Lotemax 0.5% Ophthalmic 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 anti-inflammatory
Pharmacologic Class
Corticosteroid
Pregnancy Category
Category C
FDA Approved
Feb 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 irritation in the eye caused by certain eye conditions or after eye surgery.
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 about when it is safe to replace your contact lenses after use. 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.
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, use 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 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 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 about when it is safe to replace your contact lenses after use. 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.
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, use 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 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.
- Remove contact lenses 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.
- Follow your doctor's instructions carefully regarding the duration of treatment; do not stop using the drops suddenly unless advised by your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
1 drop into the affected eye(s) four times daily.
Dose Range:
1 - 2 mg
Condition-Specific Dosing:
Post-operative inflammation:
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 post-operatively.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment required due to minimal systemic absorption.
Moderate:
No specific adjustment required due to minimal systemic absorption.
Severe:
No specific adjustment required due to minimal systemic absorption.
Dialysis:
No specific adjustment required due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment required due to minimal systemic absorption.
Moderate:
No specific adjustment required due to minimal systemic absorption.
Severe:
No specific adjustment required due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Loteprednol etabonate is a corticosteroid that inhibits the inflammatory response to a variety of agents. Corticosteroids induce 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; plasma concentrations of loteprednol etabonate and its active metabolite, PJ-91, are below the limit of quantitation (0.1 ng/mL) in most subjects.
Tmax:
Not quantifiable due to minimal systemic absorption.
FoodEffect:
Not applicable for ophthalmic administration.
Distribution:
Vd:
Not quantifiable due to minimal systemic absorption.
ProteinBinding:
Not extensively studied systemically due to minimal absorption.
CnssPenetration:
Limited
Elimination:
HalfLife:
Rapidly metabolized, systemic half-life not clinically relevant due to minimal absorption.
Clearance:
Rapid local metabolism.
ExcretionRoute:
Not applicable for systemic excretion due to minimal absorption; local metabolites are likely cleared via aqueous humor turnover.
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Within hours
PeakEffect:
Days to weeks depending on condition severity.
DurationOfAction:
Varies with dosing frequency and condition; typically maintained with q.i.d. 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. 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:
- 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, consult 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 any other unusual symptoms that bother you or do not go away, contact your doctor:
- 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, consult 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 decrease in vision
- New or worsening eye discharge
- Severe eye redness or irritation
- Signs of a new eye infection (e.g., pus, severe swelling)
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. Never start, stop, or adjust 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.
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. Never start, stop, or adjust 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 performing tasks that require clear vision, such as driving, exercise caution to ensure your safety. Regularly schedule eye exams and have your eye pressure checked 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 do not use 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 use due to minimal systemic absorption. Local irritation may occur with excessive use.
What to Do:
If accidentally ingested, drink fluids to dilute. If local irritation occurs, flush eye with water. If symptoms persist or are severe, contact a poison control center (1-800-222-1222) or seek medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Intraocular Pressure (IOP)
Rationale: To establish baseline and monitor for corticosteroid-induced glaucoma, especially with prolonged use (typically >10 days).
Timing: Before initiating treatment if prolonged use is anticipated.
Slit lamp examination
Rationale: To assess the initial ocular condition and monitor for progression of disease or adverse effects.
Timing: Before initiating treatment.
Routine Monitoring
Intraocular Pressure (IOP)
Frequency: Periodically, especially if treatment exceeds 10 days.
Target: Individualized, typically <21 mmHg or within patient's normal range.
Action Threshold: Significant increase from baseline or above normal range; consider dose reduction, discontinuation, or glaucoma management.
Visual Acuity
Frequency: Periodically, as clinically indicated.
Target: Stable or improving.
Action Threshold: Decreased vision; investigate for cataract formation or other complications.
Signs of secondary ocular infection (e.g., bacterial, fungal, viral)
Frequency: Regularly throughout treatment.
Target: Absence of new or worsening infection.
Action Threshold: Presence of new or worsening infection; consider appropriate antimicrobial therapy and/or discontinuation of corticosteroid.
Symptom Monitoring
- Eye pain
- Redness
- Blurred vision
- Discharge
- Sensitivity to light
- Foreign body sensation
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 exposure is minimal.
Second Trimester:
Minimal systemic exposure, unlikely to pose significant risk.
Third Trimester:
Minimal systemic exposure, unlikely to pose significant risk.
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 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, considering the potential for increased systemic absorption and adverse effects (e.g., IOP elevation, growth suppression) compared to adults.
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
- Shake the bottle well before each use to ensure uniform suspension.
- 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 (bacterial, fungal, viral).
- Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid application. Fungal invasion should be considered in any persistent corneal ulceration where a corticosteroid has been used or is in use.
- Not for injection. For topical ophthalmic use only.
Alternative Therapies
- Prednisolone acetate ophthalmic suspension (e.g., Pred Forte)
- Dexamethasone ophthalmic solution/suspension
- Difluprednate ophthalmic emulsion (Durezol)
- Fluorometholone ophthalmic suspension (FML)
- Rimexolone ophthalmic suspension (Vexol)
- Non-steroidal anti-inflammatory drugs (NSAIDs) ophthalmic drops (e.g., ketorolac, bromfenac) for non-infectious inflammation.
Cost & Coverage
Average Cost:
Varies, typically $100-$300 per 10ml 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 promptly. To ensure safe and effective treatment, 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 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 details about the overdose, including the medication taken, the amount, and the time it occurred.