Loteprednol 0.2% Ophth Susp 5ml
It is used to ease allergy signs.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Ophthalmic Corticosteroid
Pharmacologic Class
Corticosteroid, Ester
Pregnancy Category
Category C
FDA Approved
Sep 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 irritation in the eye, often 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 your eye, lid, or other skin, as this can introduce bacteria into the medication 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 them at least 5 minutes apart.
6. Shake the container well before use.
7. Remove contact lenses before using this medication. You can reinsert your lenses 10 minutes after administration, unless your eyes are irritated or infected.
8. Tilt your head back and gently drop the medication into your eye.
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 your eye, lid, or other skin, as this can introduce bacteria into the medication 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 them at least 5 minutes apart.
6. Shake the container well before use.
7. Remove contact lenses before using this medication. You can reinsert your lenses 10 minutes after administration, unless your eyes are irritated or infected.
8. Tilt your head back and gently drop the medication into your eye.
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 prevent 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 eye is red or inflamed.
- Follow the prescribed dosing schedule carefully, even if symptoms improve.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Instill 1 drop into the conjunctival sac of the affected eye(s) 4 times daily, beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period.
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
postoperative_inflammation:
1 drop 4 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 adjustment needed 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 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. Corticosteroids are capable of producing a profound and varied increase or decrease in the synthesis of proteins.
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:
Approximately 97% (in vitro, for loteprednol).
CnssPenetration:
Limited
Elimination:
HalfLife:
Not applicable (rapid local metabolism, minimal systemic elimination).
Clearance:
Not applicable (rapid local metabolism).
ExcretionRoute:
Not applicable (minimal systemic absorption and rapid local metabolism).
Unchanged:
Not applicable (minimal systemic absorption).
Pharmacodynamics
OnsetOfAction:
Within hours (anti-inflammatory effect).
PeakEffect:
Days to weeks depending on condition.
DurationOfAction:
Varies, typically requires multiple daily dosing to maintain effect.
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. 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 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. 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 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:
- New or worsening eye pain
- Persistent or worsening redness, swelling, or irritation
- Pus or discharge from the eye
- Sudden decrease in vision
- Increased 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, 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 any ongoing health issues, particularly:
+ Fungal infections of the eye
+ Tuberculosis (TB) infections of the eye
+ Viral infections of the eye
Please note that this is not an exhaustive list of potential interactions. Therefore, it is crucial to discuss all of your:
Medications, including prescription and over-the-counter (OTC) drugs, as well as natural products and vitamins
Health problems
with your doctor and pharmacist. This will help ensure that it is safe for you to take this medication in conjunction with your other treatments. Never start, stop, or modify 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, 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 any ongoing health issues, particularly:
+ Fungal infections of the eye
+ Tuberculosis (TB) infections of the eye
+ Viral infections of the eye
Please note that this is not an exhaustive list of potential interactions. Therefore, it is crucial to discuss all of your:
Medications, including prescription and over-the-counter (OTC) drugs, as well as natural products and vitamins
Health problems
with your doctor and pharmacist. This will help ensure that it is safe for you to take this medication in conjunction with your other treatments. Never start, stop, or modify 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, 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, 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 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 (1-800-222-1222) or seek medical attention. For ocular overdose, flush the eye with copious amounts of water.
Drug Interactions
Monitoring
Baseline Monitoring
Intraocular Pressure (IOP)
Rationale: Corticosteroids can cause an increase in IOP, especially with prolonged use. Baseline measurement is important for comparison.
Timing: Prior to initiation of therapy, if prolonged use (beyond 10 days) is anticipated.
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., every 2-4 weeks if used for more than 10 days).
Target: Individualized, typically <21 mmHg or within patient's normal range.
Action Threshold: Significant increase from baseline or above 21 mmHg; consider discontinuation or alternative therapy.
Signs of infection (e.g., worsening redness, pain, discharge)
Frequency: Daily by patient, periodically by clinician.
Target: Absence of signs of infection.
Action Threshold: Presence of new or worsening signs of infection; consider discontinuing loteprednol and initiating appropriate anti-infective therapy.
Corneal integrity/healing
Frequency: Periodically, especially in patients with corneal defects.
Target: Normal healing progression.
Action Threshold: Delayed healing or worsening corneal condition; consider discontinuation.
Symptom Monitoring
- Worsening eye pain
- Increased redness or irritation
- Blurred vision or other visual disturbances
- Discharge from the eye
- Sensitivity to light (photophobia)
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, but systemic exposure from ophthalmic use is minimal.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though systemic absorption is minimal.
Second Trimester:
Minimal risk due to low systemic absorption.
Third Trimester:
Minimal risk due to low systemic absorption.
Lactation
Caution should be exercised when loteprednol etabonate is administered to a nursing woman. It is not known whether topical ophthalmic administration could result in sufficient systemic absorption to produce detectable quantities in human breast milk. However, due to the rapid metabolism of loteprednol to inactive metabolites, the risk to the infant is considered low.
Infant Risk:
Low
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 systemic absorption and IOP elevation, especially in infants and young children.
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 an 'ester' corticosteroid, meaning it is rapidly metabolized to inactive compounds once absorbed systemically, which theoretically reduces the risk of systemic side effects and potentially lessens the risk of IOP elevation compared to other corticosteroids.
- Shake the suspension well before each use to ensure uniform distribution of the active ingredient.
- Patients should be advised not to wear contact lenses during treatment for ocular inflammation or infection.
- Prolonged use of corticosteroids may result in posterior subcapsular cataracts, glaucoma with optic nerve damage, and may enhance the establishment of secondary ocular infections from fungi or viruses.
Alternative Therapies
- Prednisolone acetate ophthalmic suspension
- Dexamethasone ophthalmic solution/suspension
- Difluprednate ophthalmic emulsion
- Fluorometholone ophthalmic suspension
- Topical NSAIDs (e.g., ketorolac, bromfenac) for postoperative inflammation (non-steroidal option)
Cost & Coverage
Average Cost:
Varies, typically $50-$150 per 5mL bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (generic often 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 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.