Eysuvis 0.25% Ophth Susp 8.3ml
It is used to treat dry eyes.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Ophthalmic Corticosteroid
Pharmacologic Class
Corticosteroid
Pregnancy Category
Category C
FDA Approved
Sep 2021
DEA Schedule
Not Controlled
Overview
What is this medicine?
Eysuvis is an eye drop that contains a type of medicine called a corticosteroid. It works by reducing inflammation in your eyes, which can help relieve the signs and symptoms of dry eye disease.
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. Continue using the medication as directed, even if your symptoms improve.
Administration Instructions
1. Use this medication for the eye only.
2. Wash your hands before and after use to maintain cleanliness.
3. Shake the container well before each use.
4. Remove contact lenses before applying the medication. You can put them back in 15 minutes after use, but avoid doing so if your eyes are irritated or infected.
5. Tilt your head back and gently drop the medication into your eye.
6. Be careful not to touch the container tip to your eye, eyelid, or surrounding skin, as this can introduce bacteria and lead to severe eye problems or vision loss.
7. Replace the cap after each use.
8. If you are using multiple medications in the same eye, apply them at least 5 minutes apart.
Storage and Disposal
1. Store the medication at room temperature, avoiding freezing.
2. Keep the container upright with the cap on.
3. Store all medications in a safe location, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, take 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. Continue using the medication as directed, even if your symptoms improve.
Administration Instructions
1. Use this medication for the eye only.
2. Wash your hands before and after use to maintain cleanliness.
3. Shake the container well before each use.
4. Remove contact lenses before applying the medication. You can put them back in 15 minutes after use, but avoid doing so if your eyes are irritated or infected.
5. Tilt your head back and gently drop the medication into your eye.
6. Be careful not to touch the container tip to your eye, eyelid, or surrounding skin, as this can introduce bacteria and lead to severe eye problems or vision loss.
7. Replace the cap after each use.
8. If you are using multiple medications in the same eye, apply them at least 5 minutes apart.
Storage and Disposal
1. Store the medication at room temperature, avoiding freezing.
2. Keep the container upright with the cap on.
3. Store all medications in a safe location, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, take 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 any surface, including your eye, to avoid contamination.
- Shake the bottle well before each use.
- If you wear contact lenses, remove them before applying the drops and wait at least 15 minutes before reinserting them.
- If using other eye drops, wait at least 5 minutes between applications.
- Store the bottle upright at room temperature.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One drop in each eye four times daily for two weeks
Dose Range:
0.25 - 0.25 mg
Condition-Specific Dosing:
dryEyeDisease:
One drop in each eye four times daily for two weeks
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
Loteprednol etabonate is a corticosteroid that inhibits the inflammatory response to a variety of inciting agents. It acts by inducing phospholipase A2 inhibitory proteins, lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Corticosteroids are capable of producing a profound and varied increase or decrease in the synthesis of proteins, enzymes, and other substances that suppress inflammation.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable (ophthalmic administration)
Distribution:
Vd:
Not applicable (minimal systemic distribution)
ProteinBinding:
Approximately 97% (for loteprednol and its active metabolite, PJ-91) in vitro
CnssPenetration:
Limited
Elimination:
HalfLife:
Not precisely determined due to minimal systemic absorption; systemic half-life of loteprednol etabonate is approximately 1-2 hours.
Clearance:
Rapid systemic clearance of absorbed drug.
ExcretionRoute:
Primarily renal and fecal for systemically absorbed drug, but minimal systemic absorption occurs.
Unchanged:
Negligible
Pharmacodynamics
OnsetOfAction:
Within hours (anti-inflammatory effect)
PeakEffect:
Days to weeks (for full therapeutic effect in dry eye)
DurationOfAction:
Dependent on dosing frequency (typically 6-8 hours per dose)
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 medical attention immediately:
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
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:
Short-term pain after using the medication
Feeling that something is 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, 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 medical attention immediately:
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
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:
Short-term pain after using the medication
Feeling that something is 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, 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:
- New or worsening eye pain
- Persistent redness or irritation
- Changes in vision (e.g., blurred vision, halos around lights)
- Signs of eye infection (e.g., pus, discharge, severe swelling)
- Headache
- Nausea
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 any of the following health conditions:
+ Fungal infections of the eye
+ Tuberculosis (TB) infections of the eye
+ Viral infections of the eye
This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.
To ensure your safety, please provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including all health problems
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe for you 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 any of the following health conditions:
+ Fungal infections of the eye
+ Tuberculosis (TB) infections of the eye
+ Viral infections of the eye
This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.
