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.
Topical steroids are available as creams, lotions, gels and ointments; selection of an appropriate product can also provide good moisturization of the skin. The wide spectrum of potencies and bases allows these mediations to be used both effectively and safely while under the care of an experienced physician.
During flares, over-the-counter moisturizing preparations that include a topical corticosteroid (such as clobetasone butyrate and hydrocortisone) are helpful to control inflammation and restore the skin barrier. The intensive use of emollient-based products can reduce the need for topical steroids.
Yes. Topical corticosteroids have not been studied in women who are breastfeeding. However, significant absorption into the blood stream and then into the milk would only be expected with very potent corticosteroids used on large areas of the body. Make sure medication is not placed on the breast area (especially high potency corticosteroids) or in any area that may come in contact with your baby’s skin and mouth. Also be sure to wash your hands thoroughly after applying the medication. Be sure to talk to your health care provider about any question or concerns regarding brestfeeding.