Bromsite 0.075% Eye Drops
It is used to treat swelling and pain after cataract surgery.
Drug Class
Ophthalmic Nonsteroidal Anti-inflammatory Drug (NSAID)
Pharmacologic Class
Cyclooxygenase (COX) inhibitor
Pregnancy Category
Category C
FDA Approved
Oct 2015
DEA Schedule
Not Controlled
Overview
What is this medicine?
Bromsite eye drops are used to reduce eye pain and swelling (inflammation) that can occur after cataract surgery. It works by blocking certain natural substances in the eye that cause inflammation.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is for use in the eyes only.
Remove your contact lenses before using this medication. Consult your doctor to determine if you can reinsert your contact lenses after use. However, do not put your contact lenses back in if your eyes are irritated or infected.
Wash your hands thoroughly before and after using this medication.
To avoid contaminating the medication with bacteria, which could lead to severe eye problems or vision loss, do not touch the container tip to your eye, eyelid, or surrounding skin.
Tilt your head back and gently drop the medication into your eye.
If you are using multiple medications in the same eye, administer each medication at least 5 minutes apart.
If you have undergone surgery on both eyes and are using this medication, do not use the same bottle for both eyes. Your doctor may prescribe two separate bottles, one for each eye. Ensure that you do not mix up the two bottles.
Storage and Disposal
Store this medication at room temperature.
Keep all medications in a safe and secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. Consult your pharmacist for guidance on the best disposal method. You may also have access to drug take-back programs in your area.
Missed Dose
If you miss a dose, use it as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not use two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is for use in the eyes only.
Remove your contact lenses before using this medication. Consult your doctor to determine if you can reinsert your contact lenses after use. However, do not put your contact lenses back in if your eyes are irritated or infected.
Wash your hands thoroughly before and after using this medication.
To avoid contaminating the medication with bacteria, which could lead to severe eye problems or vision loss, do not touch the container tip to your eye, eyelid, or surrounding skin.
Tilt your head back and gently drop the medication into your eye.
If you are using multiple medications in the same eye, administer each medication at least 5 minutes apart.
If you have undergone surgery on both eyes and are using this medication, do not use the same bottle for both eyes. Your doctor may prescribe two separate bottles, one for each eye. Ensure that you do not mix up the two bottles.
Storage and Disposal
Store this medication at room temperature.
Keep all medications in a safe and secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. Consult your pharmacist for guidance on the best disposal method. You may also have access to drug take-back programs in your area.
Missed Dose
If you miss a dose, use it as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not use two doses at the same time or take extra doses.
Lifestyle & Tips
- Do not wear contact lenses during treatment with Bromsite unless directed by your doctor.
- Do not touch the dropper tip to your eye or any other surface to avoid contamination.
- Wash your hands before and after using eye drops.
- If you use other eye drops, wait at least 5 minutes between applications.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
One drop in the affected eye(s) once daily, beginning 1 day prior to cataract surgery, continued on the day of surgery, and for 14 days post-surgery.
Condition-Specific Dosing:
post_cataract_surgery_inflammation:
One drop in the affected eye(s) once daily, beginning 1 day prior to cataract surgery, continued on the day of surgery, and for 14 days post-surgery.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Dialysis:
No specific considerations (minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Pharmacology
Mechanism of Action
Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits prostaglandin synthesis by decreasing the activity of cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), enzymes that catalyze the formation of prostaglandin precursors from arachidonic acid. Prostaglandins are mediators of inflammation.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (plasma concentrations generally below 0.5 ng/mL)
Tmax:
Not clinically relevant for systemic absorption
FoodEffect:
Not applicable (ophthalmic administration)
Distribution:
Vd:
Not characterized systemically due to minimal absorption
ProteinBinding:
Not characterized systemically due to minimal absorption
CnssPenetration:
No (minimal systemic absorption)
Elimination:
HalfLife:
Approximately 1.5 hours (systemic, if absorbed)
Clearance:
Not characterized systemically
ExcretionRoute:
Not characterized systemically
Unchanged:
Not characterized systemically
Pharmacodynamics
OnsetOfAction:
Clinical effect typically observed within days of initiation
PeakEffect:
Within days to one week of consistent use
DurationOfAction:
Once daily dosing provides sustained anti-inflammatory effect for 24 hours
Confidence:
Medium
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Changes in vision, eye pain, or severe eye irritation
- Bleeding in the eye
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor for advice:
- Headache
- Eye irritation
- Burning or stinging sensations
- Redness
- Feeling of having something in the eye
- Seeing floaters
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Changes in vision, eye pain, or severe eye irritation
- Bleeding in the eye
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor for advice:
- Headache
- Eye irritation
- Burning or stinging sensations
- Redness
- Feeling of having something in the eye
- Seeing floaters
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Worsening eye pain or redness
- Changes in vision
- Signs of eye infection (e.g., pus, severe redness, increasing pain)
- Persistent eye irritation or discomfort
- New or worsening sensitivity to light
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
If you are more than 24 weeks pregnant, as this medication may have specific implications for your condition.