To ensure your safety, please provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including all health problems
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe for you 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. When taking this drug, exercise caution while driving or performing tasks that require clear vision to ensure your safety. Regular eye exams, including eye pressure checks, should be conducted as directed by your healthcare provider. Prolonged use of this medication may increase the risk of developing cataracts or glaucoma; therefore, discuss this potential risk with your doctor. Adhere to your doctor's instructions regarding the duration of treatment, and do not exceed the recommended treatment period. If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with ophthalmic administration due to minimal systemic absorption. Local irritation may occur with excessive use.
What to Do:
If an overdose is suspected or if the drops are accidentally ingested, contact a poison control center or seek medical attention. For accidental ingestion, call 1-800-222-1222.
Drug Interactions
Monitoring
Baseline Monitoring
Intraocular Pressure (IOP)
Rationale: To establish baseline before initiating corticosteroid therapy, especially if prolonged use is anticipated, due to the risk of IOP elevation.
Timing: Prior to initiation of therapy
Ocular examination (e.g., slit lamp)
Rationale: To assess baseline ocular health and identify pre-existing conditions (e.g., corneal defects, infections) that may be exacerbated by corticosteroids.
Timing: Prior to initiation of therapy
Routine Monitoring
Intraocular Pressure (IOP)
Frequency: Periodically, especially with prolonged use (e.g., >10 days)
Target: Individualized, typically <21 mmHg or within patient's normal range
Action Threshold: Significant increase from baseline or above normal range; consider discontinuation or alternative therapy.
Signs of ocular infection (e.g., redness, discharge, pain)
Frequency: At each follow-up visit and patient self-monitoring
Target: Absence of signs of infection
Action Threshold: Presence of new or worsening signs of infection; consider appropriate antimicrobial therapy or discontinuation.
Corneal integrity (e.g., epithelial defects)
Frequency: Periodically, especially if patient has pre-existing corneal conditions
Target: Intact corneal epithelium
Action Threshold: Presence of persistent corneal epithelial defects or ulceration; discontinue use.
Symptom Monitoring
- Blurred vision
- Eye pain
- Redness
- Discharge
- Foreign body sensation
- Light sensitivity
- Changes in vision
Special Patient Groups
Pregnancy
Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenicity with corticosteroids, but systemic exposure from ophthalmic use is low.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity observed in animal studies with systemic corticosteroids; low risk with ophthalmic due to minimal absorption.
Second Trimester:
Low risk due to minimal systemic absorption.
Third Trimester:
Low risk due to minimal systemic absorption.
Lactation
It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Due to the minimal systemic absorption of loteprednol etabonate, it is considered compatible with breastfeeding, but caution is advised.
Infant Risk:
Low risk of adverse effects to the breastfed infant due to minimal systemic absorption.
Pediatric Use
The safety and effectiveness of Eysuvis in pediatric patients have not been established. Dry eye disease is less common in pediatric populations. Other formulations of loteprednol etabonate are used in pediatric patients for other ophthalmic inflammatory conditions.
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
- Eysuvis is specifically formulated as a 0.25% suspension for the treatment of dry eye disease, offering a lower concentration of loteprednol etabonate compared to other ophthalmic formulations (e.g., 0.5% or 1%).
- Shake the bottle well before each use to ensure uniform suspension.
- Patients should be monitored for increases in intraocular pressure (IOP) if therapy extends beyond 10 days, although the risk of IOP elevation is generally lower with loteprednol etabonate compared to other corticosteroids due to its rapid metabolism to inactive metabolites.
- Advise patients to avoid wearing contact lenses during treatment or to remove them prior to instillation and wait 15 minutes before reinsertion.
- Eysuvis is intended for short-term use (up to two weeks) for the signs and symptoms of dry eye disease.
Alternative Therapies
- Cyclosporine ophthalmic emulsion (Restasis, Cequa)
- Lifitegrast ophthalmic solution (Xiidra)
- Topical ophthalmic NSAIDs (for inflammation, but not primary dry eye treatment)
- Other ophthalmic corticosteroids (e.g., Dexamethasone, Prednisolone, Fluorometholone - generally for more severe inflammation or post-surgical use)
- Artificial tears/lubricating eye drops
- Punctal plugs
- Warm compresses
Cost & Coverage
Average Cost:
Check current market price per 8.3ml bottle
Insurance Coverage:
Tier 2 or 3 (Specialty/Non-preferred Brand)
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 is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.