awal 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. in a trial evaluating the effects of betamethasone dipropionate ointment (augmented) on the hpa axis, at 14 g per day, betamethasone dipropionate ointment (augmented) was shown to suppress the plasma levels of adrenal cortical hormones following repeated application to diseased skin in subjects with psoriasis. these effects were reversible upon discontinuation of treatment. at 7 g per day, betamethasone dipropionate ointment (augmented) was shown to cause minimal inhibition of the hpa axis when applied 2 times daily for 2 to 3 weeks in healthy subjects and in subjects with psoriasis and eczematous disorders. with 6 g to 7 g of betamethasone dipropionate ointment (augmented) applied once daily for 3 weeks, no significant inhibition of the hpa axis was observed in subjects with psoriasis and atopic dermatitis, as measured by plasma cortisol and 24-hour urinary 17-hydroxy-corticosteroid levels. 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 ophthalmic adverse reactions use of topical corticosteroids, including betamethasone dipropionate ointment (augmented), 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 ointment (augmented) [see adverse reactions ( 6.2 )]. avoid contact of betamethasone dipropionate ointment (augmented) 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.

or intravaginal use. apply a thin film to the affected skin areas once or twice daily. ( 2 ) discontinue therapy when control is achieved. ( 2 ) limit therapy to no more than 2 consecutive weeks. ( 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 )

drug exposure. postmarketing reports for local adverse reactions to topical corticosteroids may also include: skin atrophy, telangiectasias, burning, irritation, dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis, 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.

between the systemic exposure of betamethasone dipropionate in animal studies to the systemic exposure that would be expected in humans after topical use of betamethasone dipropionate ointment (augmented) (see data). the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data betamethasone dipropionate has been shown to cause malformations in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. the abnormalities observed included umbilical hernias, cephalocele, and cleft palate. 8.2 lactation risk summary there are no data regarding the presence of betamethasone dipropionate in human milk, the effects on the breastfed infant, or the effects on milk production after topical application of betamethasone dipropionate ointment (augmented) to women who are breastfeeding. it is possible that topical administration of betamethasone dipropionate could result in sufficient systemic absorption to produce detectable quantities in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for betamethasone dipropionate ointment (augmented) and any potential adverse effects on the breastfed infant from betamethasone dipropionate ointment (augmented) or from the underlying maternal condition. clinical considerations to minimize potential exposure to the breastfed infant via breast milk, use betamethasone dipropionate ointment (augmented) on the smallest area of skin and for the shortest duration possible while breastfeeding. advise breastfeeding women not to apply betamethasone dipropionate ointment (augmented) directly to the nipple and areola to avoid direct infant exposure [see use in specific populations ( 8.4 )] . 8.4 pediatric use use of betamethasone dipropionate ointment (augmented) 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 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 less than or equal to 5 mcg/dl pre-stimulation cortisol, or a cosyntropin post-stimulation cortisol less than or equal to 18 mcg/dl and/or an increase of less than 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, 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. 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 ointment (augmented) in the treatment of diaper dermatitis. 8.5 geriatric use clinical trials of betamethasone dipropionate ointment (augmented) included 225 subjects who were 65 years of age and over and 46 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.

of betamethasone dipropionate in animal studies to the systemic exposure that would be expected in humans after topical use of betamethasone dipropionate ointment (augmented) (see data). the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data betamethasone dipropionate has been shown to cause malformations in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. the abnormalities observed included umbilical hernias, cephalocele, and cleft palate.

ppression in this trial was progressively greater, the younger the age group. 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 ointment (augmented) in the treatment of diaper dermatitis.

rticosteroids 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.

nant or breastfeeding. advise breastfeeding women not to apply betamethasone dipropionate ointment (augmented) directly to the nipple and areola to avoid direct infant exposure. distributed by: actavis pharma, inc. parsippany, nj 07054 usa rev. a 5/2019