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Bromfenac

Pronunciation

(BROME fen ak)

Index Terms

  • Bromfenac Sodium
  • BromSite

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]
  • BromSite
  • Prolensa

Pharmacologic Category

  • Nonsteroidal Anti-inflammatory Drug (NSAID), Ophthalmic

Pharmacology

Inhibits prostaglandin synthesis by decreasing the activity of the enzyme, cyclooxygenase 1 and 2, 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

Half-Life Elimination

0.5 to 4 hours (following oral administration)

Use: Labeled Indications

Postoperative ocular inflammation/pain: Treatment of postoperative inflammation and reduction of ocular pain following cataract surgery.

Contraindications

There are no contraindications listed in the manufacturer’s labeling.

Documentation of allergenic cross-reactivity for nonsteroidal anti-inflammatory drugs (NSAIDs) is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Dosing: Adult

Postoperative ocular inflammation/pain:

Ophthalmic (0.07%): Instill 1 drop into affected eye(s) once daily beginning 1 day prior to cataract surgery and continue on the day of surgery and for 14 days postoperatively

Ophthalmic (0.075%): Instill 1 drop into affected eye(s) twice daily beginning 1 day prior to cataract surgery and continue on the day of surgery and for 14 days postoperatively.

Ophthalmic (0.09%): Instill 1 drop into affected eye(s) twice daily beginning 24 hours after cataract surgery and continue through the first 14 days 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

For topical ophthalmic use only; wash hands prior to use. 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

1% to 10%:

Central nervous system: Headache (≥1% to ≤8%)

Ophthalmic: Anterior chamber inflammation (1% to 8%), iritis (1% to 8%), ocular hypertension (1% to 8%), vitreous opacity (1% to 8%), eye pain (≤1% to ≤8%), abnormal sensation in eyes (2% to 7%), conjunctival hyperemia (2% to 7%), eye irritation (burning/stinging; 2% to 7%), eye pruritus (2% to 7%), eye redness (2% to 7%)

Frequency not defined:

Hematologic & oncologic: Prolonged bleeding time

Miscellaneous: Wound healing impairment

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

Warnings/Precautions

Concerns related to adverse effects:

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

• Corneal effects: May cause keratitis. Continued use may cause severe corneal adverse effects, including corneal thinning, erosion, perforation, or ulceration; may result in loss of vision. Discontinue use in patients with evidence of corneal epithelial damage.

• Delayed healing: Healing time may be slowed or delayed. Use with caution in patients receiving concomitant topical steroid therapy due to an increased risk for healing problems.

Disease-related concerns:

• Bleeding disorders: Use with caution in patients with a predisposition to bleeding (bleeding tendencies or medications which interfere with coagulation). Increased intraocular bleeding (including hyphema) has been reported following surgery.

• 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:

• Postsurgical patients: 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: May contain benzalkonium chloride as a preservative.

• Sulfites: May contain sulfites, which may cause allergic-type reactions in susceptible individuals.

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

Adverse events have been observed in animal reproduction studies. Exposure to nonsteroidal anti-inflammatory drugs late in pregnancy may lead to premature closure of the ductus arteriosus and may inhibit uterine contractions; some manufacturers recommend avoiding use in late pregnancy.

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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