Ilevro 0.3% Ophth Drops 3ml
It is used to treat swelling and pain after cataract surgery.
Drug Class
Ophthalmic Anti-inflammatory
Pharmacologic Class
Nonsteroidal Anti-inflammatory Drug (NSAID); Cyclooxygenase Inhibitor
Pregnancy Category
Category C
FDA Approved
Oct 2010
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ilevro is an eye drop used to reduce pain and swelling in your eye after cataract surgery. It belongs to a group of medicines called NSAIDs, which work by blocking 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. For optimal use:
Use this medication only in the eye.
Shake the container well before each use.
Avoid wearing contact lenses during treatment with this medication.
To prevent contamination and potential severe eye problems, do not touch the container tip to your eye, eyelid, or surrounding skin.
Wash your hands thoroughly before and after using the medication.
Tilt your head back and gently drop the medication into your eye.
If you are using more than one medication in the same eye, administer each medication at least 5 minutes apart.
If you have had surgery on both eyes and are using this medication, your doctor may prescribe two separate bottles, one for each eye. Ensure you do not mix up the bottles.
Storage and Disposal
To store and dispose of this medication properly:
Keep the medication at room temperature or in the refrigerator. Do not freeze.
Store all medications in a safe location, out of the reach of children and pets.
Dispose of unused or expired medications. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best disposal method, as drug take-back programs may be available in your area.
Missed Dose
If you miss a dose, follow these steps:
Use the missed dose as soon as you remember.
If the missed dose 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. For optimal use:
Use this medication only in the eye.
Shake the container well before each use.
Avoid wearing contact lenses during treatment with this medication.
To prevent contamination and potential severe eye problems, do not touch the container tip to your eye, eyelid, or surrounding skin.
Wash your hands thoroughly before and after using the medication.
Tilt your head back and gently drop the medication into your eye.
If you are using more than one medication in the same eye, administer each medication at least 5 minutes apart.
If you have had surgery on both eyes and are using this medication, your doctor may prescribe two separate bottles, one for each eye. Ensure you do not mix up the bottles.
Storage and Disposal
To store and dispose of this medication properly:
Keep the medication at room temperature or in the refrigerator. Do not freeze.
Store all medications in a safe location, out of the reach of children and pets.
Dispose of unused or expired medications. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best disposal method, as drug take-back programs may be available in your area.
Missed Dose
If you miss a dose, follow these steps:
Use the missed dose as soon as you remember.
If the missed dose 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
- Shake the bottle well before each use.
- Do not touch the dropper tip to your eye or any other surface to avoid contamination.
- If you wear contact lenses, remove them before using Ilevro and wait at least 15 minutes before reinserting them.
- If you are using other eye drops, wait at least 5 minutes between applying each medication.
- Do not use more often than prescribed by your doctor.
- Store at room temperature, away from light and moisture.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One drop to the affected eye(s) once daily, beginning 1 day prior to cataract surgery, continued on the day of surgery and for 2 weeks post-surgery.
