Eucrisa 2% Ointment 60gm

Manufacturer ANACOR PHARMACEUTICALS Active Ingredient Crisaborole(kris a BOR ole) Pronunciation kris-a-BOR-ole
It is used to treat eczema.
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Drug Class
Topical anti-inflammatory
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Pharmacologic Class
Phosphodiesterase 4 (PDE4) inhibitor
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Pregnancy Category
Not available
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FDA Approved
Dec 2016
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Eucrisa is a non-steroidal ointment used on the skin to treat mild to moderate eczema (atopic dermatitis). It works by reducing inflammation and itching.
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How to Use This Medicine

Using Your Medication Correctly

To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. Avoid getting it in your mouth, nose, or eyes, as it may cause irritation or burning. Do not apply it to the vagina.

Before applying the medication, wash your hands thoroughly. If the affected area is on your hand, you do not need to wash that hand after application. Clean the affected area before use and make sure it is completely dry. Then, apply a thin layer of the medication to the affected area.

Storing and Disposing of Your Medication

To maintain the quality and safety of your medication, store it at room temperature with the lid tightly closed. Keep all medications out of the reach of children and pets. When you no longer need this medication or it has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of unused or expired medications, and ask about potential drug take-back programs in your area.

What to Do If You Miss a Dose

If you forget to apply a dose, put it on 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 application schedule. Do not apply two doses at the same time or use extra doses to make up for a missed one.
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Lifestyle & Tips

  • Apply a thin layer to affected areas only.
  • Wash hands before and after applying the ointment.
  • Avoid getting the ointment in your eyes, mouth, or vagina.
  • Do not use on open wounds or infected skin unless directed by a doctor.
  • Continue using as directed, even if symptoms improve.
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Available Forms & Alternatives

Dosing & Administration

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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
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Pediatric Dosing

Neonatal: Not established
Infant: Apply a thin layer to affected areas twice daily (3 months and older)
Child: Apply a thin layer to affected areas twice daily
Adolescent: Apply a thin layer to affected areas twice daily
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No adjustment needed

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed

Pharmacology

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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 leads to the suppression of various inflammatory mediators (e.g., TNF-alpha, IL-2, IL-4, IL-5, IL-6, IL-10, IL-13, IFN-gamma) involved in the pathogenesis of atopic dermatitis.
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Pharmacokinetics

Absorption:

Bioavailability: Not available (topical application)
Tmax: Not available (systemic absorption is low)
FoodEffect: Not applicable (topical)

Distribution:

Vd: Not available
ProteinBinding: 97% (in vitro)
CnssPenetration: Limited

Elimination:

HalfLife: Not available (systemic half-life not clinically relevant due to low systemic exposure)
Clearance: Not available
ExcretionRoute: Primarily urine (inactive metabolites)
Unchanged: Not available
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Pharmacodynamics

OnsetOfAction: Within 1-2 weeks
PeakEffect: Within 4 weeks
DurationOfAction: Not available (requires continuous application)

Safety & Warnings

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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 immediately or seek emergency 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
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. Although 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 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 experience other side effects not mentioned here. If you have questions or concerns about side effects, 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe burning or stinging at the application site that does not go away
  • Signs of an allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)
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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.
Potential interactions with other medications or health conditions. To ensure safe use, disclose all prescription and over-the-counter (OTC) medications, natural products, and vitamins you are taking to both your doctor and pharmacist.
* All your health problems, as they may affect the safety of taking this medication.

To avoid potential risks, do not start, stop, or change the dosage of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication in combination with your other medications and health conditions.
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Precautions & Cautions

It is essential to inform all 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 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.
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Overdose Information

Overdose Symptoms:

  • Due to minimal systemic absorption, overdose from topical application is unlikely.

What to Do:

If swallowed, call a poison control center (1-800-222-1222) or seek medical attention immediately. For topical overdose, wipe off excess ointment.

Drug Interactions

Monitoring

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Symptom Monitoring

  • Application site pain
  • Burning or stinging at application site
  • Contact dermatitis
  • Urticaria

Special Patient Groups

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Pregnancy

There are no adequate and well-controlled studies of Eucrisa in pregnant women. Systemic absorption is low following topical administration. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Risk unknown, low systemic exposure expected.
Second Trimester: Risk unknown, low systemic exposure expected.
Third Trimester: Risk unknown, low systemic exposure expected.
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Lactation

It is not known whether crisaborole is excreted in human milk. Due to minimal systemic absorption, crisaborole is considered to have a low risk to a breastfed infant. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Eucrisa and any potential adverse effects on the breastfed infant from Eucrisa or from the underlying maternal condition.

Infant Risk: Low risk
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Pediatric Use

Approved for use in patients 3 months of age and older. Safety and effectiveness in pediatric patients younger than 3 months of age have not been established.

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Geriatric Use

No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. No dosage adjustment is needed.

Clinical Information

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Clinical Pearls

  • Eucrisa is a non-steroidal option for atopic dermatitis, making it suitable for long-term use or for areas where corticosteroids are less desirable (e.g., face, skin folds).
  • 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 an ointment and should be applied thinly to affected areas only, not as a general moisturizer.
  • It can be used in combination with other therapies for atopic dermatitis, including moisturizers and sometimes corticosteroids (used sequentially or on different body areas).
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Alternative Therapies

  • Topical corticosteroids (e.g., hydrocortisone, triamcinolone)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus)
  • Topical JAK inhibitors (e.g., ruxolitinib)
  • Systemic immunomodulators (e.g., cyclosporine, methotrexate, dupilumab, tralokinumab, oral JAK inhibitors)
  • Phototherapy
  • Emollients/moisturizers
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Cost & Coverage

Average Cost: $700 - $900 per 60gm tube
Insurance Coverage: Tier 2 or 3 (Specialty)
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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 happened.