Loteprednol 0.5% Opth Gel Drops 5gm
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
Corticosteroid, Anti-inflammatory
Pregnancy Category
C
FDA Approved
Sep 2012
DEA Schedule
Not Controlled
Overview
What is this medicine?
Loteprednol is an eye gel that contains a corticosteroid medicine. It is used to reduce swelling, redness, and pain in the eye, often after eye surgery. It works by calming down the body's 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 maintain cleanliness.
3. Avoid touching the container tip to the eye, lid, or other skin, as this can introduce bacteria into the medication, potentially leading 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. Before each use, turn the bottle upside down with the lid on and shake it once.
7. Do not wear contact lenses while using this medication.
8. To administer the medication, 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 you do not mix up the bottles.
Storage and Disposal
- Store the medication at room temperature, avoiding freezing.
- Keep the bottle upright with the cap on.
- Store all medications in a safe location, out of the reach of children and pets.
Missed Dose Instructions
- If you miss a dose, use it as soon as you remember.
- If the missed dose is close to the time for your next dose, skip the missed dose and continue with 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. 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 maintain cleanliness.
3. Avoid touching the container tip to the eye, lid, or other skin, as this can introduce bacteria into the medication, potentially leading 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. Before each use, turn the bottle upside down with the lid on and shake it once.
7. Do not wear contact lenses while using this medication.
8. To administer the medication, 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 you do not mix up the bottles.
Storage and Disposal
- Store the medication at room temperature, avoiding freezing.
- Keep the bottle upright with the cap on.
- Store all medications in a safe location, out of the reach of children and pets.
Missed Dose Instructions
- If you miss a dose, use it as soon as you remember.
- If the missed dose is close to the time for your next dose, skip the missed dose and continue with 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 Loteprednol ophthalmic gel, unless directed by your doctor. If you must wear them, remove them before applying the gel and wait at least 15 minutes before reinserting them.
- Avoid touching the tip of the dropper/tube to your eye or any other surface to prevent contamination.
- Wash your hands thoroughly before and after applying the eye gel.
- Follow your doctor's instructions carefully regarding the duration of treatment. Do not stop using the gel suddenly without consulting your doctor.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply one drop into the affected eye(s) four times daily, beginning the day after surgery and continuing throughout the first 2 weeks post-operatively.
Condition-Specific Dosing:
post-operative inflammation and pain:
One drop four times daily for 2 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and effectiveness in pediatric patients have not been established.
Adolescent:
Safety and effectiveness in pediatric patients have not been 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
Loteprednol etabonate is a corticosteroid that inhibits the inflammatory response to a variety of 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. Loteprednol etabonate is a 'soft drug' designed to be rapidly metabolized to inactive metabolites upon systemic absorption, thereby minimizing systemic side effects.
Pharmacokinetics
Absorption:
Bioavailability:
Negligible systemic bioavailability (<0.1%)
Tmax:
Not clinically relevant for systemic absorption
FoodEffect:
Not applicable for ophthalmic administration
Distribution:
Vd:
Not applicable due to minimal systemic absorption
ProteinBinding:
Approximately 97% (in vitro)
CnssPenetration:
Limited
Elimination:
HalfLife:
Not well-defined systemically due to rapid metabolism to inactive metabolites
Clearance:
Rapid local metabolism
ExcretionRoute:
Metabolites primarily excreted renally
Unchanged:
Negligible
Pharmacodynamics
OnsetOfAction:
Within hours
PeakEffect:
Within days of consistent use
DurationOfAction:
Dependent on dosing frequency, typically maintains effect with QID dosing
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
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 right away:
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 right away:
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:
- Worsening eye pain or discomfort
- Increased redness or swelling of the eye
- New or worsening blurred vision
- Increased sensitivity to light
- Any signs of a new eye infection (e.g., pus, discharge, fever)
- Headache or nausea (rare, but report any unusual 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 allergic reaction you experienced, including any symptoms that occurred.
