Bromfenac Ophthalmic Solution, 0.07%

The dosage of Bromfenac depends strictly on the concentration of the solution prescribed by your ophthalmologist (eye surgeon).

• For Bromfenac 0.07% (e.g., Prolensa): The standard adult dose is one drop instilled into the affected eye(s) once daily. Treatment typically begins one day prior to cataract surgery, continues on the day of surgery, and extends through the first 14 days of the postoperative period.
• For Bromfenac 0.075% (e.g., BromSite): The standard dose is one drop in the affected eye(s) twice daily (morning and evening). This usually starts one day before surgery and continues for 14 days after surgery.
• For Bromfenac 0.09% (Generic): The dosage may be one drop once daily or twice daily, depending on the specific manufacturer's instructions and the severity of the inflammation.

Always adhere to the specific schedule provided by your surgeon, as they may adjust the duration of therapy based on your eye's healing progress.

The safety and effectiveness of Bromfenac ophthalmic solution in pediatric patients (below the age of 18) have not been established. Clinical trials for this medication primarily focused on the adult population undergoing cataract surgery, which is rare in children. Consequently, Bromfenac is generally not recommended for use in children unless specifically directed by a pediatric ophthalmologist who has weighed the risks and benefits.

Renal Impairment

Because Bromfenac ophthalmic solution results in negligible systemic absorption, no dosage adjustments are typically required for patients with kidney disease. The amount of drug that reaches the kidneys is insufficient to cause further damage or require a reduction in the ocular dose.

Hepatic Impairment

While the oral form of Bromfenac was toxic to the liver, the ophthalmic form does not reach the liver in significant quantities. Therefore, no dosage adjustments are necessary for patients with hepatic impairment. However, patients with a history of severe liver disease should still inform their doctor of all medications.

Elderly Patients

No overall differences in safety or effectiveness have been observed between elderly and younger patients. The standard adult dose is appropriate for geriatric populations, who represent the majority of cataract surgery patients.

Proper administration is crucial to ensure the medication works effectively and to prevent infection. Follow these steps:

1. 1Wash your hands: Always start with clean hands to avoid introducing bacteria into the eye.
2. 2Prepare the bottle: Shake the bottle if instructed (specifically for BromSite). Remove the cap and place it on a clean surface.
3. 3Positioning: Tilt your head back or lie down. Use one finger to gently pull down your lower eyelid to create a small pocket.
4. 4Instillation: Hold the dropper bottle above the eye. Do NOT touch the tip of the dropper to your eye, eyelid, fingers, or any other surface. Contamination of the tip can lead to serious eye infections.
5. 5The Drop: Squeeze one drop into the lower eyelid pocket.
6. 6Closing: Close your eye gently. Do not rub the eye. Press your finger against the inner corner of your eye (near the nose) for about 1 minute. This technique, called punctal occlusion, helps keep the medicine in the eye and reduces the amount that drains into your system.

If you miss a dose of Bromfenac, apply it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and return to your regular routine. Do not apply a double dose to make up for a missed one. Consistency is key to controlling post-surgical inflammation.

An overdose of Bromfenac ophthalmic solution is unlikely to cause systemic toxicity. If too many drops are placed in the eye, the eye's capacity to hold fluid will simply result in the excess liquid running down the cheek. If the solution is accidentally swallowed, drink plenty of water to dilute the medication and contact a poison control center or seek emergency medical care, especially if a large quantity (the whole bottle) was consumed by a child.

> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or stop using the drops earlier than prescribed without medical guidance, as this could lead to a rebound of inflammation.

Most patients tolerate Bromfenac well, but local reactions are common due to the nature of eye drops.

• Ocular Discomfort: The most frequently reported side effect is a transient (temporary) burning, stinging, or 'gritty' sensation immediately after instilling the drop. This usually lasts for only a few seconds to a minute.
• Foreign Body Sensation: Some patients feel as though something is in their eye. This is often a result of the medication altering the tear film briefly.
• Conjunctival Hyperemia: This is the medical term for redness of the white part of the eye. It occurs as the blood vessels on the surface of the eye react to the solution.

These effects may occur in a smaller percentage of the population and should be monitored:

• Headache: Some patients report a mild headache following use, likely due to the proximity of the ophthalmic nerves.
• Blurred Vision: Temporary blurring may occur immediately after application. This is why patients are advised not to drive until their vision clears.
• Eye Pain or Irritation: More persistent aching or soreness in the eye.
• Iritis: Inflammation of the iris (the colored part of the eye) can occasionally occur, though the drug is intended to treat this; in rare cases, a paradoxical reaction occurs.
• Ocular Hypertension: A slight increase in the pressure inside the eye (intraocular pressure).

