HYDROCORTISONE BUTYRATE- hydrocortisone butyrate lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teligent Pharma, Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hydrocortisone Butyrate Lotion is indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. None. 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/m2 /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

Product summary:

Hydrocortisone Butyrate Lotion, 0.1%, is white to off white in color and supplied in bottles of 2 fl. oz. (NDC 52565-087-02) and 4 fl. oz. (NDC 52565-087-04). 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
TELIGENT PHARMA, INC.
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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
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DOSAGE FORMS AND STRENGTHS
Lotion, 0.1% (1 mg/g), supplied in bottles of 2 fl. oz. and 4 fl. oz.
(3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
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•
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ADVERSE REACTIONS
The most common adverse reactions (> 1%) are application site
reactions. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TELIGENT PHARMA, INC.
AT 1- 856-697-1441 AND/OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 11/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
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 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)
Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may
occur, with the potential for
glucocorticosteroid insufficiency. Consider periodic evaluations fo