Roflumilast is a phosphodiesterase (PDE) type 4 inhibitor. Class: 84:92 • Skin and Mucous Membrane Agents, Miscellaneous (AHFS primary) Brands: Zoryve® Roflumilast has the following uses: Roflumilast is available in the following dosage form(s) and strength(s): Cream, 0.3%: 3 mg of roflumilast per gram in 60-gram tubes. It is essential that the manufacturer’s labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary: For topical use only. Not for ophthalmic, oral, or intravaginal use. There are no randomized clinical trials of oral or topical roflumilast in pregnant women. In animal reproduction studies, roflumilast administered orally to pregnant rats and rabbits during the period of organogenesis produced no fetal structural abnormalities at doses up to 9 and 8 times the maximum recommended human dose (MRHD), respectively. Roflumilast induced post-implantation loss in rats at oral doses greater than or equal to 3 times the MRHD. Roflumilast induced stillbirth and decreased pup viability in mice at oral doses 5 and 15 times the MRHD, respectively. Roflumilast has been shown to adversely affect pup post-natal development when dams were treated with an oral dose 15 times the MRHD during pregnancy and lactation periods in mice.