Loteprednol 0.5% Opth Susp 10ml
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
Corticosteroid (ester-based)
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 medicine called a corticosteroid. It works by reducing swelling, redness, and irritation in the eye. It's often used after eye surgery to help with inflammation and pain, or to treat eye itching caused by allergies.
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
Use this medication for the eye only.
Wash your hands before and after use to prevent contamination.
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.
Replace the cap after each use.
If you are using multiple medications in the same eye, administer each medication at least 5 minutes apart.
Shake the container well before use.
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.
Tilt your head back and gently 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 bottles.
Storage and Disposal
Store the medication at room temperature, away from freezing temperatures.
Keep the container 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 it is close to the time for your next 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. Use the medication as directed, even if your symptoms improve.
Administration Instructions
Use this medication for the eye only.
Wash your hands before and after use to prevent contamination.
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.
Replace the cap after each use.
If you are using multiple medications in the same eye, administer each medication at least 5 minutes apart.
Shake the container well before use.
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.
Tilt your head back and gently 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 bottles.
Storage and Disposal
Store the medication at room temperature, away from freezing temperatures.
Keep the container 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 it is close to the time for your next 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
- Do not touch the dropper tip to any surface, including the eye, to avoid contamination.
- Wash hands before and after use.
- 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.
- Do not use for longer than prescribed by your doctor, as prolonged use can lead to serious eye problems.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
For post-operative inflammation and pain: 1-2 drops into the conjunctival sac of the affected eye(s) four times daily, beginning 24 hours after surgery and continuing throughout the first 2 weeks of the post-operative period. For seasonal allergic conjunctivitis: 1 drop into the conjunctival sac of the affected eye(s) four times daily.
Condition-Specific Dosing:
post_operative_inflammation:
1-2 drops QID for 2 weeks
seasonal_allergic_conjunctivitis:
1 drop QID
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (safety and efficacy not established in pediatric patients below the age of 2 years)
Child:
For seasonal allergic conjunctivitis (2 years and older): 1 drop into the conjunctival sac of the affected eye(s) four times daily. For post-operative inflammation (older children): Dosing similar to adults, consult ophthalmologist.
Adolescent:
Dosing similar to adults.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed; systemic absorption is minimal.
Hepatic Impairment:
Mild:
No adjustment
Moderate:
No adjustment
Severe:
No adjustment
Pharmacology
Mechanism of Action
Loteprednol etabonate is a corticosteroid that inhibits the inflammatory response to a variety of inciting agents and probably delays or slows 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. Loteprednol etabonate is a 'soft' steroid, meaning it is designed to be rapidly metabolized to inactive metabolites upon systemic absorption, thereby minimizing systemic side effects.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption
Tmax:
Not applicable (topical ophthalmic)
FoodEffect:
Not applicable
Distribution:
Vd:
Not available (minimal systemic)
ProteinBinding:
Not available (minimal systemic)
CnssPenetration:
Limited
Elimination:
HalfLife:
Not precisely determined due to rapid metabolism and minimal systemic levels; estimated to be very short for active drug.
Clearance:
Rapid
ExcretionRoute:
Not precisely determined due to minimal systemic absorption and rapid metabolism.
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Within hours for anti-inflammatory effect
PeakEffect:
Within days of consistent use
DurationOfAction:
Dependent on dosing frequency (e.g., 6 hours for QID dosing)
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention 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 help 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, or swelling of the mouth, face, lips, tongue, or throat
- Changes in eyesight, eye pain, or severe eye irritation
Common 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 if they bother you or do not go away, contact your doctor or seek medical help:
- Short-term pain after use
- Feeling that something is in the eye
- Burning sensation
- Itching
- Dry eyes
- Blurred eyesight
- Headache
- Runny nose
- Sore throat
- Sensitivity to bright lights (wearing sunglasses may help)
Reporting Side Effects
This list does not include all possible 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 help 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, or swelling of the mouth, face, lips, tongue, or throat
- Changes in eyesight, eye pain, or severe eye irritation
Common 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 if they bother you or do not go away, contact your doctor or seek medical help:
- Short-term pain after use
- Feeling that something is in the eye
- Burning sensation
- Itching
- Dry eyes
- Blurred eyesight
- Headache
- Runny nose
- Sore throat
- Sensitivity to bright lights (wearing sunglasses may help)
Reporting Side Effects
This list does not include all possible 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
- Significant decrease in vision
- Persistent redness or irritation
- Pus or discharge from the eye
- Sensitivity to light
- Signs of a new eye infection
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, 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
Carefully review your medications and health problems with your doctor to confirm that it is safe to take this medication. Do not initiate, 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 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, 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
Carefully review your medications and health problems with your doctor to confirm that it is safe to take this medication. Do not initiate, stop, or adjust the dosage of any medication without first consulting your doctor.
