Pimecrolimus

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Pimecrolimus
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

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Black Box Warning

Title
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content

Overview

Pimecrolimus is an analgesic that is FDA approved for the treatment of atopic dermatitis. There is a Black Box Warning for this drug as shown here. Common adverse reactions include sensation of burning of skin, risk for viral infection, headache, fever.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Atopic dermatitis, Second-line therapy
  • ELIDEL® (pimecrolimus) Cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable.
  • ELIDEL Cream, 1% is not indicated for use in children less than 2 years of age.
  • Dosing Information
  • Apply a thin layer of ELIDEL (pimecrolimus) Cream, 1% to the affected skin twice daily. The patient should stop using ELIDEL Cream, 1% when signs and symptoms (e.g., itch, rash and redness) resolve and should be instructed on what actions to take if symptoms recur.
  • If signs and symptoms persist beyond 6 weeks, patients should be re-examined by their health care provider to confirm the diagnosis of atopic dermatitis.
  • Continuous long-term use of ELIDEL Cream, 1% should be avoided, and application should be limited to areas of involvement with atopic dermatitis.
  • The safety of ELIDEL Cream, 1% under occlusion, which may promote systemic exposure, has not been evaluated. Avoid use of ELIDEL Cream, 1% with occlusive dressings.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Pimecrolimus in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Pimecrolimus in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Pimecrolimus in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Pimecrolimus in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Pimecrolimus in pediatric patients.

Contraindications

  • Condition1

Warnings

Title
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Pimecrolimus in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Pimecrolimus in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Pimecrolimus in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Pimecrolimus during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Pimecrolimus with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Pimecrolimus with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Pimecrolimus with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Pimecrolimus with respect to specific gender populations.

Race

There is no FDA guidance on the use of Pimecrolimus with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Pimecrolimus in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Pimecrolimus in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Pimecrolimus in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Pimecrolimus in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Pimecrolimus in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Pimecrolimus in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Pimecrolimus in the drug label.

Pharmacology

There is limited information regarding Pimecrolimus Pharmacology in the drug label.

Mechanism of Action

Structure

File:Pimecrolimus01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Pimecrolimus in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Pimecrolimus in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Pimecrolimus in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Pimecrolimus in the drug label.

How Supplied

Storage

There is limited information regarding Pimecrolimus Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Pimecrolimus in the drug label.

Precautions with Alcohol

  • Alcohol-Pimecrolimus interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Elidel

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ "http://www.ismp.org". External link in |title= (help)

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