HYDROCORTISONE BUTYRATE lotion

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

HYDROCORTISONE BUTYRATE (UNII: 05RMF7YPWN) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

Mevcut itibaren:

Oceanside Pharmaceuticals

Uygulama yolu:

TOPICAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Hydrocortisone Butyrate Lotion is indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. None. Risk Summary There are no controlled or large-scale epidemiologic studies with Hydrocortisone Butyrate Lotion in pregnant women, and available data on hydrocortisone butyrate use in pregnant women have not identified a drug associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. In animal reproduction studies, when administered subcutaneously or topically to pregnant rats, rabbits, and mice, hydrocortisone butyrate induced adverse reproductive and developmental outcomes, including abortion, fetal death, malformation, delayed ossification, decrease in fetal weight, and delay in sexual maturation (see Data) . The available data do not allow the calculation of relevant comparisons between the systemic exposure of hydrocortisone butyrate observed in animal studies and the systemic exposure that would be expected in humans after topical use of Hydrocortisone Butyrate Lotion. 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 background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Systemic embryofetal development studies were conducted in rats and rabbits. Subcutaneous doses of 0.6, 1.8, and 5.4 mg/kg/day hydrocortisone butyrate were administered to pregnant female rats during gestation days 6 – 17. In the presence of maternal toxicity, fetal effects noted at 5.4 mg/kg/day included increased ossification variations and unossified sternebra. No treatment-related embryofetal toxicity or malformation were noted at 5.4 and 1.8 mg/kg/day, respectively. Subcutaneous doses of 0.1, 0.2 and 0.3 mg/kg/day hydrocortisone butyrate were administered to pregnant female rabbits during gestation days 7 – 20. Increased abortion was noted at 0.3 mg/kg/day. In the absence of maternal toxicity, a dose-dependent decrease in fetal body weight was noted at doses ≥0.1 mg/kg/day. Embryofetal toxicities (reduction in litter size, decreased number of viable fetuses, and increased post-implantation loss) were noted at doses ≥0.2 mg/kg/day. Additional fetal effects included delayed ossification noted at doses ≥0.1 mg/kg/day and increased fetal malformations (primarily skeletal malformations) noted at doses ≥0.2 mg/kg/day. A dose at which no embryofetal toxicity or malformation was observed was not established in this study. Additional systemic embryofetal development studies were conducted in rats and mice. Subcutaneous doses of 0.1 and 9 mg/kg/day hydrocortisone butyrate were administered to pregnant female rats during gestation days 9 – 15. In the presence of maternal toxicity, an increase in fetal death and fetal resorption and an increase in ossification of caudal vertebrae were noted at 9 mg/kg/day. No treatment-related embryofetal toxicity or malformation was noted at 0.1 mg/kg/day. Subcutaneous doses of 0.2 and 1 mg/kg/day hydrocortisone butyrate were administered to pregnant female mice during gestation days 7 – 13. In the absence of maternal toxicity, an increased number of cervical ribs and one fetus with clubbed legs were noted at 1 mg/kg/day. No treatment-related embryofetal toxicity or malformation was noted at 1 and 0.2 mg/kg/day. No topical embryofetal development studies were conducted with hydrocortisone butyrate lotion. However, topical embryofetal development studies were conducted in rats and rabbits with a hydrocortisone butyrate ointment formulation. Topical doses of 1% and 10% hydrocortisone butyrate ointment were administered to pregnant female rats during gestation days 6 – 15 or pregnant female rabbits during gestation days 6 – 18. A dose-dependent increase in fetal resorption was noted in rabbits and fetal resorptions were noted in rats at the 10% hydrocortisone butyrate ointment dose. No treatment-related embryofetal toxicity was noted at the 1% hydrocortisone butyrate ointment dose in rats. A dose at which no embryofetal toxicity was observed in rabbits after topical administration of hydrocortisone butyrate ointment was not established. No treatment-related malformation was noted at a dose of 10% hydrocortisone butyrate ointment in rats or rabbits. A peri- and post-natal development study was conducted in rats. Subcutaneous doses of 0.6, 1.8 and 5.4 mg/kg/day hydrocortisone butyrate were administered to pregnant female rats from gestation day 6 to lactation day 20. In the presence of maternal toxicity, a dose-dependent decrease in fetal weight was noted at doses ≥1.8 mg/kg/day. No treatment-related fetal toxicity was noted at 0.6 mg/kg/day. A delay in sexual maturation was noted at 5.4 mg/kg/day. No treatment-related effects on sexual maturation were noted at 1.8 mg/kg/day. No treatment-related effects on behavioral development or subsequent reproductive performance were noted at 5.4 mg/kg/day. Risk Summary There are no data on the presence of hydrocortisone butyrate in human or animal milk, effects on the breastfed infant, or effects on milk production. 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 Hydrocortisone Butyrate Lotion 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 Hydrocortisone Butyrate Lotion and any potential adverse effects on the breastfed infant from Hydrocortisone Butyrate Lotion or from the underlying maternal condition. Clinical Considerations To minimize potential exposure to the breastfed infant via breast milk, use Hydrocortisone Butyrate Lotion on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women to wash off prior to breastfeeding any Hydrocortisone Butyrate Lotion that has been applied to the areas at risk for direct infant contact. The safety and effectiveness of Hydrocortisone Butyrate Lotion for the topical treatment of mild to moderate atopic dermatitis have been established in pediatric patients 3 months of age and older. Use of Hydrocortisone Butyrate Lotion for this indication is supported by evidence from an adequate and well-controlled trial in 284 pediatric patients 3 months to 18 years of age with mild to moderate atopic dermatitis. The safety and effectiveness of Hydrocortisone Butyrate Lotion have not been established in pediatric patients younger than 3 months of age. Endocrine Adverse Reactions Eighty-four (84) pediatric subjects (3 months to less than 18 years of age) with moderate to severe atopic dermatitis affecting at least 25% of body surface area (BSA) treated with Hydrocortisone Butyrate Lotion three times daily for up to 4 weeks were assessed for HPA axis suppression. The disease severity (moderate to severe atopic dermatitis) and the dosing regimen (three times daily) in this HPA axis trial were different from the subject population (mild to moderate atopic dermatitis) and the dosing regimen (twice daily) for which Hydrocortisone Butyrate Lotion is indicated. Seven of the 82 evaluable subjects (8.5%) demonstrated laboratory evidence of HPA axis suppression, where the criterion for defining HPA axis suppression was a serum cortisol level of less than or equal to 18 mcg/dL after cosyntropin stimulation. Subjects with HPA axis suppression ranged from 1 to 12 years of age and, at the time of enrollment, had 35% to 90% BSA involvement. These subjects did not develop any other signs or symptoms of HPA axis suppression. At the first follow-up visit, approximately 1 month after the conclusion of treatment, cosyntropin stimulation results of all subjects had returned to normal, with the exception of one subject. This last subject recovered adrenal function by the second post-treatment visit, 55 days post-treatment [see Clinical Pharmacology (12.2)] . Because of higher skin-surface-to-body-mass ratios, pediatric patients are at a greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids [see Warnings and Precautions (5.1)] . They are therefore also at a greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of Cushing’s syndrome while on treatment. Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include low plasma cortisol levels to an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Clinical trials of Hydrocortisone Butyrate Lotion did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger adult subjects.

