Eucrisa 2% Ointment 100gm
It is used to treat eczema.
Drug Class
Topical anti-inflammatory
Pharmacologic Class
Phosphodiesterase 4 (PDE4) inhibitor
Pregnancy Category
Not available
FDA Approved
Dec 2016
DEA Schedule
Not Controlled
Overview
What is this medicine?
Eucrisa is a non-steroid ointment used to treat mild to moderate eczema (atopic dermatitis). It works by blocking a specific enzyme in the skin that contributes to inflammation, helping to reduce redness, itching, and swelling.
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.
Apply this medication topically, directly to the affected area of your skin. Do not ingest it or apply it to mucous membranes, including your mouth, nose, eyes, or vagina, as it may cause irritation or burning.
Before and after applying the medication, wash your hands thoroughly, unless the treated area is on your hand. In that case, do not wash your hand after application.
Ensure the affected area is clean and dry before applying the medication. Apply a thin layer to the affected area.
Storage and Disposal
To maintain the medication's effectiveness and safety:
Store the medication at room temperature, keeping the lid tightly closed.
Keep all medications in a secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best disposal method or to see if there are drug take-back programs available in your area.
Missed Dose
If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not apply two doses at once or use extra doses to make up for a missed dose.
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.
Apply this medication topically, directly to the affected area of your skin. Do not ingest it or apply it to mucous membranes, including your mouth, nose, eyes, or vagina, as it may cause irritation or burning.
Before and after applying the medication, wash your hands thoroughly, unless the treated area is on your hand. In that case, do not wash your hand after application.
Ensure the affected area is clean and dry before applying the medication. Apply a thin layer to the affected area.
Storage and Disposal
To maintain the medication's effectiveness and safety:
Store the medication at room temperature, keeping the lid tightly closed.
Keep all medications in a secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best disposal method or to see if there are drug take-back programs available in your area.
Missed Dose
If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not apply two doses at once or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Apply a thin layer of ointment to the affected skin areas twice a day, as directed by your doctor.
- Wash your hands before and after applying the ointment.
- Do not use Eucrisa in your eyes, mouth, or vagina. If it gets into these areas, rinse thoroughly with water.
- Do not cover the treated skin with bandages or wraps unless your doctor tells you to.
- Continue to use moisturizers as part of your daily skin care routine for eczema, even when using Eucrisa.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected areas twice daily.
Condition-Specific Dosing:
atopicDermatitis:
Apply a thin layer to affected areas twice daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Apply a thin layer to affected areas twice daily for infants 3 months of age and older.
Child:
Apply a thin layer to affected areas twice daily for children 3 months of age and older.
Adolescent:
Apply a thin layer to affected areas twice daily.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Crisaborole is a phosphodiesterase 4 (PDE4) inhibitor. PDE4 is an enzyme that breaks down cyclic adenosine monophosphate (cAMP). By inhibiting PDE4, crisaborole increases intracellular cAMP levels, which can lead to the suppression of various inflammatory mediators involved in atopic dermatitis.
Pharmacokinetics
Absorption:
Bioavailability:
Low systemic absorption
Tmax:
Not precisely defined due to low systemic exposure (typically 1-8 hours for detectable levels)
FoodEffect:
Not applicable (topical administration)
Distribution:
Vd:
Not precisely quantified due to low systemic exposure
ProteinBinding:
Not precisely quantified due to low systemic exposure
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 8-10 hours (systemic half-life, but systemic exposure is minimal)
Clearance:
Not precisely quantified due to low systemic exposure
ExcretionRoute:
Primarily via metabolism, followed by renal and fecal excretion of metabolites.
Unchanged:
Negligible
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 1-2 weeks
PeakEffect:
Not precisely defined for topical agents; sustained effect with continued use
DurationOfAction:
Maintained with twice-daily application
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following severe side effects, contact your doctor immediately or seek emergency medical attention. Although rare, some people may have life-threatening reactions to this medication. Be alert for:
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
Dizziness
Redness, swelling, or severe irritation at the site where the medication was applied
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only have mild 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 persist, contact your doctor for advice:
Burning, stinging, or irritation at the site where the medication was applied
Reporting Side Effects
This list is not exhaustive, and you may have questions about other potential side effects. If you have concerns, don't hesitate to reach out to your doctor. You can also 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 immediately or seek emergency medical attention. Although rare, some people may have life-threatening reactions to this medication. Be alert for:
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
Dizziness
Redness, swelling, or severe irritation at the site where the medication was applied
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only have mild 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 persist, contact your doctor for advice:
Burning, stinging, or irritation at the site where the medication was applied
Reporting Side Effects
This list is not exhaustive, and you may have questions about other potential side effects. If you have concerns, don't hesitate to reach out to 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:
- Application site pain, burning, or stinging (common, usually mild and temporary)
- Allergic reactions (rare, but seek medical attention if you experience severe rash, itching, swelling, severe dizziness, or 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, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to:
Discuss all your medications and health problems with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other treatments.
