Crisaderm - Ointment Crisaborole topical - 2% 1 10gm tube(s) / 10gm tube Incepta Pharmaceuticals Ltd. Indication: Indicated for mild-to-moderate atopic dermatitis Administration: Topical Administration Apply thin layer of ointment to affected areas BID Wash hands after applying ointment, unless hands are being treated For topical use only; not for ophthalmic, oral, or intravaginal use Adult Dose: Topical Atopic Dermatitis Indicated for mild-to-moderate atopic dermatitis Apply a thin layer topically to affected area(s) BID Child Dose: Atopic Dermatitis Indicated for mild-to-moderate atopic dermatitis in children aged >2 yr 2 years: Apply a thin layer topically to affected area(s) BID Contraindication: History of hypersensitivity to crisaborole or any component of the formulation Mode of Action: Phosphodiesterase (PDE)-4 inhibitor; results in increased intracellular cyclic adenosine monophosphate (cAMP) levels The specific mechanism by which crisaborole exerts its therapeutic action for atopic dermatitis is not well defined, although cAMP is thought to decrease the proinflammatory response (eg, cytokine release) associated with atopic dermatitis Precaution: 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 Side Effect: 1-10% Application site pain, burning, or stinging (4%) <1% Contact urticaria Pregnancy Category Note: Pregnancy There are no available data in pregnant women to inform the drug-associated risk for major birth defects and miscarriage Crisaborole is systemically absorbed Lactation Unknown if distributed in human breast milk Crisaborole is systemically absorbed Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition