Accuzyme Debriding Ointment (Healthpoint)

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DESCRIPTION

ACCUZYME enzymatic debriding ointment contains papain, USP (6.5 × 10 ⁵ USP units of activity based on Lot I0C389 per gram of ointment) and urea, USP 10% in a hydrophilic ointment base composed of emulsifying wax, fragrance, glycerin, isopropyl palmitate, lactose, methylparaben, potassium phosphate monobasic, propylparaben, and purified water.

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 Ointment, 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 Ointment 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 Ointment is generally well-tolerated and non-irritating. A transient "burning" sensation may be experienced by a small percentage of patients upon applying ACCUZYME Ointment. 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. Apply ACCUZYME Ointment directly to the wound, cover with appropriate dressing, and secure into place. Daily or twice daily applications are preferred. Irrigate the wound at each redressing to remove any accumulation of liquefied necrotic material. 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.

HOW SUPPLIED

30g tube, 6g tube. Store in a cool place.

ACCUZYME Ointment is a registered trademark of Healthpoint, Ltd.

ALLCLENZ Wound Cleanser is a registered trademark of Healthpoint, Ltd.

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

128143-1104

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