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Kovia
Ointment Insert
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| KOVIA®
OINTMENT (Papain-Urea Debriding Ointment) Rx only Description | Clinical Pharmacology | Indications and Uses | Contraindications | Precautions | Adverse Reactions | Dosage and Administration | How Supplied Description: Each gram of Kovia ointment contains ACTIVES: Papain (8.3 x 105 USP units of activity) and 100mg urea in a hydrophilic ointment base composed of INACTIVES: purified water, isopropyl palmitate, glycerin, promulgen G, potassium phosphate monobasic, fragrance, methylparaben and propyl paraben. ^Back to Top 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 Kovia, 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. ^Back to Top Indications and Uses: Kovia 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. ^Back to Top Contraindications: Kovia is contradicted in patients who have shown sensitivity to papain or any other components of this preparation. ^Back to Top Precautions: See Dosage and Administration. FOR EXTERNAL USE ONLY: NOT FOR OPHTHALMIC, NASAL OR OTIC USE. ^Back to Top Adverse Reactions: Kovia is generally well-tolerated and non-irritating. A transient “burning” sensation may be experienced by a small percentage of patients upon applying Kovia. Occasionally, the profuse exudates from enzymatic digestion may irritate the skin. In such cases, more frequent dressing changes will alleviate discomfort until exudates decreases. ^Back to Top Dosage and Administration: Cleanse the wound with saline. Avoid cleansing with hydrogen peroxide solution as it may inactivate the papain. Apply Kovia 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. ^Back to Top How Supplied: SIZE: 30g tube NDC NUMBER: 58980-711-11 SIZE: 3.5g unit dose packette NDC NUMBER: 58980-711-35 Store in a cool place. 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 Customer Service: Telephone: 1-800-442-7882 Fax: 305-254-6875 ©2001 Stratus Pharmaceuticals Inc KO12IN99 12/99 ^Back to Top |
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