HYDROCORTISONE BUTYRATE lotion

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

The J. Molner Company LLC

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

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:

Abbreviated New Drug Application

Ürün özellikleri

HYDROCORTISONE BUTYRATE- HYDROCORTISONE BUTYRATE LOTION
THE J. MOLNER COMPANY LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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, 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 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:_ (5)
o 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) (5)
o Systemic effects of topical corticosteroids may also include
manifestations of Cushing’s syndrome,
hyperglycemia, and glucosuria. (5.1, 8.4) (5)
o Pediatric patients may be more susceptible to systemic toxicity due
to their larger skin-surface-to-body-
mass ra