Epiceram CR Emulsion 90gm
It is used to treat or prevent certain skin problems.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Topical Emollient; Skin Barrier Repair Agent
Pharmacologic Class
Physiological Lipid-containing Emulsion; Skin Protectant
Pregnancy Category
Not applicable (topical medical device)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Epiceram CR Emulsion is a special moisturizer designed to help repair and strengthen your skin's natural protective barrier. It contains natural skin lipids (fats) that are often missing in dry, irritated, or eczema-prone skin. By putting these lipids back, it helps your skin hold onto moisture better, reduces dryness and itching, and makes your skin feel smoother and healthier.
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. It is essential to use this medication only as directed.
Application Instructions
Do not take this medication by mouth. It is for topical use only, and you should only apply it to your skin.
Avoid getting the medication in your mouth, nose, ears, or eyes, as it may cause burning.
Before using the medication, check if it needs to be shaken. Some products require shaking before application.
Wash your hands before and after applying the medication. However, if your hand is the treated area, do not wash it after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply the medication to the affected area as instructed by your doctor. You may need to cover the treated area with a bandage or dressing; consult with your doctor for guidance.
Storage and Disposal
Store the medication at room temperature and do not freeze it.
Check the storage information provided with the medication to determine how long you can store it before disposing of it. If you have questions, consult with your pharmacist.
Missed Dose
If you miss a dose, apply it as soon as you remember.
Since this medication is often used as needed, do not use it more frequently than instructed by your doctor.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication only as directed.
Application Instructions
Do not take this medication by mouth. It is for topical use only, and you should only apply it to your skin.
Avoid getting the medication in your mouth, nose, ears, or eyes, as it may cause burning.
Before using the medication, check if it needs to be shaken. Some products require shaking before application.
Wash your hands before and after applying the medication. However, if your hand is the treated area, do not wash it after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply the medication to the affected area as instructed by your doctor. You may need to cover the treated area with a bandage or dressing; consult with your doctor for guidance.
Storage and Disposal
Store the medication at room temperature and do not freeze it.
Check the storage information provided with the medication to determine how long you can store it before disposing of it. If you have questions, consult with your pharmacist.
Missed Dose
If you miss a dose, apply it as soon as you remember.
Since this medication is often used as needed, do not use it more frequently than instructed by your doctor.
Lifestyle & Tips
- Apply to clean, dry skin.
- Use gentle, fragrance-free cleansers.
- Avoid harsh soaps, hot water, and prolonged baths/showers.
- Pat skin dry instead of rubbing.
- Apply moisturizer immediately after bathing to lock in moisture.
- Wear loose-fitting, breathable clothing.
- Avoid known skin irritants or allergens.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected skin areas twice daily or as directed by a healthcare professional.
Condition-Specific Dosing:
dry_skin:
Apply as needed to maintain hydration.
eczema:
Apply twice daily to affected areas.
Pediatric Dosing
Neonatal:
Apply as directed by a healthcare professional.
Infant:
Apply as directed by a healthcare professional.
Child:
Apply a thin layer to affected skin areas twice daily or as directed by a healthcare professional.
Adolescent:
Apply a thin layer to affected skin areas twice daily or as directed by a healthcare professional.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (topical application, minimal systemic absorption).
Moderate:
No adjustment needed (topical application, minimal systemic absorption).
Severe:
No adjustment needed (topical application, minimal systemic absorption).
Dialysis:
No specific considerations (topical application, minimal systemic absorption).
Hepatic Impairment:
Mild:
No adjustment needed (topical application, minimal systemic absorption).
Moderate:
No adjustment needed (topical application, minimal systemic absorption).
Severe:
No adjustment needed (topical application, minimal systemic absorption).
Pharmacology
Mechanism of Action
Epiceram CR Emulsion is designed to mimic the natural lipid composition of the skin barrier. It contains a proprietary blend of ceramides, cholesterol, and free fatty acids in a physiologically optimal ratio (3:1:1). These lipids are essential components of the stratum corneum, the outermost layer of the skin. By replenishing these lipids, the emulsion helps to restore and repair the compromised skin barrier, reduce transepidermal water loss (TEWL), improve skin hydration, and alleviate symptoms associated with dry, irritated, or inflamed skin conditions such as atopic dermatitis.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal to no systemic absorption (designed for topical, local action).
Tmax:
Not applicable (local action, not systemic).
FoodEffect:
Not applicable (topical).
Distribution:
Vd:
Not applicable (local action, not systemic).
ProteinBinding:
Not applicable (local action, not systemic).
CnssPenetration:
No (topical, not intended for CNS penetration).
Elimination:
HalfLife:
Not applicable (local action, not systemic elimination).
Clearance:
Not applicable (local action, not systemic elimination).
ExcretionRoute:
Not applicable (local action, not systemic elimination).
Unchanged:
Not applicable (local action, not systemic elimination).
Pharmacodynamics
OnsetOfAction:
Immediate (moisturizing effect); Days to weeks (skin barrier repair and symptom improvement).
PeakEffect:
Not applicable (continuous barrier support).
