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

sola pharmaceuticals - halobetasol propionate (unii: 91a0k1ty3z) (halobetasol - unii:9p6159hm7t) - halobetasol propionate ointment is 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)

pharmasol corporation - halobetasol propionate (unii: 91a0k1ty3z) (halobetasol - unii:9p6159hm7t) - halobetasol propionate topical foam is indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older. none. risk summary there are no available data on halobetasol propionate topical foam use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. in animal reproduction studies, increased malformations, including cleft palate and omphalocele, were observed after oral administration of halobetasol propionate during organogenesis to pregnant rats and rabbits. no comparisons of animal exposure with human exposure may be calculated due to minimal systemic exposure in humans after topical administration of halobetasol propionate topical foam [see clinical pharmacology (12.3)] . the background risk of major birth defects and miscarriage for the indicated population are unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognize

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

teligent pharma, inc. - halobetasol propionate (unii: 91a0k1ty3z) (halobetasol - unii:9p6159hm7t) - halobetasol propionate ointment, 0.05% is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (hpa) axis. use in children under 12 years of age is not recommended. as with other highly active corticosteroids, therapy should be discontinued when control has been achieved. if no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. halobetasol propionate ointment is 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)

ranbaxy laboratories inc. - halobetasol propionate (unii: 91a0k1ty3z) (halobetasol - unii:9p6159hm7t) - halobetasol propionate 0.5 mg in 1 g - ultravate cream 0.05% is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (hpa) axis. use in children under 12 years of age is not recommended. as with other highly active corticosteroids, therapy should be discontinued when control has been achieved. if no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. ultravate cream is 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)

ranbaxy laboratories inc. - halobetasol propionate (unii: 91a0k1ty3z) (halobetasol - unii:9p6159hm7t) - halobetasol propionate 0.50 mg in 1 g - ultravate ointment 0.05% is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (hpa) axis. use in children under 12 years of age is not recommended. as with other highly active corticosteroids, therapy should be discontinued when control has been achieved. if no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. ultravate ointment is 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)

mayne pharma - halobetasol propionate (unii: 91a0k1ty3z) (halobetasol - unii:9p6159hm7t) - halobetasol propionate topical foam is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. none. risk summary there are no available data on halobetasol propionate topical foam use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. published data report an increased risk of low birthweight with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. in animal reproduction studies, increased malformations, including cleft palate and omphalocele, were observed after oral administration of halobetasol propionate during organogenesis to pregnant rats and rabbits. no comparisons of animal exposure with human exposure may be calculated due to minimal systemic exposure in humans after topical administration of halobetasol propionate topical foam [see clinical pharmacology (12.3) ]. the background risk of major birth defects and miscarriage for the indica

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

sun pharmaceutical industries, inc. - halobetasol propionate (unii: 91a0k1ty3z) (halobetasol - unii:9p6159hm7t) - halobetasol propionate 0.5 mg in 1 g - ultravate lotion is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. none. risk summary there are no available data on ultravate lotion use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. published data report an increased risk of low birthweight with the use of greater than 300 grams of potent or very potent topical corticosteroid during pregnancy. in animal reproduction studies, halobetasol propionate administered systemically during organogenesis to pregnant rats at 13 and 33 times the human topical dose and to pregnant rabbits at 3 times the human topical dose resulted in teratogenic and embryotoxic effects [see data]. the clinical relevance of the animal findings is not clear. the background risk of major birth defects and miscarriage for the indicated population are unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in cli

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

mayne pharma - halobetasol propionate (unii: 91a0k1ty3z) (halobetasol - unii:9p6159hm7t) - halobetasol propionate topical foam is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. none. risk summary there are no available data on halobetasol propionate topical foam use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. in animal reproduction studies, increased malformations, including cleft palate and omphalocele, were observed after oral administration of halobetasol propionate during organogenesis to pregnant rats and rabbits. no comparisons of animal exposure with human exposure may be calculated due to minimal systemic exposure in humans after topical administration of halobetasol propionate topical foam [see clinical pharmacology (12.3)] . the background risk of major birth defects and miscarriage for the indicated population are unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data halobetasol propionate has been shown to cause malformations in rats and rabbits when given orally during organogenesis at doses of 0.04 to 0.1 mg/kg/day in rats and 0.01 mg/kg/day in rabbits. halobetasol propionate was embryotoxic in rabbits, but not in rats. cleft palate was observed in both rats and rabbits. omphalocele was seen in rats, but not in rabbits. risk summary there are no data on the presence of halobetasol propionate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production after topical application to women who are breastfeeding. systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. it is not known whether topical administration of corticosteroids 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 halobetasol propionate topical foam and any potential adverse effects on the breastfed infant from halobetasol propionate topical foam or from the underlying maternal condition. clinical considerations advise breastfeeding women not to apply halobetasol propionate topical foam directly to the nipple and/or areola to avoid direct infant exposure. safety and effectiveness of halobetasol propionate topical toam in patients younger than 12 years of age have not been established; therefore, use in children younger than 12 years is not recommended. the safety and effectiveness of halobetasol propionate topical foam for the treatment of stable plaque psoriasis in subjects 12 to less than 18 years of age is supported by evidence from adequate and well-controlled studies in adults and from one open-label safety study in 24 subjects aged 12 to less than 18 years. subjects 12 to less than 18 years with stable plaque psoriasis covering a minimum of 10% of the total body surface area at baseline were treated twice daily for 2 weeks with halobetasol propionate topical foam. hypothalamic-pituitary adrenal (hpa) axis function (acth stimulation test) was evaluated in a subset of 23 subjects. after 2 weeks of treatment, 6 of 23 subjects (26.1%) experienced laboratory evidence of adrenal suppression (i.e., cortisol serum level of ≤18 µg/dl) that recovered upon retesting after at least 4 weeks of stopping the treatment [see clinical pharmacology (12.2)] . because of higher skin surface area to body mass ratios, pediatric patients are at a greater risk than adults of hpa axis suppression and cushing's syndrome when they are treated with topical corticosteroids. they are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. adverse reactions including striae have been reported with use of topical corticosteroids in infants and children [see warnings and precautions (5.1)] . hpa axis suppression, cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to acth stimulation. manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema [see warnings and precautions (5.1)] . clinical studies with halobetasol propionate topical foam included 131 patients aged 65 years and over. no overall differences in safety or effectiveness were observed between these patients and those younger than 65 years. instructions for use halobetasol propionate (hal-oh-bay-ta-sol pro-pee-oh-nate) topical foam, 0.05% read the patient information and instructions for use before you use halobetasol propionate topical foam. important information: halobetasol propionate topical foam is for skin use only. do not get halobetasol propionate topical foam in your mouth, eyes, or vagina. this instructions for use has been approved by the u.s. food and drug administration. distributed by: mayne pharma raleigh, nc 27609 rev 05/2023

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

bryant ranch prepack - halobetasol propionate (unii: 91a0k1ty3z) (halobetasol - unii:9p6159hm7t) - halobetasol propionate ointment 0.05% is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (hpa) axis. use in children under 12 years of age is not recommended. as with other highly active corticosteroids, therapy should be discontinued when control has been achieved. if no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. halobetasol propionate ointment is 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)

bryant ranch prepack - halobetasol propionate (unii: 91a0k1ty3z) (halobetasol - unii:9p6159hm7t) - halobetasol propionate ointment 0.05% is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (hpa) axis. use in children under 12 years of age is not recommended. as with other highly active corticosteroids, therapy should be discontinued when control has been achieved. if no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. halobetasol propionate ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.