Bromfenac 0.075% Opth Sol 5ml
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
Apr 2013
DEA Schedule
Not Controlled
Overview
What is this medicine?
Bromfenac is an eye drop that belongs to a group of medicines called NSAIDs (nonsteroidal anti-inflammatory drugs). It works by reducing swelling, pain, and discomfort in your eye, especially after eye surgery like cataract removal. It helps your eye heal by calming down the 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.
Preparation and Administration
1. Remove contact lenses before using this medication. Consult your doctor to determine if you can reinsert your contact lenses after use. Do not put your contact lenses back in if your eyes are irritated or infected.
2. Wash your hands before and after using this medication.
3. To avoid contamination, do not touch the container tip to your eye, eyelid, or surrounding skin, as this can introduce bacteria into the medication and potentially cause severe eye problems or vision loss.
4. Tilt your head back and gently drop the medication into your eye.
5. If you are using multiple medications in the same eye, administer each medication at least 5 minutes apart.
6. 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 bottles.
Storage and Disposal
Store this medication at room temperature, in a safe location, and out of the reach of children and pets. Dispose of unused or expired medication according to the following guidelines:
- Do not flush medication down the toilet or pour it down the drain unless instructed to do so.
- Consult your pharmacist for guidance on the proper disposal method.
- Check if there are any drug take-back programs available in your area.
Missed Dose
If you miss a dose, use it as soon as you remember. However, 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.
Preparation and Administration
1. Remove contact lenses before using this medication. Consult your doctor to determine if you can reinsert your contact lenses after use. Do not put your contact lenses back in if your eyes are irritated or infected.
2. Wash your hands before and after using this medication.
3. To avoid contamination, do not touch the container tip to your eye, eyelid, or surrounding skin, as this can introduce bacteria into the medication and potentially cause severe eye problems or vision loss.
4. Tilt your head back and gently drop the medication into your eye.
5. If you are using multiple medications in the same eye, administer each medication at least 5 minutes apart.
6. 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 bottles.
Storage and Disposal
Store this medication at room temperature, in a safe location, and out of the reach of children and pets. Dispose of unused or expired medication according to the following guidelines:
- Do not flush medication down the toilet or pour it down the drain unless instructed to do so.
- Consult your pharmacist for guidance on the proper disposal method.
- Check if there are any drug take-back programs available in your area.
Missed Dose
If you miss a dose, use it as soon as you remember. However, 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
- Wash hands thoroughly before and after using eye drops.
- Do not touch the dropper tip to your eye or any other surface to avoid contamination.
- If you wear contact lenses, remove them before applying the drops and wait at least 10 minutes before reinserting them.
- If using other eye drops, wait at least 5 minutes between applications.
- Do not rub your eyes after applying the drops.
- Store at room temperature, away from light and moisture. Do not freeze.
Available Forms & 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 (Safety and effectiveness in pediatric patients below the age of 2 years have not been established).
Child:
Not established (Safety and effectiveness in pediatric patients below the age of 2 years have not been established). Use in older children is off-label and based on physician discretion.
Adolescent:
Not established (Safety and effectiveness in pediatric patients below the age of 2 years have not been established). Use in older adolescents is off-label and based on physician discretion, often similar to adult dosing.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment required due to minimal systemic absorption.
Moderate:
No specific adjustment required due to minimal systemic absorption.
Severe:
No specific adjustment required due to minimal systemic absorption.
Dialysis:
No specific adjustment required due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment required due to minimal systemic absorption.
Moderate:
No specific adjustment required due to minimal systemic_absorption.
Severe:
No specific adjustment required due to 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), key enzymes in the arachidonic acid cascade. Prostaglandins are mediators of inflammation, and their inhibition reduces ocular inflammation and pain.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (not quantifiable in most patients after ocular administration).
Tmax:
Not applicable (minimal systemic absorption).
FoodEffect:
Not applicable (ophthalmic administration).
Distribution:
Vd:
Not applicable (minimal systemic absorption).
ProteinBinding:
Not applicable (minimal systemic absorption).
CnssPenetration:
Limited (minimal systemic absorption).
Elimination:
HalfLife:
Not applicable (minimal systemic absorption).
Clearance:
Not applicable (minimal systemic absorption).
ExcretionRoute:
Not applicable (minimal systemic absorption).
Unchanged:
Not applicable (minimal systemic absorption).
Pharmacodynamics
OnsetOfAction:
Within hours (for anti-inflammatory effect).
PeakEffect:
Within 1-2 days of consistent use.
DurationOfAction:
Approximately 24 hours (allows for once-daily dosing).
