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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Bromfenac Ophthalmic Solution 0.09%
Generic Name
Bromfenac Ophthalmic Solution 0.09%
Active Ingredient
BromfenacCategory
Other
Salt Form
Sodium
Variants
1
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 1.035 mg/mL | SOLUTION/ DROPS | OPHTHALMIC | 62332-508 |
Detailed information about Bromfenac Ophthalmic Solution 0.09%
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Bromfenac Ophthalmic Solution 0.09%, you must consult a qualified healthcare professional.
Bromfenac is a potent nonsteroidal anti-inflammatory drug (NSAID) used primarily as an ophthalmic solution to treat inflammation and pain following cataract surgery by inhibiting prostaglandin synthesis.
The dosage of Bromfenac depends strictly on the concentration of the solution prescribed by your ophthalmologist (eye surgeon).
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.
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.
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.
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:
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.
These effects may occur in a smaller percentage of the population and should be monitored:
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.
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.
During treatment with Bromfenac, your ophthalmologist will perform several checks:
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:
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.
> 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:
These are conditions where the drug should only be used if the benefits clearly outweigh the risks, and under intense supervision:
There is a high potential for cross-sensitivity between Bromfenac and other NSAIDs. This includes:
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.
There are no adequate and well-controlled studies of Bromfenac in pregnant women. Animal studies have shown that Bromfenac can cross the placental barrier.
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%) |
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.
Common questions about Bromfenac Ophthalmic Solution 0.09%
Bromfenac is primarily used as an eye drop to treat inflammation and pain in patients who have recently undergone cataract surgery. It belongs to the NSAID class of drugs and works by blocking the production of prostaglandins, which are chemicals in the body that cause swelling and discomfort. By reducing this inflammation, Bromfenac helps the eye heal more comfortably and prevents complications like macular edema. It is typically started a day before surgery and continued for two weeks afterward. Your surgeon may also use it off-label for other types of eye surgeries or inflammatory conditions.
The most common side effects of Bromfenac eye drops are localized to the eye and include temporary stinging, burning, or a 'gritty' feeling immediately after the drop is applied. Some patients may also experience temporary blurred vision, watery eyes, or a mild headache. Redness of the white part of the eye (conjunctival hyperemia) is also frequently reported. These symptoms are usually mild and disappear quickly. However, if you experience severe pain or a sudden change in vision, you should contact your eye doctor immediately.
There is no known direct interaction between alcohol and Bromfenac ophthalmic solution. Because the medication is applied to the eye and very little reaches the bloodstream, alcohol does not change how the drug works. However, it is important to remember that you are recovering from eye surgery. Alcohol can interfere with your coordination, increasing the risk of accidentally bumping or rubbing your eye, and it can also affect the general healing process. It is always best to follow your surgeon's specific advice regarding alcohol consumption during your postoperative recovery.
Bromfenac is classified as Pregnancy Category C, meaning it should only be used if the potential benefits outweigh the risks to the fetus. It is particularly important to avoid using Bromfenac during the third trimester of pregnancy (the last three months). Like other NSAIDs, it can cause the premature closure of a vital blood vessel in the fetal heart, known as the ductus arteriosus, which can lead to serious complications for the baby. If you are pregnant or planning to become pregnant, you must discuss the risks and benefits of this medication with your obstetrician and your eye surgeon.
Bromfenac begins to work very quickly after application, with peak levels in the eye tissues reached within 30 to 90 minutes. Most patients notice a significant reduction in eye pain and sensitivity to light within the first 24 hours of starting the medication. However, the full anti-inflammatory effect builds over several days of consistent use. This is why surgeons often have patients start the drops the day before surgery—to ensure the medication is already active in the eye tissues when the surgical trauma occurs.
You should not stop taking Bromfenac suddenly unless your doctor instructs you to do so. While there is no 'withdrawal' effect like you might see with some oral medications, stopping the drops too early can cause the inflammation in your eye to return or worsen. This 'rebound inflammation' can lead to increased pain and may slow down your recovery from surgery. Most prescriptions are designed for a 14-day course to ensure the eye has passed the most critical phase of postoperative healing. Always complete the full course as prescribed by your ophthalmologist.
If you miss a dose of Bromfenac, you should apply the missed drop as soon as you remember. However, if it is nearly time for your next scheduled dose, it is better to skip the missed dose entirely and stay on your regular schedule. You should never apply two drops at once to make up for a missed one, as the eye cannot hold that much fluid and the excess will simply run out. Consistency is the most important factor in managing inflammation, so try to use your drops at the same time each day.
No, Bromfenac ophthalmic solution does not cause weight gain. Weight gain is sometimes a side effect of systemic corticosteroids or certain oral medications, but Bromfenac is a nonsteroidal anti-inflammatory drug used locally in the eye. The amount of the drug that enters your general circulation is extremely small—not enough to affect your metabolism, appetite, or fluid retention. If you notice unusual weight gain while recovering from surgery, it is likely due to other factors or medications and should be discussed with your primary care physician.
Bromfenac can generally be taken with other systemic medications, but you must be careful with other eye drops. It is very common to be prescribed Bromfenac alongside steroid eye drops and antibiotic eye drops after surgery. To ensure each medication is absorbed properly, you should wait at least 5 minutes between applying different types of drops. You should also inform your doctor if you are taking blood thinners like warfarin or aspirin, as these can theoretically increase the risk of minor bleeding in the eye when combined with an NSAID like Bromfenac.
Yes, Bromfenac is available as a generic medication, specifically in the 0.09% concentration. Generic versions are typically more cost-effective than brand-name versions like Prolensa or BromSite. While the active ingredient is the same, some inactive ingredients or the frequency of dosing may differ between the generic and the brand-name versions. Your pharmacist or surgeon can help determine which version is covered by your insurance and most appropriate for your needs. Always ensure you are following the specific dosing instructions for the version you receive.
Other drugs with the same active ingredient (Bromfenac)