, see prescribing information for those products. children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. (see precautions-pediatric use ) allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than noting a clinical exacerbation, which may occur with most topical products not containing corticosteroids. such an observation should be corroborated with appropriate diagnostic testing. one peanut sensitive child experienced a flare of his atopic dermatitis after 5 days of twice daily treatment with fluocinolone acetonide topical oil, 0.01% (see clinical studies section). if wheal and flare type reactions (which may be limited to pruritus) or other manifestations of hypersensitivity develop, fluocinolone acetonide topical oil, 0.01% should be discontinued immediately and appropriate therapy instituted. if concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. if a favorable response does not occur promptly, use of fluocinolone acetonide topical oil, 0.01% should be discontinued until the infection has been adequately controlled. fluocinolone acetonide topical oil, 0.01% is formulated with 48% refined peanut oil nf. physicians should use caution in prescribing fluocinolone acetonide topical oil, 0.01% for peanut sensitive individuals.

ents (%) n=58 adverse event (ae) the number of individual adverse events reported does not necessarily reflect the number of individual subjects, since one subject could have multiple reporting of an adverse event. # of patients (%) day 14 day 28 end of treatment day 56 four weeks post treatment any ae 15 (25.9) 6 (10.3) 7 (12.1) 7 (12.1) telangiectasia 5 (8.6) 3 (5.2) 4 (6.9) 2 (3.5) erythema 3 (5.2) 3 (5.2) itching 3 (5.2) 3 (5.2) irritation 3 (5.2) 3 (5.2) burning 3 (5.2) 3 (5.2) hypopigmentation 2 (3.5) 2 (3.5) shiny skin 1 (1.7) 1 (1.7) secondary atopic dermatitis 1 (1.7) 1 (1.7) papules and pustules 1 (1.7) 1 (1.7) keratosis pilaris 1 (1.7) 1 (1.7) folliculitis 1 (1.7) 1 (1.7) facial herpes simplex 1 (1.7) 1 (1.7) acneiform eruption 1 (1.7) 1 (1.7) ear infection 1 (1.7) 1 (1.7) to report suspected adverse reactions, contact rising pharmaceuticals, inc. at 1-866-562-4597 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.

nt and of cushing’s syndrome while on treatment. adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. (see precautions ). hpa axis suppression, cushing’s syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to acth stimulation. manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. fluocinolone acetonide topical oil, 0.01% is formulated with 48% refined peanut oil nf. physicians should use caution in prescribing fluocinolone acetonide topical oil, 0.01% for peanut sensitive individuals.

lation (cortisol > 18 µg/dl). a clinical study was conducted to assess the safety of fluocinolone acetonide topical oil, 0.01%, which contains refined peanut oil, on subjects with known peanut allergies. the study enrolled 13 patients with atopic dermatitis, 6 to 17 years of age. of the 13 patients, 9 were radioallergosorbent test (rast) positive to peanuts and 4 had no peanut sensitivity (controls). the study evaluated the responses to both prick test and patch test utilizing refined peanut oil nf, fluocinolone acetonide topical oil, 0.01% and histamine/saline controls, on the 13 individuals. these subjects were also treated with fluocinolone acetonide topical oil, 0.01% twice daily for 7 days. prick test and patch test results for all 13 patients were negative to fluocinolone acetonide topical oil, 0.01% and the refined peanut oil. one of the 9 peanut-sensitive patients experienced an exacerbation of atopic dermatitis after 5 days of fluocinolone acetonide topical oil, 0.01% use. importantly, the bulk peanut oil nf, used in fluocinolone acetonide topical oil, 0.01% is heated to between 232˚c – 246˚c (450˚f – 475˚f) for at least 15 minutes, which should provide for adequate decomposition of allergenic proteins.

ntact the physician.