f 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 augmented betamethasone dipropionate ointment on the hpa axis, at 14 g per day, augmented betamethasone dipropionate ointment 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, augmented betamethasone dipropionate ointment 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 augmented betamethasone dipropionate ointment 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 augmented betamethasone dipropionate ointment, 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 augmented betamethasone dipropionate ointment [see adverse reactions (6.2) ]. avoid contact of augmented betamethasone dipropionate ointment 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.

inal 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 )

a causal relationship to 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.

n the systemic exposure of betamethasone dipropionate in animal studies to the systemic exposure that would be expected in humans after topical use of augmented betamethasone dipropionate ointment (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 augmented betamethasone dipropionate ointment 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 augmented betamethasone dipropionate ointment and any potential adverse effects on the breastfed infant from augmented betamethasone dipropionate ointment or from the underlying maternal condition. clinical considerations to minimize potential exposure to the breastfed infant via breast milk, use augmented betamethasone dipropionate ointment on the smallest area of skin and for the shortest duration possible while breastfeeding. advise breastfeeding women not to apply augmented betamethasone dipropionate ointment directly to the nipple and areola to avoid direct infant exposure [see use in specific populations (8.4) ] . 8.4 pediatric use use of augmented betamethasone dipropionate ointment 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, diprolene ® af 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 ≤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 diprolene af 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 augmented betamethasone dipropionate ointment in the treatment of diaper dermatitis. 8.5 geriatric use clinical trials of augmented betamethasone dipropionate ointment 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.

amethasone dipropionate in animal studies to the systemic exposure that would be expected in humans after topical use of augmented betamethasone dipropionate ointment (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.

e 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 augmented betamethasone dipropionate ointment in the treatment of diaper dermatitis.

eroids 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.

r breastfeeding. advise breastfeeding women not to apply augmented betamethasone dipropionate ointment directly to the nipple and areola to avoid direct infant exposure.

ngredients in augmented betamethasone dipropionate ointment. before using augmented betamethasone dipropionate ointment, tell your healthcare provider about all of your medical conditions, including if you: have had irritation or other skin reaction to a steroid medicine in the past. have thinning of the skin (atrophy) at the treatment site. have diabetes. have adrenal gland problems. have liver problems. have cataracts or glaucoma. are pregnant or plan to become pregnant. it is not known if augmented betamethasone dipropionate ointment will harm your unborn baby. if you use augmented betamethasone dipropionate ointment during pregnancy, use augmented betamethasone dipropionate ointment on the smallest area of the skin and for the shortest time needed. are breastfeeding or plan to breastfeed. it is not known if augmented betamethasone dipropionate ointment passes into your breast milk. breastfeeding women should use augmented betamethasone dipropionate ointment on the smallest area of skin and for the shortest time needed while breastfeeding. do not apply augmented betamethasone dipropionate ointment directly to the nipple and areola to avoid contact with your baby. tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. especially tell your healthcare provider if you take other corticosteroid medicines by mouth or injection or use other products on your skin or scalp that contain corticosteroids. do not use other products containing a steroid medicine with augmented betamethasone dipropionate ointment without talking to your healthcare provider first. how should i use augmented betamethasone dipropionate ointment? use augmented betamethasone dipropionate ointment exactly as your healthcare provider tells you to use it. apply a thin layer (film) of augmented betamethasone dipropionate ointment to the affected skin area 1 or 2 times each day. do not use more than 50 grams of augmented betamethasone dipropionate ointment in 1 week. do not use augmented betamethasone dipropionate ointment for longer than 2 weeks in a row unless your healthcare provider tells you to. tell your healthcare provider if the treated skin area does not get better after 2 weeks of treatment with augmented betamethasone dipropionate ointment. do not bandage, cover, or wrap the treated skin area unless your healthcare provider tells you to. augmented betamethasone dipropionate ointment should not be used to treat diaper rash or redness. avoid using augmented betamethasone dipropionate ointment on the face, groin, or underarms (armpits) or if thinning of the skin (atrophy) is present at the treatment site. wash your hands after applying augmented betamethasone dipropionate ointment unless you are using the medicine to treat your hands. what are the possible side effects of augmented betamethasone dipropionate ointment? augmented betamethasone dipropionate ointment may cause serious side effects, including: augmented betamethasone dipropionate ointment can pass through your skin . too much augmented betamethasone dipropionate ointment passing through your skin can cause your adrenal glands to stop working properly. your healthcare provider may do blood tests to check for adrenal gland problems. cushing's syndrome, a condition that happens when your body is exposed to too much of the hormone cortisol. high blood sugar (hyperglycemia). effects on growth and weight in children. vision problems. topical corticosteroids including augmented betamethasone dipropionate ointment may increase your chance of developing cataract(s) and glaucoma. tell your healthcare provider if you develop blurred vision or other vision problems during treatment with augmented betamethasone dipropionate ointment. skin problems. skin problems including, allergic reactions (contact dermatitis) may happen during treatment with augmented betamethasone dipropionate ointment. stop using augmented betamethasone dipropionate ointment and tell your healthcare provider if you develop any skin reactions or have problems with healing during treatment with augmented betamethasone dipropionate ointment. your healthcare provider may do certain blood tests to check for side effects. the most common side effects of augmented betamethasone dipropionate ointment include redness of the skin, inflamed hair follicles, itching and blistering. these are not all of the possible side effects of augmented betamethasone dipropionate ointment. call your doctor for medical advice about side effects. you may report side effects to fda at 1-800-fda-1088. how should i store augmented betamethasone dipropionate ointment? store augmented betamethasone dipropionate ointment at room temperature between 68°f to 77°f (20°c to 25°c). keep augmented betamethasone dipropionate ointment and all medicines out of the reach of children. general information about the safe and effective use of augmented betamethasone dipropionate ointment. medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. do not use augmented betamethasone dipropionate ointment for a condition for which it was not prescribed. do not give augmented betamethasone dipropionate ointment to other people, even if they have the same symptoms that you have. it may harm them. you can ask your pharmacist or healthcare provider for information about augmented betamethasone dipropionate ointment that is written for health professionals. what are the ingredients in augmented betamethasone dipropionate ointment? active ingredient: augmented betamethasone dipropionate inactive ingredients: propylene glycol; propylene glycol stearate; white petrolatum; and white wax. manufactured for: prasco laboratories mason, oh 45040, usa manufactured by: delpharm montréal inc. pointe-claire, qc h9r 1b4, canada usppi-gog1460-ot-2106r000