* Avoid starting, stopping, or changing the dosage of any medication without first consulting your doctor. This will help prevent potential interactions or adverse effects.
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 symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to:
Discuss all your medications and health problems with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other treatments.
* Avoid starting, stopping, or changing the dosage of any medication without first consulting your doctor. This will help prevent potential interactions or adverse effects.
Precautions & Cautions
It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are pregnant, planning to become pregnant, or are currently breast-feeding, be sure to discuss this with your doctor. You and your doctor will need to carefully weigh the benefits and risks of using this medication to ensure the best possible outcome for both you and your baby.
Overdose Information
Overdose Symptoms:
- Due to minimal systemic absorption, overdose from topical application is unlikely to cause systemic toxicity.
What to Do:
If accidentally ingested, contact a poison control center or seek medical attention. For topical overuse, wash off excess ointment. Call 1-800-222-1222
Drug Interactions
Monitoring
Baseline Monitoring
Assessment of affected skin areas
Rationale: To establish baseline severity of atopic dermatitis (e.g., Eczema Area and Severity Index - EASI, Investigator's Global Assessment - IGA)
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical response (reduction in erythema, induration, pruritus)
Frequency: Periodically, as determined by clinician (e.g., every 2-4 weeks initially, then as needed)
Target: Improvement in signs and symptoms of atopic dermatitis
Action Threshold: Lack of improvement or worsening of symptoms may warrant re-evaluation of diagnosis or treatment plan.
Application site reactions (e.g., burning, stinging, pain)
Frequency: At each follow-up visit and patient self-monitoring
Target: Absence or mildness of reactions
Action Threshold: Severe or persistent reactions may require discontinuation.
Symptom Monitoring
- Reduction in itching (pruritus)
- Decrease in redness (erythema)
- Decrease in skin thickening (lichenification)
- Reduction in oozing/crusting
- Improvement in overall skin appearance
- Monitoring for application site pain, burning, or stinging
Special Patient Groups
Pregnancy
Crisaborole is minimally absorbed systemically following topical application, and maternal use is not expected to result in fetal exposure. Therefore, use during pregnancy is unlikely to cause harm to the fetus.
Trimester-Specific Risks:
First Trimester:
Low risk due to minimal systemic absorption.
Second Trimester:
Low risk due to minimal systemic absorption.
Third Trimester:
Low risk due to minimal systemic absorption.
Lactation
Crisaborole is minimally absorbed systemically, and therefore, breastfed infants are not expected to be exposed to crisaborole through breast milk. It is considered compatible with breastfeeding.
Infant Risk:
Low risk
Pediatric Use
Approved for use in patients 3 months of age and older. Safety and effectiveness have been established in this population. No dosage adjustment is needed based on age.
Geriatric Use
No dosage adjustment is needed for geriatric patients. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects, but given the minimal systemic absorption, no specific concerns are anticipated.
Clinical Information
Clinical Pearls
- Eucrisa is a non-steroidal option for atopic dermatitis, making it suitable for long-term use and for sensitive skin areas where topical corticosteroids might be less desirable.
- It can be used as a steroid-sparing agent or in rotation with topical corticosteroids.
- Patients may experience transient burning or stinging upon application, especially on inflamed skin. This usually subsides with continued use.
- Ensure patients understand that it is for external use only and should not be applied to eyes, mouth, or mucous membranes.
Alternative Therapies
- Topical corticosteroids (e.g., hydrocortisone, triamcinolone, fluticasone)
- Topical calcineurin inhibitors (e.g., tacrolimus ointment, pimecrolimus cream)
- Topical Janus kinase (JAK) inhibitors (e.g., ruxolitinib cream)
- Systemic therapies for severe atopic dermatitis (e.g., dupilumab, tralokinumab, oral JAK inhibitors, cyclosporine)
- Emollients and moisturizers
Cost & Coverage
Average Cost:
Varies, typically $700-$1000+ per 60gm tube
Insurance Coverage:
Tier 3 or higher (Specialty drug)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 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.