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Accuzyme Spray (Healthpoint)

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  • Description
  • Clinical Pharmacology
  • Indications and Usage
  • Contraindications
  • Precautions
  • Adverse Reactions
  • Dosage and Administration
  • How Supplied

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  • DESCRIPTION

    ACCUZYME enzymatic debriding spray contains papain, USP (6.5 × 10 5 USP units of activity based on Lot I0C389 per gram of spray) and urea, USP 10% in a base composed of anhydrous lactose, cetearyl alcohol & ceteth-20 phosphate & dicetyl phosphate, fragrance, glycerin, methylparaben, mineral oil, potassium phosphate monobasic, propylparaben, purified water, and sodium hydroxide.

    CLINICAL PHARMACOLOGY

    Papain, the proteolytic enzyme from the fruit of carica papaya, is a potent digestant of nonviable protein matter but is harmless to viable tissue. It is active over a pH range of 3 to 12. Papain is relatively ineffective when used alone as a debriding agent and requires the presence of activators to stimulate its digestive potency. In ACCUZYME Spray, papain is combined with urea, a denaturant of proteins, to bring about two supplemental chemical actions: (1) to expose by solvent action the activators of papain, and (2) to denature the nonviable protein matter in lesions and thereby render it more susceptible to enzymatic digestion. Pharmacologic studies have shown that the combination of papain and urea result in twice as much digestive activity as papain alone.

    INDICATIONS AND USES

    ACCUZYME Spray is indicated for debridement of necrotic tissue and liquefaction of slough in acute and chronic lesions such as pressure ulcers, varicose and diabetic ulcers, burns, postoperative wounds, pilonidal cyst wounds, carbuncles and miscellaneous traumatic or infected wounds.

    CONTRAINDICATIONS

    Do not use if you are allergic to or have known or suspected hypersensitivity to any ingredient in this product.

    PRECAUTIONS

    See Dosage and Administration . Not to be used in eyes.

    ADVERSE REACTIONS

    ACCUZYME Spray is generally well-tolerated and non-irritating. A transient "burning" sensation may be experienced by a small percentage of patients upon applying ACCUZYME Spray. Occasionally, the profuse exudate from enzymatic digestion may irritate the skin. In such cases, more frequent dressing changes will alleviate discomfort until exudate decreases.

    DOSAGE AND ADMINISTRATION

    Cleanse the wound with ALLCLENZ® Wound Cleanser or saline. Avoid cleansing with hydrogen peroxide solution as it may inactivate the papain. NOTE: Papain may also be inactivated by the salts of heavy metals such as lead, silver and mercury. Contact with medications containing these metals should be avoided. In accordance with good wound care practices, protect the periwound with a skin protectant of choice to prevent and/or reduce maceration and irritation due to drainage from the wound. Apply a single, even layer of ACCUZYME Spray daily or twice daily with dressing change or as recommended by physician. Irrigate the wound at each redressing to remove any accumulation of liquefied necrotic material.

    If eschar is present, it may be necessary to consult a qualified practitioner in the use of a #10 blade to cross-hatch the eschar prior to application of ACCUZYME Spray in order to improve penetration of the product. Prior to cross-hatching, moisten the eschar with saline or a suitable wound cleanser such as ALLCLENZ Wound Cleanser.

    INSTRUCTIONS FOR USE

    Shake well before use.

    Prime Container:   Upon initial use only, the user will need to prime the non-aerosol ACCUZYME Spray pump. Begin first time use by holding ACCUZYME Spray upright directly over the wound, and prime the pump 10-14 times.

    Once the pump has been primed, hold the ACCUZYME Spray bottle approximately 1[Prime ]-2[Prime ] from the wound and use even, firm, and consistent pressure to dispense product. When sprayed from the appropriate distance of 1[Prime ]-2[Prime ], the spray should appear in a nickel-sized diameter. Shake well prior to each use. Then tap bottom of bottle on solid surface several times to loosen liquid from inside walls.

    Completely cover the wound site with ACCUZYME Spray. The wound should not be visible under the product. Cover with saline-moistened gauze or appropriate dressing of choice as recommended by your physician, and secure into place.

    ACCUZYME Spray is designed to be used at an angle; however, as the product is dispensed, it may be necessary to hold the ACCUZYME Spray bottle in an upright position to achieve a full pump. Wipe nozzle with clean gauze after each use.

    HOW SUPPLIED

    33 mL spray bottle. Store upright in a cool place.

    Marketed by:

    Healthpoint

    Healthpoint, Ltd.

    Fort Worth, Texas 76107

    1-800-441-8227

    www.Healthpoint.com

    Manufactured by:

    DPT Laboratories, Ltd.

    San Antonio, Texas 78215

    REORDER NO. 0064-1001-33        (33 mL spray)

    128144-1204

    ACCUZYME is a registered trademark of Healthpoint, Ltd.

    ALLCLENZ is a registered trademark of Healthpoint, Ltd.













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    This page was last modified 30-JUN-07
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