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Ziox
Ointment Insert
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| ZIOX™OINTMENT (Papain-Urea-Chlorophyllin Copper Complex Sodium) Rx only Description | Clinical Pharmacology | Indications and Uses | Contraindications | Precautions | Adverse Reactions | Dosage and Administration | How Supplied Description: Ziox Ointment is an enzymatic debriding-healing ointment which contains standardized Papain USP (NOT LESS THAN 521,700 USP units per gram of ointment), Urea USP 10%, and Chlorophyllin Copper Complex Sodium USP 0.5% in a hydrophilic base of Purified Water, Propylene Glycol USP, White Petrolatum USP, Stearyl Alcohol, Sorbitan Monostearate, Polyoxyl 40 Stearate, Boric Acid, Sodium Borate and Chlorobutanol (Anhydrous). ^Back to Top Clinical Pharmacology: Papain, the proteolytic enzyme derived from the fruit of carica papaya, is a potent digestant of nonviable protein matter, but is harmless to viable tissue. It has the unique advantage of being active over a wide pH range, 3 to 12. Despite its recognized value as a digestive agent, papain is relatively ineffective when used alone as a debriding agent, primarily because it requires the presence of activators to exert its digestive function. Urea is combined with papain to provide two supplementary chemical actions: 1) to expose by solvent action the activators of papain (sulfhydryl groups) which are always present, but not necessarily accessible, in the nonviable tissue or debris of lesions, and 2) to denature the nonviable protein matter in lesions and thereby render it more susceptible to enzymatic digestion. In pharmacologic studies involving digestion of beef powder, Miller1 showed that the combination of papain and urea produced twice as much digestion as papain alone. Chlorophyllin Copper Complex Sodium adds healing action to the cleansing action of the proteolytic papain-urea combination. The basic wound-healing properties of Chlorophyllin Copper Complex Sodium are promotion of healthy granulations, control of local inflammation and reduction of wound odors.2 Specifically, Chlorophyllin Copper Complex Sodium inhibits the hemagglutinating and inflammatory properties of protein degradation products in the wound, including the products of enzymatic digestion, thus providing an additional protective factor.1,3 The incorporation of Chlorophyllin Copper Complex Sodium in ZIOX Ointment permits its continuous use for as long as desired to help produce and then maintain a clean wound base and to promote healing. ^Back to Top Indications and Uses: ZIOX Ointment is suggested for treatment of acute and chronic lesions such as varicose, diabetic and decubitus ulcers, burns, postoperative wounds, pilonidal cyst wounds, carbuncles and miscellaneous traumatic or infected wounds. ZIOX Ointment is applied continuously throughout treatment of these conditions (1) for enzymatic debridement of necrotic tissue and liquefaction of fibrinous, purulent debris, (2) to keep the wound clean, and simultaneously (3) to promote normal healing. ^Back to Top Contraindications: None known. ^Back to Top Precautions: See Dosage and Administration. Not to be used in eyes. ^Back to Top Adverse Reactions: ZIOX Ointment is generally well tolerated and nonirritating. A small percentage of patients may experience a transient "burning" sensation on application of the ointment. Occasionally, the profuse exudate resulting from enzymatic digestion may cause irritation. In such cases, more frequent changes of dressings until exudate diminishes will alleviate discomfort. ^Back to Top Dosage and Administration: Cleanse the wound with saline. Avoid cleansing with hydrogen peroxide solution as it may inactivate the papain. Apply ZIOX directly to the wound, cover with appropriate dressing, and secure into place. 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. When practicable, daily or twice daily changes of dressings are preferred. Longer intervals between redressings (two or three days) have proved satisfactory, and ZIOX Ointment may be applied under pressure dressings. ^Back to Top How Supplied: SIZE: 30 g tube NDC NUMBER: 58980-765-11 Store at controlled room temperature 15°-30°C (59°-86°F). ^Back to Top References: 1. Miller, J.M.: The Interaction of Papain, Urea and Water-Soluble Chlorophyll in a Proteolytic Ointment for Infected Wounds, Surgery 43:939, 1958. 2. Smith, L.W.: The Present Status of Topical Chlorophyll Therapy, New York J. Med. 55:2041, 1955. 3. Barnard, R.D.: Elucidation of Chemically Defined Haptens For Competitive Inhibition of Aggressin Activity. Immunol. 8:78, 1954. Distributed by: STRATUS PHARMACEUTICALS, INC. Manufactured by: Sonar Products Inc., Carlstadt, NJ 07072 exclusively for Stratus Pharmaceuticals Inc. 14377 Southwest 142nd Street, Miami, Florida 33186-6727 ©2001 Stratus Pharmaceuticals Inc ZI08IN00 08/2000 ^Back to Top |
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