HYDROCORTISONE BUTYRATE- hydrocortisone butyrate lotion lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sola Pharmaceuticals

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

None. 8.1 Pregnancy Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Therefore, Hydrocortisone Butyrate Lotion should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. Note: The animal multiples of human exposure calculations in this label were based on body surface area comparisons for an adult (i.e., mg/m 2 /day dose comparisons) assuming 100% human percutaneous absorption of a maximum topical human dose (MTHD) for hydrocortisone butyrate lotion (25 g lotion). 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 d

Product summary:

Hydrocortisone Butyrate Lotion, 0.1%, is white to off white in color and supplied in bottles of 4 fl. oz. (NDC 70512-032-04). Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from freezing.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROCORTISONE BUTYRATE- HYDROCORTISONE BUTYRATE LOTION LOTION
SOLA PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HYDROCORTISONE BUTYRATE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR HYDROCORTISONE
BUTYRATE.
HYDROCORTISONE BUTYRATE LOTION, 0.1%, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1982
INDICATIONS AND USAGE
Hydrocortisone Butyrate Lotion, 0.1% 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, and additional
benefits of extending treatment to 4 weeks should be weighed against
the risk of HPA axis suppression and local
adverse events. Safety and efficacy of Hydrocortisone ButyrateLotion
has not been established beyond 4 weeks of use.
(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), supplied in bottles of 4 fl. oz. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
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 ski