Lotemax 0.5% Ophth Ointment
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
Pregnancy Category
Category C
FDA Approved
Sep 1998
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lotemax 0.5% Ophthalmic Ointment is an eye medicine containing a corticosteroid called loteprednol. 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. This medication is for eye use only.
2. Wash your hands before and after applying the medication to prevent contamination.
3. Avoid touching the container tip to your eye, lid, or surrounding 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, apply them at least 5 minutes apart.
6. To administer the medication, gently pull down your lower eyelid and instill the prescribed amount.
7. Release your lower eyelid and keep your eyes closed for 1 to 2 minutes.
8. Do not wear contact lenses while using this medication.
Storage and Disposal
Store this medication at room temperature, avoiding freezing. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist. You may also have access to drug take-back programs in your area.
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 scheduled 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
1. This medication is for eye use only.
2. Wash your hands before and after applying the medication to prevent contamination.
3. Avoid touching the container tip to your eye, lid, or surrounding 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, apply them at least 5 minutes apart.
6. To administer the medication, gently pull down your lower eyelid and instill the prescribed amount.
7. Release your lower eyelid and keep your eyes closed for 1 to 2 minutes.
8. Do not wear contact lenses while using this medication.
Storage and Disposal
Store this medication at room temperature, avoiding freezing. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist. You may also have access to drug take-back programs in your area.
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 scheduled 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 tip of the ointment tube to your eye or any other surface to avoid contamination.
- Wash your hands thoroughly before and after applying the ointment.
- Remove contact lenses before applying the ointment and wait at least 15 minutes before reinserting them.
- Do not share your eye medication with others.
- Avoid rubbing your eyes after application.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a small amount (approximately 1/2 inch ribbon) into the conjunctival sac 2 to 4 times daily.
Dose Range:
2 - 4 mg
Condition-Specific Dosing:
post-operative inflammation and pain:
Apply a small amount (approximately 1/2 inch ribbon) into the conjunctival sac 2 to 4 times daily, beginning 24 hours after surgery and continuing throughout the first 2 weeks of the post-operative period.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and effectiveness have not been established in pediatric patients.
Adolescent:
Safety and effectiveness have not been established in pediatric patients.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Dialysis:
No specific considerations (minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
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, collectively called 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% of the administered dose)
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:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not precisely determined due to minimal systemic absorption; rapid local metabolism.
Clearance:
Not precisely determined due to minimal systemic absorption.
ExcretionRoute:
Primarily local metabolism, then systemic excretion of inactive metabolites.
Unchanged:
Not applicable (rapidly metabolized)
Pharmacodynamics
OnsetOfAction:
Within hours (anti-inflammatory effect)
PeakEffect:
Days to weeks depending on condition severity
DurationOfAction:
Varies with dosing frequency; generally maintains effect with 2-4 times daily application.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening side effect:
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 for advice:
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, call your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening side effect:
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 for advice:
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, call your doctor. 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 vision changes (e.g., decreased vision, halos around lights)
- Persistent or worsening redness or swelling of the eye
- Pus or discharge from the eye
- Signs of a new eye infection (e.g., fever, severe headache, eye swelling)
- Allergic reaction symptoms (e.g., rash, itching, severe dizziness, trouble breathing)
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 symptoms you experienced.
Certain health conditions, including:
+ Fungal, tuberculosis (TB), or viral infections affecting the eye.
If the patient is a child, as this medication is not intended for pediatric use.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health conditions.
Please note that this is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to consult with your doctor and pharmacist about all your medications and health issues before starting, stopping, or modifying the dose of any medication, including this one.
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 symptoms you experienced.
Certain health conditions, including:
+ Fungal, tuberculosis (TB), or viral infections affecting the eye.
If the patient is a child, as this medication is not intended for pediatric use.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health conditions.
Please note that this is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to consult with your doctor and pharmacist about all your medications and health issues before starting, stopping, or modifying the dose of any medication, including this one.
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 are breastfeeding, consult your doctor to carefully weigh the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with ophthalmic administration due to minimal systemic absorption. Local irritation may occur.
What to Do:
If an overdose is suspected, flush the eye with lukewarm water. If irritation persists or if the product is accidentally ingested, contact a poison control center (1-800-222-1222) or seek medical attention immediately.
Drug Interactions
Monitoring
Baseline Monitoring
Intraocular Pressure (IOP)
Rationale: Corticosteroids can cause elevated IOP, especially with prolonged use.
Timing: Before initiating treatment, particularly if treatment duration is expected to exceed 10 days.
Ocular examination (e.g., slit lamp)
Rationale: To assess baseline ocular health and identify pre-existing conditions (e.g., glaucoma, cataracts, infections).
Timing: Before initiating treatment.
Routine Monitoring
Intraocular Pressure (IOP)
Frequency: Regularly, especially if treatment exceeds 10 days or in patients with glaucoma.
Target: Normal range (typically 10-21 mmHg)
Action Threshold: Significant or sustained elevation above baseline; consider discontinuation or alternative therapy.
Signs of ocular infection (e.g., redness, discharge, pain)
Frequency: At each follow-up visit and patient self-monitoring.
Target: Absence of signs of infection
Action Threshold: Presence of new or worsening signs of infection; consider appropriate antimicrobial therapy or discontinuation.
Corneal integrity/healing
Frequency: As clinically indicated, especially in patients with corneal defects.
Target: Normal healing progression
Action Threshold: Delayed healing or worsening corneal condition; consider discontinuation.
Symptom Monitoring
- Blurred vision
- Eye pain
- Redness
- Discharge
- Sensitivity to light
- Foreign body sensation
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects, but human data are limited. Systemic absorption after ophthalmic use is minimal.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity observed in animal studies at high systemic doses; minimal risk with ophthalmic use due to low absorption.
Second Trimester:
Minimal risk with ophthalmic use due to low systemic absorption.
Third Trimester:
Minimal risk with ophthalmic use due to low systemic absorption.
Lactation
L3 (Moderately Safe). 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, the risk to the breastfed infant is considered low. Use with caution.
Infant Risk:
Low risk due to minimal systemic absorption by the mother.
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 physician.
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
- Lotemax 0.5% Ophthalmic Ointment is particularly useful for post-operative inflammation as the ointment formulation provides longer contact time with the ocular surface compared to drops.
- Unlike some other corticosteroids, loteprednol etabonate is designed to be rapidly metabolized to inactive metabolites, potentially reducing the risk of IOP elevation and cataract formation compared to older corticosteroids, though these risks still exist with prolonged use.
- Patients should be instructed on proper ointment application technique to ensure efficacy and minimize contamination.
- Long-term use (beyond 10 days) requires regular monitoring of intraocular pressure due to the risk of steroid-induced glaucoma.
- Corticosteroids can mask or exacerbate ocular infections; careful monitoring for signs of infection is crucial.
Alternative Therapies
- Other ophthalmic corticosteroids (e.g., Dexamethasone, Prednisolone, Difluprednate)
- Ophthalmic NSAIDs (e.g., Ketorolac, Bromfenac, Nepafenac) for inflammation and pain, especially post-operatively.
- Combination products (e.g., antibiotic/corticosteroid combinations if infection risk is present).
Cost & Coverage
Average Cost:
$150 - $300 per 3.5g tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (varies by plan)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.