Halobetasol Propionate (Page 2 of 2)

Pediatric Use

Safety and effectiveness of halobetasol propionate cream, 0.05% in pedriatric patients have not been established and use in pediatric patients under 12 is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.

HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Geriatric Use

Of approximately 400 patients treated with halobetasol propionate cream, 0.05% in clinical studies, 25% were 61 years and over and 6% were 71 years and over. No overall differences in safety or effectiveness were observed between these patients and younger patients; and other reported clinical experience has not indentified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Adverse Reactions to Halobetasol Propionate

In controlled clinical trials, the most frequent adverse events reported for halobetasol propionate cream, 0.05% included stinging, burning or itching in 4.4% of the patients. Less frequently reported adverse reactions were dry skin, erythema, skin atrophy, leukoderma, vesicles and rash.

The following additional local adverse reactions are reported infrequently with topical corticosteroids, and they may occur more frequently with high potency corticosteroids, such as halobetasol propionate cream, 0.05%. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria.

OVERDOSAGE

Topically applied halobetasol propionate cream, 0.05% can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

DOSAGE AND ADMINISTRATION

Apply a thin layer of halobetasol propionate cream, 0.05% to the affected skin once or twice daily, as directed by your physician, and rub in gently and completely.

Halobetasol propionate cream, 0.05% is a super-high potency topical corticosteroid; therefore, treatment should be limited to two weeks, and amounts greater than 50 g/wk should not be used. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Halobetasol propionate cream, 0.05% should not be used with occlusive dressings.

HOW SUPPLIED/STORAGE AND HANDLING

Halobetasol propionate cream, 0.05% is supplied in the following tube sizes:

50 g (NDC 54868-4907-0)

STORAGE

Store at 20 — 25°C (68 — 77°F) (See USP Controlled Room Temperature).

MADE IN ISRAEL

MANUFACTURED BY PERRIGO, YERUHAM, ISRAEL 80500

DISTRIBUTED BY

PERRIGO®

ALLEGAN, MI 49010

Rev. 5/07

4C600 RC J2

Relabeling of “Additional Barcode Label” by:
Physicians Total Care, Inc.
Tulsa, OK 74146

PRINCIPAL DISPLAY PANEL

Halobetasol propionate cream, 0.05%

50 g

image of 50 gram cream package label
(click image for full-size original)
HALOBETASOL PROPIONATE
halobetasol propionate cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4907(NDC:45802-129)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HALOBETASOL PROPIONATE (HALOBETASOL) HALOBETASOL PROPIONATE 0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL
DIAZOLIDINYL UREA
GLYCERIN
ISOPROPYL PALMITATE
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE
STEARETH-21
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4907-0 1 TUBE (TUBE) in 1 CARTON contains a TUBE
1 50 g in 1 TUBE This package is contained within the CARTON (54868-4907-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077123 05/25/2005
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 10/2010 Physicians Total Care, Inc.

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