Dosing & Uses
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
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
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
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.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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| bromfenac ophthalmic (eye) - | 0.09 % drops |  | |
| bromfenac ophthalmic (eye) - | 0.09 % drops |  | |
| bromfenac ophthalmic (eye) - | 0.09 % drops |  | |
| BromSite ophthalmic (eye) - | 0.075 % drops |  | |
| Prolensa ophthalmic (eye) - | 0.07 % drops |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
bromfenac ophthalmic (eye)
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: Read the Instructions for Use if available from your pharmacist before you start using bromfenac and each time you get a refill. If you have any questions, ask your doctor or pharmacist.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 you have any serious side effects, including: 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, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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.Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), bleeding disorders, other eye problems (such as dry eye syndrome, corneal problems), diabetes, rheumatoid arthritis, 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 can do it safely.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug are: anti-platelet medications (such as clopidogrel), other NSAID medications (such as aspirin, ibuprofen), blood thinners (such as warfarin, heparin).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.
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. Keep all medications 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.
Information last revised May 2023. Copyright(c) 2023 First Databank, Inc.
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
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