Medicine Overview

Adult Dose
Clinical InformationAdministration Information
Indication: Plaque psoriasis
Age: Adult
Condition: Normal hepatic function
Dose: Topical - Apply once daily to affected areas
Frequency: once daily
Note: Rub in completely. Indicated for plaque psoriasis, including intertriginous areas.
Indication: Plaque psoriasis
Age: Adult
Condition: Moderate-to-severe hepatic impairment (Child-Pugh B or C)
Dose: Topical - Contraindicated
Note: Contraindicated with moderate-to-severe impairment (Child-Pugh B or C). No studies conducted with topical roflumilast in patients with hepatic impairment. In oral studies (250 mcg/day), AUC of roflumilast and roflumilast N-oxide increased by 51% and 24% in Child-Pugh A and 92% and 41% in Child-Pugh B. Peak plasma concentrations increased by 3% and 26% in Child-Pugh A and 26% and 40% in Child-Pugh B.

Child Dose
Clinical InformationAdministration Information
Indication: Plaque psoriasis (including intertriginous areas)
Age: <12 years
Dose: Topical
Note: Safety and efficacy not established.
Indication: Plaque psoriasis (including intertriginous areas)
Age: >12 years
Dose: Topical application
Frequency: once daily
Note: Apply to affected areas and rub in completely.
Administration

Apply a thin layer of roflumilast cream or foam once daily to affected areas of the skin or scalp. For the foam, shake the container well before dispensing a small amount with the can held upside down. Rub the preparation in completely and wash hands immediately after application. This medication is for topical use only; avoid contact with eyes, mouth, or vaginal areas. The foam is flammable, so patients must avoid fire, flames, and smoking during and immediately after application. Roflumilast is contraindicated in patients with moderate to severe hepatic impairment. Safety and dosage vary by age and indication, with specific cream strengths indicated for pediatric patients as young as 2 years for atopic dermatitis.

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Data Sources

Clinical & regulatory information on this page is compiled from the following government sources:

DISCLAIMER: This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment.