LOCOID- 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:

Bausch Health US, LLC

INN (International Name):

HYDROCORTISONE BUTYRATE

Composition:

HYDROCORTISONE BUTYRATE 1 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

LOCOID® Lotion is indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. None. Pregnancy   Risk Summary There are no controlled or large-scale epidemiologic studies with LOCOID 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 after topical use of LO

Product summary:

How Supplied LOCOID 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.

Authorization status:

New Drug Application

Summary of Product characteristics

LOCOID- HYDROCORTISONE BUTYRATE LOTION
BAUSCH HEALTH US, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LOCOID LOTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LOCOID LOTION.
LOCOID (HYDROCORTISONE BUTYRATE) LOTION, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1982
INDICATIONS AND USAGE
LOCOID 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
•
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Lotion: 0.1% (1 mg/g) (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
•
o
o
o
•
•
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 AND/OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 10/2023
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
®
Apply a thin layer to the affected skin two times daily. (2)
Rub in gently. (2)
Discontinue LOCOID 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 up 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)
LOCOID Lotion is not for oral, ophthalmic, or intravaginal use. (2)
_Endocrine System Adverse Reactions:_
Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may
occur, with the potential for
glucocorticosteroid insufficiency. Consider periodic evaluations for
HPA axis suppression if LOCOID
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 co