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Zoryve Foam Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Foam—60g
Manufacturer
Generic Availability
NO
Mechanism of Action
Roflumilast and its active metabolite (roflumilast N-oxide) are inhibitors of phosphodiesterase 4 (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 Foam Indications
Indications
Seborrheic dermatitis.
Zoryve Foam Dosage and Administration
Adults and Children
<9yrs: not established. ≥9yrs: Apply a thin layer once daily to the affected area(s) on dry skin and/or scalp; rub in completely.
Zoryve Foam Contraindications
Contraindications
Moderate to severe liver impairment (Child-Pugh B or C).
Zoryve Foam Boxed Warnings
Not Applicable
Zoryve Foam Warnings/Precautions
Warnings/Precautions
Not for oral, ophthalmic, or intravaginal use. Flammable. Labor & delivery: avoid. Pregnancy. Nursing mothers: avoid direct infant exposure.
Zoryve Foam Pharmacokinetics
Absorption
Mean ± SD systemic exposure (AUC0-24): 36.6 ± 23.7 (adults); 25.1 ± 30.2 (pediatrics).
Distribution
Plasma protein bound: ~99%.
Elimination
Half-life: 3.6 days.
Zoryve Foam Interactions
Interactions
May be potentiated by systemic CYP3A4 inhibitors, dual CYP3A4/CYP1A2 inhibitors (eg, erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine); consider risks vs benefits prior to concomitant use.
Zoryve Foam Adverse Reactions
Adverse Reactions
Nasopharyngitis, nausea, headache.
Zoryve Foam Clinical Trials
See Literature
Zoryve Foam Note
Not Applicable
Zoryve Foam Patient Counseling
See Literature
