Pimecrolimus Cream is indicated as second-line therapy for the short-term and non-continuous long-term management of mild to moderate atopic dermatitis in non-immunocompromised adults and children aged 2 years and older, who do not respond adequately to other topical prescription treatments or when such treatments are not suitable.

The exact mechanism of action of Pimecrolimus in atopic dermatitis is not fully understood. However, it binds to macrophilin-12 (FKBP-12) and inhibits the calcium-dependent phosphatase enzyme calcineurin. This leads to suppression of T-cell activation. Specifically, Pimecrolimus inhibits the production of cytokines such as Interleukin-2 and Interferon-gamma (Th1 type), as well as Interleukin-4 and Interleukin-10 (Th2 type) in human T cells. It also prevents the release of inflammatory cytokines and mediators from mast cells following antigen/IgE stimulation in vitro.

Skin should be cleaned before applying the cream. One finger tip unit (measured by distance from the tip of an adult index finger to the first crease of that finger) to be applied thinly and evenly on the affected area of skin twice daily. Treatment should be stopped if signs and symptoms (e.g. itch, rash and redness) resolve. If signs and symptoms persist and beyond 6 weeks, patients should be re-examined to confirm the diagnosis of atopic dermatitis. A patient should not use sun lamps, tanning beds, or get treatment with ultraviolet light therapy during treatment with Pimecrolimus Cream. Continuous long-term use of Pimecrolimus should be avoided. A patient should not cover the skin being treated with bandages, dressings or wraps. Loose fitting clothing that protects the treated area from the sun are encouraged.

Use in Children and Adolescents: Pimecrolimus cream is not indicated for use in children less than 2 years of age.

Due to very low systemic absorption of pimecrolimus after topical application, significant systemic drug interactions are not expected. However, concomitant use with erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers, and cimetidine should be done with caution.

Pimecrolimus cream is contraindicated in patients with known hypersensitivity to pimecrolimus or any of the ingredients of the formulation.

Common side effect includes burning sensation or warmth at the application site. These are usually mild to moderate, occur during the first few days of treatment, and resolve spontaneously. Less common effects include headache, common cold or nasal congestion, sore throat, cough, influenza-like symptoms, fever, and viral infections.

Pregnancy Category C. It is not known whether pimecrolimus is excreted in human breast milk. Use during pregnancy and breastfeeding should be avoided together unless clearly necessary.

Pimecrolimus cream should not be used on malignant or premalignant skin conditions such as cutaneous T-cell lymphoma (CTCL), Netherton’s syndrome, or bacterial and viral skin infections. It should be avoided on mucous membranes such as eyes, nose, mouth, vagina, or rectum.

There are no available data on overdose of pimecrolimus. In case of suspected overdose, immediate medical attention should be sought.

Drugs affecting the immune response

Store below 30°C in a dry place, protected from light. Keep out of reach of children.