BromSite, Prolensa (bromfenac ophthalmic) dosing, indications, interactions, adverse effects, and more

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Sections bromfenac ophthalmic
Dosing & Uses
Adverse Effects
Warnings
Pregnancy
Pharmacology
Images
Patient Handout
Formulary

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

Frequency Not Defined

Abnormal sensation in eye

Conjunctival hyperemia

Eye irriation (burning/stinging)

Eye pain

Eye pruritus

Eye redness

Headache

Iritis

Corneal erosion

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

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.

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

BRAND	FORM.	UNIT PRICE	PILL IMAGE
Prolensa ophthalmic (eye) -	0.07 % drops
BromSite ophthalmic (eye) -	0.075 % drops
bromfenac ophthalmic (eye) -	0.09 % drops
bromfenac ophthalmic (eye) -	0.09 % drops
bromfenac ophthalmic (eye) -	0.09 % drops

Patient Handout

BROMFENAC - OPHTHALMIC

(BROME-fen-ak)

COMMON BRAND NAME(S): Bromday, Prolensa, Xibrom

USES: This medication is used to treat swelling (inflammation) and pain in the eye after a certain type of eye surgery (cataract surgery). Bromfenac belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). It works by blocking the effects of certain natural substances (prostaglandins) that cause pain and inflammation.

HOW TO USE: Your doctor may direct you to start using this medication the day before or the day after your surgery. Place 1 drop into the affected eye as directed by your doctor, usually once or twice a day for 2 weeks. Carefully follow your doctor's specific directions.To apply eye drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.This medication should not be used while wearing contact lenses. Consult your doctor or pharmacist for details.If you are wearing contact lenses, remove them before using eye drops. Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place 1 drop into the pouch. Look downward and gently close your eyes for 1 to 2 minutes. Place one finger at the corner of your eye (near the nose) and apply gentle pressure. This will prevent the medication from draining out. Try not to blink and do not rub your eye.Do not rinse the dropper. Replace the dropper cap after each use.If you are using another kind of eye medication (such as drops or ointments), wait at least 5 to 10 minutes before applying other medications. Use eye drops before eye ointments to allow the drops to enter the eye.Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day. Continue using it for the full time prescribed.Do not apply this medication more often than prescribed or continue using it for longer than directed by your doctor. Prolonged use of bromfenac eye drops may increase the risk of very serious side effects of the eye.

SIDE EFFECTS: Temporary irritation/burning/stinging of the eye, temporary blurred vision, watery eyes, or headache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if any of these unlikely but serious side effects occur: severe pain/redness in the eye, sensitivity of the eyes to light (photophobia), eye discharge, blurry/abnormal vision, feeling as if something is in the eye, itching/redness/pain around the eyes.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using bromfenac, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs).Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding disorders, other eye problems (such as dry eye syndrome, corneal problems), diabetes, rheumatoid arthritis, asthma, growths in the nose (nasal polyps).After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: anti-platelet medications (such as clopidogrel), other NSAID medications (such as aspirin, ibuprofen), blood thinners (such as warfarin, heparin), other eye medications.If your doctor has directed you to take low doses of aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should continue to take the aspirin. Consult your doctor or pharmacist for more details.This document does not contain all possible interactions. Before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-77 degrees F (15-25 degrees C) away from heat and light. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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.

View explanations for tiers and restrictions

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.

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

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