Label: PRAMOSONE- hydrocortisone acetate and pramoxine hydrochloride cream

  • NDC Code(s): 0496-0760-03, 0496-0760-04
  • Packager: Ferndale Laboratories, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 11/12

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  • DESCRIPTION

    DESCRIPTION: Pramosone® Cream 2.5% is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic cream base containing stearic acid, cetyl alcohol, Aquaphor®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water.

    Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below:

    hydrocortisone acetate

    hydrocortisone acetate
    Pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)-
    C23H32O6; mol.wt.: 404.50

    pramoxine hcl

    pramoxine hydrochloride
    4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride
    C17H27NO3.HCl; mol. wt.: 329.87


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  • CLINICAL PHARMACOLOGY

    CLINICAL PHARMACOLOGY: Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions.

    The mechanism of anti-inflammatory activity of 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.

    Pramoxine hydrochloride is a topical anesthetic agent which provides temporary relief from itching and pain. It acts by stabilizing the neuronal membrane of nerve endings with which it comes into contact.

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  • PHARMACOKINETICS

    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 abound 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.

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  • INDICATIONS & USAGE

    INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

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  • CONTRAINDICATIONS

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

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  • PRECAUTIONS

    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 and 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 corticotseroids.  Children may absorb proportionally larger amounts of topical corticotseroidsa nd thus be more susceptible to systemic toxicity.  (See PRECAUTIONS-Pediatric Use)

    If irritaion 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.

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  • INFORMATION FOR PATIENTS

    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 tuse 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 dressings.
    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.
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  • LABORATORY TESTS

    Laboratory Tests: The following tests may be helpful in evaluating the HPA axis suppression:

    Urinary free cortisol test
    ACTH stimulation test

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  • CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

    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.

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  • PREGNANCY

    Pregnanacy: 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.

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  • NURSING MOTHERS

    Nursing Mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable amounts 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.

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  • PEDIATRIC USE

    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 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.

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  • ADVERSE REACTIONS

    ADVERSE REACTIONS: The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressing. 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, and miliaria.

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  • OVERDOSAGE

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

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  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION: Topical corticosteroids are generally applied to the affected area as a thin film three 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.

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  • STORAGE AND HANDLING

    Storage Conditions: Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].

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  • HOW SUPPLIED

    HOW SUPPLIED:

    Pramosone® Cream 2.5%

    1 oz tube (NDC 0496-0760-04)
    2 oz tube (NDC 0496-0760-03)

    Rx only.

    Manufactured for Ferndale Healthcare®, Inc.

    Ferndale, MI 48220 U.S.A.

    Toll free (888) 548-0900

    www.ferndalehealthcare.com

    Manufactured by Ferndale Laboratories, Inc.

    Ferndale, MI 48220 U.S.A.

    Pramosone® is a registered trademark of Ferndale IP, Inc.
    Aquaphor® is a registered trademark of Beiersdorf AG.

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  • INGREDIENTS AND APPEARANCE
    PRAMOSONE 
    hydrocortisone acetate and pramoxine hydrochloride cream
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0496-0760
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE 25 mg  in 1 g
    PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    STEARIC ACID  
    CETYL ALCOHOL  
    ISOPROPYL PALMITATE  
    POLYOXYL 40 STEARATE  
    PROPYLENE GLYCOL  
    POTASSIUM SORBATE  
    SORBIC ACID  
    TROLAMINE LAURYL SULFATE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0496-0760-04 28.4 g in 1 TUBE
    2 NDC:0496-0760-03 57 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 02/08/2010
    Labeler - Ferndale Laboratories, Inc. (005320536)
    Establishment
    Name Address ID/FEI Business Operations
    Ferndale Laboratories, Inc. 005320536 manufacture(0496-0760)
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