reatment or after withdrawal of treatment. factors that predispose to hpa axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. evaluation for hpa axis suppression may be done by using the adrenocorticotropic hormone (acth) stimulation test. betamethasone dipropionate cream (augmented), 0.05% was applied once daily at 7 grams per day for 1 week to diseased skin, in adult subjects with psoriasis or atopic dermatitis, to study its effects on the hpa axis. the results suggested that the drug lowered adrenal corticosteroid secretion, although plasma cortisol levels did not go below the lower limit of the normal range. in an open-label pediatric trial of 60 evaluable subjects (3 months to 12 years of age), 19 subjects showed evidence of hpa axis suppression. four (4) subjects were tested 2 weeks after discontinuation of betamethasone dipropionate cream (augmented), 0.05%, 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. if hpa axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. cushing’s syndrome and hyperglycemia may also occur with topical corticosteroids. these events are rare and generally occur after prolonged exposure to excessively large doses, especially of high-potency topical corticosteroids. pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios [ see use in specific populations (8.4) ]. 5.2 visual disturbance use of topical corticosteroids, including betamethasone dipropionate cream usp (augmented), 0.05%, may increase the risk of posterior subcapsular cataracts and glaucoma. cataracts and glaucoma have been reported postmarketing with the use of topical corticosteroid products, including betamethasone dipropionate cream usp (augmented), 0.05% [ see adverse reactions (6.2) ]. avoid contact of betamethasone dipropionate cream usp (augmented), 0.05% with eyes. advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation. 5.3 allergic contact dermatitis allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. such an observation should be corroborated with appropriate diagnostic patch testing. if irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

skin areas once or twice daily. (2) • discontinue therapy when control is achieved. (2) • use no more than 50 g per week. (2) • do not use with occlusive dressings unless directed by a physician. (2) • avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. (2) • not for oral, ophthalmic, or intravaginal use. (2)

nths to 12 years of age, the adverse reactions associated with the use of betamethasone dipropionate cream (augmented), 0.05% occurred in 7 of 67 (10%) subjects. reported reactions included signs of skin atrophy (telangiectasia, bruising, shininess). 6.2 postmarketing experience because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. postmarketing reports for local adverse reactions to topical corticosteroids may also include: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis, skin atrophy, striae, and miliaria. hypersensitivity reactions, consisting of predominantly skin signs and symptoms, e.g., contact dermatitis, pruritus, bullous dermatitis, and erythematous rash have been reported. ophthalmic adverse reactions of cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy have been reported with the use of topical corticosteroids, including topical betamethasone products.

usp (augmented), 0.05% is administered to a nursing woman. 8.4 pediatric use use of betamethasone dipropionate cream usp (augmented), 0.05% in pediatric patients younger than 13 years of age is not recommended due to the potential for hpa axis suppression [ see warnings and precautions (5.1) ]. in an open-label hpa axis safety trial in subjects 3 months to 12 years of age with atopic dermatitis, betamethasone dipropionate cream (augmented), 0.05% 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), 0.05%, 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 [ see warnings and precautions (5.1) ]. because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic toxicity when treated with topical drugs. they are, therefore, also at greater risk of hpa axis suppression and adrenal insufficiency upon the use of topical corticosteroids. rare systemic effects such as cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids. local adverse reactions including skin atrophy have also been reported with use of topical corticosteroids in pediatric patients. avoid use of betamethasone dipropionate cream usp (augmented), 0.05% in the treatment of diaper dermatitis. 8.5 geriatric use clinical trials of betamethasone dipropionate cream (augmented), 0.05% included 104 subjects who were 65 years of age and over and 8 subjects who were 75 years of age and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. however, greater sensitivity of some older individuals cannot be ruled out.

ppression in this trial was progressively greater, the younger the age group [ see warnings and precautions (5.1) ]. because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic toxicity when treated with topical drugs. they are, therefore, also at greater risk of hpa axis suppression and adrenal insufficiency upon the use of topical corticosteroids. rare systemic effects such as cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids. local adverse reactions including skin atrophy have also been reported with use of topical corticosteroids in pediatric patients. avoid use of betamethasone dipropionate cream usp (augmented), 0.05% in the treatment of diaper dermatitis.

dosage and administration (2) ]. topical corticosteroids can be absorbed through normal intact skin. inflammation and/or other disease processes in the skin may increase percutaneous absorption. occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids [ see dosage and administration (2) ]. once absorbed through the skin, topical corticosteroids enter pharmacokinetic pathways similar to systemically administered corticosteroids. corticosteroids are bound to plasma proteins in varying degrees, are metabolized primarily in the liver, and excreted by the kidneys. some of the topical corticosteroids and their metabolites are also excreted into the bile.

lso excreted into the bile.