Bromfenac 0.09% Opth Sol 1.7ml
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 (first and second trimesters); Category D (third trimester)
FDA Approved
Mar 2005
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 belongs to a group of medicines called NSAIDs, which work by blocking substances in the body 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 eye use 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 thoroughly before and after using this medication.
3. To avoid contaminating the medication, do not touch the container tip to your eye, eyelid, or surrounding skin, as this can lead to bacterial infection, 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
1. Store this medication at room temperature.
2. Keep all medications in a safe and secure location, out of the reach of children and pets.
3. 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.
4. Consult your pharmacist for guidance on the best method for disposing of medications. You may also want to explore drug take-back programs 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 eye use 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 thoroughly before and after using this medication.
3. To avoid contaminating the medication, do not touch the container tip to your eye, eyelid, or surrounding skin, as this can lead to bacterial infection, 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
1. Store this medication at room temperature.
2. Keep all medications in a safe and secure location, out of the reach of children and pets.
3. 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.
4. Consult your pharmacist for guidance on the best method for disposing of medications. You may also want to explore drug take-back programs 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
- Do not wear contact lenses during treatment with bromfenac ophthalmic solution.
- Avoid touching the dropper tip to any surface, including the eye, to prevent contamination.
- If using other eye drops, wait at least 5 minutes between applications.
- Store at room temperature, away from light and moisture.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
One drop to the affected eye(s) once daily, beginning 1 day prior to cataract surgery and continuing for 14 days post-surgery.
Condition-Specific Dosing:
post-cataract surgery inflammation:
One drop to the affected eye(s) once daily, beginning 1 day prior to cataract surgery and continuing 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 due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory activity by inhibiting prostaglandin synthesis. It is thought to act by inhibiting cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), enzymes essential in the biosynthesis of prostaglandins. Prostaglandins are mediators of inflammation and are involved in the pathogenesis of certain types of ocular inflammation.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (minimal systemic absorption)
Tmax:
Not clinically relevant (minimal systemic absorption)
FoodEffect:
Not applicable (ophthalmic administration)
Distribution:
Vd:
Not clinically relevant (minimal systemic absorption)
ProteinBinding:
Not clinically relevant (minimal systemic absorption)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Approximately 1.5 hours (systemic, but not clinically relevant for ophthalmic use)
Clearance:
Not clinically relevant (minimal systemic absorption)
ExcretionRoute:
Primarily renal (systemic, but not clinically relevant for ophthalmic use)
Unchanged:
Not clinically relevant (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Within hours (for anti-inflammatory effect)
PeakEffect:
Within 24 hours
DurationOfAction:
Approximately 24 hours (with once-daily dosing)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 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. 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:
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, 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.
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 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. 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:
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, 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 discomfort
- Increased redness or swelling of the eye
- Changes in vision (e.g., blurred vision, decreased vision)
- Signs of eye infection (e.g., pus or discharge from the eye, severe itching)
- Sensitivity to light
- Any new or unusual 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 symptoms you experienced.
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 discuss the following with your doctor and pharmacist:
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 treatment regimen, consult with your doctor to confirm that it is safe to:
Start taking this medication
Stop taking this medication
* Change the dosage of this medication or any other medication you are taking
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.
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 discuss the following with your doctor and pharmacist:
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 treatment regimen, consult with your doctor to confirm that it is safe to:
Start taking this medication
Stop taking this medication
* Change the dosage of this medication or any other medication you are taking
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 both you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with ophthalmic administration due to minimal systemic absorption. Local irritation may occur.
What to Do:
If accidentally ingested, drink fluids to dilute. If eye irritation occurs, rinse eye with water. Contact a poison control center or seek medical attention if symptoms are severe or persistent. Call 1-800-222-1222 for poison control.
Drug Interactions
Moderate Interactions
- Other topical NSAIDs (increased risk of corneal complications)
- Topical corticosteroids (increased risk of corneal complications, delayed healing)
Monitoring
Baseline Monitoring
Ocular examination (visual acuity, slit lamp, intraocular pressure)
Rationale: To establish baseline ocular health and identify any pre-existing conditions.
Timing: Prior to initiation of therapy
Routine Monitoring
Ocular examination (visual acuity, slit lamp)
Frequency: As clinically indicated, especially if symptoms worsen or new symptoms appear
Target: Stable or improving vision and ocular health
Action Threshold: Worsening vision, persistent pain, signs of infection, corneal complications (e.g., thinning, erosion, ulceration)
Intraocular pressure (IOP)
Frequency: As clinically indicated, especially if patient is on concomitant steroid therapy or has glaucoma
Target: Normal range for the patient
Action Threshold: Significant increase in IOP
Symptom Monitoring
- Eye pain
- Redness
- Blurred vision
- Discharge
- Photophobia
- Foreign body sensation
- Signs of infection (e.g., purulent discharge, severe redness, swelling)
Special Patient Groups
Pregnancy
Use with caution during pregnancy. While systemic absorption is minimal, NSAIDs can cause premature closure of the fetal ductus arteriosus if used during the third trimester. Avoid use in late pregnancy.
Trimester-Specific Risks:
First Trimester:
Category C: Risk cannot be ruled out. Use only if potential benefit justifies potential risk to the fetus.
Second Trimester:
Category C: Risk cannot be ruled out. Use only if potential benefit justifies potential risk to the fetus.
Third Trimester:
Category D: Positive evidence of human fetal risk. Avoid use due to potential for premature closure of the fetal ductus arteriosus.
Lactation
Minimal systemic absorption suggests low risk to a breastfed infant. However, caution is advised. Consider the developmental and health benefits of breastfeeding, the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.
Infant Risk:
Low risk (L3 - Moderately Safe)
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended in children.
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 0.09% is typically dosed once daily, which can improve patient adherence compared to multi-dose regimens.
- It is crucial to instruct patients on proper eye drop instillation technique to maximize efficacy and minimize contamination.
- Patients should be advised to remove contact lenses prior to instilling bromfenac and wait at least 15 minutes before reinserting them.
- While systemic absorption is minimal, patients with a history of bleeding disorders or those on anticoagulants should be monitored for any unusual bleeding, though this is rare with ophthalmic use.
- Prolonged use of topical NSAIDs, especially in patients with compromised corneas, can lead to corneal adverse events, including thinning, erosion, ulceration, and perforation. Monitor patients closely.
Alternative Therapies
- Other ophthalmic NSAIDs (e.g., ketorolac, nepafenac, diclofenac, flurbiprofen)
- Topical corticosteroids (e.g., prednisolone acetate, dexamethasone, loteprednol) for inflammation, often used in combination or sequentially with NSAIDs.
- Combination products (e.g., antibiotic/steroid combinations if infection is also a concern)
Cost & Coverage
Average Cost:
Varies, typically $100-$300 per 1.7ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (generic often Tier 1 or 2)
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.