Lotemax 0.5% Opth Gel Drops 5gm
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, Ester-based
Pregnancy Category
Category C
FDA Approved
Sep 2012
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lotemax Gel is an eye drop that contains a type of steroid called loteprednol. It's used to reduce swelling, redness, and discomfort in your eyes, especially 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
Use this medication for the eye only.
Wash your hands before and after use to maintain cleanliness.
Avoid touching the container tip to the eye, lid, or other skin, as this can introduce bacteria into the medication and potentially cause severe eye problems or vision loss.
Replace the cap after each use.
If you are using multiple medications in the same eye, administer each medication at least 5 minutes apart.
Before each use, turn the bottle upside down with the lid on and shake it once.
Do not wear contact lenses while using this medication.
To administer the medication, tilt your head back and drop the medication into the eye.
If you are using this medication after surgery on both eyes, 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
Store the medication at room temperature, avoiding freezing.
Keep the bottle upright with the cap on.
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.
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
Use this medication for the eye only.
Wash your hands before and after use to maintain cleanliness.
Avoid touching the container tip to the eye, lid, or other skin, as this can introduce bacteria into the medication and potentially cause severe eye problems or vision loss.
Replace the cap after each use.
If you are using multiple medications in the same eye, administer each medication at least 5 minutes apart.
Before each use, turn the bottle upside down with the lid on and shake it once.
Do not wear contact lenses while using this medication.
To administer the medication, tilt your head back and drop the medication into the eye.
If you are using this medication after surgery on both eyes, 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
Store the medication at room temperature, avoiding freezing.
Keep the bottle upright with the cap on.
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.
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
- Do not wear contact lenses during treatment unless directed by your doctor.
- Wash hands thoroughly before and after administering eye drops.
- Avoid touching the dropper tip to any surface (eye, fingers, etc.) to prevent contamination.
- If using other eye drops, wait at least 5 minutes between applications.
- Shake the bottle well before each use (if suspension, though this is a gel, still good practice to ensure even distribution if any settling occurs).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
One drop into the affected eye(s) four times daily starting the day after surgery and continuing throughout the first 2 weeks post-operatively.
Condition-Specific Dosing:
post_operative_inflammation:
One drop into the affected eye(s) four times daily starting the day after surgery and continuing throughout the first 2 weeks post-operatively.
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 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. 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. It is a 'soft steroid' designed for rapid metabolism to inactive metabolites after exerting its therapeutic effect, thereby minimizing systemic side effects, including intraocular pressure (IOP) elevation.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption; plasma concentrations of loteprednol etabonate and its inactive metabolite, PJ-91, were below the limit of quantitation (1 ng/mL) in most subjects following ocular administration.
Tmax:
Not applicable for systemic absorption due to minimal levels; local ocular concentration peak is rapid.
FoodEffect:
Not applicable for ophthalmic administration.
Distribution:
Vd:
Not quantifiable due to minimal systemic absorption.
ProteinBinding:
Approximately 97% bound to plasma proteins (in vitro data for loteprednol etabonate).
CnssPenetration:
Limited
Elimination:
HalfLife:
Not well-defined systemically due to minimal absorption and rapid metabolism.
Clearance:
Not quantifiable due to minimal systemic absorption.
ExcretionRoute:
Primarily via metabolism to inactive compounds; systemic excretion routes are not clinically significant.
Unchanged:
Not quantifiable systemically.
Pharmacodynamics
OnsetOfAction:
Within hours for anti-inflammatory effect.
PeakEffect:
Days to weeks depending on the inflammatory condition.
DurationOfAction:
Dependent on dosing frequency and severity of inflammation.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
If you experience any of the following severe side effects, contact your doctor or seek medical help right away, as they can be life-threatening:
- 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
Most medications can cause side effects, but many people either do not experience them or have only mild symptoms. If you encounter any of the following side effects, or if any other side effects bother you or do not go away, contact your doctor for advice:
- Short-term pain after using the medication.
- A feeling that something is in the eye.
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 about side effects, you can also contact your doctor. Additionally, you can 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 severe side effects, contact your doctor or seek medical help right away, as they can be life-threatening:
- 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
Most medications can cause side effects, but many people either do not experience them or have only mild symptoms. If you encounter any of the following side effects, or if any other side effects bother you or do not go away, contact your doctor for advice:
- Short-term pain after using the medication.
