In an open-label HPA axis safety trial in subjects 3 months to 12 years of age with atopic dermatitis, betamethasone dipropionate cream (augmented), % was applied twice daily for 2 to 3 weeks over a mean body surface area of 58% (range 35% to 95%). In 19 of 60 (32%) evaluable subjects, adrenal suppression was indicated by either a ≤5 mcg/dL pre-stimulation cortisol, or a cosyntropin post-stimulation cortisol ≤18 mcg/dL and/or an increase of <7 mcg/dL from the baseline cortisol. Out of the 19 subjects with HPA axis suppression, 4 subjects were tested 2 weeks after discontinuation of betamethasone dipropionate cream (augmented), % and 3 of the 4 (75%) had complete recovery of HPA axis function. The proportion of subjects with adrenal suppression in this trial was progressively greater, the younger the age group.
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The external ear should be thoroughly cleaned and dried before treatment. Remove foreign material, debris, crusted exudates, etc., with suitable non-irritating solutions. Excessive hair should be clipped from the treatment area. After verifying that the eardrum is intact, instill 4 drops from the g and 15 g tube, and 15 g and 30 g bottle (2 drops from the 215 g bottle) of OTOMAX ointment twice daily into the ear canal of dogs weighing less than 30 lbs. Instill 8 drops from the g and 15 g tube, and 15 g and 30 g bottle (4 drops from the 215 g bottle) twice daily into the ear canal of dogs weighing 30 lbs or more. Massage external ear canal carefully after instillation to ensure appropriate distribution of medication. Therapy should continue for 7 consecutive days.