References: 1. Bikowski J, Pillai R, Shroot B. The position not the presence of the halogen in corticosteroids influences potency and side effects. J Drugs Dermatol . 2006;5(2):125-130. 2. Del Rosso J, Friedlander SF. Corticosteroids: options in the era of steroid-sparing therapy. J Am Acad Dermatol . 2005; 53(1 Suppl 1):s50-s58. 3. US Food and Drug Administration NDA 017765. Promius Pharma, LLC, Princeton, NJ: Aug 1977. 4. Rosenthal AL. Clocortolone pivalate: a paired comparison clinical trial of a new topical steroid in eczema/atopic dermatitis. Cutis . 1980;25(1):96-98. 5. Kircik LH. A study to assess the occlusivity and moisturization potential of three topical corticosteroid products using the skin trauma after razor shaving (STARS) bioassay. J Drugs Dermatol . 2014;13(5):582-585. 6. Cloderm [package insert]. Princeton, NJ: Promius Pharma, LLC; 2017.
In a Phase 2 HPA clinical study [see Pharmacodynamics ], pharmacokinetics was evaluated in a subgroup of 12 adult subjects. On Day 8, blood was taken just prior to and at 1, 2, 4, 6, 8, and 12 hours following the last application. Plasma concentration of halobetasol propionate was measureable in all subjects. Based on the geometric mean plasma concentrations at 12 hour post-application across time, steady-state was achieved by Day 8. The mean (±standard deviation) Cmax concentrations for ULTRAVATE lotion on Day 8 was ± pg/mL, with the corresponding median Tmax value of 3 hours (range 0 – 6 hours); mean area under the halobetasol propionate concentration versus time curve over the dosing interval (AUCτ) was 1632 ± 1147 pg•h/mL.
There is no evidence of safe and effective use of topical corticosteroids in pregnant mothers. Therefore, they should be used only if clearly needed. Long term use and large applications of topical corticosteroids may cause birth defects in the unborn. It is not known whether topical corticosteroids enter breast milk. Therefore, caution must be exercised before using it in nursing mothers. Topical corticosteroids should not be applied to the breasts of nursing mothers unless the mothers instructed to do so by the physician.