- A feeling that something is in the eye.
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 about side effects, you can also contact your doctor. Additionally, you can 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, redness, or swelling.
- New symptoms such as discharge, crusting, or severe itching.
- Blurred vision or vision changes.
- Signs of a new eye infection (e.g., pus, increased sensitivity to light).
- Any signs of an allergic reaction (e.g., rash, severe itching, swelling of face/tongue/throat, 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, 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.
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 with your doctor.
Additionally, provide your doctor and pharmacist with a comprehensive list of all the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins
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, 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.
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 with your doctor.
Additionally, provide your doctor and pharmacist with a comprehensive list of all the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins
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 performing tasks that require clear vision, such as driving, exercise caution to ensure your safety. Regularly schedule eye pressure checks and other eye examinations as advised 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 your doctor's prescribed treatment duration and avoid using this medication for an extended period beyond the recommended timeframe. 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 administration due to minimal systemic absorption.
- Local irritation or increased ocular side effects may occur with excessive use.
What to Do:
If an overdose is suspected, contact a poison control center (1-800-222-1222) or seek immediate medical attention. Flush eye(s) with copious amounts of water if irritation occurs.
Drug Interactions
Monitoring
Baseline Monitoring
Intraocular Pressure (IOP)
Rationale: To establish baseline and monitor for corticosteroid-induced IOP elevation.
Timing: Prior to initiation of therapy.
Slit Lamp Examination
Rationale: To assess the severity of inflammation, corneal integrity, and rule out pre-existing infections.
Timing: Prior to initiation of therapy.
Routine Monitoring
Intraocular Pressure (IOP)
Frequency: Regularly, especially with prolonged use (e.g., >10 days).
Target: Individualized, typically <21 mmHg or within patient's normal range.
Action Threshold: Significant or sustained elevation above baseline; consider discontinuation or alternative therapy.
Slit Lamp Examination
Frequency: As clinically indicated, especially with prolonged use.
Target: Resolution of inflammation, absence of new signs of infection or corneal damage.
Action Threshold: Worsening inflammation, signs of infection (e.g., dendritic ulcers), or corneal thinning/perforation.
Visual Acuity
Frequency: As clinically indicated.
Target: Stable or improving.
Action Threshold: Decreased vision.
Symptom Monitoring
- Eye pain
- Redness
- Swelling
- Discharge
- Blurred vision
- 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 teratogenic effects with systemic corticosteroids, but ocular administration results in minimal systemic exposure.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenic effects, though risk is low with minimal systemic absorption.
Second Trimester:
Risk considered low due to minimal systemic absorption.
Third Trimester:
Risk considered low due to minimal systemic absorption.
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 Lotemax Gel is administered to a nursing woman. The risk to the infant is considered low due to minimal systemic absorption.
Infant Risk:
Low
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Use with caution and only if clearly indicated, considering the potential for systemic effects and IOP elevation with prolonged use.
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
- Loteprednol etabonate is considered a 'soft steroid' because it is rapidly metabolized to inactive compounds after exerting its therapeutic effect, which may lead to a lower risk of intraocular pressure (IOP) elevation compared to other corticosteroids.
- It is important to monitor IOP, especially with prolonged use (e.g., beyond 10 days), as corticosteroids can cause IOP elevation in susceptible individuals.
- Patients should be advised not to wear contact lenses during treatment with Lotemax Gel.
- This formulation is a gel, which may provide longer ocular surface retention compared to traditional suspensions, potentially enhancing efficacy and reducing frequency of administration for some conditions (though standard dosing is 4 times daily for post-op inflammation).
Alternative Therapies
- Dexamethasone ophthalmic (e.g., Maxidex)
- Prednisolone acetate ophthalmic (e.g., Pred Forte)
- Difluprednate ophthalmic (e.g., Durezol)
- Fluorometholone ophthalmic (e.g., FML)
- Nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic inflammation (e.g., ketorolac, bromfenac, nepafenac)
Cost & Coverage
Average Cost:
$200 - $350 per 5gm tube
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 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.