Dosing and uses of Elidel (pimecrolimus)
Adult dosage forms and strengths
cream
- 1%
Atopic Dermatitis
Apply thin layer to affected area q12hr; limit application to affected area; continue as long as symptomes persist
Pediatric dosage forms and strengths
cream
- 1%
Atopic Dermatitis
<2 years: Safety and efficacy not established
>2 years: Apply thin layer to affected area q12hr; limit application to affected area; continue as long as symptoms persist
Elidel (pimecrolimus) adverse (side) effects
>10%
Burning sensation (2-26%)
Headache (7-25%)
Fever (1-13%)
Nasopharyngitis (8-27%)
Cough (2-16%)
Bronchitis (<11%)
Upper respiratory tract infection (4-19%)
<1%
Basal cell carcinoma of skin
Malignant melanoma
Squamous cell carcinoma
Malignant lymphoma
Septic arthritis
Skin discoloration
Eczema
Flushing
Ocular irritation
Frequency not defined
Skin infection
Rash
Application site pain
Paraesthesia
Desquamation
Dryness
Warnings
Black box warnings
Rare cases of malignancy reported (although causal relationship not identified); rare cases of lymphoma and skin malignancies reported
Avoid long-term use and limit application to areas of atopic dermatitis; use short-term and intermitent using the minimum necessary to achieve control of symptoms
Not indicated for use in children <2 years
Contraindications
Hypersensitivity
Age <2 years
Not recommended in Netherton's syndrome, immunocompromised patients
Cautions
Preferably use as second-line agents for short-term and intermittent treatment in unresponsive to, or intolerant of other treatments
Re-evaluate if symptoms persist beyond 6 weeks
Do not use with occlusive dressings; do not apply to areas of active cutaneous viral infection
Potential risk of lymphoma and skin cancer; papilloma/warts, observed with use
Reassess diagnosis of atopic dermatitis if symptoms do not improve within 6 weeks of treatment
Safety not established in patients with generalized erythroderma
Pregnancy and lactation
Pregnancy category: C
Lactation: not known whether distributed in breast milk; may cause unwanted effects in nursing babies
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Elidel (pimecrolimus)
Mechanism of action
Calcineurin inhibitor; inhibits T-cell activation; also shown to inhibit release of inflammatory mediators from mast cells
Pharmacokinetics
Absorption: Poor