• Corneal Edema: Swelling of the cornea which can lead to hazy vision.
• Photophobia: Increased sensitivity to light.
• Eyelid Swelling: Also known as palpebral edema.
• Vitreous Floaters: Seeing small spots or 'cobwebs' in the field of vision.

While rare, some side effects are clinically significant and require an immediate visit to your ophthalmologist.

> Warning: Stop taking Bromfenac and call your doctor immediately if you experience any of these.

1. 1Corneal Erosion or Thinning: NSAIDs, including Bromfenac, can occasionally cause the cornea to thin or develop 'pits.' If left untreated, this can lead to corneal perforation (a hole in the eye), which is a sight-threatening emergency.
2. 2Epithelial Breakdown: The surface layer of the cornea may begin to break down, causing intense pain, redness, and a sudden drop in vision.
3. 3Hypersensitivity Reactions: Signs include severe swelling of the face, lips, or tongue, difficulty breathing, or a widespread skin rash. This may indicate an allergy to Bromfenac or the sulfites used as preservatives in some formulations.
4. 4Delayed Healing: Like all NSAIDs, Bromfenac can slow down the rate at which the surgical incision heals. If your eye feels 'worse' after several days of use rather than 'better,' notify your surgeon.
5. 5Severe Eye Pain: Any sudden, sharp, or worsening pain that is not relieved by resting the eye.

Bromfenac is not intended for long-term use. It is typically prescribed for a maximum of 14 to 28 days. Prolonged use of topical NSAIDs (beyond several weeks) significantly increases the risk of corneal complications, including permanent corneal scarring and thinning. In patients with pre-existing corneal surface disease (like severe dry eye), the risk of these long-term effects is higher even with short-term use.

No FDA black box warnings for Bromfenac ophthalmic solution. It is important to distinguish this from the discontinued oral form (Duract), which carried severe warnings regarding hepatotoxicity (liver damage). The eye drop formulation is considered safe for the liver because the amount of drug that reaches the bloodstream is negligible.

Report any unusual symptoms or changes in your vision to your healthcare provider immediately. Early detection of corneal issues is vital for preserving your sight.

Bromfenac is a potent medication that must be used exactly as prescribed. It is intended for topical ophthalmic use only and should never be injected or swallowed. Patients should be aware that using this medication can mask the signs of an eye infection, as it reduces the redness and pain that usually signal a problem. Therefore, regular follow-up appointments with your eye surgeon are mandatory.

No FDA black box warnings for Bromfenac ophthalmic solution. The safety profile of the topical solution is well-established for short-term postoperative use.

• Allergic Reactions / Anaphylaxis Risk: There is a potential for cross-sensitivity to aspirin, phenylacetic acid derivatives, and other NSAIDs (like ibuprofen or naproxen). If you have a history of 'aspirin asthma' or have experienced hives after taking other NSAIDs, use Bromfenac with extreme caution. Furthermore, some brands of Bromfenac contain sodium sulfite, which can cause life-threatening anaphylactic symptoms in sulfite-sensitive individuals.
• Corneal Effects: Use of topical NSAIDs may result in keratitis (inflammation of the cornea). In some susceptible patients, continued use 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 Bromfenac.
• Bleeding Risk: Because NSAIDs interfere with platelet aggregation, there is a theoretical risk that topical Bromfenac may increase the bleeding of ocular tissues (including hyphemas—blood in the front chamber of the eye) in conjunction with ocular surgery. Use caution if you have known bleeding tendencies or are taking other medications that prolong bleeding time (like warfarin).
• Delayed Healing: Topical 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.
• Contact Lens Wear: Bromfenac should not be administered while wearing contact lenses. The preservative in many formulations (benzalkonium chloride) can be absorbed by soft contact lenses and may discolor them. Furthermore, contact lenses should generally not be worn during the immediate postoperative period following cataract surgery.

During treatment with Bromfenac, your ophthalmologist will perform several checks:

• Visual Acuity: To ensure your vision is improving as expected.
• Slit-Lamp Examination: A detailed look at the cornea to check for signs of thinning or epithelial breakdown.
• Intraocular Pressure (IOP): To ensure the pressure inside your eye remains within a safe range.
• Infection Check: Monitoring for signs of bacterial or viral infection that the NSAID might be masking.

Your vision may be temporarily blurred immediately after using Bromfenac drops. Additionally, the recovery from cataract surgery itself involves changes in vision. Do not drive, use machinery, or perform any activity that requires clear vision until you are certain you can do so safely and your doctor has cleared you to drive.

There are no known direct interactions between alcohol and Bromfenac ophthalmic solution. However, alcohol can cause dehydration and may interfere with the general healing process after surgery. It is best to consult your surgeon regarding alcohol consumption during your recovery period.

