Loteprednol 0.5% Opth Susp 15ml
It is used to treat eye irritation.It is used to treat eye pain and swelling after eye surgery.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Ophthalmic Corticosteroid
Pharmacologic Class
Glucocorticoid Receptor Agonist
Pregnancy Category
Category C
FDA Approved
Feb 1998
DEA Schedule
Not Controlled
Overview
What is this medicine?
Loteprednol is an eye drop that contains a type of steroid. It is used to reduce swelling, redness, and itching in the eyes caused by certain eye conditions, such as allergies or after eye surgery. It works by calming down the body's natural inflammatory response.
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. Use 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 prevent infection.
3. Avoid touching the container tip to the eye, lid, or other skin, as this can introduce bacteria and lead to severe eye problems or vision loss.
4. Replace the cap after each use.
5. If you are using multiple medications in the same eye, administer each medication at least 5 minutes apart.
6. Shake the container well before use.
7. Remove contact lenses before using this medication. Consult your doctor to determine if you can reinsert your contact lenses after use. Do not reinsert contact lenses if your eyes are irritated or infected.
8. Tilt your head back and drop the medication into the eye.
Special Considerations
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 two bottles.
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 dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or use extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Use 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 prevent infection.
3. Avoid touching the container tip to the eye, lid, or other skin, as this can introduce bacteria and lead to severe eye problems or vision loss.
4. Replace the cap after each use.
5. If you are using multiple medications in the same eye, administer each medication at least 5 minutes apart.
6. Shake the container well before use.
7. Remove contact lenses before using this medication. Consult your doctor to determine if you can reinsert your contact lenses after use. Do not reinsert contact lenses if your eyes are irritated or infected.
8. Tilt your head back and drop the medication into the eye.
Special Considerations
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 two bottles.
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 dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or use extra doses.
Lifestyle & Tips
- Shake the bottle well before each use.
- Wash hands thoroughly before administering eye drops.
- Do not touch the dropper tip to any surface (including the eye) to avoid contamination.
- If using other eye drops, wait at least 5 minutes between applications.
- Remove contact lenses before instilling drops and wait at least 15 minutes before reinserting them.
- Do not wear contact lenses if your eyes are red or inflamed.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
1 drop into the affected eye(s) four times daily
Dose Range:
1 - 2 mg
Condition-Specific Dosing:
post-operative inflammation and pain:
1-2 drops into the conjunctival sac of the affected eye(s) four times daily beginning the day after surgery and continuing throughout the first 2 weeks post-operatively.
seasonal allergic conjunctivitis:
1 drop into the affected eye(s) four times daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and effectiveness in pediatric patients have not been established for all indications. For post-operative inflammation and pain, safety and effectiveness in pediatric patients 2 years of age and older have been established.
Adolescent:
Safety and effectiveness in pediatric patients 2 years of age and older have been established for post-operative inflammation and pain.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed; 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 agents and may delay or slow healing. 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.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 1%)
Tmax:
Not applicable (topical)
FoodEffect:
Not applicable
Distribution:
Vd:
Not available (minimal systemic)
ProteinBinding:
Not available (minimal systemic)
CnssPenetration:
No
Elimination:
HalfLife:
Not precisely quantifiable due to rapid metabolism and minimal systemic absorption.
Clearance:
Not precisely quantifiable due to rapid metabolism and minimal systemic absorption.
ExcretionRoute:
Primarily via metabolism to inactive compounds; minimal systemic excretion.
