Halobetasol Propionate (Page 2 of 2)

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 is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Halobetasol Propionate Ointment in pediatric 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 axis 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 850 patients treated with Halobetasol Propionate Ointment in clinical studies, 21% 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 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, urticaria, 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. 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.

To report SUSPECTED ADVERSE REACTIONS, contact Quagen Pharmaceuticals LLC at 1-888-344-9603 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

Topically applied Halobetasol Propionate Ointment can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).

DOSAGE AND ADMINISTRATION

Apply a thin layer of Halobetasol Propionate Ointment to the affected skin once or twice daily, as directed by your physician, and rub in gently and completely.

Halobetasol Propionate Ointment 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 Ointment should not be used with occlusive dressings.

HOW SUPPLIED

Halobetasol Propionate Ointment, 0.05% is supplied in the following tube sizes:

15 g (NDC 70752-119-02)
50 g (NDC 70752-119-04)

STORAGE

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Manufactured by:
Quagen Pharmaceuticals LLC
West Caldwell, NJ 07006

52010
Rev. 10/20

Principal Display Panel – 15 g Carton Label

Halobetasol Propionate
Ointment 0.05%
RX Only
15 g

Principal Display Panel – 50 g Carton Label

Halobetasol Propionate
Ointment 0.05%
RX Only
50 g

HALOBETASOL PROPIONATE halobetasol propionate ointment

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70752-119 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 PETROLATUM WHITE WAX PROPYLENE GLYCOL SORBITAN SESQUIOLEATE MONOSTEARYL CITRATE PENTAERYTHRITOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70752-119-02 1 TUBE in 1 CARTON contains a TUBE 1 15 g in 1 TUBE This package is contained within the CARTON (70752-119-02) 2 NDC:70752-119-04 1 TUBE in 1 CARTON contains a TUBE 2 50 g in 1 TUBE This package is contained within the CARTON (70752-119-04)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA213560 10/06/2020

Labeler — QUAGEN PHARMACEUTICALS LLC (073645339)

Registrant — QUAGEN PHARMACEUTICALS LLC (073645339)

Establishment
Name	Address	ID/FEI	Operations
QUAGEN PHARMACEUTICALS LLC		080281331	MANUFACTURE (70752-119), PACK (70752-119)

Revised: 02/2023 QUAGEN PHARMACEUTICALS LLC