Roflumilast cream 0.3% and 0.15%
Roflumilast and its active metabolite (roflumilast N-oxide) are inhibitors of PDE4. Roflumilast and roflumilast N-oxide inhibition of PDE4 (a major cyclic 3′,5′-adenosine monophosphate [cyclic AMP] metabolizing enzyme) activity leads to accumulation of intracellular cyclic AMP. The specific mechanism(s) by which roflumilast exerts its therapeutic action is not well defined.
ZORYVE cream is a phosphodiesterase 4 inhibitor:
- ZORYVE cream, 0.3%, is indicated for the topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older.
- ZORYVE cream, 0.15%, is indicated for the topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older.
- Apply ZORYVE cream:
- 0.3%, once daily to affected areas of plaque psoriasis.
- 0.15%, once daily to affected areas of mild to moderate atopic dermatitis.
- For topical use only.
- Not for ophthalmic, oral, or intravaginal use.
The most common adverse reactions (reported in ≥1% of subjects) are:
- Plaque Psoriasis: diarrhea, headache, insomnia, nausea, application site pain, upper respiratory tract infections, and urinary tract infections.
- Atopic Dermatitis: headache, nausea, application site pain, diarrhea, and vomiting.
Moderate to severe liver impairment (Child-Pugh B or C).
N/A