LOCOID LIPOCREAM- 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:

Bausch Health US, LLC

INN (International Name):

HYDROCORTISONE BUTYRATE

Composition:

HYDROCORTISONE BUTYRATE 1 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Locoid Lipocream is indicated for: None. Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Therefore, Locoid Lipocream 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 cream (25 g). 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

Product summary:

Locoid Lipocream® Cream, 0.1% is white to off-white in color, and supplied in tubes of 45 g (NDC 16781-384-45) and 60 g (NDC 16781-384-60). 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.

Authorization status:

New Drug Application

Summary of Product characteristics

LOCOID LIPOCREAM- HYDROCORTISONE BUTYRATE CREAM
BAUSCH HEALTH US, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LOCOID LIPOCREAM
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LOCOID
LIPOCREAM.
LOCOID LIPOCREAM (HYDROCORTISONE BUTYRATE) CREAM, 0.1%,
FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1982
INDICATIONS AND USAGE
Locoid Lipocream is a corticosteroid indicated for:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Cream, 0.1% (1 mg/g) supplied in tubes of 45 g and 60 g. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reactions (≥1%) are application site
reactions. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BAUSCH HEALTH US, LLC
AT 1-800-321-
4576 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 3/2021
®
®
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)
Apply a thin layer to the affected skin areas 2 or 3 times daily for
corticosteroid-responsive
dermatoses in adults. (2)
Apply a thin layer to the affected skin areas 2 times daily for atopic
dermatitis in patients 3 months of
age and older. (2)
Rub in gently. (2)
Discontinue Locoid Lipocream 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 hypothalamic-pituitary-adrenal (HPA) axis suppression and local
adverse events. Safety and
efficacy of Locoid Lipocream has not been established beyond 4 weeks
of use. (2)
Avoid use under occlusion or in the diaper area. (2)
Locoid Lipocream is not for oral, ophthalmic, or intravaginal use. (2)
Reversible hypothalamic-pituitary-adrenal (HPA) a