Flurbiprofen 0.03% Ophthsoln 2.5ml
It is used to help prevent pupils from getting smaller.It is used for eye surgeries.
Drug Class
Ophthalmic Anti-inflammatory
Pharmacologic Class
Nonsteroidal Anti-inflammatory Drug (NSAID), Ophthalmic
Pregnancy Category
Category C (first/second trimester), Category D (third trimester)
FDA Approved
Sep 1983
DEA Schedule
Not Controlled
Overview
What is this medicine?
Flurbiprofen ophthalmic solution is an eye drop that belongs to a class of medicines called NSAIDs (nonsteroidal anti-inflammatory drugs). It works by reducing certain natural substances in the eye that cause inflammation and pupil constriction during eye surgery. It is primarily used to prevent the pupil from getting smaller during cataract surgery.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. This medication is for ocular use only.
Administration Instructions
1. Wash your hands thoroughly before and after using this medication.
2. Avoid wearing contact lenses during treatment with this medication.
3. To prevent contamination and potential severe eye problems or vision loss, do not touch the container tip to your eye, eyelid, or surrounding skin.
4. Tilt your head back and gently drop the medication into your eye.
Important Safety Precaution
If you are using this medication for both eyes at home, use a separate bottle for each eye to prevent cross-contamination.
Storage and Disposal
Store this medication at room temperature.
Missed Dose
If you miss a dose, consult your doctor for guidance on what to do next.
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. This medication is for ocular use only.
Administration Instructions
1. Wash your hands thoroughly before and after using this medication.
2. Avoid wearing contact lenses during treatment with this medication.
3. To prevent contamination and potential severe eye problems or vision loss, do not touch the container tip to your eye, eyelid, or surrounding skin.
4. Tilt your head back and gently drop the medication into your eye.
Important Safety Precaution
If you are using this medication for both eyes at home, use a separate bottle for each eye to prevent cross-contamination.
Storage and Disposal
Store this medication at room temperature.
Missed Dose
If you miss a dose, consult your doctor for guidance on what to do next.
Lifestyle & Tips
- Do not touch the dropper tip to any surface, including the eye, to avoid contamination.
- Remove contact lenses before instilling drops and wait at least 15 minutes before reinserting them.
- If using other eye drops, wait at least 5 minutes between applications.
- Store at room temperature, away from light and moisture.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One drop instilled into the affected eye every 30 minutes, beginning 2 hours before surgery (total of 4 drops)
Dose Range:
4 - 4 mg
Condition-Specific Dosing:
inhibition_of_intraoperative_miosis:
One drop every 30 minutes, starting 2 hours before surgery (total of 4 drops).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for ophthalmic use due to minimal systemic absorption.
Moderate:
No specific adjustment needed for ophthalmic use due to minimal systemic absorption.
Severe:
No specific adjustment needed for ophthalmic use due to minimal systemic absorption.
Dialysis:
No specific adjustment needed for ophthalmic use due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment needed for ophthalmic use due to minimal systemic absorption.
Moderate:
No specific adjustment needed for ophthalmic use due to minimal systemic absorption.
Severe:
No specific adjustment needed for ophthalmic use due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Flurbiprofen is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits prostaglandin synthesis by reversibly inhibiting cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) enzymes. In the eye, prostaglandins are known to be mediators of certain kinds of intraocular inflammation. In animal studies, prostaglandins have been shown to produce disruption of the blood-aqueous barrier, vasodilation, increased vascular permeability, leukocytosis, and increased intraocular pressure. Prostaglandins also appear to play a role in the miotic response produced during ocular surgery by constricting the iris sphincter independently of cholinergic mechanisms.
Pharmacokinetics
Absorption:
Bioavailability:
Limited systemic absorption from ophthalmic administration.
Tmax:
Not readily quantifiable for ophthalmic use due to local action.
FoodEffect:
Not applicable for ophthalmic use.
Distribution:
Vd:
Not readily quantifiable for ophthalmic use.
ProteinBinding:
Not readily quantifiable for ophthalmic use; systemically, flurbiprofen is highly protein bound (>99%).
CnssPenetration:
Limited/Negligible from ophthalmic administration.
Elimination:
HalfLife:
Systemic half-life is approximately 3-6 hours (if systemically absorbed).
Clearance:
Not readily quantifiable for ophthalmic use.
ExcretionRoute:
Primarily renal (as metabolites) if systemically absorbed.
