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
Indication
Indicated for mild-to-moderate atopic dermatitis
Contra Indication
History of hypersensitivity to crisaborole or any component of the formulation
Dose
Topical
Atopic Dermatitis
Indicated for mild-to-moderate atopic dermatitis
Apply a thin layer topically to affected area(s) BID
Side Effect
1-10%
Application site pain, burning, or stinging (4%)
<1%
Contact urticaria
Pregnancy Category
Name :
Not Classified
Description
FDA has not yet classified the drug into a specified pregnancy category.
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
Interaction
N/A
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
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 infants and children aged ?3 months
<3 months: Safety and efficacy not established
>3 months: Apply a thin layer topically to affected area(s) BID
Renal Dose
N/A
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
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