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Drug Description

DESCRIPTION

ACCUZYME (papain and urea) enzymatic debriding ointment contains papain, USP (8.3 x 105 USP units of activity per gram) 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.

Indications & Dosage

INDICATIONS

ACCUZYME (papain and urea) 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.

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 (papain and urea) 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 tube, 6g tube. Store in a cool place 8°-15°C (46°-59°F).

Do not refrigerate.

ACCUZYME (papain and urea) 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

REORDER NO. 0064-1000-01 (30g tube)
                           0064-1000-07 (6g tube)
Side Effects & Drug Interactions

SIDE EFFECTS

ACCUZYME (papain and urea) Ointment is generally well-tolerated and non-irritating. A transient "burning" sensation may be experienced by a small percentage of patients upon applying ACCUZYME (papain and urea) 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.

DRUG INTERACTIONS

No Information Provided.

Warnings & Precautions

WARNINGS

No Information Provided.

PRECAUTIONS

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

Overdosage & Contraindications

OVERDOSE

No Information Provided.

CONTRAINDICATIONS

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

Clinical Pharmacology

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 (papain and urea) , 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.

Medication Guide

PATIENT INFORMATION

No Information Provided.

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