Indications

Pimecrolimus Cream is indicated as second-line therapy for the short-term and noncontinuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments or when those treatments are not advisable.

Composition

Pharmacology

The mechanism of action of Pimecrolimus in atopic dermatitis is not known. It has been demonstrated that Pimecrolimus binds with macrophilin-12 (FKBP-12) and inhibits the calcium-dependent phosphatase, calcineurin. As a consequence, it inhibits T cell activation. In particular, Pimecrolimus inhibits Interleukin-2 and Interferon gamma (Th1-type), Interleukin-4 and Interleukin-10 (Th2-type) cytokine synthesis in human T cells. In addition, Pimecrolimus prevents the release of inflammatory cytokines and mediators from mast cells in vitro after stimulation by antigen/IgE.

Dosage & Administration

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

Contraindications

Pimecrolimus cream is contraindicated in individuals with a history of hypersensitivity to Pimecrolimus or any of the components of the cream.

Side Effects

Burning or a feeling of warmth on application site. These side effects are usually mild or moderate, happen during the first few days of treatment, and usually clear up in a few days. Other uncommon side effects may include headache, common cold or stuffy nose, sore throat, cough, flu (influenza), fever & viral infection.

Pregnancy & Lactation

Pregnancy Category C. It is not known whether the components of the preparation are excreted in human milk. Not to continue both at a time.

Precautions & Warnings

The use of Pimecrolimus Cream should be avoided on malignant or pre-malignant skin conditions, such as cutaneous T-cell lymphoma (CTCL), Netherton’s Syndrome, Bacterial and Viral Skin Infections or other skin diseases where there is the potential for increased systemic absorption of Pimecrolimus. To be avoided entrance in eyes, nose, mouth, vagina, or rectum (mucous membranes).

Therapeutic Class

Drugs affecting the immune response

Storage Conditions

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