Lotemax 0.5% Ophthalmic Susp 15ml
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
Sep 1998
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lotemax is an eye drop that contains a type of medicine called a corticosteroid. It works by reducing swelling, redness, and discomfort in the eye caused by inflammation, often after eye surgery or due to 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
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 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 them at least 5 minutes apart.
6. Shake the container well before use.
7. Remove contact lenses before using this medication. Consult your doctor about when it is safe to reinsert them. Do not put contact lenses back in if your eyes are irritated or infected.
8. Tilt your head back and drop the medication into the eye.
Special Considerations
If you have had 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.
If you wear contact lenses, discuss with your doctor when it is safe to put them back in after using this medication.
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 place, 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
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 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 them at least 5 minutes apart.
6. Shake the container well before use.
7. Remove contact lenses before using this medication. Consult your doctor about when it is safe to reinsert them. Do not put contact lenses back in if your eyes are irritated or infected.
8. Tilt your head back and drop the medication into the eye.
Special Considerations
If you have had 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.
If you wear contact lenses, discuss with your doctor when it is safe to put them back in after using this medication.
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 place, 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
- Shake the bottle well before each use.
- Do not touch the dropper tip to your eye or any other surface to avoid contamination.
- If you wear contact lenses, remove them before applying the drops and wait at least 15 minutes before reinserting them.
- If you are using other eye drops, wait at least 5-10 minutes between applications.
- Follow your doctor's instructions carefully regarding the duration of treatment; do not stop using the drops suddenly without consulting your doctor.
- Store at room temperature, away from light and moisture.
Available Forms & Alternatives
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 allergic conjunctivitis: 1 drop into the conjunctival sac of the affected eye(s) four times daily.
Dose Range:
1 - 2 mg
Condition-Specific Dosing:
post_operative_inflammation:
1-2 drops QID for 2 weeks
allergic_conjunctivitis:
1 drop QID
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and efficacy not established in pediatric patients)
Adolescent:
Not established (Safety and efficacy not established in pediatric patients)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment typically required due to minimal systemic absorption.
Moderate:
No adjustment typically required due to minimal systemic absorption.
Severe:
No adjustment typically required due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment typically required due to minimal systemic absorption.
Moderate:
No adjustment typically required due to minimal systemic absorption.
Severe:
No adjustment typically required 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. Corticosteroids inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, collagen deposition, scar formation, and also the proliferation of fibroblasts that are associated with inflammation. Loteprednol etabonate is a 'soft' steroid, meaning it is designed to be rapidly metabolized to inactive metabolites (e.g., PJ-91 and PJ-90) after exerting its therapeutic effect, thereby minimizing systemic side effects.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption; plasma concentrations generally below the limit of quantitation (0.1 ng/mL).
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable (ophthalmic administration)
Distribution:
Vd:
Not extensively characterized due to minimal systemic absorption.
ProteinBinding:
Not extensively characterized due to minimal systemic absorption.
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not well characterized systemically due to minimal absorption.
Clearance:
Not well characterized systemically due to minimal absorption.
ExcretionRoute:
Not well characterized systemically due to minimal absorption.
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Within hours (anti-inflammatory effect)
PeakEffect:
Days to weeks depending on condition severity.
DurationOfAction:
Hours (requires multiple daily dosing)
Confidence:
Medium
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. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or do not go away:
- Short-term pain after using the medication
- 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
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. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or do not go away:
- Short-term pain after using the medication
- 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:
- Persistent or worsening eye pain
- Significant vision changes (e.g., decreased vision, halos around lights)
- Increased redness or swelling of the eye
- Pus or discharge from the eye
- New or worsening 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.
Certain health conditions, including:
+ 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
* All your health problems
It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose 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.
Certain health conditions, including:
+ 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
* All your health problems
It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose 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, notify your doctor to discuss the potential 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, redness, or discomfort may occur with excessive application.
What to Do:
If an overdose is suspected or if the drops are accidentally ingested, contact a poison control center or emergency medical services immediately. For eye exposure, flush the eye with copious amounts of water. 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: Prior to initiation of therapy, particularly if treatment is expected to exceed 10 days.
Ocular examination (e.g., slit lamp)
Rationale: To assess baseline ocular health and identify any pre-existing conditions that may be exacerbated by corticosteroids (e.g., corneal defects, infections).
Timing: Prior to initiation of therapy.
Routine Monitoring
Intraocular Pressure (IOP)
Frequency: Regularly, especially if treatment exceeds 10 days.
Target: Normal range (typically 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: At each follow-up visit and as clinically indicated.
Target: Absence of infection
Action Threshold: Presence of new or worsening infection; discontinue corticosteroid and initiate appropriate anti-infective therapy.
Corneal integrity (e.g., epithelial defects, thinning)
Frequency: At each follow-up visit, especially with prolonged use.
Target: Intact cornea
Action Threshold: Evidence of corneal thinning or perforation; discontinue use.
Symptom Monitoring
- Blurred vision
- Eye pain
- Redness or irritation of the eye
- Discharge from the eye
- Sensitivity to light
- Foreign body sensation
- Signs of new or worsening infection
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 on fetal development at systemically toxic doses.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects, but systemic exposure is minimal with ophthalmic use.
Second Trimester:
Potential for adverse effects, but systemic exposure is minimal with ophthalmic use.
Third Trimester:
Potential for adverse effects, but systemic exposure is minimal with ophthalmic use.
Lactation
It is not known whether topical ophthalmic loteprednol etabonate is excreted in human milk. Caution should be exercised when loteprednol etabonate is administered to a nursing woman. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Lotemax and any potential adverse effects on the breastfed infant from Lotemax or from the underlying maternal condition.
Infant Risk:
Low risk due to minimal systemic absorption, but unknown if excreted in human milk.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Use in children should be approached with caution and only if clearly indicated, with close monitoring for adverse effects, particularly elevated IOP.
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, designed for rapid metabolism to inactive metabolites, which theoretically reduces the risk of systemic side effects compared to other corticosteroids.
- Patients should be advised that 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 existing ocular infections (bacterial, fungal, viral). Fungal infections of the cornea are particularly prone to develop coincidentally with long-term corticosteroid application.
- Patients should not wear contact lenses during treatment with Lotemax, especially if they have active inflammation or infection.
- Shake the bottle well before each use to ensure uniform suspension.
Alternative Therapies
- Other ophthalmic corticosteroids (e.g., Prednisolone acetate, Dexamethasone, Difluprednate, Fluorometholone)
- Ophthalmic NSAIDs (e.g., Ketorolac, Bromfenac, Nepafenac) for inflammation and pain
- Mast cell stabilizers (e.g., Cromolyn, Lodoxamide) for allergic conjunctivitis
- Antihistamine/mast cell stabilizer combinations (e.g., Olopatadine, Azelastine) for allergic conjunctivitis
Cost & Coverage
Average Cost:
Varies widely, typically $150-$300+ per 15ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 (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.