HYDROCORTISONE BUTYRATE- hydrocortisone butyrate cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Actavis Pharma, Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) is indicated for: - Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adults. - The topical treatment of mild to moderate atopic dermatitis in pediatric patients 3 months to 18 years of age. None. Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Therefore, Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) 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/m2 /day dose comparisons) assuming 100% human percutaneous absorption of a maximum topic

Product summary:

Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) is supplied in tubes of 15 g (NDC 0472-0490-15), 45 g (NDC 0472-0490-45), and 60 g (NDC 0472-0490-60). Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° 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 CREAM
ACTAVIS PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HYDROCORTISONE BUTYRATE CREAM
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
HYDROCORTISONE BUTYRATE CREAM.
HYDROCORTISONE BUTYRATE CREAM, 0.1% (LIPOPHILIC), FOR TOPICAL USE ONLY
INITIAL U.S. APPROVAL: 1982
INDICATIONS AND USAGE
Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) is a
corticosteroid indicated for:
Relief of the inflammatory and pruritic manifestations of
corticosteroid-responsive dermatoses in adults. (1)
The treatment of mild to moderate atopic dermatitis in patients 3
months to 18 years of age. (1)
DOSAGE AND ADMINISTRATION
Apply a thin layer to the affected skin areas two or three times daily
for corticosteroid-responsive dermatoses in adults.
(2)
Apply a thin layer to the affected skin areas two times daily for
atopic dermatitis in patients 3 months of age and older.
(2)
Rub in gently. (2)
Discontinue Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) 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 events. Safety and efficacy of Hydrocortisone Butyrate Cream
USP, 0.1% (Lipophilic) has not been established
beyond 4 weeks of use. (2)
Avoid use under occlusion or in the diaper area. (2)
Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) is not for oral,
ophthalmic, or intravaginal use. (2)
DOSAGE FORMS AND STRENGTHS
Cream, 0.1% (1 mg/g), supplied in tubes of 15 g, 45 g, and 60 g. (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 Cream USP, 0.1%
(Lipophili