Bromfenac 0.07% Opth Solution 3ml
It is used to treat swelling and pain after cataract surgery.
Drug Class
Ophthalmic anti-inflammatory agent
Pharmacologic Class
Nonsteroidal anti-inflammatory drug (NSAID)
Pregnancy Category
Category C/D
FDA Approved
Apr 2013
DEA Schedule
Not Controlled
Overview
What is this medicine?
Bromfenac ophthalmic solution is an eye drop used to reduce pain and swelling in the eye 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.
Before Using the Medication
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 the medication.
Administering the 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, allow at least a 5-minute interval between each medication.
Special Considerations
If you have undergone surgery on both eyes and are using this medication, your doctor may prescribe two separate bottles, one for each eye. Ensure that you do not mix up the bottles.
Storage and Disposal
Store the medication at room temperature, keeping it out of reach of children and pets.
Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so. Consult your pharmacist for guidance on the best disposal method or to inquire about 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.
Before Using the Medication
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 the medication.
Administering the 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, allow at least a 5-minute interval between each medication.
Special Considerations
If you have undergone surgery on both eyes and are using this medication, your doctor may prescribe two separate bottles, one for each eye. Ensure that you do not mix up the bottles.
Storage and Disposal
Store the medication at room temperature, keeping it out of reach of children and pets.
Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so. Consult your pharmacist for guidance on the best disposal method or to inquire about 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 bromfenac ophthalmic solution.
- Avoid touching the dropper tip to the eye or any other surface to prevent contamination.
- Wash hands thoroughly before and after using eye drops.
- If using other eye drops, wait at least 5 minutes between applications.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
1 drop in the affected eye(s) once daily
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
post-cataract surgery inflammation:
Start 1 day prior to cataract surgery and continue 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
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific considerations due to minimal systemic absorption
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits prostaglandin synthesis by inhibiting cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). Prostaglandins are mediators of inflammation and pain.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption
Tmax:
Approximately 150-180 minutes in aqueous humor (after single dose)
FoodEffect:
Not applicable for ophthalmic solution
Distribution:
Vd:
Not available (primarily ocular distribution)
ProteinBinding:
Approximately 99.8% (in vitro)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Approximately 1.4 hours (in aqueous humor); Systemic half-life not clinically relevant due to minimal absorption
Clearance:
Not available (primarily ocular elimination)
ExcretionRoute:
Primarily renal (for systemically absorbed drug), but negligible for ophthalmic use
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Within hours for anti-inflammatory effect
PeakEffect:
Within 24 hours
DurationOfAction:
Approximately 24 hours (allows once-daily dosing)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help 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
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Changes in eyesight, eye pain, or severe eye irritation
Bleeding in the eye
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although 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 or seek medical help:
Headache
Eye irritation
Burning or stinging sensation
Redness
Feeling of something in the eye
* Seeing floaters
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help 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
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Changes in eyesight, eye pain, or severe eye irritation
Bleeding in the eye
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although 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 or seek medical help:
Headache
Eye irritation
Burning or stinging sensation
Redness
Feeling of something in the eye
* Seeing floaters
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor for medical advice. 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:
- Severe eye pain
- Sudden vision changes or decreased vision
- Signs of eye infection (e.g., pus or discharge, severe redness, increased pain)
- Persistent or worsening eye irritation
- 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 allergic reaction you experienced, including any symptoms that occurred.
If you are more than 24 weeks pregnant, as this medication may have specific implications for your pregnancy.
Potential interactions with other medications or health conditions. To ensure your safety, disclose all of your current medications, including:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
Any existing health problems, as they may affect the safety or efficacy of this medication.
Remember to consult with your doctor before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any medication. This will help ensure that it is safe for you to take this medication in conjunction with your other medications and health conditions.
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 allergic reaction you experienced, including any symptoms that occurred.
If you are more than 24 weeks pregnant, as this medication may have specific implications for your pregnancy.
Potential interactions with other medications or health conditions. To ensure your safety, disclose all of your current medications, including:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
Any existing health problems, as they may affect the safety or efficacy of this medication.
Remember to consult with your doctor before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any medication. This will help ensure that it is safe for you to take this medication in conjunction with your other medications and health conditions.
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 the potential benefits and risks with your doctor to determine the best course of action for you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with ophthalmic use due to minimal systemic absorption. Local irritation may occur with excessive application.
What to Do:
If accidentally ingested, drink fluids to dilute. If eye irritation occurs, rinse eye with lukewarm water. Call 1-800-222-1222 (Poison Control) for advice if concerned.
Drug Interactions
Moderate Interactions
- Topical corticosteroids (increased risk of corneal healing complications)
Monitoring
Baseline Monitoring
Ocular examination
Rationale: To assess baseline inflammation and identify pre-existing conditions
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, absence of adverse effects
Action Threshold: Persistent inflammation, signs of infection, corneal complications, or increased intraocular pressure
Intraocular pressure (IOP)
Frequency: As clinically indicated, especially in patients with glaucoma or ocular hypertension
Target: Normal range for the patient
Action Threshold: Significant increase in IOP
Symptom Monitoring
- Eye pain
- Redness
- Blurred vision
- Discharge
- Photophobia
- Foreign body sensation
- Itching
Special Patient Groups
Pregnancy
Category C for first and second trimesters; Category D for third trimester. Use only if the potential benefit justifies the potential risk to the fetus. NSAIDs, including ophthalmic ones, may cause premature closure of the fetal ductus arteriosus if used during the third trimester.
Trimester-Specific Risks:
First Trimester:
Category C: Animal studies have shown adverse effects, but no adequate human studies. Use only if benefit outweighs risk.
Second Trimester:
Category C: Similar to first trimester.
Third Trimester:
Category D: Known human fetal risk (premature closure of ductus arteriosus, persistent pulmonary hypertension of the newborn, renal dysfunction). Avoid use.
Lactation
L3 (Moderately Safe). Minimal systemic absorption is expected to result in low levels in breast milk. Monitor infant for potential adverse effects, though unlikely.
Infant Risk:
Low risk of adverse effects to the breastfed infant due to minimal systemic absorption.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not recommended for use in children.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. No specific dose adjustment is needed.
Clinical Information
Clinical Pearls
- Bromfenac 0.07% is dosed once daily, which can improve patient adherence compared to multi-dose regimens.
- It is specifically indicated for post-cataract surgery inflammation and pain, not for general eye irritation or other inflammatory conditions.
- Patients should be instructed to remove contact lenses prior to administration and wait at least 15 minutes before reinserting them.
- Advise patients that transient blurred vision or stinging may occur immediately after instillation.
- Caution should be exercised in patients with a history of corneal complications or those undergoing complicated ocular surgeries, as NSAIDs can potentially increase the risk of corneal adverse events.
Alternative Therapies
- Other ophthalmic NSAIDs (e.g., ketorolac, nepafenac, diclofenac, flurbiprofen)
- Ophthalmic corticosteroids (e.g., prednisolone, dexamethasone, loteprednol)
- Combination ophthalmic NSAID/corticosteroid products (if available and indicated)
Cost & Coverage
Average Cost:
Varies widely (e.g., $100-$400+) per 3ml 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 is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.