DESOXIMETASONE- desoximetasone cream

Padagis Israel Pharmaceuticals Ltd

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DESOXIMETASONE CREAM USP, 0.25%
For Dermatologic Use Only
Not For Use In Eyes
Rx Only

DESCRIPTION
Desoximetasone Cream USP, 0.25% contains the active synthetic corticosteroid
desoximetasone. The topical corticosteroids constitute a class of primarily synthetic
steroids used as anti-inflammatory and anti-pruritic agents.
Each gram of Desoximetasone Cream USP, 0.25% contains 2.5 mg of desoximetasone
in an emollient cream consisting of aluminum monostearate, cetostearyl alcohol,
isopropyl myristate, lanolin alcohols, magnesium stearate, mineral oil, paraffin wax,
purified water, and white petrolatum.
The chemical name of desoximetasone is Pregna-1,4-diene-3,20-dione,9-fluoro-11,21-
dihydroxy-16-methyl-,(11β,16α)-. Desoximetasone has the molecular formula
C22H29FO 4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2.
The chemical structure is:

CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive
actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is
unclear. Various laboratory methods, including vasoconstrictor assays, are used to
compare and predict potencies and/or clinical efficacies of the topical corticosteroids.
There is some evidence to suggest that a recognizable correlation exists between
vasoconstrictor potency and therapeutic efficacy in man.

Pharmacokinetics -
The extent of percutaneous absorption of topical corticosteroids is determined by many
factors including the vehicle, the integrity of the epidermal barrier, and the use of
occlusive dressings.
Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or
other disease processes in the skin increase percutaneous absorption. Occlusive
dressings substantially increase the percutaneous absorption of topical corticosteroids.
Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of
resistant dermatoses.
Once absorbed through the skin, topical corticosteroids are handled through
pharmacokinetic pathways similar to systemically administered corticosteroids.
Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are
metabolized primarily in the liver and are then excreted by the kidneys. Some of the
topical corticosteroids and their metabolites are also excreted into the bile.
Pharmacokinetic studies in men with desoximetasone cream 0.25% with tagged
desoximetasone showed a total of 5.2% ± 2.9% excretion in urine (4.1% ± 2.3%) and
feces (1.1% ± 0.6%) and no detectable level (limit of sensitivity: 0.005 µg/mL) in the
blood when it was applied topically on the back followed by occlusion for 24 hours.
Seven days after application, no further radioactivity was detected in urine or feces. The
half-life of the material was 15 ± 2 hours (for urine) and 17 ± 2 hours (for feces)
between the third and fifth trial day. Studies with other similarly structured steroids have
shown that predominant metabolite reaction occurs through conjugation to form the
glucuronide and sulfate ester.

INDICATIONS AND USAGE

Desoximetasone Cream USP, 0.25% is indicated for the relief of the inflammatory and
pruritic manifestations of corticosteroid-responsive dermatoses.

CONTRAINDICATIONS
Topical corticosteroids are contraindicated in those patients with a history of
hypersensitivity to any of the components of the preparation.

WARNINGS
Desoximetasone Cream USP, 0.25% is not for ophthalmic use.
Keep out of reach of children.

PRECAUTIONS

General -
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-
pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome,
hyperglycemia, and glucosuria in some patients. Conditions which augment systemic
absorption include the application of the more potent steroids, use over large surface
areas, prolonged use, and the addition of occlusive dressings.
Therefore, patients receiving a large dose of a potent topical steroid applied to a large
surface area or under an occlusive dressing should be evaluated periodically for
evidence of HPA axis suppression by using the urinary free cortisol and ACTH
stimulation tests. If HPA axis suppression is noted, an attempt should be made to
withdraw the drug, to reduce the frequency of application, or to substitute a less potent
steroid. Recovery of HPA axis function is generally prompt and complete upon
discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal
may occur, requiring supplemental systemic corticosteroids.
Pediatric patients may absorb proportionally larger amounts of topical corticosteroids
and thus be more susceptible to systemic toxicity. (See PRECAUTIONS – Pediatric
Use). If irritation develops, topical corticosteroids should be discontinued and
appropriate therapy instituted.
In the presence of dermatological infections, the use of an appropriate antifungal or
antibacterial agent should be instituted. If a favorable response does not occur
promptly, the corticosteroid should be discontinued until the infection has been
adequately controlled.