If you have any ongoing health issues, particularly:
+ 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 any health problems you are experiencing
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm that it is safe to do so. This will help prevent any potential interactions or adverse effects.
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 ongoing health issues, particularly:
+ 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 any health problems you are experiencing
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm that it is safe to do so. This will help prevent any potential interactions or adverse effects.
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, it is crucial to 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 are breastfeeding, notify your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Local irritation
- Redness
- Watering of the eye
What to Do:
An overdose with ophthalmic administration is unlikely to cause systemic toxicity due to minimal absorption. If excessive gel is applied, it can be rinsed from the eye with lukewarm water. If swallowed, contact a poison control center or emergency room. Call 1-800-222-1222.
Drug Interactions
Monitoring
Baseline Monitoring
Intraocular Pressure (IOP)
Rationale: Corticosteroids can cause an increase in IOP, especially with prolonged use.
Timing: Prior to initiation of therapy, particularly if treatment duration exceeds 10 days.
Ocular examination (e.g., slit lamp)
Rationale: To assess baseline inflammation, corneal integrity, and rule out pre-existing infections.
Timing: Prior to initiation of therapy.
Routine Monitoring
Intraocular Pressure (IOP)
Frequency: Periodically, especially with prolonged use (e.g., >10 days).
Target: Individualized, generally within normal limits (10-21 mmHg).
Action Threshold: Significant or sustained elevation above baseline; consider discontinuation or alternative therapy.
Signs of secondary ocular infection (e.g., bacterial, fungal, viral)
Frequency: During follow-up visits.
Target: Absence of new or worsening infection.
Action Threshold: Presence of new or worsening infection; consider appropriate anti-infective therapy and/or discontinuation of corticosteroid.
Corneal integrity
Frequency: During follow-up visits.
Target: Absence of corneal thinning or perforation.
Action Threshold: Evidence of corneal thinning or perforation; discontinue use.
Symptom Monitoring
- Worsening eye pain
- Increased redness or irritation
- Blurred vision or other vision changes
- Increased sensitivity to light
- New or worsening discharge from the eye
- Signs of new infection (e.g., pus, fever)
Special Patient Groups
Pregnancy
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Loteprednol etabonate should be used 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 teratogenicity, though systemic exposure from ophthalmic use is minimal.
Second Trimester:
Minimal systemic exposure suggests low risk, but caution advised.
Third Trimester:
Minimal systemic exposure suggests low risk, but caution advised.
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 minimal systemic absorption, risk to the infant is considered low, but caution should be exercised when administered to a nursing mother.
Infant Risk:
Low risk (L3) due to minimal systemic absorption and rapid metabolism to inactive compounds.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Use in children should be based on a careful risk-benefit assessment by a specialist.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. Dosage adjustment is generally not required.
Clinical Information
Clinical Pearls
- Loteprednol etabonate is considered a 'soft steroid' because it is rapidly metabolized to inactive compounds after exerting its therapeutic effect, leading to a lower risk of systemic side effects and potentially a lower risk of significant intraocular pressure (IOP) elevation compared to other ophthalmic corticosteroids.
- It is crucial to complete the full prescribed course of treatment, even if symptoms improve, to ensure optimal therapeutic outcome and prevent recurrence of inflammation.
- Patients should be advised not to share their eye medication to prevent cross-contamination.
- The gel formulation may cause temporary blurring of vision upon application; patients should be advised to wait until vision clears before driving or operating machinery.
Alternative Therapies
- Other ophthalmic corticosteroids (e.g., Prednisolone acetate, Dexamethasone, Difluprednate, Fluorometholone)
- Ophthalmic NSAIDs (e.g., Ketorolac, Bromfenac, Nepafenac) for inflammation and pain, particularly when IOP elevation is a concern or for non-infectious inflammation.
- Combination products with antibiotics if infection is present or suspected.
Cost & Coverage
Average Cost:
Varies widely, typically $100-$300+ per 5gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (preferred or non-preferred brand/generic)
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.