Stadaqs Crisaborole Ointment

1. Indications and Usage
Atopic Dermatitis:
Indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older .
2. Dosage and Administration
Route of Administration:
For Dermatologic Use ONLY. Not for oral, ophthalmic, or vaginal use.
Recommended Dosage:
Apply a thin layer to the affected skin areas twice daily .
After achieving clinical response, the dosing frequency may be reduced to once daily .
Administration Instructions:
Wash hands after application unless hands are the treated area.
3. Mechanism of Action
PDE-4 Inhibition:
Crisaborole is a small-molecule inhibitor of phosphodiesterase 4 (PDE-4).
Anti-inflammatory Effect:
By inhibiting PDE-4, it increases intracellular cyclic adenosine monophosphate (cAMP) levels. This modulation inhibits the production and release of inflammatory cytokines, thereby reducing inflammation associated with atopic dermatitis .
4. Safety and Warnings
Hypersensitivity Reactions:
Hypersensitivity reactions, including contact urticaria, have been reported. Signs may include severe pruritus, swelling, and erythema at the application site or distant sites. Discontinue use if severe hypersensitivity occurs .
Pregnancy and Lactation:
Although systemic absorption is low, there are no adequate data on use in pregnant or lactating women; use only if clearly needed .
5. Adverse Reactions
Most Common:
Application Site Pain: Burning or stinging at the site of application (reported in approximately 4% of patients) .
Skin and Subcutaneous Disorders: Contact dermatitis or allergic contact dermatitis (<1%) .
Other: Upper respiratory tract infection, skin infection, and erythema have also been reported .
6. Drug Interactions
Metabolic Pathway:
Crisaborole and its metabolites are not expected to significantly inhibit or induce major CYP450 enzymes or UGTs in a clinically relevant manner .
Clinical Significance:
No clinically significant drug-drug interactions have been established. Caution is advised when combining with other topical agents.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Crisaborole (2%).
Inactive Ingredients: White petrolatum, propylene glycol, glycerol monostearate, paraffin, butylated hydroxytoluene (BHT), and edetate calcium disodium .
Appearance:
White to off-white ointment .
Storage:
Store at controlled room temperature.