Information for Patients

Patients using topical corticosteroids should receive the following information and
instructions:

1. This medication is to be used as directed by the physician. It is for external use

only. Avoid contact with the eyes.
2. Patients should be advised not to use this medication for any disorder other than
for which it was prescribed.
3. The treated skin area should not be bandaged or otherwise covered or wrapped as
to be occlusive unless directed by the physician.
4. Patients should report any signs of local adverse reactions, especially under
occlusive dressing.
5. Parents of pediatric patients should be advised not to use tight-fitting diapers or
plastic pants on a child being treated in the diaper area, as these garments may
constitute occlusive dressings.

Laboratory Tests
The following tests may be helpful in evaluating the HPA axis suppression:
Urinary free cortisol test
ACTH stimulation test

Carcinogenesis, Mutagenesis, Impairment of Fertility -

Long-term animal studies have not been performed to evaluate the carcinogenic
potential or the effect on fertility of topical corticosteroids.
Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed
negative results. Desoximetasone did not show potential for mutagenic activity in vitro in
the Ames microbial mutagen test with or without metabolic activation.
Pregnancy:

Teratogenic Effects:

Pregnancy Category C -
Corticosteroids are generally teratogenic in laboratory animals when administered
systemically at relatively low dosage levels. The more potent 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%.
There are no adequate and well-controlled studies in pregnant women on teratogenic
effects from topically applied corticosteroids. Therefore, Desoximetasone Cream USP,
0.25% should be used during pregnancy only if the potential benefit justifies the potential
risk to the fetus. Drugs of this class should not be used extensively on pregnant
patients, in large amounts, or for prolonged periods of time.

Nursing Mothers -
It is not known whether topical administration of corticosteroids could 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, caution should be exercised when
topical corticosteroids are administered to a nursing woman.

Pediatric Use -
Pediatric patients may demonstrate greater susceptibility to topical
corticosteroid-induced HPA axis suppression and Cushing's syndrome than
mature patients because of a larger skin surface area to body weight ratio.
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.
Administration of topical corticosteroids to pediatric patients should be limited to the
least amount compatible with an effective therapeutic regimen. Chronic corticosteroid
therapy may interfere with the growth and development of pediatric patients.

ADVERSE REACTIONS
The following local adverse reactions are reported infrequently with topical
corticosteroids, but may occur more frequently with the use of occlusive dressings.
These reactions 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, miliaria
In controlled clinical studies, the incidence of adverse reactions was low (0.8%) for
desoximetasone cream 0.25%, and included burning, folliculitis and folliculo-pustular
lesions.

OVERDOSAGE
Topically applied corticosteroids can be absorbed in sufficient amounts to produce
systemic effects (see PRECAUTIONS).

DOSAGE AND ADMINISTRATION

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

HOW SUPPLIED
Desoximetasone Cream USP, 0.25% is available as follows:
15 g tube (NDC 45802-495-35)
60 g tube (NDC 45802-495-37)

STORAGE
Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].
Manufactured By Perrigo
Bronx, NY 10457
Distributed By Perrigo
Allegan, MI 49010 ∙ www.perrigo.com
Rev 05-15
: 2C500 RC JX1

PRINCIPAL DISPLAY PANEL

Rx Only
Desoximetasone Cream USP, 0.25%
For Dermatologic Use Only. Not For Use In Eyes.
NET WT 15 g
The following image is a placeholder representing the product identifier that is either
affixed or imprinted on the drug package label during the packaging operation.

DESOXIMETASONE
desoximetasone cream

Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-495

Route of Administration TOPICAL

Active Ingredient/Active Moiety

 Ingredient Name Basis of Strength Strength
Desoximetasone (UNII: 4E07GXB7AU) (Des oximetas one - UNII:4E07GXB7AU) Des oximetas one 2.5 mg in 1 g

Inactive Ingredients
Ingredient Name Strength
ALUMINUM MONOSTEARATE (UNII: P9BC99461E)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2Z E)
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
Marketing Start Marketing End
# Item Code Package Description
Date Date
NDC:45802-495-
1 1 in 1 CARTON 11/16/2006
35
15 g in 1 TUBE; Type 0: Not a Combination
1
Product
NDC:45802-495-
2 1 in 1 CARTON 10/24/2006
37
60 g in 1 TUBE; Type 0: Not a Combination
2
Product

Marketing Information
Marketing Application Number or Monograph Marketing Start Marketing End
Category Citation Date Date
ANDA ANDA076510 10/24/2006

Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)

Revised: 8/2021 Padagis Israel Pharmaceuticals Ltd