Unchanged:
Not available (minimal systemic)
Pharmacodynamics
OnsetOfAction:
Within hours (anti-inflammatory effect)
PeakEffect:
Days to weeks depending on condition severity
DurationOfAction:
Hours (requires QID dosing)
Safety & Warnings
Side Effects
Important Side Effects to Report to Your Doctor Immediately
Although rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Seek medical attention right away if you experience any of the following symptoms, which may indicate a serious reaction:
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 of something being in the eye
Burning sensation
Itching
Dry eyes
Blurred vision
Headache
Runny nose
Sore throat
Sensitivity to bright lights (wearing sunglasses may help)
Reporting Side Effects
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 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, some people may experience severe and potentially life-threatening side effects when taking this medication. Seek medical attention right away if you experience any of the following symptoms, which may indicate a serious reaction:
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 of something being in the eye
Burning sensation
Itching
Dry eyes
Blurred vision
Headache
Runny nose
Sore throat
Sensitivity to bright lights (wearing sunglasses may help)
Reporting Side Effects
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 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:
- Persistent or worsening eye pain
- Increased redness or swelling
- Pus or discharge from the eye
- Significant decrease in vision
- New or worsening sensitivity to light
- Signs of a new eye infection (e.g., bacterial, fungal, viral)
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 safe treatment, 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 supplements you are using
Vitamins you are taking
Any health problems you have
Before starting, stopping, or changing the dose of any medication, including this one, consult with 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 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 safe treatment, 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 supplements you are using
Vitamins you are taking
Any health problems you have
Before starting, stopping, or changing the dose of any medication, including this one, consult with 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. 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 the prescribed duration of treatment and avoid using this medication for an extended period beyond what your doctor has recommended. If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to weigh the benefits and risks of this medication to both you and your baby.
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 excessive topical application, flush eye with water. Contact a poison control center or seek medical attention if symptoms are severe or unusual. Call 1-800-222-1222
Drug Interactions
Monitoring
Routine Monitoring
Intraocular Pressure (IOP)
Frequency: Periodically, especially with prolonged use (more than 10 days)
Target: Normal range (e.g., 10-21 mmHg)
Action Threshold: Significant increase in IOP; consider discontinuing or adjusting treatment.
Slit lamp examination
Frequency: Periodically, especially with prolonged use
Target: Normal corneal and lens appearance
Action Threshold: Signs of infection, corneal damage, or cataract formation.
Visual acuity
Frequency: Periodically
Target: Stable or improving
Action Threshold: Decreased vision not attributable to underlying condition.
Symptom Monitoring
- Eye pain
- Redness
- Discharge
- Blurred vision
- Sensitivity to light
- Signs of new or worsening infection
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects with systemic corticosteroids.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenic effects, though systemic exposure is minimal with ophthalmic use.
Second Trimester:
Risk generally considered lower than first trimester, but still use with caution.
Third Trimester:
Risk generally considered lower than first trimester, but still use with caution.
Lactation
It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Caution should be exercised when loteprednol etabonate is administered to a nursing woman.
Infant Risk:
Low risk due to minimal systemic absorption and rapid metabolism to inactive compounds, but theoretical risk exists.
Pediatric Use
Safety and effectiveness in pediatric patients 2 years of age and older have been established for post-operative inflammation and pain. Safety and effectiveness in pediatric patients below the age of 2 years have not been established. Prolonged corticosteroid use in children may suppress growth and development.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. No special dosage adjustment is required.
Clinical Information
Clinical Pearls
- Loteprednol etabonate is considered a 'soft' steroid due to its rapid metabolism to inactive metabolites, which minimizes systemic side effects compared to other corticosteroids.
- Shake the bottle well before each use, as it is a suspension.
- Prolonged use (typically more than 10 days) requires regular monitoring of intraocular pressure (IOP) due to the risk of steroid-induced glaucoma.
- Patients should be advised not to wear contact lenses during treatment for ocular inflammation or if they have an eye infection.
- This medication is for ophthalmic use only; do not inject or ingest.
Alternative Therapies
- Prednisolone acetate ophthalmic suspension
- Dexamethasone ophthalmic suspension/solution
- Fluorometholone ophthalmic suspension
- Difluprednate ophthalmic emulsion
- Non-steroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use (e.g., ketorolac, bromfenac, nepafenac) for certain inflammatory conditions.
Cost & Coverage
Average Cost:
Varies widely, typically $100-$300 per 5ml or 15ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 (Generic)
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.