Ürün özeti:

How Supplied Hydrocortisone Butyrate Lotion, 0.1% is white to off-white in color and supplied in: Storage and Handling Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from freezing.

Yetkilendirme durumu:

New Drug Application Authorized Generic

Ürün özellikleri

HYDROCORTISONE BUTYRATE- HYDROCORTISONE BUTYRATE LOTION
OCEANSIDE PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HYDROCORTISONE
BUTYRATE LOTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
HYDROCORTISONE BUTYRATE LOTION.
HYDROCORTISONE BUTYRATE LOTION, 0.1%, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1982
INDICATIONS AND USAGE
Hydrocortisone Butyrate Lotion is a corticosteroid indicated for the
topical treatment of mild to moderate
atopic dermatitis in patients 3 months of age and older. ( 1)
DOSAGE AND ADMINISTRATION
Apply a thin layer to the affected skin two times daily. ( 2)
Rub in gently. ( 2)
Discontinue Hydrocortisone Butyrate Lotion when control is achieved. (
2)
Reassess diagnosis if no improvement is seen within 2 weeks. Before
prescribing for more than 2
weeks, any additional benefits of extending treatment up to 4 weeks
should be weighed against the risk
of HPA axis suppression and local adverse reactions. ( 2)
Avoid use under occlusion or in the diaper area. ( 2)
Hydrocortisone Butyrate Lotion is not for oral, ophthalmic, or
intravaginal use. ( 2)
DOSAGE FORMS AND STRENGTHS
Lotion: 0.1% (1 mg/g) ( 3)
CONTRAINDICATIONS
None. ( 4)
WARNINGS AND PRECAUTIONS
_Endocrine System Adverse Reactions:_
Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may
occur, with the potential for
glucocorticosteroid insufficiency. Consider periodic evaluations for
HPA axis suppression if
Hydrocortisone Butyrate Lotion is applied to large surface areas or
used under occlusion. If HPA axis
suppression is noted, reduce the application frequency, discontinue
use, or switch to a lower potency
corticosteroid. ( 5.1, 8.4)
Systemic effects of topical corticosteroids may also include
manifestations of Cushing’s syndrome,
hyperglycemia, and glucosuria. ( 5.1, 8.4)
Pediatric patients may be more susceptible to systemic toxicity due to
their larger skin-surface-to-
body-mass ratios. ( 5.1, 8.4)
_Ophthalmic Adverse Reactions: