Drug Information

Bromfenac

Natax Bromday Xibrom Nonsteroidal Anti-inflammatory Drug (NSAID) Ophthalmic Bromfenac

Bromfenac

Brand Names: U.S.

  • Bromday™;
  • Xibrom® [DSC]
Pharmacologic Category

Dosing: AdultBromday™: Ophthalmic: 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

Xibrom®: Ophthalmic: Instill 1 drop into affected eye(s) twice daily beginning 24 hours after surgery and continuing for 2 weeks postoperatively

Dosing: GeriatricRefer to adult dosing.

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

Solution, ophthalmic [drops] : 0.09% (2.5 mL)

Bromday™: 0.09% (1.7 mL) [contains benzalkonium chloride, sodium sulfite]

Xibrom®: 0.09% (2.5 mL [DSC] , 5 mL [DSC] ) [contains benzalkonium chloride, sodium sulfite]

Generic Equivalent Available: U.S.No

AdministrationRemove contact lenses prior to administration and wait 15 minutes before reinserting.

Bromday™: May be used with other eye drops. If using more than 1 ophthalmic product, wait at least 5 minutes between application of each medication.

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

Adverse Reactions Significant2% to 7%:

Central nervous system: Headache

Ocular: Abnormal sensation, conjunctival hyperemia, iritis, irritation (burning/stinging), pain, pruritus, redness

Postmarketing and/or case reports: Corneal erosion, corneal perforation, corneal thinning, corneal ulceration, epithelial breakdown

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

Xibrom®: Hypersensitivity to bromfenac or any components of the formulation

Warnings/PrecautionsConcerns 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.

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• 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.

Dosage form specific issues:

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

Other warnings/precautions:

• Contact lenses: Patients using ophthalmic drops should not wear contact lenses during administration.

• 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

Drug ratings in pregnancy (US Food & Drug Administration)
Category Interpretation
A Controlled studies show no risk
Controlled studies in pregnant women fail to demonstrate a risk to the fetus in the first trimester with no evidence of risk in later trimesters. The possibility of fetal harm appears remote.
B No evidence of human risk in controlled studies
Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women, or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the first trimester and there is no evidence of a risk in later trimesters.
C Risk cannot be ruled out
Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal effects or other) and there are no controlled studies in women, or studies in women and animals are not available. Drugs should be given only if the potential benefits justify the potential risk to the fetus.
D Positive evidence of risk
There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (eg, if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
X Contraindicated in pregnancy
Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience, or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
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Reproduced with permission from: Lacy CF, Armstrong LL, Goldman MP, Lance LL. Lexi-Comp Drug Information Handbook, 20th Edition. Hudson, OH: Lexi-Comp, 2011. Copyright © 2011.
Pregnancy ImplicationsSafety and efficacy in pregnant women have not been established. In animal 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.

LactationExcretion in breast milk unknown/use caution

Pricing: U.S. (www.drugstore.com)Solution (Xibrom)

0.09% (2.5): $145.99

0.09% (5): $279.99

International Brand Names

  • Natax (AR)
Mechanism of ActionInhibits prostaglandin synthesis by decreasing the activity of the enzyme, cyclooxygenase, which results in decreased formation of prostaglandin precursors.

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

Metabolism: Hepatic

Half-life elimination: 0.5-4 hours (following oral administration)

REFERENCES

  1. Skjodt NM and Davies NM, “Clinical Pharmacokinetics and Pharmacodynamics of Bromfenac,” Clin Pharmacokinet, 1999, 36(6):399-408.[PubMed 10427465]

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