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Bromfenac

Pronunciation

(BROME fen ak)

Index Terms

  • Bromfenac Sodium

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Ophthalmic:

Bromday: 0.09% (1.7 mL [DSC]) [contains benzalkonium chloride, edetate disodium, polysorbate 80, sodium sulfite]

Prolensa: 0.07% (1.6 mL [DSC], 3 mL) [contains benzalkonium chloride, edetate disodium, sodium sulfite]

Generic: 0.09% (1.7 mL, 2.5 mL, 5 mL [DSC])

Brand Names: U.S.

  • Bromday [DSC]
  • Prolensa

Pharmacologic Category

  • Nonsteroidal Anti-inflammatory Drug (NSAID), Ophthalmic

Pharmacology

Inhibits prostaglandin synthesis by decreasing the activity of the enzyme, cyclooxygenase, which results in decreased formation of prostaglandin precursors.

Absorption

Theoretically, systemic absorption may occur following ophthalmic use (not characterized); anticipated levels are below the limits of assay detection

Metabolism

Hepatic

Half-Life Elimination

0.5 to 4 hours (following oral administration)

Use: Labeled Indications

Treatment of postoperative inflammation and reduction in ocular pain following cataract removal

Contraindications

There are no contraindications listed in the manufacturer’s prescribing information.

Dosing: Adult

Pain, inflammation associated with cataract surgery: Ophthalmic (0.07%, 0.09%): Instill 1 drop into affected eye(s) once daily beginning 1 day prior to surgery and continuing on the day of surgery and for 2 weeks postoperatively

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Administration

Remove contact lenses prior to administration and wait 10 minutes before reinserting. May be used with other eye drops. If using more than 1 ophthalmic product, wait at least 5 minutes between application of each medication. Minimize contamination by not touching the eyelids or surrounding areas with the dropper tip; keep bottle tightly closed when not in use. Also, to minimize the risk of infection following surgery of both eyes, two separate bottles of eye drops (one for each eye) should be used; instruct patients not to use the same bottle for both eyes.

Storage

Store at 15°C to 25°C (59°F to 77°F).

Drug Interactions

Corticosteroids (Ophthalmic): NSAID (Ophthalmic) may enhance the adverse/toxic effect of Corticosteroids (Ophthalmic). Healing of ophthalmic tissue during concomitant administration of ophthalmic products may be delayed. Exceptions: Loteprednol. Monitor therapy

Adverse Reactions

Frequency not defined.

2% to 7%:

Central nervous system: Headache

Ophthalmic: Abnormal sensation in eyes, conjunctival hyperemia, eye irritation (burning/stinging), eye pain, eye pruritus, eye redness, iritis

<1% (Limited to important or life-threatening): Corneal erosion, corneal perforation, corneal thinning, corneal ulcer, epithelial keratopathy

Warnings/Precautions

Concerns related to adverse effects:

• Aspirin/NSAID sensitivity: Use with caution in patients with previous sensitivity to acetylsalicylic acid and phenylacetic acid derivatives, including patients who experience bronchospasm, asthma, rhinitis, or urticaria following NSAID or aspirin therapy.

• Keratitis: May cause keratitis; continued use in a patient with keratitis may cause severe corneal adverse reactions, potentially resulting in loss of vision. Immediately discontinue use in patients with evidence of corneal epithelial damage.

Disease-related concerns:

• Bleeding disorders: Use with caution in patients with a predisposition to bleeding (bleeding tendencies or medications which interfere with coagulation).

• Diabetes: Use with caution in patients with diabetes mellitus; may be at risk of corneal adverse events, potentially resulting in loss of vision.

• Ocular disease: Use with caution in patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, ocular surface disease, or repeat ocular surgeries (within a short timeframe); may be at risk of corneal adverse events, potentially resulting in loss of vision.

• Rheumatoid arthritis: Use with caution in patients with rheumatoid arthritis; may be at risk of corneal adverse events, potentially resulting in loss of vision.

Special populations:

• Surgery patients: May slow/delay healing or prolong bleeding time following surgery. Also, to minimize the risk of infection following surgery of both eyes, two separate bottles of eye drops (one for each eye) should be used; instruct patients not to use the same bottle for both eyes.

Dosage form specific issues:

• Benzalkonium chloride: Contains benzalkonium chloride as a preservative.

• Sulfites: Contains sulfites, which may cause allergic reactions.

Other warnings/precautions:

• Contact lenses: Contact lenses should be removed prior to instillation (bromfenac drops contain benzalkonium chloride which may be adsorbed by contact lens); may be reinserted after 10 minutes.

• Duration of therapy: Use for more than 1 day prior to surgery or for 14 days beyond surgery may increase risk and severity of corneal adverse events.

Pregnancy Risk Factor

C

Pregnancy Considerations

In animal reproduction studies, at exposures much higher than those which would result from ophthalmic use, embryo-fetal lethality and increased postimplantation loss occurred. Exposure to nonsteroidal anti-inflammatory drugs late in pregnancy may lead to premature closure of the ductus arteriosus and may inhibit uterine contractions.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, burning, stinging, or redness. Have patient report immediately to prescriber vision changes, eye pain, severe eye irritation, or bleeding in the eye (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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