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:
- Excessive eye irritation
- Redness
- Watering
What to Do:
Due to the topical nature and minimal systemic absorption, overdose is unlikely to cause systemic toxicity. Flush the eye with lukewarm water. If irritation persists, seek medical attention. Call 1-800-222-1222 for poison control advice.
Drug Interactions
Monitoring
Baseline Monitoring
Intraocular Pressure (IOP)
Rationale: Corticosteroids can cause an increase in IOP, potentially leading to glaucoma.
Timing: Prior to initiation of therapy, especially for prolonged use.
Slit lamp examination
Rationale: To assess for pre-existing ocular conditions and monitor for potential adverse effects like posterior subcapsular cataracts or secondary infections.
Timing: Prior to initiation of therapy.
Routine Monitoring
Intraocular Pressure (IOP)
Frequency: Regularly, especially with prolonged use (e.g., >10 days).
Target: Normal range (typically 10-21 mmHg)
Action Threshold: Significant increase above baseline or normal range; consider discontinuation or alternative therapy.
Slit lamp examination
Frequency: Periodically, especially with prolonged use.
Target: Not applicable
Action Threshold: Development of cataracts, signs of infection, or corneal changes.
Visual acuity
Frequency: Periodically
Target: Not applicable
Action Threshold: Significant decrease in vision.
Symptom Monitoring
- Eye pain
- Redness
- Blurred vision
- Photophobia
- Discharge
- Foreign body sensation
- Signs of secondary infection (e.g., worsening redness, pain, purulent discharge)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenicity with systemically administered corticosteroids, but ophthalmic use results in minimal systemic absorption.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though risk is low with topical ophthalmic use.
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. Caution should be exercised when administered to a nursing woman. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Loteprednol and any potential adverse effects on the breastfed infant from Loteprednol or from the underlying maternal condition.
Infant Risk:
Low risk due to minimal systemic absorption and rapid metabolism of the drug.
Pediatric Use
Safety and efficacy have not been established in pediatric patients below the age of 2 years. For children 2 years and older, dosing for seasonal allergic conjunctivitis is similar to adults. For post-operative inflammation, use in older children should be under strict ophthalmological supervision due to the risk of increased IOP and other corticosteroid-related side effects.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. Dosage adjustment is generally not necessary.
Clinical Information
Clinical Pearls
- Loteprednol etabonate is considered a 'soft' steroid due to its rapid metabolism to inactive metabolites, which may lead to a lower risk of systemic side effects compared to other corticosteroids.
- Despite being a 'soft' steroid, it can still cause increased intraocular pressure (IOP) and posterior subcapsular cataracts, especially with prolonged use. Regular IOP monitoring is crucial.
- Shake the bottle well before each use as it is a suspension.
- Contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, as well as mycobacterial infection of the eye and fungal diseases of ocular structures.
- Patients should be advised not to wear contact lenses during treatment for ocular inflammation or infection.
Alternative Therapies
- Dexamethasone ophthalmic
- Prednisolone acetate ophthalmic
- Fluorometholone ophthalmic
- Difluprednate ophthalmic
- Non-steroidal anti-inflammatory drugs (NSAIDs) for post-operative inflammation (e.g., Ketorolac ophthalmic, Bromfenac ophthalmic)
- Mast cell stabilizers/antihistamines for allergic conjunctivitis (e.g., Olopatadine ophthalmic, Azelastine ophthalmic)
Cost & Coverage
Average Cost:
$100 - $250 per 10ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3
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.