U-CORT - hydrocortisone acetate cream 
Taro Pharmaceuticals U.S.A., Inc.

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U-cort®
(HYDROCORTISONE ACETATE CREAM USP, 1%)

Rx only

DESCRIPTION

The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Hydrocortisone acetate cream is a member of this class. Hydrocortisone Acetate has the chemical name pregn-4-ene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-11β)-. It has the following structural formula:

Molecular Weight: 404.50       Molecular Formula C23H32O6

Each gram of the cream contains 10 mg Hydrocortisone Acetate, USP in a water-washable vanishing cream base containing urea (10%), purified water, stearic acid, propylene glycol, isopropyl myristate, isopropyl palmitate, PPG-26 oleate, sodium laureth sulfate, triethanolamine, xanthan gum, sodium bisulfite, cetyl alcohol, edetate disodium, carbomer 940 with hypoallergenic perfume. It is non-occlusive, and contains no mineral oil, petrolatum, lanolin or parabens.

CLINICAL PHARMACOLOGY

Topical corticosteroids share anti-inflammatory, antipruritic 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. (See DOSAGE AND ADMINISTRATION.)

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma protein 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.

INDICATIONS AND USAGE

U-cort (Hydrocortisone Acetate Cream USP, 1%) 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

Contains sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

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 additions of occlusive dressings.

Therefore, patients receiving a large dose of potent topical steroids 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.

Children 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. As with any topical corticosteroid product, prolonged use may produce atrophy of the skin and subcutaneous tissues. When used on intertriginous or flexor areas, or on the face, this may occur even with short-term use.

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 the Patient

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, and 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.

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. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids 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 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 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 a topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature 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 children receiving topical corticosteroids. Manifestations of adrenal suppression in children 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 children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

ADVERSE REACTIONS

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence beginning with column 1:

Burning	Hypertrichosis
Maceration of the skin	Itching
Acneiform eruptions	Secondary infection
Irritation	Hypopigmentation
Skin atrophy	Dryness
Perioral dermatitis	Striae
Folliculitis	Allergic contact dermatitis
Miliaria

OVERDOSAGE

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

DOSAGE AND ADMINISTRATION

U-cort (Hydrocortisone Acetate Cream USP, 1%) is generally applied to the affected area as a thin film two to four times daily, depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

HOW SUPPLIED

U-cort® (Hydrocortisone Acetate Cream USP, 1%) is supplied in 5 g (NDC 51672-3009-5) for physician samples,1 oz (28.35 g) (NDC 51672-3009-2), 3 oz (85 g) (NDC 51672-3009-8) and 4.3 oz (123 g) (NDC 51672-3009-4) tube sizes.

Store at controlled room tempertature 15° - 30°C (59°-86°F). Protect from freezing.

Pharmacist: Dispense in tight containers as specified in USP.

Manufactured by:	Taro Pharmaceuticals Inc.
	Brampton, Ontario, Canada L6T 1C1

Distributed by:	TaroPharma
	a division of Taro Pharmaceuticals U.S.A., Inc.
	Hawthorne, NY 10532

U-cort® & TaroPharma® are trademarks of Taro Pharmaceuticals U.S.A., Inc. and/or its affiliates.

Revised: November, 2008

U-CORT  hydrocortisone acetate   cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51672-3009 Route of Administration TOPICAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Hydrocortisone Acetate (Hydrocortisone) Active 10 MILLIGRAM  In 1 GRAM urea Inactive   water Inactive   stearic acid Inactive   propylene glycol Inactive   isopropyl myristate Inactive   isopropyl palmitate Inactive   PPG-26 oleate Inactive   sodium laureth sulfate Inactive   triethanolamine Inactive   xanthan gum Inactive   sodium bisulfite Inactive   cetyl alcohol Inactive   edetate disodium Inactive   carbomer 940 with hypoallergenic perfume Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 51672-3009-5 5 g (GRAM) In 1 TUBE None 2 51672-3009-2 1 TUBE In 1 CARTON contains a TUBE 2 28.35 g (GRAM) In 1 TUBE This package is contained within the CARTON (51672-3009-2) 3 51672-3009-8 1 TUBE In 1 CARTON contains a TUBE 3 85 g (GRAM) In 1 TUBE This package is contained within the CARTON (51672-3009-8) 4 51672-3009-4 1 TUBE In 1 CARTON contains a TUBE 4 123 g (GRAM) In 1 TUBE This package is contained within the CARTON (51672-3009-4)

Revised: 12/2008Taro Pharmaceuticals U.S.A., Inc.