Unchanged:
<1% (systemically)
Pharmacodynamics
OnsetOfAction:
Within 2 hours (for anti-miotic effect)
PeakEffect:
Within 2 hours (for anti-miotic effect)
DurationOfAction:
Several hours (effect for intraoperative miosis is maintained during surgery)
Confidence:
High
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 for advice:
Burning or stinging
Note: This list is not exhaustive, and you may experience other side effects not mentioned here. 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 for advice:
Burning or stinging
Note: This list is not exhaustive, and you may experience other side effects not mentioned here. 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:
- Severe or persistent eye pain
- Vision changes
- Signs of infection (e.g., pus, severe redness, swelling)
- Corneal changes (e.g., white spots on the cornea, thinning)
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 have an allergy to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or naproxen.
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 you have.
This information will help your doctor determine if it is safe for you to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so.
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 have an allergy to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or naproxen.
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 you have.
This information will help your doctor determine if it is safe for you to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so.
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 experience an eye wound or irritation that does not heal, consult your doctor promptly. Additionally, if you are pregnant, planning to become pregnant, or are breast-feeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both 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 swallowed, call a poison control center (1-800-222-1222) or seek emergency medical attention. For ocular overdose, flush eye with copious amounts of water.
Drug Interactions
Moderate Interactions
- Anticoagulants (e.g., warfarin): Theoretical increased bleeding risk due to NSAID effect on platelet aggregation, though systemic absorption is minimal.
- Other NSAIDs (systemic or ophthalmic): Increased risk of adverse effects, especially corneal complications.
Confidence Interactions
Monitoring
Routine Monitoring
Ocular irritation/discomfort
Frequency: During and after administration
Target: Minimal to none
Action Threshold: Persistent or severe irritation, pain, or vision changes warrant discontinuation and medical evaluation.
Corneal integrity
Frequency: As clinically indicated, especially in patients with compromised corneas or prolonged use.
Target: Intact cornea
Action Threshold: Signs of corneal epithelial breakdown, thinning, or melting.
Symptom Monitoring
- Ocular pain
- Burning
- Stinging
- Itching
- Redness
- Blurred vision
- Corneal changes (e.g., opacities, thinning)
Special Patient Groups
Pregnancy
Use during pregnancy should be avoided, especially in the third trimester, due to potential for premature closure of the fetal ductus arteriosus and other adverse effects on the fetus. Category C in first/second trimester, Category D in third trimester. Use only if potential benefit justifies potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Category C: Animal studies show adverse effects, but human data are lacking. Use only if clearly needed.
Second Trimester:
Category C: Animal studies show adverse effects, but human data are lacking. Use only if clearly needed.
Third Trimester:
Category D: Known human fetal risk (e.g., premature closure of ductus arteriosus, persistent pulmonary hypertension, renal dysfunction). Contraindicated.
Lactation
Flurbiprofen is excreted in human milk after systemic administration. While systemic absorption from ophthalmic use is minimal, caution should be exercised when administered to a nursing mother. Consider the developmental and health benefits of breastfeeding along with 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:
L3 (Moderate concern; possible effects on infant or milk production, but controlled studies are lacking or are too small to be definitive. Use only if potential benefit outweighs risk.)
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. Dosage adjustment is generally not needed for ophthalmic use.
Clinical Information
Clinical Pearls
- Flurbiprofen ophthalmic solution is specifically indicated for inhibition of intraoperative miosis during cataract extraction, not for general post-operative inflammation.
- It should be administered starting 2 hours before surgery, with a total of 4 drops.
- Patients with compromised corneas (e.g., diabetes, rheumatoid arthritis, previous ocular surgery) may be at increased risk of corneal complications (e.g., thinning, melting) with NSAID ophthalmic use, especially with prolonged use.
- While systemic absorption is minimal, theoretical risks associated with systemic NSAIDs (e.g., bleeding tendency) should be considered in patients on anticoagulants, though clinically significant interactions are rare with ophthalmic use.
Alternative Therapies
- Other ophthalmic NSAIDs (e.g., ketorolac, bromfenac, nepafenac, diclofenac) for post-operative inflammation, but not specifically for intraoperative miosis prevention.
- Topical corticosteroids (e.g., prednisolone acetate, dexamethasone) for ocular inflammation, but with different mechanisms and side effect profiles (e.g., IOP elevation, cataract formation).
Cost & Coverage
Average Cost:
$50 - $150 per 2.5ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 (brand)
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 this 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, including the amount taken and the time it happened, to facilitate prompt and effective treatment.