Loteprednol 0.5% Opth Susp 5ml
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 anti-inflammatory
Pharmacologic Class
Corticosteroid
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 works by reducing swelling, redness, and irritation in the eye caused by allergies or after eye surgery. It helps to calm 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 contamination.
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 contamination.
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
- Do not touch the dropper tip to any surface, including the eye, to avoid contamination.
- Shake the bottle well before each use.
- Remove contact lenses before instilling drops and wait at least 15 minutes before reinserting them.
- If using other eye drops, wait at least 5 minutes between applications.
- Do not wear contact lenses if you have an eye infection or inflammation.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
1 drop instilled into the conjunctival sac of the affected eye(s) four times daily (QID)
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
Post-operative inflammation and pain:
1 drop QID, starting 24 hours after surgery and continuing for 2 weeks.
Seasonal allergic conjunctivitis:
1 drop QID.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and efficacy not established in pediatric patients under 18 years of age.
Adolescent:
Safety and efficacy not established in pediatric patients under 18 years of age.
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. 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 thought to act by the induction of phospholipase A2 inhibitory proteins, lipocortins. These proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 1 ng/mL plasma concentration after ocular administration)
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable (ophthalmic administration)
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
No
Elimination:
HalfLife:
Not precisely determined due to minimal systemic absorption and rapid metabolism.
Clearance:
Not precisely determined due to minimal systemic absorption and rapid metabolism.
ExcretionRoute:
Not precisely determined due to minimal systemic absorption.
Unchanged:
Not precisely determined due to minimal systemic absorption.
Pharmacodynamics
OnsetOfAction:
Within hours to days for anti-inflammatory effect.
PeakEffect:
Variable, depends on condition being treated.
DurationOfAction:
Approximately 6-8 hours per dose, requiring QID administration.
Safety & Warnings
Side Effects
Urgent 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
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
- Short-term pain after using the medication
- Feeling like something is in your 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 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
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
- Short-term pain after using the medication
- Feeling like something is in your 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 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:
- Worsening eye pain
- Persistent or worsening redness
- Significant vision changes (e.g., decreased vision, halos around lights)
- New or increased discharge from the eye
- Signs of a new eye infection (e.g., pus, severe swelling)
- Severe headache
- 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, any of 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 a fungal, tuberculosis (TB), or viral infection affecting the eye.
This list is not exhaustive, and it is crucial to discuss all your health concerns with your doctor. Additionally, 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, consult with your doctor to ensure your safety. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of 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 a fungal, tuberculosis (TB), or viral infection affecting the eye.
This list is not exhaustive, and it is crucial to discuss all your health concerns with your doctor. Additionally, 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, consult with your doctor to ensure your safety. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. When performing tasks that require clear vision, such as driving, exercise caution to ensure your safety. Regularly schedule eye pressure checks and other eye exams as advised by your healthcare provider. Be aware that long-term use of this medication may increase the risk of developing cataracts or glaucoma; 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 to occur with ophthalmic use due to minimal systemic absorption. Local irritation may occur.
What to Do:
If swallowed, drink fluids. If local irritation occurs, rinse eye with water. For any concerning symptoms, contact a poison control center or seek medical attention. Call 1-800-222-1222 for poison control.
Drug Interactions
Monitoring
Baseline Monitoring
Intraocular Pressure (IOP)
Rationale: Corticosteroids can cause an increase in IOP, especially with prolonged use.
Timing: Before initiating therapy, especially for prolonged use (more than 10 days).
Ocular examination (slit lamp)
Rationale: To assess baseline ocular health and identify any pre-existing conditions (e.g., corneal defects, infections).
Timing: Before initiating therapy.
Routine Monitoring
Intraocular Pressure (IOP)
Frequency: Periodically, especially with prolonged use (e.g., every 2-4 weeks for chronic use).
Target: Normal range (typically 10-21 mmHg)
Action Threshold: Significant increase from baseline or above normal range; consider discontinuing or reducing dose, or adding IOP-lowering medication.
Signs of ocular infection (e.g., redness, discharge, pain)
Frequency: At each follow-up visit and patient self-monitoring.
Target: Absence of infection signs
Action Threshold: Presence of new or worsening signs of infection; discontinue loteprednol and initiate appropriate anti-infective therapy.
Corneal integrity
Frequency: Periodically, especially with prolonged use or pre-existing corneal conditions.
Target: Intact cornea
Action Threshold: Evidence of corneal thinning or ulceration; discontinue loteprednol.
Symptom Monitoring
- Blurred vision
- Eye pain
- Foreign body sensation
- Itching
- Burning/stinging upon instillation
- Increased sensitivity to light
- Signs of new or worsening infection (e.g., increased redness, discharge, swelling)
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 systemic corticosteroids.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though systemic absorption is minimal.
Second Trimester:
Potential for teratogenicity, though systemic absorption is minimal.
Third Trimester:
Potential for teratogenicity, though systemic absorption is minimal.
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, but potential for unknown effects.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Use in children should be approached with caution, considering the potential for increased IOP and other steroid-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 required.
Clinical Information
Clinical Pearls
- Loteprednol etabonate is a 'soft' steroid, meaning it is rapidly metabolized to inactive compounds, which theoretically reduces the risk of systemic side effects and potentially lessens the risk of IOP elevation compared to other corticosteroids, though IOP monitoring is still crucial.
- Shake the bottle well before each use as it is a suspension.
- Patients should be advised not to wear contact lenses during treatment for ocular inflammation or infection.
- Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation.
- Corticosteroids may mask or enhance the activity of ocular infections.
Alternative Therapies
- Dexamethasone ophthalmic
- Prednisolone acetate ophthalmic
- Difluprednate ophthalmic
- Fluorometholone ophthalmic
- Non-steroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use (e.g., ketorolac, bromfenac, nepafenac) for pain and inflammation.
- Mast cell stabilizers (e.g., cromolyn, lodoxamide) or antihistamines (e.g., olopatadine, azelastine) for allergic conjunctivitis.
Cost & Coverage
Average Cost:
Varies widely, typically $100-$300+ per 5ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization for brand, generic may be Tier 1 or 2)
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 this 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 occurred.