Version July 2025
Atopic dermatitis: Topical: 0.15 % cream: Apply once daily to affected areas.
Plaque psoriasis: Topical: 0.3 % cream: Apply once daily to affected areas.
Seborrheic dermatitis: Topical: Foam: Apply once daily to affected areas.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Child-Turcotte-Pugh class A: No dosage adjustment needed.
Child-Turcotte-Pugh class B and C: Use is contraindicated.
Refer to adult dosing.
(For additional information see "Roflumilast (topical): Pediatric drug information")
Atopic dermatitis: Children ≥6 years and Adolescents: Cream 0.15%: Topical: Apply to affected area(s) once daily.
Plaque psoriasis: Children ≥6 years and Adolescents: Cream 0.3%: Topical: Apply to affected area(s) once daily.
Seborrheic dermatitis: Children ≥9 years and Adolescents: Foam 0.3%: Topical: Apply to dry affected area(s) of skin or scalp once daily.
There are no dosage adjustments provided in the manufacturer's labeling; however, adjustment likely not necessary; in one study, pharmacokinetic parameters did not differ in patients with severe kidney impairment.
Children ≥6 years and Adolescents: Topical:
Mild impairment: No dosage adjustment needed.
Moderate or severe impairment: Use is contraindicated; systemic exposure of roflumilast and active metabolites are increased with moderate liver impairment.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in children, adolescents, and adults.
1% to 10%:
Gastrointestinal: Diarrhea (≤3%), nausea (1% to 2%), vomiting (2%)
Genitourinary: Urinary tract infection (1%)
Local: Application-site pain (1% to 2%)
Nervous system: Headache (1% to 3%), insomnia (≤1%)
Respiratory: Nasopharyngitis (2%), upper respiratory tract infection (1%)
Moderate to severe liver impairment (Child-Turcotte-Pugh class B or C).
Canadian labeling: Additional contraindications (not in the US labeling): Hypersensitivity to roflumilast or any component of the formulation.
Dosage form specific:
• Foam: Foam contains flammable propellants. Avoid fire, flame, and smoking during and immediately following administration.
Other warnings/precautions:
• Appropriate use: For topical use only; not for ophthalmic, oral, or intravaginal use.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External:
Zoryve: 0.15% (60 g); 0.3% (60 g) [contains cetostearyl alcohol, methylparaben, propylparaben]
Foam, External:
Zoryve: 0.3% (60 g) [contains cetyl alcohol, methylparaben, propylparaben]
No
Cream (Zoryve External)
0.15% (per gram): $18.56
0.3% (per gram): $18.56
Foam (Zoryve External)
0.3% (per gram): $18.56
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External:
Zoryve: 0.15% (5 g, 60 g)
Zoryve: 0.3% (5 g, 60 g) [contains cetostearyl alcohol, methylparaben, propylparaben]
Foam, External:
Zoryve: 0.3% (25 g, 60 g) [contains cetyl alcohol, methylparaben, propylparaben]
Topical: For topical use only; not for ophthalmic, oral, or intravaginal use. Wash hands after use, unless treating the hands.
Cream: Rub in completely.
Foam: Shake well prior to use. Apply a thin layer to dry skin and/or scalp; rub in completely. Avoid fire, flame, and smoking during and immediately following use.
Topical: For topical use only; not for ophthalmic, oral, or intravaginal use.
Cream: 0.15%, 0.3%: Rub cream in completely to affected area(s). Wash hands following application unless using for treatment of atopic dermatitis or psoriasis on hands.
Foam: Shake well prior to use. Apply a thin layer to dry skin and/or scalp; rub in completely. Avoid fire, flame, and smoking during and immediately following use.
Atopic dermatitis: 0.15 % cream: Treatment of mild to moderate atopic dermatitis in adult and pediatric patients ≥6 years of age.
Plaque psoriasis: 0.3 % cream: Treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients ≥6 years of age.
Seborrheic dermatitis: Foam: Treatment of seborrheic dermatitis in adult and pediatric patients ≥9 years of age.
Substrate of CYP1A2 (Minor), CYP3A4 (Major with inhibitors), CYP3A4 (Minor with inducers); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Cimetidine: May increase serum concentration of Roflumilast-Containing Products. Cimetidine may increase active metabolite exposure of Roflumilast-Containing Products. Risk C: Monitor
Ciprofloxacin (Systemic): May increase serum concentration of Roflumilast-Containing Products. Risk C: Monitor
Clofazimine: May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor
CYP3A4 Inhibitors (Moderate): May increase serum concentration of Roflumilast-Containing Products. Risk C: Monitor
CYP3A4 Inhibitors (Strong): May increase serum concentration of Roflumilast-Containing Products. Risk C: Monitor
Ethinyl Estradiol-Containing Products: May increase serum concentration of Roflumilast-Containing Products. Risk C: Monitor
FluvoxaMINE: May increase serum concentration of Roflumilast-Containing Products. FluvoxaMINE may increase active metabolite exposure of Roflumilast-Containing Products. Risk C: Monitor
Fusidic Acid (Systemic): May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Consider avoiding this combination if possible. If required, monitor patients closely for increased adverse effects of the CYP3A4 substrate. Risk D: Consider Therapy Modification
Gestodene: May increase serum concentration of Roflumilast-Containing Products. Risk C: Monitor
Riociguat: Roflumilast-Containing Products may increase hypotensive effects of Riociguat. Risk C: Monitor
Tobacco (Smoked): May decrease serum concentration of Roflumilast-Containing Products. Risk C: Monitor
Viloxazine: May increase serum concentration of Roflumilast-Containing Products. Viloxazine may increase active metabolite exposure of Roflumilast-Containing Products. Risk C: Monitor
Animal reproduction studies have not been conducted with topical roflumilast.
Based on animal data, the manufacturer recommends avoiding topical use during labor and delivery.
It is not known if roflumilast is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Breastfeeding patients should treat the smallest area for the shortest duration possible and should not apply roflumilast to the nipple and areola area; if applied to the chest, avoid direct skin-to-skin contact with treated areas.
Roflumilast and its active N-oxide metabolite selectively inhibit phosphodiesterase-4 (PDE4), leading to accumulation of cyclic AMP (cAMP). The specific mechanism(s) by which roflumilast exerts its therapeutic action is not well defined.
Protein binding: ~99%; N-oxide metabolite: 97%.
Metabolism: Hepatic via CYP3A4 and CYP1A2 to active N-oxide metabolite; also undergoes conjugation.
Half-life elimination: 3.6 to 4 days; N-oxide metabolite: 4.4 to 4.6 days.