Bromfenac does not typically require a tapering schedule because it is used for a short duration. However, you should not stop the medication earlier than the 14 days (or the duration prescribed) unless directed by your doctor, as the inflammation may return. There is no known withdrawal syndrome associated with Bromfenac.

> Important: Discuss all your medical conditions, especially asthma or a history of eye infections, with your healthcare provider before starting Bromfenac.

There are no absolute drug-drug contraindications where Bromfenac ophthalmic solution must never be used with another drug, provided the other drugs are systemic. However, in the context of ophthalmic care:

• Other Ophthalmic NSAIDs: Using two different NSAID eye drops (e.g., Bromfenac and Ketorolac) simultaneously is contraindicated as it significantly increases the risk of corneal toxicity and perforation without providing additional therapeutic benefit.

• Topical Corticosteroids: Many patients are prescribed both an NSAID (Bromfenac) and a steroid (like Prednisolone) after surgery. While common, this combination must be monitored closely. Both classes of drugs can slow the healing of the cornea. When used together, the risk of developing 'corneal melting' or severe thinning increases.
• Anticoagulants and Antiplatelets: For patients taking systemic blood thinners like Warfarin (Coumadin), Clopidogrel (Plavix), or high-dose Aspirin, there is a theoretical increase in the risk of ocular bleeding (hyphema) during and after surgery when using Bromfenac. While the systemic absorption of Bromfenac is low, the local effect on platelet function in the eye tissues can be significant.

• Prostaglandin Analogs: Drugs used for glaucoma, such as Latanoprost or Bimatoprost, work by mimicking prostaglandins. Since Bromfenac inhibits prostaglandin synthesis, there is a theoretical possibility that Bromfenac could reduce the pressure-lowering efficacy of these glaucoma drops. Patients should have their intraocular pressure monitored if using both.

• General Food: There are no known interactions between Bromfenac ophthalmic solution and specific foods. Unlike oral medications, the absorption of eye drops is not affected by the contents of the stomach.
• Alcohol: As noted previously, alcohol does not interact with the drug molecule itself but may impair the overall postoperative recovery and increase the risk of accidental eye injury.

• Omega-3 Fatty Acids / Fish Oil: Often taken for dry eye or heart health, these have mild antiplatelet effects. When combined with the local effects of Bromfenac, they could theoretically contribute to a slightly higher risk of minor bruising or bleeding around the eye after surgery.
• Garlic, Ginkgo Biloba, and Vitamin E: These supplements are known to have blood-thinning properties. Patients should inform their surgeon if they are taking high doses of these supplements prior to surgery.

Bromfenac ophthalmic solution is not known to interfere with common blood or urine laboratory tests. Because the systemic levels are so low, it does not affect liver function tests, creatinine, or blood counts in the way that oral NSAIDs might.

Mechanism of Interactions

1. 1Pharmacodynamic Interaction: The interaction with corticosteroids is pharmacodynamic, meaning both drugs act on the same physiological process (wound healing) in a way that compounds the risk.
2. 2Protein Binding Displacement: While Bromfenac is highly protein-bound, the systemic concentration is too low to displace other drugs (like Warfarin or Phenytoin) from albumin.
3. 3CYP Inhibition: Bromfenac does not reach high enough systemic concentrations to inhibit or induce the Cytochrome P450 enzyme system.

> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, including those you only use occasionally.

Bromfenac must NEVER be used in the following circumstances:

• Hypersensitivity to Bromfenac: Any patient with a known allergy to Bromfenac or any of the inactive ingredients in the formulation (such as benzalkonium chloride or sodium sulfite) must not use the drug. An allergic reaction could lead to severe ocular surface damage or systemic anaphylaxis.
• Aspirin-Induced Asthma: Patients who have experienced asthma, rhinitis (runny nose), or urticaria (hives) after taking aspirin or other NSAIDs are at high risk for a cross-reactive, potentially fatal allergic reaction. This is known as the 'aspirin triad' and is a strict contraindication.

These are conditions where the drug should only be used if the benefits clearly outweigh the risks, and under intense supervision:

• Pre-existing Corneal Disease: Patients with severe dry eye syndrome, corneal denervation (as seen in diabetes), or epithelial defects are at a much higher risk for corneal thinning and perforation when using Bromfenac. The drug can exacerbate these underlying issues.
• Complicated Ocular Surgery: If a surgery was particularly difficult or resulted in significant tissue trauma, the surgeon may opt for a different anti-inflammatory approach to avoid further stressing the corneal tissue.
• Bleeding Diathesis: Patients with hemophilia or other bleeding disorders should be treated with caution due to the potential for increased bleeding time in the ocular tissues.
• Sulfite Sensitivity: Some formulations of Bromfenac contain sulfites. In patients with a known sulfite allergy, these specific brands are contraindicated, though sulfite-free versions may be available.

