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Pharmacologic class: Dermatologic agent
Therapeutic class: Immunomodulator
Pregnancy risk category C
FDA Box Warning
• Drug's long-term safety hasn't been established.
• Rare cases of lymphoma and skin cancer have occurred in patients who used drug. Avoid continuous long-term use in any age-group and limit application to areas of atopic dermatitis.
• Drug isn't indicated for use in children younger than age 2.
Unknown. Thought to inhibit T-cell activation by blocking transcription of early cytokines. Also blocks release of inflammatory cytokines and mediators from mast cells after stimulation by antigen/immunoglobin E.
Indications and dosages
➣ Mild to moderate atopic dermatitis
Adults and children ages 2 and older: Apply 1% cream topically b.i.d. to clean, dry, affected area.
• Hypersensitivity to drug or its components
Use cautiously in:
• eczema herpeticum (Kaposi's varicelliform eruption), varicella zoster (chickenpox or shingles), herpes simplex infection, lymphadenopathy, mononucleosis, acute infectious Netherton's syndrome, skin infections or papilloma, warts, immunocompromised state
• concurrent use of CYP3A inhibitors
• pregnant or breastfeeding patients
• children younger than age 2 (safety not established).
• Apply thin layer to affected area.
• Don't use with occlusive dressing (may increase systemic absorption).
EENT: sinus congestion, rhinorrhea
GI: nausea, vomiting, diarrhea, gastritis
Respiratory: upper respiratory tract infection
Skin: pruritus, application-site reaction or discomfort
Other: pyrexia, increased risk of viral or bacterial infections
Drug-drug. CYP3A inhibitors (such as calcium channel blockers, cimetidine, erythromycin): inhibition of action by hepatic enzymes that eliminate pimecrolimus
Drug-behaviors. Sunbathing: possible increased risk of skin cancer
• Reevaluate at 6 weeks if lesions haven't healed.
• Discontinue therapy, as prescribed, if disease resolves.
• Tell patient to apply to clean, dry skin and to wash hands afterward (unless hands are being treated).
• Caution patient not to use occlusive dressings.
• Tell patient drug may cause local reaction, such as a feeling of warmth or burning sensation. Advise him to contact prescriber if reaction is severe or lasts more than 1 week.
• Advise patient to apply missed dose as soon as possible. If it's almost time for next dose, tell him to skip missed dose and resume regular schedule.
• Tell patient to avoid natural or artificial sunlight and to use adequate sunblock on skin and lips.
• Instruct patient to contact prescriber if no improvement occurs after 6 weeks or if condition worsens.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs and behaviors mentioned above.
Time/action profile (improvement in symptoms)
|topical||within 6 days||unknown||unknown|
Adverse Reactions/Side Effects
- burning (most frequent)
- ↑ risk of lymphoma/skin cancer
Drug-Drug interactionNone significant as systemic absorption is negligible.
- Assess skin lesions prior to and periodically during therapy. Discontinue therapy after signs and symptoms of atopic dermatitis have resolved. Resume treatment at the first signs and symptoms of recurrence.
Potential Nursing DiagnosesImpaired skin integrity (Indications)
- Topical: Apply a thin layer to affected area twice daily and rub in gently and completely. May be used on all skin areas including head, neck, and intertriginous areas. Do not use with occlusive dressings.
- Instruct patient on correct technique for application. Apply only as directed to external areas. Wash hands following application, unless hands are areas of application. Advise patient to read Medication Guide before starting and with each Rx refill in case of changes.
- Caution patient to avoid exposure to natural or artificial sunlight, including tanning beds, while using cream.
- Advise patient that pimecrolimus may cause skin burning. This occurs most commonly during first few days of application, is of mild to moderate severity, and improves within 5 days or as atopic dermatitis resolves.
- Advise patient to notify health care provider if no improvement is seen following 6 wk of treatment or at any time if condition worsens.
- Resolution of signs and symptoms of atopic dermatitis.