Pimecrolimus
Class: Skin and Mucous Membrane Agents, Miscellaneous
VA Class: DE900
Chemical Name: (3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS)-3-[(1E)-2-[(1R,3R,4S)-4-Chloro-3-methoxycyclohexyl]-1-methyl-ethenyl]-8-ethyl-5,6,8,11,12,13,14,15,16,17,18,19,24,26,26a-hexadecahydro-5,19-dihydroxy-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,17,20,21(4H,23H)-tetrone
Molecular Formula: C43H68ClNO11
CAS Number: 137071-32-0
Brands: Elidel
Warning
Long-term safety of topical pimecrolimus not established.
Malignancies (e.g., skin cancers, lymphoma) reported rarely in patients treated with topical calcineurin inhibitors, including pimecrolimus; causal relationship not established.
Avoid continuous long-term use of topical pimecrolimus; limit application to areas affected by atopic dermatitis. (See Carcinogenicity under Cautions.)
Not indicated for use in children <2 years of age.
Introduction
Immunosuppressive agent; derivative of ascomycin (a macrolactam); structurally related to tacrolimus.
Uses for Pimecrolimus
Atopic Dermatitis
Second-line therapy for short-term treatment and noncontinuous chronic treatment of mild to moderate atopic dermatitis (eczema) in immunocompetent adults and children ≥2 years of age who are unable to tolerate or have not responded to first-line therapies (e.g., corticosteroids) or for whom first-line therapies are inadvisable. (See Carcinogenicity under Cautions.)
Not indicated for use in children <2 years of age.
Pimecrolimus Dosage and Administration
Administration
Topical Administration
Apply topically to the skin as a 1% cream. For external use only; do not use in the eyes or ingest.
Apply in thin layers to affected areas of skin.
Use minimum amount required to control symptoms; limit application to areas affected with atopic dermatitis. (See Carcinogenicity under Cautions.)
Do not use occlusive dressings or wrappings.
Dosage
Pediatric Patients
Atopic Dermatitis
Topical
Children ≥2 years of age: Apply to affected areas twice daily.
Treatment effects usually evident within 15 days; erythema and infiltration or papulation generally reduced within 8 days. Discontinue treatment following resolution of signs and symptoms (e.g., pruritus, rash, erythema). If manifestations persist beyond 6 weeks, reexamine patient and confirm diagnosis.
Adults
Atopic Dermatitis
Topical
Apply to affected areas twice daily.
Treatment effects usually evident within 15 days; erythema and infiltration or papulation generally reduced within 8 days. Discontinue treatment following resolution of signs and symptoms (e.g., pruritus, rash, erythema). If manifestations persist beyond 6 weeks, reexamine patient and confirm diagnosis.
