Halobetasol Propionate (Page 2 of 2)

Pregnancy Catergory C

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.

Halobetasol propionate has been shown to be teratogenic in SPF rats and chinchilla-type rabbits when given systemically during gestation at doses of 0.04 to 0.1 mg/kg in rats and 0.01 mg/kg in rabbits. These doses are approximately 13, 33 and 3 times, respectively, the human topical dose of halobetasol propionate ointment, 0.05%. Halobetasol propionate was embryotoxic in rabbits but not in rats.

Cleft palate was observed in both rats and rabbits. Omphalocele was seen in rats, but not in rabbits.

There are no adequate and well-controlled studies of teratogenic potential of halobetasol propionate in pregnant women. Halobetasol propionate ointment, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when halobetasol propionate ointment, 0.05% is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of halobetasol propionate ointment, 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 ointment, 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 identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

ADVERSE REACTIONS

In controlled clinical trials, the most frequent adverse events reported for halobetasol propionate ointment, 0.05% included stinging or burning in 1.6% of the patients. Less frequently reported adverse reactions were pustulation, erythema, skin atrophy, leukoderma, acne, itching, secondary infection, telangiectasia, urticara, dry skin, miliaria, paresthesia, 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 ointment, 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 ointment, 0.05% can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

DOSAGE AND ADMINISTRATION

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

Halobetasol propionate ointment, 0.05% is a high potency topical corticosteroid; therefore, treatment should be limited to two weeks, and amounts greater than 50g/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 ointment, 0.05% should not be used with occlusive dressings.

HOW SUPPLIED

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

15 g (NDC 45802-131-35) and 50 g (NDC 45802-131-32)

STORAGE

Store between 15°C and 30°C (59°F and 86°F).

MADE IN ISRAEL

MANUFACTURED BY PERRIGO, YERUHAM 80500, ISRAEL

DISTRIBUTED BY
PERRIGO ®
ALLEGAN, MI 49010

REV. 10/31/2011

Repacked By:

H.J. Harkins Company, Inc.

Nipomo, CA 93444

: 9R500 RC J2

Principal Display Panel

Halobetasol Propionate Ointment, 0.05%

Rx Only

Halobetasol Propionate Ointment, 0.05% Carton Image #1
(click image for full-size original)

Halobetasol Propionate Ointment, 0.05% Carton Image #1

HALOBETASOL PROPIONATE
halobetasol propionate ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52959-961(NDC:45802-131)
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
ALUMINUM STEARATE
YELLOW WAX
PETROLATUM
PROPYLENE GLYCOL
SORBITAN SESQUIOLEATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52959-961-50 1 TUBE (TUBE) in 1 CARTON contains a TUBE
1 50 g in 1 TUBE This package is contained within the CARTON (52959-961-50)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076872 02/05/2009
Labeler — H.J. Harkins Company, Inc. (147681894)
Registrant — Otsuka America Pharmaceutical, Inc. (008314390)
Establishment
Name Address ID/FEI Operations
Perrigo Nwe York Inc 078846912 manufacture

Revised: 12/2011 H.J. Harkins Company, Inc.

Page 2 of 2 1 2

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2023. All Rights Reserved.