Label: ZYPRAM- hydrocortisone acetate and pramoxine hydrochloride cream

  • NDC Code(s): 68025-040-30
  • Packager: Vertical Pharmaceuticals, Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 07/09

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  • SPL UNCLASSIFIED SECTION

    Rx Only

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  • DESCRIPTION

    ZyPram™ Cream is a topical preparation containing hydrocortisone acetate 2.35% in a cream base and pramoxine hydrochloride 1% in a hydrophilic cream base1. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11,17-dihydroxy-(11β)-. It has the following structural formula:

    Chemical Structure

    Pramoxine hydrochloride has chemical name 4-[3-(4-butoxyphenoxy) propyl]morpholine hydrochloride, and has the following structure:

    Chemical Structure

    Active ingredients: Hydrocortisone Acetate 2.35% and Pramoxine Hydrochloride 1%.

    Inactive ingredients: Ammonium Acryloyldimethyltaurate/VP-Copolymer, Benzyl Alcohol, Cetearyl Alcohol, Cetearyl Olivate (&) Sorbitan Olivate, PEG-12 Glyceryl Distearate=GDS-12, PEG-12 Glyceryl Dimyristate=GDM-12, Glycerine, Glyceryl Stearate, Methyl Paraben, PEG 100 Stearate, Polysorbate 60, Propylene Glycol, Purified Water, Sodium Lauryl Sulfate, White Petrolatum.

    Cleansing Wipe (2.2 grams solution per wipe) Contains:

         Citric Acid . . . . . . . . . . . . . . . . . . . . . . . 22 mg

         Aloe Vera . . . . . . . . . . . . . . . . . . . . . . . 11 mg

         Vitamin E (dl-tocopheryl acetate) . . . . . . 2.2 mg

    Inactive Ingredients: Water, Polysorbate 20, Phenoxyethanol, Methyl Paraben, Ethyl Paraben, Propyl Paraben, Butyl Paraben, Isobutyl Paraben, Extract Blend, Fragrance/Perfume.


    1
    This unique Lipid base delivery system provides more of the active ingredients, and out-performs traditional (active) ingredient applications.
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  • 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.

    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.

    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.

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  • INDICATIONS

    ZyPram™ is used for anti-inflammatory and anesthetic relief of itching, pain and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.

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  • 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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  • WARNINGS

    For external use only. Not for ophthalmic use. Product could harm small children if chewed or swallowed. Individual tubes are NOT child resistant.

    Keep product and cleansing wipes out of the reach of children.

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  • 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 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. 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.

    Directions for Using ZyPram™

    Remove cleansing wipe from package and gently clean the affected area. Discard wipe after use (it is flushable). Remove cap from tube and puncture foil. Attach the provided applicator. Squeeze tube until the applicator is full. Gently insert the tip of the filled applicator approximately ½ inch into the anal area and squeeze the tube, applying ZyPram™ cream to the anus and the peri-anal area. Do not insert the applicator any additional length into the anus or into the rectum. Remove the applicator and tube. Thoroughly clean the applicator. If directed by a physician, a small amount of cream may be applied to the anal area using a fingertip.

    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

    Use in 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 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.

    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

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

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

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  • DOSAGE AND ADMINISTRATION

    Apply ZyPram™ cream to the affected area(s) three times daily or as directed by a physician. ZyPram™ should not be used in excess of recommendations or for prolonged use in the anal canal. If the condition does not respond to repeated courses of ZyPram™, or should worsen, discontinue use and seek the advice of your physician. 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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  • HOW SUPPLIED

    ZyPram™ NDC 68025-040-30, contains 1 tube 30 g, 2 wipes, 1 applicator and insert.

    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

    Storage Conditions

    Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

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  • SPL UNCLASSIFIED SECTION

    05/09

    Rx Only

    Manufactured For:
    Vertical Pharmaceuticals, Inc.
    Sayreville, NJ 08872

    Lipid Base Delivery System
    QuSomes
    U.S. Patent No. 6,610,322
    U.S. Patent No. 6,958,160
    U.S. Patent No. 7,150,883
    2 Other patents pending


    2
    BioZone Laboratories, Inc. Qusomes™. Available at: http://www.biozonelabs.com/html/qusomes/qusomes.htm. Accessed 4/15/09.
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  • PRINCIPAL DISPLAY PANEL-30 g Tube

    NDC 68025-040-30

    ZYPRAM™
    (Hydrocortisone Acetate 2.35%, Pramoxine HCl 1%) Cream

    For External Use Only
    Not For Oral or Ophthalmic Use

    Lipid Base Delivery System
    QuSomes
    U.S. Patent No. 6,610,322
    U.S. Patent No. 6,958,160
    U.S. Patent No. 7,150,883
    * Other patents pending

    Rx Only

    VERTICAL
    PHARMACEUTICALS, INC

    Net Wt. 30 g

    PRINCIPAL DISPLAY PANEL-30 g Tube
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  • PRINCIPAL DISPLAY PANEL-30 g Carton

    NDC 68025-040-30

    ZYPRAM™
    (Hydrocortisone Acetate 2.35%, Pramoxine HCl 1%) Cream

    30 gram Tube
    One Applicator
    2 Cleansing Wipes

    Rx Only

    Lipid Base Delivery System
    QuSomes
    U.S. Patent No. 6,610,322
    U.S. Patent No. 6,958,160
    U.S. Patent No. 7,150,883
    * Other patents pending

    VERTICAL
    PHARMACEUTICALS, INC

    PRINCIPAL DISPLAY PANEL-30 g Carton
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  • INGREDIENTS AND APPEARANCE
    ZYPRAM 
    hydrocortisone acetate and pramoxine hydrochloride cream
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68025-040
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Hydrocortisone Acetate (Hydrocortisone) Hydrocortisone 705 mg  in 30 g
    Pramoxine Hydrochloride (Pramoxine) Pramoxine 300 mg  in 30 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68025-040-30 30 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved other 07/21/2009
    Labeler - Vertical Pharmaceuticals, Inc (173169017)
    Registrant - Sonar Products, Inc. (104283945)
    Establishment
    Name Address ID/FEI Business Operations
    Sonar Products, Inc. 104283945 MANUFACTURE
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