Bromfenac Ophthalmic

Bromfenac Ophthalmic is a prescription medication used to treat pain and inflammation in the eye after cataract surgery. 

• Bromfenac Ophthalmic is available under the following different brand names: BromSite, Prolensa

Common side effects of Bromfenac Ophthalmic include:

• Increased sensitivity of the eyes to light,
• Mild eye irritation,
• Feeling like something is in the eye,
• Headache,
• Seeing flashes or light, and
• “floaters” in the vision

Serious side effects of Bromfenac Ophthalmic include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Any change in the vision,
• Slow healing after the eye surgery,
• Eye redness or bleeding,
• Eye pain or swelling,
• Severe eye discomfort,
• Increased tears, and
• Crusting or drainage from the eye

Rare side effects of Bromfenac Ophthalmic include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Ophthalmic solution

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

Cataract Postoperative Ocular Inflammation/Pain

Adult dosage

• 1 drop into the affected eye(s) once a day beginning 1 day before surgery, continued day of surgery, and through the first 14 days post-surgery.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, 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, health care provider, or pharmacist first.

• Bromfenac Ophthalmic has no noted severe interactions with any other drugs.
• Bromfenac Ophthalmic has no noted serious interactions with any other drugs.
• Bromfenac Ophthalmic has no noted moderate interactions with any other drugs.
• Bromfenac Ophthalmic has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None listed by the manufacturer

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Bromfenac Ophthalmic?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Bromfenac Ophthalmic?”

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 the 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 them 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 the 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 (. g, dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period 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 before surgery or use beyond 14 days post-surgery may increase patient risk for the occurrence and severity of corneal adverse events

Pregnancy and Lactation

• There are no adequate and well-controlled studies in pregnant women to inform any drug-associated risks
• Because of the 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
• Lactation
  • There are no data on the presence of bromfenac in human milk, its effects on breastfed infants, or 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 the underlying maternal condition