Desoximetasone (Page 2 of 2)

Laboratory Tests

The following tests may be helpful in evaluating patients for HPA axis suppression:

ACTH stimulation test
Urinary free cortisol test

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of desoximetasone.

Desoximetasone was nonmutagenic in the Ames test.

Pregnancy

Teratogenic Effects

Pregnancy Category 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.

Desoximetasone has been shown to be teratogenic and embryotoxic in mice, rats, and rabbits when given by subcutaneous or dermal routes of administration in doses 3 to 30 times the human dose of Desoximetasone Cream USP, 0.25% or in doses 15 to 150 times the human dose of Desoximetasone Cream USP, 0.05% or Desoximetasone Gel USP, 0.05%.

There are no adequate and well-controlled studies in pregnant women. Desoximetasone Cream USP, 0.05%; Desoximetasone Cream USP, 0.25% and Desoximetasone Gel USP, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than adult patients because of a larger skin surface area to body weight ratio.

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Chronic corticosteroid therapy may interfere with linear bone growth in pediatric patients.

Geriatric Use

Clinical studies of Desoximetasone Cream USP, 0.05%; Desoximetasone Cream USP, 0.25% and Desoximetasone Gel USP, 0.05% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In generally, dose selection for an elderly patient should be cautious.

ADVERSE REACTIONS

In controlled clinical studies the incidence of adverse reactions was low (0.8%) for Desoximetasone Cream USP, 0.05% and included pruritus, erythema, vesiculation and burning sensation. The incidence of adverse reactions was also 0.8% for Desoximetasone Cream USP, 0.25% and included burning, folliculitis, and folliculopustular lesions. The incidence of adverse reactions for Desoximetasone Gel USP, 0.05% was 0.3% with one subject reporting stinging and burning at the site of application.

The following local adverse reactions are reported infrequently when topical corticosteroids are used as recommended but may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.

Systemic absorption of topical corticosteroids has produced hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

OVERDOSAGE

Topically applied Desoximetasone Cream USP, 0.05%; Desoximetasone Cream USP, 0.25% and Desoximetasone Gel USP, 0.05% can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

DOSAGE AND ADMINISTRATION

Apply a thin film of Desoximetasone Cream USP, 0.05% or Desoximetasone Cream USP, 0.25% or Desoximetasone Gel USP, 0.05% to the affected skin areas twice daily. Rub in gently.

HOW SUPPLIED

Desoximetasone Cream USP, 0.05% is supplied in 15 gram (NDC 51672-1271-1), 60 gram (NDC 51672-1271-3), 100 gram (NDC 51672-1271-7) tubes and 300 gram carton (3 × 100 gram tubes) (NDC 51672-1271-8).

Desoximetasone Cream USP, 0.25% is supplied in 15 gram (NDC 51672-1270-1), 60 gram (NDC 51672-1270-3), 100 gram (NDC 51672-1270-7) tubes and 200 gram carton (2 × 100 gram tubes) (NDC 51672-1270-9)

Desoximetasone Gel USP, 0.05% is supplied in 15 gram (NDC 51672-1261-1) and 60 gram (NDC 51672-1261-3) tubes.

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

Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1
Revised June, 2009

PK-6352-0

PRINCIPAL DISPLAY PANEL — 0.05%, 15 g Tube Carton

NDC 51672-1271-1

15 g

Desoximetasone Cream USP, 0.05%

FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.

Rx only

Keep this and all medications out of the reach of children.

TARO

PRINCIPAL DISPLAY PANEL -- 0.05%, 15 g Tube Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.25%, 15 g Tube Carton

NDC 51672-1270-1

15 g

Desoximetasone Cream USP, 0.25%

FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.

Rx only

Keep this and all medications out of the reach of children.

TARO

PRINCIPAL DISPLAY PANEL -- 0.25%, 15 g Tube Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.05%, 15 g Tube Carton

NDC 51672-1261-1

15 g

Desoximetasone Gel USP, 0.05%

FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.

Rx only

Keep this and all medications out of the reach of children.

TARO

PRINCIPAL DISPLAY PANEL -- 0.05%, 15 g Gel Tube Carton
(click image for full-size original)
DESOXIMETASONE
desoximetasone cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42254-015(NDC:51672-1270)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
desoximetasone (desoximetasone) desoximetasone 2.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
petrolatum
water
isopropyl myristate
mineral oil
cetostearyl alcohol
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42254-015-60 1 TUBE (TUBE) in 1 CARTON contains a TUBE
1 60 g in 1 TUBE This package is contained within the CARTON (42254-015-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA073193 11/30/1990
Labeler — Rebel Distributors Corp (118802834)
Establishment
Name Address ID/FEI Operations
Rebel Distributors Corp 118802834 RELABEL, REPACK

Revised: 11/2011 Rebel Distributors Corp

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