DurationOfAction:
Hours (moisturizing effect); Continuous with regular application (barrier repair).
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of skin infection, including:
+ Oozing
+ Heat
+ Swelling
+ Redness
+ Pain
Abnormal bleeding from the affected area
Fever
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people do not experience any side effects or only have mild ones, it is 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:
* Skin irritation
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of skin infection, including:
+ Oozing
+ Heat
+ Swelling
+ Redness
+ Pain
Abnormal bleeding from the affected area
Fever
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people do not experience any side effects or only have mild ones, it is 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:
* Skin irritation
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. 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:
- Increased redness or irritation after application
- Worsening of skin condition
- Signs of allergic reaction (e.g., rash, hives, 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 and its symptoms.
If you have a skin rash caused by an allergic reaction to a food or medication.
* If you have a bleeding wound.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not 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 and its symptoms.
If you have a skin rash caused by an allergic reaction to a food or medication.
* If you have a bleeding wound.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not 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. Before using sunscreen with this drug, consult with your doctor to determine the best approach. Additionally, discuss with your doctor the use of other medications or products on your skin, including soaps, to ensure safe and effective treatment.
Certain brands of this medication may not be suitable for application on open sores, broken skin, or severe burns. Be sure to check with your doctor or pharmacist to confirm the appropriate usage.
Some products containing this medication may include metal components. If you have an upcoming procedure, such as an MRI, cardioversion, radiation, or other medical treatment, it is crucial to remove these products beforehand. Consult with your doctor about the necessary precautions to take before any procedures.
In the event that this medication is swallowed, it can cause harm. If ingestion occurs, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor. It is necessary to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
Certain brands of this medication may not be suitable for application on open sores, broken skin, or severe burns. Be sure to check with your doctor or pharmacist to confirm the appropriate usage.
Some products containing this medication may include metal components. If you have an upcoming procedure, such as an MRI, cardioversion, radiation, or other medical treatment, it is crucial to remove these products beforehand. Consult with your doctor about the necessary precautions to take before any procedures.
In the event that this medication is swallowed, it can cause harm. If ingestion occurs, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor. It is necessary to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
Overdose Information
Overdose Symptoms:
- Not applicable for topical overdose; minimal systemic absorption. Excessive application may lead to a greasy feeling or temporary skin occlusion.
What to Do:
If accidentally ingested, rinse mouth with water. If irritation occurs from excessive topical application, wash off with mild soap and water. For any concerning symptoms, contact a healthcare professional or Poison Control (1-800-222-1222).
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment (dryness, redness, itching, integrity)
Rationale: To establish baseline severity of skin symptoms and guide treatment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin hydration and barrier function (visual inspection, patient report)
Frequency: Daily to weekly, or as needed.
Target: Improved skin texture, reduced dryness, decreased itching/irritation.
Action Threshold: If symptoms worsen or no improvement is seen after consistent use, re-evaluate diagnosis or treatment plan.
Symptom Monitoring
- Reduction in skin dryness
- Decrease in itching
- Reduction in redness or inflammation
- Improvement in skin texture and suppleness
- Absence of new irritation or allergic reactions
Special Patient Groups
Pregnancy
Considered safe for use during pregnancy as it is a topical product with minimal to no systemic absorption. Consult with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
No known risks.
Second Trimester:
No known risks.
Third Trimester:
No known risks.
Lactation
Considered safe for use during lactation as it is a topical product with minimal to no systemic absorption. Avoid applying to areas where the infant may ingest the product directly (e.g., nipples) without wiping off first.
Infant Risk:
Very low to none.
Pediatric Use
Generally safe and effective for use in pediatric patients, including infants, for conditions like atopic dermatitis and dry skin. Dosing is similar to adults (apply a thin layer to affected areas).
Geriatric Use
Generally safe and effective for use in geriatric patients. No specific dose adjustments or precautions are typically needed beyond general skin care considerations for aging skin.
Clinical Information
Clinical Pearls
- Epiceram CR Emulsion is a medical device, not a drug, specifically formulated to restore the skin barrier with a physiological lipid ratio (ceramides, cholesterol, free fatty acids).
- It is often prescribed for conditions where the skin barrier is compromised, such as atopic dermatitis (eczema), severe dry skin, or irritated skin.
- Advise patients to apply to clean, damp skin (e.g., after bathing) to maximize hydration and absorption.
- Can be used in conjunction with topical corticosteroids or calcineurin inhibitors to help maintain skin barrier function and potentially reduce the need for stronger medications.
- Patients should be educated that consistent, regular use is key for optimal barrier repair and symptom management, not just during flare-ups.
Alternative Therapies
- Other emollient creams (e.g., petroleum jelly, mineral oil-based products)
- Topical corticosteroids (for inflammation)
- Topical calcineurin inhibitors (for inflammation)
- Antihistamines (for itching, if systemic)
Cost & Coverage
Average Cost:
$100 - $200 per 90gm tube
Generic Available:
Yes
Insurance Coverage:
Often covered by prescription drug plans, but may require prior authorization or be placed on a higher tier depending on the specific plan and indication (e.g., for atopic dermatitis).
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.