Australia - English - Department of Health (Therapeutic Goods Administration)

organon pharma pty ltd - betamethasone dipropionate, quantity: 0.64 mg/g (equivalent: betamethasone, qty 0.5 mg/g) - ointment - excipient ingredients: white soft paraffin; liquid paraffin - topical treatment of corticosteroid-responsive dermatoses. these include atopic eczema, infantile eczema, nummular eczema, contact dermatitis, neurodermatitis, anogenital and senile pruritus, lechen planus, intertrigo and psoriasis. indications as at 26 august 1992: eleuphrat is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. these include atopic eczema, infantile eczema, nummular eczema, contact dermatitis, neurodermatitis, anogenital and senile pruritus, lichen planus, intertrigo and psoriasis.

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - betamethasone dipropionate cream (augmented) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older. betamethasone dipropionate cream (augmented) is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation. risk summary there are no available data on betamethasone dipropionate cream (augmented) use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. advise pregnant women that betamethasone dipropionate cream (augmented) may increase the risk of having a low birthweight infant and to use betamethasone dipropionate cream (augmented) on the smallest area of skin and for the shortest duration possible. in animal reproduction studies, increased malformations, including umbilical hernias, cephalocele, and cleft palate, were observed after intramuscular administration of betamethasone dipropionate to pregnant rabbits. the available data do not allow the calculation of relevant comparisons 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 cream (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. risk summary there are no data regarding the excretion of betamethasone dipropionate in breast milk, the effects on the breastfed infant, or the effects on milk production after topical application of betamethasone dipropionate cream (augmented) to women who are breastfeeding. it is possible that topical administration of large amounts 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 cream (augmented) and any potential adverse effects on the breastfed infant from betamethasone dipropionate cream (augmented) or from the underlying maternal condition. clinical considerations to minimize potential exposure to the breastfed infant via breast milk, use betamethasone dipropionate cream (augmented) on the smallest area of skin and for the shortest duration possible while breastfeeding. advise breastfeeding women not to apply betamethasone dipropionate cream (augmented) directly to the nipple and areola to avoid direct infant exposure [see use in specific populations (8.4) ]. use of betamethasone dipropionate cream (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 (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. 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 (augmented) in the treatment of diaper dermatitis. clinical trials of betamethasone dipropionate cream (augmented) 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.

United States - English - NLM (National Library of Medicine)

tasman pharma inc. - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

United States - English - NLM (National Library of Medicine)

trupharma llc - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - betamethasone dipropionate cream is a medium-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older. betamethasone dipropionate cream is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.

United States - English - NLM (National Library of Medicine)

direct rx - clotrimazole (unii: g07gz97h65) (clotrimazole - unii:g07gz97h65), betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - clotrimazole and betamethasone dipropionate cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to epidermophyton floccosum, trichophyton mentagrophytes, and trichophyton rubrum in patients 17 years and older. none. 8.1 pregnancy risk summary there are no available data on topical betamethasone dipropionate or clotrimazole use in pregnant women to identify clotrimazole and betamethasone dipropionate cream associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. observational studies suggest an increased risk of low birthweight infants with the use of potent or very potent topical corticosteroid during pregnancy. advise pregnant women that clotrimazole and betamethasone dipropionate cream may increase the risk of having a low birthweight infant and to use clotrimazole and betamethasone dipropionate cream on the smallest area of skin and for the

United States - English - NLM (National Library of Medicine)

merck sharp & dohme corp. - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - betamethasone 0.5 mg in 1 g - diprolene® ointment is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older. diprolene ointment is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation. risk summary there are no available data on diprolene ointment use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. advise pregnant women that diprolene ointment may increase the risk of having a low birthweight infant and to use diprolene ointment on the smallest area of skin and for the shortest duration possible. in animal reproduction studies, increased malformations, including umbilical he

United States - English - NLM (National Library of Medicine)

merck sharp & dohme corp. - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - betamethasone 0.5 mg in 1 g - diprolene® af cream is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older. diprolene af cream is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation. risk summary there are no available data on diprolene af cream use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. advise pregnant women that diprolene af cream may increase the risk of having a low birthweight infant and to use diprolene af cream on the smallest area of skin and for the shortest duration possible. in animal reproduction studies, increased malformations, including umbilical he

United States - English - NLM (National Library of Medicine)

merck sharp & dohme corp. - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - betamethasone 0.5 mg in 1 ml - diprolene® lotion is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older. diprolene lotion is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation. risk summary there are no available data on diprolene lotion use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. advise pregnant women that diprolene lotion may increase the risk of having a low birthweight infant and to use diprolene lotion on the smallest area of skin and for the shortest duration possible. in animal reproduction studies, increased malformations, including umbilical hernias, ceph

United States - English - NLM (National Library of Medicine)

physicians total care, inc. - clotrimazole (unii: g07gz97h65) (clotrimazole - unii:g07gz97h65), betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - clotrimazole 10 mg in 1 g - clotrimazole and betamethasone dipropionate cream and lotion are indicated in patients 17 years and older for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to epidermophyton floccosum, trichophyton mentagrophytes and trichophyton rubrum. effective treatment without the risks associated with topical corticosteroid use may be obtained using a topical antifungal agent that does not contain a corticosteroid, especially for noninflammatory tinea infections. the efficacy of clotrimazole and betamethasone dipropionate cream or lotion for the treatment of infections caused by zoophilic dermatophytes (e.g. microsporum canis ) has not been established. several cases of treatment failure of clotrimazole and betamethasone dipropionate cream, usp in the treatment of infections caused by microsporum canis have been reported. clotrimazole and betamethasone dipropionate cream or lotion is contraindicated in patients who are sensitive to clotrimazole, betamethasone dip