Lotemax 0.5% Ophthalmic Susp 5ml
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 Corticosteroid
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 corticosteroid medicine. It is used to reduce swelling, redness, itching, and discomfort in the eye caused by certain eye conditions, such as allergies 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
Use this medication for the eye only.
Wash your hands before and after use to prevent contamination.
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.
Replace the cap after each use.
If you are using multiple medications in the same eye, administer each medication at least 5 minutes apart.
Shake the container well before use.
Remove contact lenses before using this medication. Consult your doctor to determine if you can reinsert your contact lenses after use. Do not reinsert contact lenses if your eyes are irritated or infected.
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, away from freezing temperatures.
Keep the container 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 prevent contamination.
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.
Replace the cap after each use.
If you are using multiple medications in the same eye, administer each medication at least 5 minutes apart.
Shake the container well before use.
Remove contact lenses before using this medication. Consult your doctor to determine if you can reinsert your contact lenses after use. Do not reinsert contact lenses if your eyes are irritated or infected.
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, away from freezing temperatures.
Keep the container 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
- 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 instilling the drops and wait at least 15 minutes before reinserting them.
- If using other eye drops, wait at least 5 minutes between applications.
- Follow the prescribed dosing schedule carefully, even if symptoms improve.
- Do not stop using the medication suddenly without consulting your doctor, especially if used for a prolonged period.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
For post-operative inflammation and pain: Instill 1 to 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 seasonal allergic conjunctivitis: Instill 1 drop into the conjunctival sac of the affected eye(s) four times daily.
Condition-Specific Dosing:
post_operative_inflammation_pain:
1-2 drops QID for 2 weeks
seasonal_allergic_conjunctivitis:
1 drop QID
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for infants under 2 years of age.
Child:
Safety and effectiveness have been established in pediatric patients 2 years of age and older for post-operative inflammation and pain. Dosing generally similar to adults.
Adolescent:
Dosing generally similar to adults.
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
Corticosteroids, such as loteprednol etabonate, inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They act 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. Plasma concentrations of loteprednol etabonate and its inactive metabolite, PJ-91, are below the limit of quantitation (1 ng/mL) in most subjects.
Tmax:
Not well-defined due to minimal systemic absorption.
FoodEffect:
Not applicable for ophthalmic administration.
Distribution:
Vd:
Not well-defined due to minimal systemic absorption.
ProteinBinding:
Not well-defined due to minimal systemic absorption.
CnssPenetration:
Limited
Elimination:
HalfLife:
Not well-defined due to rapid metabolism and minimal systemic absorption.
Clearance:
Not well-defined due to rapid metabolism and minimal systemic absorption.
ExcretionRoute:
Not primary route of elimination for active drug due to local action and rapid metabolism.
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Within hours
PeakEffect:
Within days of consistent use
DurationOfAction:
Varies, typically requires multiple daily dosing for sustained effect.
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 and do not go away:
- Short-term pain after using the medication
- Feeling like something is in your 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 and do not go away:
- Short-term pain after using the medication
- Feeling like something is in your 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:
- New or worsening eye pain
- Significant increase in eye redness or irritation
- Blurred vision or other changes in vision
- Eye discharge or pus
- Increased sensitivity to light
- Signs of a new eye infection (e.g., fever, severe pain, swelling around the eye)
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 of the following health conditions:
+ 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. Do not initiate, stop, or modify 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.
If you have any of the following health conditions:
+ 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. Do not initiate, stop, or modify 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 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 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 swallowed, drink fluids. If eye irritation occurs, rinse eye with water. Call 1-800-222-1222 (Poison Control) for advice if concerned.
Drug Interactions
Monitoring
Baseline Monitoring
Intraocular Pressure (IOP)
Rationale: To establish baseline and monitor for corticosteroid-induced ocular hypertension/glaucoma, especially with prolonged use.
Timing: Prior to initiation of therapy, if prolonged use (>10 days) is anticipated.
Ophthalmic Examination
Rationale: To assess baseline ocular health and identify any pre-existing conditions (e.g., infection, corneal defects).
Timing: Prior to initiation of therapy.
Routine Monitoring
Intraocular Pressure (IOP)
Frequency: Regularly, especially if therapy exceeds 10 days.
Target: Normal range (typically 10-21 mmHg)
Action Threshold: Significant increase from baseline or above normal range; consider discontinuation or alternative therapy.
Signs of Ocular Infection
Frequency: Daily by patient, periodically by clinician.
Target: Absence of new or worsening infection.
Action Threshold: Presence of new pain, redness, discharge, or worsening symptoms; requires immediate evaluation.
Corneal Integrity/Healing
Frequency: Periodically, especially in post-operative or trauma cases.
Target: Normal healing progression.
Action Threshold: Delayed healing or signs of corneal thinning/perforation; requires immediate evaluation.
Symptom Monitoring
- Worsening eye pain
- Increased redness or irritation
- Blurred vision or other vision changes
- Eye discharge
- Sensitivity to light
- Signs of new infection (e.g., pus, fever)
Special Patient Groups
Pregnancy
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Loteprednol etabonate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential risk to fetus, use only if clearly needed.
Second Trimester:
Potential risk to fetus, use only if clearly needed.
Third Trimester:
Potential risk to fetus, use only if clearly needed.
Lactation
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, risk to a breastfed infant is considered low. Use with caution.
Infant Risk:
Low
Pediatric Use
Safety and effectiveness have been established in pediatric patients 2 years of age and older for post-operative inflammation and pain. Safety and effectiveness in pediatric patients below the age of 2 years have not been established. For seasonal allergic conjunctivitis, safety and effectiveness in pediatric patients have not been established.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. No specific dosage adjustment is required.
Clinical Information
Clinical Pearls
- Shake the bottle vigorously before each use to ensure uniform suspension.
- Prolonged use of ophthalmic corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. Monitor IOP if used for more than 10 days.
- Corticosteroids may mask or enhance the activity of existing ocular infections (bacterial, viral, fungal). Do not use in active viral (e.g., herpes simplex keratitis) or fungal eye infections.
- Fungal infections of the cornea are particularly prone to develop coincidentally with long-term corticosteroid applications. Fungal invasion should be considered in any persistent corneal ulceration where a corticosteroid has been used or is in use.
- Loteprednol etabonate is designed to be rapidly metabolized to an inactive form, potentially reducing systemic side effects compared to other corticosteroids, while maintaining local efficacy.
Alternative Therapies
- Other ophthalmic corticosteroids (e.g., prednisolone acetate, dexamethasone)
- Topical ophthalmic NSAIDs (e.g., ketorolac, bromfenac) for inflammation and pain
- Topical ophthalmic antihistamines/mast cell stabilizers (e.g., olopatadine, azelastine) for allergic conjunctivitis
Cost & Coverage
Average Cost:
Varies widely, typically $50-$200+ per 5ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for brand), Tier 1 (for 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.