There is a high potential for cross-sensitivity between Bromfenac and other NSAIDs. This includes:

• Ketorolac (Acular)
• Diclofenac (Voltaren)
• Nepafenac (Nevanac)
• Flurbiprofen (Ocufen)

If a patient has had a severe reaction to any of these ophthalmic NSAIDs, Bromfenac should generally be avoided.

> Important: Your healthcare provider will evaluate your complete medical history, including any history of asthma or nasal polyps, before prescribing Bromfenac.

FDA Pregnancy Category C.

There are no adequate and well-controlled studies of Bromfenac in pregnant women. Animal studies have shown that Bromfenac can cross the placental barrier.

• First and Second Trimester: Bromfenac should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• Third Trimester: Use of Bromfenac during late pregnancy (starting around week 30) should be avoided. Like all NSAIDs, Bromfenac may cause premature closure of the ductus arteriosus (a vital blood vessel in the fetal heart), which can lead to fetal pulmonary hypertension and other cardiac issues. It may also inhibit uterine contractions, potentially delaying or prolonging labor.

It is not known whether Bromfenac is excreted in human milk following ophthalmic administration. However, because systemic absorption is minimal, the amount of drug that could potentially reach a nursing infant is likely very low. Nevertheless, caution should be exercised when Bromfenac is administered to a nursing woman. The benefits of the treatment to the mother should be weighed against the potential risks to the infant.

As previously noted, Bromfenac is not approved for use in patients under 18 years of age. The safety and efficacy have not been established in this population. If a child requires anti-inflammatory treatment after eye surgery, alternative medications with established pediatric safety profiles are typically preferred.

Cataracts are primarily an age-related condition, and therefore the majority of patients in clinical trials for Bromfenac were over the age of 65. No overall differences in safety or effectiveness have been observed between these patients and younger adult patients. Geriatric patients do not require a dose adjustment, but they should be monitored closely for corneal health, as the elderly may have a higher prevalence of dry eye syndrome, which increases the risk of NSAID-related corneal thinning.

No dosage adjustment is necessary for patients with renal (kidney) impairment. The systemic exposure to Bromfenac after eye drop use is roughly 1,000 to 10,000 times lower than the exposure seen with the former oral version of the drug. Therefore, the kidneys are not put at risk by the ophthalmic solution.

No dosage adjustment is necessary for patients with hepatic (liver) impairment. While the history of oral Bromfenac is linked to liver failure, the ophthalmic solution does not reach the liver in concentrations high enough to cause hepatotoxicity. However, patients with active liver disease should always be monitored by their physician when starting any new medication.

> Important: Special populations require individualized medical assessment. Always inform your surgeon if you are pregnant, planning to become pregnant, or breastfeeding.

Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits analgesic and anti-inflammatory activity. Its primary mechanism of action is the inhibition of the enzyme cyclooxygenase (COX). Specifically, it blocks both COX-1 and COX-2, though it shows a high degree of potency against COX-2. By inhibiting these enzymes, Bromfenac prevents the synthesis of prostaglandins from arachidonic acid. In the eye, prostaglandins are responsible for disrupting the blood-aqueous humor barrier, causing vasodilation, increasing vascular permeability, and inducing leukocytosis (migration of white blood cells). By stopping prostaglandin production, Bromfenac maintains the integrity of the blood-aqueous barrier and prevents postoperative miosis (constriction of the pupil) and edema.

Bromfenac provides a rapid onset of anti-inflammatory action. In clinical trials, a reduction in pain and inflammation was often noted within the first 24 hours after the first dose. The duration of effect is sufficient to allow for once-daily or twice-daily dosing depending on the concentration. There is no evidence of tolerance development (the drug becoming less effective over time) during the standard 14-day treatment course.

| Parameter | Value |

|---|---|

| Bioavailability | High Ocular / Negligible Systemic |

| Protein Binding | ~99% (to Albumin) |

| Half-life | 6 - 9 hours (Plasma) |

| Tmax | 30 - 90 minutes (Ocular) |

| Metabolism | Hepatic (CYP2C9) - minimal systemic |

| Excretion | Renal (82%), Fecal (13%) |

• Molecular Formula: C15H11BrNNaO3 (as Sodium Salt)
• Molecular Weight: 356.15 g/mol
• Solubility: Soluble in water and methanol.
• Description: Bromfenac sodium is a yellow to orange crystalline powder. The ophthalmic solution is typically a clear, yellow liquid with a pH of approximately 8.3.

Bromfenac is classified as an ophthalmic nonsteroidal anti-inflammatory drug (NSAID). It is part of the phenylacetic acid derivative family, which also includes diclofenac and nepafenac. Within the therapeutic hierarchy, it is used as a first-line agent for the prevention and treatment of inflammation following ocular surgery.