pimecrolimus

REMS

Short-term and intermittent long-term management of mild to moderate atopic dermatitis unresponsive to or in patients intolerant of conventional treatment.

Action ⬆ ⬇

Inhibits T-cell and mast cell activation by interfering with production of inflammatory cytokines.

Therapeutic effects:

Decreased severity of atopic dermatitis.

Pharmacokinetics ⬆ ⬇

Absorption: Minimally absorbed through intact skin.

Distribution: Local distribution after topical administration.

Metabolism/Excretion: Systemic metabolism and excretion are negligible with local application.

Half-Life: Not applicable.

Time/Action Profile ⬆ ⬇

(improvement in symptoms)

ROUTE	ONSET	PEAK	DURATION
topical	within 6 days	unknown	unknown

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Should not be applied to areas of active cutaneous viral infections (↑ risk of dissemination);
Concurrent use of occlusive dressings;
Netherton’s syndrome (↑ absorption of pimecrolimus);
Lactation: Lactation.

Use Cautiously in:

Clinical infection at treatment site (infection should be treated/cleared prior to use);
Skin papillomas (warts); allow treatment/resolution prior to use;
Natural/artificial sunlight (minimize exposure);
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Pedi: Children <2 yr (safety and effectiveness not established).

Adv. Reactions/Side Effects ⬆ ⬇

Local: burning

Misc: ↑risk of lymphoma/skin cancer

Interactions ⬆ ⬇

Drug-drug:

None reported.

Route/Dosage ⬆ ⬇

(Adults and Children ≥2 yr): Apply thin film twice daily; rub in gently and completely.

Availability ⬆ ⬇

(Generic available)

Cream: 1%

Assessment ⬆ ⬇

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.

Implementation ⬆ ⬇

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.

Patient/Family Teaching ⬆ ⬇

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 1st few days of application, is of mild to moderate severity, and improves within 5 days or as atopic dermatitis resolves.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
Advise patient to notify health care provider if no improvement is seen following 6 wk of treatment or at any time if condition worsens.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