Roflumilast (3 brand names, 3 dosage forms, 2 routes)
Available dosage forms: CREAM, TABLET, FOAM.
Routes of administration: TOPICAL, ORAL.
Brand Names
- DALIRESP
- ROFLUMILAST
- ZORYVE
Dosage and Administration
Plaque Psoriasis Use ZORYVE cream, 0.3%, for the treatment of plaque psoriasis in adult and pediatric patients 2 years of age and older. Atopic Dermatitis Use ZORYVE cream, 0.15%, for the treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older. Use ZORYVE cream, 0.05%, for the treatment of mild to moderate atopic dermatitis in pediatric patients 2 to 5 years of age. Administration Instructions Apply ZORYVE cream to affected areas once daily and rub in completely. Wash hands after application. ZORYVE cream is for topical use only and not for ophthalmic, oral, or intravaginal use.
Contraindications
ZORYVE cream is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C) [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
Mechanism of Action
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.