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.
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.
It is important to use the correct amount of topical steroid for your eczema, as instructed by your healthcare professional. Topical steroids should be applied with clean hands so that the skin just glistens. It can sometimes be difficult to judge how much steroid to use and there are guidelines on the amount required to cover body areas that are affected by eczema. These are based on the Finger Tip Unit (FTU), and explained in detail in our fact sheet which you can download as a pdf from the related documents to the right of this page.