Crisaderm

• Mild to moderate atopic dermatitis (patients 3 months and older)

The active ingredient, Crisaborole, is a phosphodiesterase-4 (PDE-4) inhibitor, mainly acting on phosphodiesterase 4B (PDE4B), which causes inflammation. Chemically, Crisaborole is a phenoxybenzoxaborole. It contains a boron atom that helps penetrate the skin and is essential for its binding activity. Inhibition of PDE4B appears to suppress the release of tumor necrosis factor alpha (TNFα), interleukin-12 (IL-12), IL-23 and other cytokines, proteins believed to be involved in the immune response and inflammation.

Adult Dose (Topical): Mild to moderate atopic dermatitis: Apply a thin layer to affected area(s) twice daily.

Pediatric Dose (>2 years): Apply a thin layer to affected area(s) twice daily.

Pediatric Dose (3 months-2 years): Apply a thin layer to affected area(s) twice daily.

Common Side Effects (1-10%): Application site pain, burning, or stinging (4%)

Rare Side Effects (<1%): Contact urticaria

Allergic Reactions: Severe pruritus, swelling, and erythema at the application site or at a distant site.

There is no available data with Crisaborole in pregnant women to inform the drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, there were no adverse developmental effects observed with oral administration of crisaborole in pregnant rats and rabbits during organogenesis at doses up to 3 and 2 times, respectively, the maximum recommended human dose (MRHD).

• Hypersensitivity reactions reported, including contact urticaria; signs and symptoms may include severe pruritus, swelling, and erythema at the application site or at a distant site. Discontinue immediately and initiate appropriate therapy if hypersensitivity suspected.
• For topical use only; not for ophthalmic, oral, or intravaginal use.

Information on Crisaborole overdosage is not available.

Do not store above 30°C temperature. Keep away from light and out of reach of children.