bromfenac ophthalmic (Rx)

Brand and Other Names:BromSite, Prolensa
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

ophthalmic solution

  • 0.07% (Prolensa)
  • 0.075% (BromSite)
  • 0.09% (generics)

Cataract Postoperative Ocular Inflammation/Pain

Prolensa indication: Indicated for treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction

BromSite indication: Indicated to prevent ocular pain and treat ocular inflammation in patients undergoing cataract surgery

1 gtt into affected eye(s) qDay beginning 1 day prior to surgery, continued on day of surgery and through the first 14 days postsurgery

Safety and efficacy not established

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Adverse Effects

Frequency Not Defined

Abnormal sensation in eye

Conjunctival hyperemia

Eye irriation (burning/stinging)

Eye pain

Eye pruritus

Eye redness

Headache

Iritis

Corneal erosion

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Warnings

Contraindications

None listed by manufacturer

Cautions

Contains sodium sulfite which may cause allergic reactions in susceptible individuals

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 potential for healing problems

Potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs; use caution when treating individuals who have previously exhibited sensitivities to these drugs

Interferes 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; recommended that the drug be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time

Remove contact lenses before application, may reinsert 10 minutes after instilling drops

Corneal adverse reactions may occur in patients with keratitis after continued use that may result in loss of vision; discontinue use in patients with evidence of corneal epithelial damage

Use caution in patients with diabetes (may be at risk of corneal adverse effects that may result in loss of vision)

Use caution in patients with complicated ocular surgeries, corneal denervation, repeat ocular surface disease, or corneal epithelial defects

Use caution in patients with rheumatoid arthritis

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, including this drug, 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 (eg, 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 postsurgery may increase patient risk for the occurrence and severity of corneal adverse events
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Pregnancy & Lactation

Pregnancy

There are no adequate and well-controlled studies in pregnant women to inform any drug-associated risks

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

Animal data

  • Treatment of pregnant rats and rabbits with oral bromfenac did not produce teratogenic effects at clinically relevant doses

Lactation

There are no data on presence of bromfenac in human milk, effects on breastfed infant, or on milk production; however, systemic exposure to this drug from ocular administration is low

Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for bromfenac and any potential adverse effects on the breastfed child from bromfenac or from the underlying maternal condition

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Nonsteroidal anti-inflammatory agent; inhibits COX-1 and COX-2, which results in decreased formation of prostaglandin precursors

Absorption

Negligible systemic absorption

Half-life: 0.5-4 hr

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Images

Pricing & Images are not currently available for this monograph.
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Patient Handout

No Patient Handout Available
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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.