, 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.

7.5 Keratitis and Corneal Reactions

Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health.

Post-marketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening. Topical NSAIDs should be used with caution in these patients.

Post-marketing experience with topical NSAIDs also suggests that use more than 24 hours prior to surgery or use beyond 14 days post surgery may increase patient risk for the occurrence and severity of corneal adverse events.

7.6 Contact Lens Wear

Bromfenac should not be administered while wearing contact lenses.

8. ADVERSE REACTIONS

8.1 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.

8.2 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, corneal perforation, corneal thinning, and epithelial breakdown [see Warnings and Precautions].

9. PHARMACOKINETICS

The plasma concentration of bromfenac following ocular administration of 0.09% bromfenac ophthalmic solution in humans is unknown. Based on the maximum proposed dose of one drop to the eye (0.045 mg) and PK information from other routes of administration, the systemic concentration of bromfenac is estimated to be below the limit of quantification (50 ng/mL) at steadystate in humans.

10. HOW SUPPLIED/STORAGE AND HANDLING

1) How Available:

a) Brand names:

BROMDAY, by ISTA Pharmaceuticals.

PROLENSA, by Bausch & Lomb.

b) Generic drugs: None.

2) How Supplied:

BROMDAY (bromfenac ophthalmic solution) 0.09% is supplied in a white LDPE plastic squeeze bottle with a 15 mm LDPE white dropper-tip and 15 mm polypropylene gray cap as follows:

1.7 mL in 7.5 mL container (NDC 67425-999-17)

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PROLENSA (bromfenac ophthalmic solution) 0.07% is supplied in a white LDPE plastic squeeze bottle with a 15 mm LDPE white dropper-tip and 15 mm polypropylene gray cap as follows:

• 1.6 mL in a 7.5 mL container (NDC 24208-602-01)

• 3 mL in a 7.5 mL container (NDC 24208-602-03)

3) Storage and Handling:

Store at 15° to 25°C (59° to 77°F). [see USP Controlled Room Temperature].

Rx only

Rev 04/13