Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Ophthalmic:
BromSite: 0.075% (5 mL) [contains benzalkonium chloride, edetate disodium dihydrate]
Prolensa: 0.07% (3 mL) [contains benzalkonium chloride, edetate disodium, sodium sulfite]
Generic: 0.09% (1.7 mL, 2.5 mL [DSC])
Pharmacology
Mechanism of Action
Inhibits prostaglandin synthesis by decreasing the activity of the enzyme, cyclooxygenase 1 and 2, which results in decreased formation of prostaglandin precursors.
Pharmacokinetics/Pharmacodynamics
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.
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to bromfenac, or any component of the formulation.
Dosage and Administration
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% once daily formulation): 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 (0.09% twice-daily formulation): 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.
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): Nonsteroidal Anti-Inflammatory Agents (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
Prostaglandins (Ophthalmic): Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may diminish the therapeutic effect of Prostaglandins (Ophthalmic). Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may enhance the therapeutic effect of Prostaglandins (Ophthalmic). 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%, postmarketing and/or case reports: 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
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
What is this drug used for?
- It is used to treat swelling and pain after cataract surgery.
Frequently reported side effects of this drug
- Headache
- Burning
- Stinging
- Foreign body sensation in eye
- Blurred vision
- Sensitivity to lights
- Redness
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Vision changes
- Eye pain
- Severe eye irritation
- Bleeding in the eye
- Signs of a significant reaction like 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. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
