Each gram of ACCUZYME enzymatic debriding ointment contains papain (8.3 × 10 ⁵ USP units of activity) and 100mg urea in a hydrophilic ointment base composed of purified water, emulsifying wax, glycerin, isopropyl palmitate, potassium phosphate monobasic, fragrance, methylparaben and propylparaben.

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, 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.

ACCUZYME is indicated for debridement of necrotic tissue and liquefication 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

ACCUZYME is contraindicated in patients who have shown sensitivity to papain or any other components of this preparation.

PRECAUTIONS

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

ADVERSE REACTIONS

ACCUZYME is generally well-tolerated and non-irritating. A transient "burning" sensation may be experienced by a small percentage of patients upon applying ACCUZYME. 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 directly to the wound, cover with appropriate dressing, 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 tubes. Store in a cool place.

CAUTION: Avoid freezing or extreme heat.

Rx only

NDC-0064-1000-01

HEALTHPOINT®

HEALTHPOINT, San Antonio, Texas 78215

1-800-441-8227

REORDER NO. 1000-01 126959-1195

PRODUCT PHOTO(S):

NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug' identity should be verified by chemical analysis.