bromfenac ophthalmic (Rx)Brand and Other Names:BromSite, Prolensa

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

ophthalmic solution

  • 0.07% (Prolensa)
  • 0.075% (BromSite)
  • 0.09% (generics)
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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 NSAIDs may slow or delay healing

Potential for cross-sensitivity to other NSAIDs or aspirin

Interferes with platelet aggregation and may increase bleeding of ocular tissues; use caution in patients with predisposition to bleeding

Corneal effects, including keratitis, reported 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

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Pregnancy & Lactation

Pregnancy Category: C; D in 3rd trimester

Lactation: Excretion in milk unknown; use with caution

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

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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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