To ensure safe treatment, it is crucial to disclose all of the following to your doctor and pharmacist:
A comprehensive list of all medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any existing health problems, as this medication may interact with other drugs or health conditions.
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
If you are more than 24 weeks pregnant, as this medication may have specific implications for your condition.
To ensure safe treatment, it is crucial to disclose all of the following to your doctor and pharmacist:
A comprehensive list of all medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any existing health problems, as this medication may interact with other drugs or health conditions.
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you have a known allergy to sulfites, consult with your doctor, as some formulations of this drug may contain sulfites. Do not exceed the prescribed duration of treatment; use this medication only for the length of time specified by your doctor. If you are pregnant, planning to become pregnant, or are currently breast-feeding, discuss this with your doctor to carefully weigh the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with ophthalmic administration due to minimal systemic absorption. Local irritation may occur with excessive use.
What to Do:
If an overdose is suspected, flush the eye with water. If irritation persists or if the drops are accidentally ingested, contact a poison control center or seek medical attention. Call 1-800-222-1222 for Poison Control.
Drug Interactions
Moderate Interactions
- Other topical ophthalmic medications (administer at least 5 minutes apart)
- Systemic anticoagulants/antiplatelets (theoretical increased bleeding risk, but unlikely due to minimal systemic absorption)
Confidence Interactions
Monitoring
Baseline Monitoring
Ocular examination (e.g., slit lamp)
Rationale: To assess baseline inflammation and corneal integrity prior to treatment.
Timing: Prior to initiation of therapy
Routine Monitoring
Ocular examination (e.g., slit lamp)
Frequency: As clinically indicated, typically at follow-up visits post-surgery
Target: Resolution of inflammation, clear cornea
Action Threshold: Worsening inflammation, signs of infection, corneal complications (e.g., thinning, ulceration)
Intraocular pressure (IOP)
Frequency: As clinically indicated (part of routine post-operative care)
Target: Normal range for patient
Action Threshold: Significant increase in IOP
Symptom Monitoring
- Eye pain
- Redness
- Blurred vision
- Discharge from the eye
- Sensitivity to light
- Signs of infection (e.g., pus, severe redness, increasing pain)
- Persistent irritation
Special Patient Groups
Pregnancy
Pregnancy Category C. There are no adequate and well-controlled studies of Bromsite in pregnant women. Bromsite should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Due to the known effects of prostaglandin biosynthesis inhibitors on the fetal cardiovascular system (closure of the ductus arteriosus), the use of Bromsite during late pregnancy should be avoided.
Trimester-Specific Risks:
First Trimester:
Potential risk, but minimal systemic absorption limits exposure.
Second Trimester:
Potential risk, but minimal systemic absorption limits exposure.
Third Trimester:
Avoid use due to potential for premature closure of the fetal ductus arteriosus, a known effect of prostaglandin biosynthesis inhibitors (NSAIDs).
Lactation
It is not known whether Bromsite is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Bromsite is administered to a nursing woman. Minimal systemic absorption suggests low risk to the infant.
Infant Risk:
Low (due to minimal systemic absorption)
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. No dosage adjustment is necessary.
Clinical Information
Clinical Pearls
- Bromsite is specifically indicated for the treatment of post-cataract surgery inflammation.
- Its once-daily dosing regimen can improve patient compliance compared to multi-dose regimens.
- Due to minimal systemic absorption, systemic side effects commonly associated with oral NSAIDs (e.g., GI upset, cardiovascular events) are not expected.
- Prolonged use of topical NSAIDs, especially in patients with compromised corneas (e.g., diabetes, rheumatoid arthritis, previous eye surgery), may increase the risk of corneal complications such as keratitis, corneal thinning, erosion, ulceration, or perforation. Monitor patients closely.
- Patients should be advised not to wear contact lenses during treatment with Bromsite.
Alternative Therapies
- Other ophthalmic NSAIDs (e.g., ketorolac ophthalmic, nepafenac ophthalmic, diclofenac ophthalmic)
- Ophthalmic corticosteroids (e.g., prednisolone acetate, dexamethasone ophthalmic) for inflammation
Cost & Coverage
Average Cost:
Varies widely per 1.7 mL bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.