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pimecrolimus (Rx)Brand and Other Names:Elidel

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

cream

  • 1%
more...

Atopic Dermatitis

Apply thin layer to affected area q12hr; limit application to affected area; continue as long as symptomes persist

Dosage Forms & Strengths

cream

  • 1%
more...

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

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Adverse 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

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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

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Pregnancy & 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.

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Pharmacology

Mechanism of Action

Calcineurin inhibitor; inhibits T-cell activation; also shown to inhibit release of inflammatory mediators from mast cells

Pharmacokinetics

Absorption: Poor

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Images

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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