Lotemax Sm 0.38% 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
Pregnancy Category
Category C
FDA Approved
Sep 2018
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lotemax SM is an eye drop that contains a type of medicine called a corticosteroid. It works by reducing swelling, redness, and pain in your eye, especially after eye surgery. It's designed to stay on the eye surface longer for better effect.
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.
Special Considerations
If you have undergone 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 that you do not mix up the 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 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.
Special Considerations
If you have undergone 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 that you do not mix up the 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 schedule.
* Do not use two doses at the same time or take extra doses.
Lifestyle & Tips
- Do not touch the dropper tip to any surface, including your eye, to avoid contamination.
- Shake the bottle gently before each use.
- 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 minutes between applications.
- Do not use for longer than prescribed by your doctor, as prolonged use can lead to serious eye problems like glaucoma or cataracts.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
One drop into the affected eye(s) twice daily, beginning the day after surgery and continuing throughout the first 2 weeks of the post-operative period.
Condition-Specific Dosing:
post-operative inflammation and pain:
One drop into the affected eye(s) twice daily for 2 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not 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 specific considerations 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 inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, collagen deposition, fibroblast proliferation, scar formation, and signs of inflammation associated with inflammation.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (plasma concentrations below 1 ng/mL).
Tmax:
Not applicable due to minimal systemic absorption.
FoodEffect:
Not applicable for ophthalmic administration.
Distribution:
Vd:
Not applicable due to minimal systemic absorption.
ProteinBinding:
Not applicable due to minimal systemic absorption.
CnssPenetration:
No
Elimination:
HalfLife:
Not precisely determined for ophthalmic use due to minimal systemic absorption.
Clearance:
Not precisely determined for ophthalmic use.
ExcretionRoute:
Primarily through metabolism and subsequent excretion of inactive metabolites.
Unchanged:
Not applicable due to rapid metabolism.
Pharmacodynamics
OnsetOfAction:
Within hours (anti-inflammatory effect).
PeakEffect:
Within days of consistent use.
DurationOfAction:
Approximately 12 hours (requiring BID dosing).
Safety & Warnings
Side Effects
Serious 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
+ 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 or seek medical help:
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, 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
+ 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 or seek medical help:
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, 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:
- Severe or worsening eye pain
- Sudden vision changes or decreased vision
- Signs of a new eye infection (e.g., pus, severe redness, swelling)
- Persistent headache
- Any new or unusual eye symptoms
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 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 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, 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 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 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 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 breastfeeding, consult your doctor to 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 accidentally ingested, drink fluids to dilute. If local irritation occurs, flush eye with water. Contact a poison control center (1-800-222-1222) or seek medical attention if symptoms are severe or persistent.
Drug Interactions
Monitoring
Baseline Monitoring
Intraocular Pressure (IOP)
Rationale: Corticosteroids can cause an increase in IOP in susceptible individuals, especially with prolonged use.
Timing: Prior to initiation of therapy, especially if treatment duration is expected to exceed 10 days.
Ocular examination (e.g., slit lamp)
Rationale: To assess baseline inflammation, pain, and rule out pre-existing conditions like fungal infections or herpes simplex keratitis.
Timing: Prior to initiation of therapy.
Routine Monitoring
Intraocular Pressure (IOP)
Frequency: Regularly, especially if therapy extends beyond 10 days or in patients with a history of elevated IOP.
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., discharge, worsening redness, pain)
Frequency: Daily by patient, periodically by clinician.
Target: Absence of new or worsening infection signs.
Action Threshold: Presence of new or worsening signs of infection; discontinue and initiate appropriate anti-infective therapy.
Corneal integrity/healing
Frequency: Periodically, especially in patients with corneal defects.
Target: Normal healing progression.
Action Threshold: Delayed healing or signs of corneal thinning/perforation; discontinue.
Symptom Monitoring
- Worsening eye pain
- Increased eye redness
- Blurred vision or vision changes
- New or increased discharge from the eye
- Sensitivity to light (photophobia)
- Feeling of something in the eye (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, but systemic exposure from ophthalmic use is minimal.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm, though systemic exposure is low.
Second Trimester:
Potential for fetal harm, though systemic exposure is low.
Third Trimester:
Potential for fetal harm, though systemic exposure is low.
Lactation
It is unknown if topical ophthalmic administration results in sufficient systemic absorption to produce detectable quantities in human milk. Systemic corticosteroids can appear in human milk. Caution should be exercised when administered to a nursing woman.
Infant Risk:
Low risk due to minimal systemic absorption, but theoretical risk of growth suppression or interference with endogenous corticosteroid production in the infant if significant systemic absorption were to occur.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Use with caution, especially for prolonged periods, due to potential for increased IOP and other corticosteroid-related adverse effects.
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 SM is a gel drop formulation designed for improved ocular surface retention and sustained drug delivery compared to traditional suspensions.
- It is specifically indicated for post-operative inflammation and pain following ocular surgery.
- Patients should be advised not to wear contact lenses during treatment.
- Monitor intraocular pressure (IOP) if treatment extends beyond 10 days, as corticosteroids can cause IOP elevation.
- Prolonged use of corticosteroids may lead to posterior subcapsular cataract formation, glaucoma with optic nerve damage, and may enhance the establishment of secondary ocular infections.
- This formulation is preservative-free, which can be beneficial for patients with preservative sensitivities or dry eye.
Alternative Therapies
- Other ophthalmic corticosteroids (e.g., Dexamethasone, Prednisolone, Difluprednate, other Loteprednol formulations like Lotemax suspension or gel)
- Topical ophthalmic NSAIDs (e.g., Ketorolac, Bromfenac, Nepafenac) for inflammation and pain, especially when corticosteroid use is contraindicated or limited.
Cost & Coverage
Average Cost:
Varies, typically $200-$400 per 5gm bottle
Insurance Coverage:
Tier 2 or 3 (preferred or non-preferred brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.