Label: ANUSOL HC- hydrocortisone cream

  • NDC Code(s): 65649-401-30
  • Packager: Salix Pharmaceuticals, Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 4, 2018

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  • DESCRIPTION

    The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Anusol-HC™ 2.5% (Hydrocortisone Cream, USP) is a topical corticosteroid with hydrocortisone 2.5% (active ingredient) in a water-washable cream containing the following inactive ingredients: benzyl alcohol, petrolatum, stearyl alcohol, propylene glycol, isopropyl myristate, polyoxyl 40 stearate, carbomer homopolymer, sodium lauryl sulfate, edetate disodium, sodium hydroxide to adjust the pH, and purified water.

    Hydrocortisone has the chemical name Pregn-4-ene-3,20-dione, 11,17, 21, trihydroxy-,(11ß) - and the following chemical structure:

    Chemical structure
  • 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 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.

  • INDICATIONS AND USAGE

    Topical corticosteroids are 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.

  • 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. 

    If HPA axis suppression is noted (by using the urinary free cortisol and ACTH stimulation tests) an attempt should be made to withdraw the drug or to reduce the frequency of application.

    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 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 that for which it has been 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 urinary free cortisol test and the ACTH stimulation test may be helpful in evaluating the HPA axis suppression.

    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 hydrocortisone have revealed negative results.

    Pregnancy:

    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 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.

    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.

    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

    To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

  • OVERDOSAGE

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

  • DOSAGE AND ADMINISTRATION

    Anusol-HC 2.5% (Hydrocortisone Cream, USP) should be applied to the affected area 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

     
    Anusol-HC 2.5% (Hydrocortisone Cream, USP) is supplied as follows:
    NDC 65649-401-30   2.5% 30 g tubes

    Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. PROTECT FROM FREEZING. 

    Manufactured for:
    Salix Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA

    Manufactured by:
    Paddock Laboratories LLC
    Minneapolis, MN 55427 USA

    Anusol-HC is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.
    © Valeant Pharmaceuticals North America LLC

    Rev. 01/2018

    9521001

    2201320

    7C800 9L J2

  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL – Anusol HC™ 2.5% Tube, 30 Grams

    NDC 65649-401-30

    Rx only

    Anusol-HC™ 2.5%

    (Hydrocortisone Cream, USP)

    For External Use Only
    For Topical Use Only

    Net Wt. 30 g

    Salix
    PHARMACEUTICALS

    carton.jpg
  • INGREDIENTS AND APPEARANCE
    ANUSOL  HC
    hydrocortisone cream
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65649-401
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE25 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65649-401-3030 g in 1 TUBE; Type 0: Not a Combination Product06/06/1984
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA08825006/06/1984
    Labeler - Salix Pharmaceuticals, Inc (793108036)
    Establishment
    NameAddressID/FEIBusiness Operations
    Paddock Laboratories, LLC967694121MANUFACTURE(65649-401) , PACK(65649-401)