Classifications: biologic response modifier; immunosuppressant; Therapeutic: immunosuppressant; antiinflammatory
Pregnancy Category: C
Pimecrolimus selectively inhibits the inflammatory action of skin cells by blocking T-cell activation and cytokine release.
It appears to inhibit the production of IL-2, IL-4, IL-10, and interferon gamma in T-cells. It also prevents release of inflammatory
cytokines and mediators from mast cells after activation by antigen and IgE.
Topically applied to the skin, pimecrolimus produces significant antiinflammatory activity without evidence of skin atrophy.
Short-term intermittent treatment of mild to moderate atopic dermatitis.
Hypersensitivity to pimecrolimus or components in the cream; Netherton's syndrome; application to active cutaneous viral
infection; occlusive dressing; pregnancy (category C); lactation; children <2 y.
Infection at topical treatment sites; history of untoward effects with topical cyclosporine or tacrolimus; skin papillomas;
Route & Dosage
Adult: Topical Apply thin layer to affected skin b.i.d.
- Do not apply to any skin surface that appears to be infected.
Adverse Effects (≥1%)Body as a Whole:
Flu-like symptoms, infections, fever, increased risk of cancer
Gastroenteritis, abdominal pain, nausea, vomiting, diarrhea, constipation
Sore throat, upper respiratory infection, cough,
nasal congestion, asthma
exacerbation, rhinitis, epistaxis. Skin: Burning,
irritation, pruritus, skin infection, impetigo, folliculitis, skin papilloma, herpes simplex dermatitis, urticaria, acne
. Special Senses:
Ear infection, earache, conjunctivitis
No clinically significant interactions established.
Minimal through intact skin. Metabolism:
No evidence of skin-mediated metabolism, metabolized in liver by CYP3A4. Elimination:
Primarily in feces.
Assessment & Drug Effects
- Assess for and report persistent skin irritation that develops following application of the cream and lasts for more than
Patient & Family Education
- Minimize exposure of treated area to natural or artificial sunlight.
- Immediately report a new or changed skin lesion to the physician.
- Stop topical application once signs of dermatitis have disappeared. Resume application at the first sign of recurrence.
- Wash hand thoroughly after application if hands are not the treatment sites.
- Report any significant skin irritation that results from application of the cream.