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 immediate medical attention:
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. 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:
Headache
Eye irritation
Burning or stinging
Redness
Feeling that something is 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, 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.
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 immediate medical attention:
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. 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:
Headache
Eye irritation
Burning or stinging
Redness
Feeling that something is 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, 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:
- Worsening eye pain or discomfort
- Increased redness or swelling of the eye
- Changes in vision (e.g., decreased vision, new floaters)
- Signs of eye infection (e.g., pus-like discharge, severe pain, fever)
- Sensitivity to light (photophobia)
- Any new or worsening eye symptoms
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 condition.
To ensure safe treatment, it is crucial to disclose all of the following to your doctor and pharmacist:
A complete list of your current medications, 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, consult with your doctor to confirm that it is safe to take this medication with your other drugs and health conditions. Do not start, stop, or adjust the dose of any medication without first discussing it 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 condition.
To ensure safe treatment, it is crucial to disclose all of the following to your doctor and pharmacist:
A complete list of your current medications, 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, consult with your doctor to confirm that it is safe to take this medication with your other drugs and health conditions. Do not start, stop, or adjust the dose of any medication without first discussing it with your doctor.
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 use.
What to Do:
If accidentally ingested, drink fluids. If eye irritation occurs, rinse eye with water. In case of significant ingestion or severe reaction, contact a poison control center (e.g., 1-800-222-1222) or seek medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Ocular examination (visual acuity, slit lamp, intraocular pressure)
Rationale: To assess baseline ocular health and inflammation prior to surgery and treatment.
Timing: Prior to initiation of therapy (pre-surgery).
Routine Monitoring
Ocular examination (visual acuity, slit lamp, intraocular pressure)
Frequency: As clinically indicated, typically at post-operative visits.
Target: Resolution of inflammation, stable or improved visual acuity, normal IOP.
Action Threshold: Worsening inflammation, persistent pain, significant vision changes, elevated IOP, signs of infection, or corneal complications (e.g., thinning, erosion, ulceration).
Corneal integrity
Frequency: As clinically indicated, especially in patients with pre-existing corneal disease or prolonged use.
Target: Intact corneal surface.
Action Threshold: Signs of corneal epithelial breakdown, thinning, erosion, or ulceration. Discontinue if these occur.
Symptom Monitoring
- Ocular pain
- Redness
- Photophobia
- Blurred vision
- Discharge
- Signs of infection (e.g., purulent discharge, severe pain, worsening redness)
Special Patient Groups
Pregnancy
Pregnancy Category C. Studies in animals have shown adverse effects on the fetus. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Avoid use in late pregnancy due to potential effects on fetal cardiovascular system (premature closure of ductus arteriosus) and inhibition of uterine contractions.
Trimester-Specific Risks:
First Trimester:
Potential risk based on animal studies; human data limited. Use with caution.
Second Trimester:
Potential risk based on animal studies; human data limited. Use with caution.
Third Trimester:
Avoid use due to potential for premature closure of the fetal ductus arteriosus and inhibition of uterine contractions.
Lactation
It is not known whether bromfenac is excreted in human milk. Given minimal systemic absorption, the risk to a nursing infant is likely low. Caution should be exercised when administered to a nursing woman.
Infant Risk:
Low risk (L3) due to minimal systemic absorption, but unknown excretion into breast milk.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 2 years have not been established. Use in older pediatric patients is off-label and should be done with caution, weighing potential benefits against risks.
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
- Bromfenac 0.075% is a once-daily ophthalmic NSAID, which can improve patient adherence compared to multi-dose regimens.
- It is specifically indicated for the treatment of post-operative inflammation and pain following cataract surgery.
- Patients should be advised about the importance of proper instillation technique to avoid contamination and ensure efficacy.
- While systemic absorption is minimal, prolonged use of ophthalmic NSAIDs, especially in patients with compromised corneas, can lead to corneal complications (e.g., thinning, erosion, ulceration). Monitor patients closely.
- Avoid concomitant use with topical corticosteroids unless specifically directed by an ophthalmologist, as this may increase the risk of corneal complications.
Alternative Therapies
- Other ophthalmic NSAIDs (e.g., Ketorolac, Nepafenac, Diclofenac)
- Ophthalmic corticosteroids (e.g., Prednisolone acetate, Dexamethasone, Difluprednate) - often used in conjunction or as alternatives depending on the specific inflammatory condition.
Cost & Coverage
Average Cost:
$100 - $300 per 5ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (preferred brand or non-preferred brand, generic usually Tier 1)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 for more information. 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.