Prescription Drugs

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.

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.

PATIENT INFORMATION No Information Provided.

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.

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 No Information Provided. PRECAUTIONS See Dosage and Administration . Not to be used in eyes.