Condition-Specific Dosing:
post-cataract surgery inflammation and pain:
One drop to the affected eye(s) once daily, beginning 1 day prior to cataract surgery, continued on the day of surgery and for 2 weeks 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
Nepafenac is a nonsteroidal anti-inflammatory drug (NSAID) that, after topical ocular administration, penetrates the cornea and is converted by hydrolases in ocular tissues to amfenac, a more potent NSAID. Amfenac is believed to inhibit the activity of cyclooxygenase (COX-1 and COX-2), an enzyme essential to prostaglandin biosynthesis. Prostaglandins are mediators of certain types of intraocular inflammation.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption
Tmax:
Not applicable (minimal systemic absorption); ocular tissue concentrations peak within hours
FoodEffect:
Not applicable (topical ophthalmic)
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Amfenac is highly protein bound (>95%) in vitro
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not precisely quantified for ocular tissues; systemic half-life of amfenac is short (approximately 1-3 hours)
Clearance:
Not precisely quantified for ocular tissues; systemic clearance is rapid
ExcretionRoute:
Primarily renal (for metabolites)
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Within hours (for anti-inflammatory effect)
PeakEffect:
Within 1-2 days of regular dosing
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 immediately or seek emergency 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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ 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. 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 persist, contact your doctor for advice:
Feeling like something is in your eye
* Sticky sensation in the eye
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, don't hesitate to reach out to 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 immediately or seek emergency 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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ 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. 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 persist, contact your doctor for advice:
Feeling like something is in your eye
* Sticky sensation in the eye
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, don't hesitate to reach out to 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 eye pain or discomfort
- Worsening eye redness or swelling
- New or worsening blurred vision
- Pus or discharge from the eye
- Sensitivity to light that worsens
- Signs of infection (e.g., fever, chills)
- 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 as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that this medication can be taken in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting 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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that this medication can be taken in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Do not exceed the recommended 2-week treatment duration without explicit instruction from your doctor to do so. If you are pregnant, planning to become pregnant, or are currently breast-feeding, notify your doctor promptly. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
Overdose Information
Overdose Symptoms:
- Unlikely with topical ophthalmic use due to minimal systemic absorption. Local irritation may occur.
What to Do:
If accidentally ingested, drink fluids. If local irritation occurs, rinse eye with water. Call a poison control center (1-800-222-1222) or seek medical attention if symptoms are severe or persistent.
Drug Interactions
Moderate Interactions
- Topical corticosteroids (potential for delayed healing)
Confidence Interactions
Monitoring
Baseline Monitoring
Ocular examination (visual acuity, slit lamp)
Rationale: To assess baseline inflammation and overall ocular health prior to surgery and treatment.
Timing: Prior to initiation of therapy
Routine Monitoring
Ocular examination (visual acuity, slit lamp)
Frequency: As clinically indicated, typically at post-operative visits
Target: Resolution of inflammation, improved visual acuity
Action Threshold: Persistent or worsening inflammation, signs of infection, delayed healing
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
- Sensitivity to light (photophobia)
- Discharge from the eye
- Signs of infection (e.g., purulent discharge, severe pain)
- Signs of corneal complications (e.g., persistent epithelial defect, corneal thinning)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Systemic NSAIDs should be avoided in late pregnancy due to the risk of premature closure of the fetal ductus arteriosus.
Trimester-Specific Risks:
First Trimester:
Risk not ruled out. Minimal systemic absorption, but caution advised.
Second Trimester:
Risk not ruled out. Minimal systemic absorption, but caution advised.
Third Trimester:
Avoid due to potential for premature closure of the fetal ductus arteriosus (based on systemic NSAID data), although systemic absorption from ophthalmic use is minimal.
Lactation
It is unknown whether nepafenac or its metabolites are excreted in human milk. Due to minimal systemic absorption, the risk to a breastfed infant is considered low, but caution is advised.
Infant Risk:
Low (L3 - Moderately Safe)
Pediatric Use
Safety and efficacy have not been established in pediatric patients.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Clinical Information
Clinical Pearls
- Ilevro 0.3% is a once-daily formulation, which can improve patient adherence compared to multi-dose regimens.
- Ensure patients shake the bottle well before each use to ensure uniform suspension.
- Advise patients to avoid wearing contact lenses during treatment, especially if the eye is inflamed or infected.
- Monitor for signs of corneal complications, such as epithelial defects or thinning, particularly in patients with pre-existing corneal disease or those receiving concomitant topical corticosteroids.
Alternative Therapies
- Ketorolac ophthalmic (e.g., Acular)
- Bromfenac ophthalmic (e.g., Prolensa, Bromday)
- Diclofenac ophthalmic (e.g., Voltaren Ophthalmic)
- Flurbiprofen ophthalmic (e.g., Ocufen)
- Ophthalmic corticosteroids (e.g., Prednisolone acetate, Dexamethasone)
Cost & Coverage
Average Cost:
$150 - $300 per 3ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand)
General Drug Facts
If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your 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 is a good idea to consult with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for clarification and guidance. 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 detailed information about the overdose, including the name of the medication taken, the amount, and the time it occurred.