Epiceram CR Emulsion Pump 225gm
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
Dermatological Agent; Emollient
Pharmacologic Class
Skin Barrier Repair Agent; Physiological Lipid Replenisher
Pregnancy Category
Not available
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Epiceram CR Emulsion is a special cream designed to help repair and protect your skin. It works by putting back the natural fats (like ceramides) that your skin needs to stay healthy and hydrated, especially if it's dry, irritated, or affected by conditions like eczema.
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 skin use only.
Avoid getting the medication in your mouth, nose, ears, or eyes, as it may cause burning.
If your medication requires shaking before use, make sure to do so.
Wash your hands before and after applying the medication, unless your hand is the treated area. In that case, do not wash your hand 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 it can be stored before disposal. 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 skin use only.
Avoid getting the medication in your mouth, nose, ears, or eyes, as it may cause burning.
If your medication requires shaking before use, make sure to do so.
Wash your hands before and after applying the medication, unless your hand is the treated area. In that case, do not wash your hand 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 it can be stored before disposal. 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, damp skin for best absorption.
- Use regularly, even when skin appears healthy, to maintain barrier function.
- Avoid harsh soaps, hot water, and prolonged baths/showers that can strip skin oils.
- Wear loose, breathable clothing to minimize skin irritation.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected skin areas three times daily or as directed by a healthcare professional.
Condition-Specific Dosing:
dry skin:
Apply liberally to dry, affected areas as needed.
eczema:
Apply to affected areas three times daily during flare-ups and as maintenance.
Pediatric Dosing
Neonatal:
Apply to affected skin areas three times daily or as directed by a healthcare professional.
Infant:
Apply to affected skin areas three times daily or as directed by a healthcare professional.
Child:
Apply to affected skin areas three times daily or as directed by a healthcare professional.
Adolescent:
Apply to affected skin areas three times daily or as directed by a healthcare professional.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (topical product with minimal systemic absorption).
Moderate:
No adjustment needed (topical product with minimal systemic absorption).
Severe:
No adjustment needed (topical product with minimal systemic absorption).
Dialysis:
No specific considerations (topical product with minimal systemic absorption).
Hepatic Impairment:
Mild:
No adjustment needed (topical product with minimal systemic absorption).
Moderate:
No adjustment needed (topical product with minimal systemic absorption).
Severe:
No adjustment needed (topical product with minimal systemic absorption).
Pharmacology
Mechanism of Action
Epiceram CR Emulsion is a topical emollient formulated to mimic the natural lipid composition of the skin barrier. It contains ceramides, cholesterol, and free fatty acids in a physiologically optimal 3:1:1 ratio. These lipids are essential components of the stratum corneum, the outermost layer of the skin. By replenishing these lipids, Epiceram helps to restore and repair the compromised skin barrier, reduce transepidermal water loss (TEWL), and improve skin hydration and integrity. It forms an occlusive layer on the skin surface, preventing moisture evaporation and protecting against external irritants.
Pharmacokinetics
Absorption:
Bioavailability:
Negligible systemic absorption
Tmax:
Not applicable (topical action)
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable (localized to skin surface)
ProteinBinding:
Not applicable
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable
ExcretionRoute:
Not applicable
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Immediate (hydration and barrier formation)
PeakEffect:
Continuous with regular application, sustained barrier improvement over days to weeks
DurationOfAction:
Hours (until washed off or absorbed into stratum corneum, with cumulative effect over time)
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
+ Trouble 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
+ Trouble 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
- Development of rash or hives
- Signs of infection (e.g., pus, fever) if skin is broken
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 drug.
* If you have a bleeding wound.
This list is not exhaustive, and it is crucial to discuss all your medications (including 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 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 and its symptoms.
If you have a skin rash caused by an allergic reaction to a food or drug.
* If you have a bleeding wound.
This list is not exhaustive, and it is crucial to discuss all your medications (including 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 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.
Before using sunscreen with this drug, consult your doctor for guidance. 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 for specific instructions.
Some products containing this drug may include metal, which requires removal before undergoing an MRI, cardioversion, radiation, or other medical procedures. It is crucial to discuss this with your doctor before any scheduled procedures.
If this medication is accidentally swallowed, it can cause harm. In such an event, 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.
Before using sunscreen with this drug, consult your doctor for guidance. 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 for specific instructions.
Some products containing this drug may include metal, which requires removal before undergoing an MRI, cardioversion, radiation, or other medical procedures. It is crucial to discuss this with your doctor before any scheduled procedures.
If this medication is accidentally swallowed, it can cause harm. In such an event, 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 application; systemic overdose is highly unlikely.
What to Do:
If accidentally ingested, seek medical advice. For excessive topical application, wipe off excess product. Call 1-800-222-1222 for poison control if concerned.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment (dryness, redness, itching, integrity)
Rationale: To establish baseline severity of skin barrier dysfunction.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical improvement of skin symptoms (dryness, itching, scaling, erythema)
Frequency: Daily to weekly, or as needed based on patient symptoms.
Target: Reduction in symptom severity, improved skin hydration and smoothness.
Action Threshold: If symptoms worsen or no improvement after consistent use, re-evaluate diagnosis or treatment plan.
Symptom Monitoring
- Reduced skin dryness
- Decreased itching
- Reduced redness and inflammation
- Improved skin texture and smoothness
- Fewer skin cracks or fissures
Special Patient Groups
Pregnancy
Generally considered safe for use during pregnancy due to minimal to no systemic absorption. Consult with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Minimal risk
Second Trimester:
Minimal risk
Third Trimester:
Minimal risk
Lactation
Generally considered safe for use during lactation. Minimal systemic absorption means negligible transfer into breast milk. Avoid applying to areas where the infant may ingest the product (e.g., nipples) without wiping off first.
Infant Risk:
Minimal risk
Pediatric Use
Safe and effective for use in pediatric patients, including infants, for conditions like atopic dermatitis and dry skin. Dosing is similar to adults.
Geriatric Use
Safe and effective for use in geriatric patients. No specific dose adjustments or precautions are typically needed beyond general skin care for aging skin.
Clinical Information
Clinical Pearls
- Epiceram CR is formulated with a specific 3:1:1 physiological lipid ratio (ceramides, cholesterol, free fatty acids) which is crucial for optimal skin barrier repair, unlike many other emollients.
- It is often recommended for patients with compromised skin barriers, such as those with atopic dermatitis, eczema, or severely dry skin.
- Can be used as an adjunct to topical corticosteroids or calcineurin inhibitors to reduce their frequency of use and maintain skin barrier integrity.
- Non-comedogenic, hypoallergenic, and free of common irritants like fragrances, dyes, and parabens, making it suitable for sensitive skin.
Alternative Therapies
- Other emollients (e.g., petroleum jelly, mineral oil, glycerin-based creams)
- Topical corticosteroids (for inflammatory flares)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus)
- Crisaborole ointment
Cost & Coverage
Average Cost:
$50 - $150 per 225gm pump
Generic Available:
Yes
Insurance Coverage:
Often covered by prescription plans, sometimes as a medical device or OTC benefit. Coverage varies by plan.
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 seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.