Country: Canada
Language: English
Source: Health Canada
COLLAGENASE
SMITH & NEPHEW INC
D03BA02
COLLAGENASE
250UNIT
OINTMENT
COLLAGENASE 250UNIT
TOPICAL
15G/30G
Prescription
MISC. SKIN AND MUCOUS MEMBRANE AGENTS
Active ingredient group (AIG) number: 0112254001; AHFS:
APPROVED
2014-12-11
PRODUCT MONOGRAPH SANTYL OINTMENT (Collagenase) Topical Enzymatic Debriding Agent Smith & Nephew Inc. Date of Authorization: Mississauga, Ontario December 7, 2023 L5N 6H8 Control number: 278543 NAME OF DRUG SANTYL OINTMENT (Collagenase) THERAPEUTIC CLASSIFICATION Topical enzymatic debriding agent STRUCTURAL FORMULA AND CHEMISTRY Collagenase is a large protein molecule of biologic origin, being derived from the fermentation of Clostridium histolyticum. The enzyme may be obtained in two forms, one a protein of 105,000 molecular weight, collagenase A and a molecule of 57,000 molecular weight, collagenase B. SANTYL contains a mixture of these two forms in an indeterminable ratio. Both collagenase A and collagenase B require free sulfhydryl groups for formation of enzyme substrate complex. Collagenase also requires enzyme bound zinc for activity. The optimal pH range for enzymatic activity is 7 to 8. Like all enzymes having sulfhydryl groups at the active site, inactivation with heavy metals, such as mercury, silver, cobalt, magnesium, and manganese can occur. The specific substrate for collagenase is collagen. However, minimal amounts of other amidase and esterase activity may be found in the collagenase enzyme preparation. DESCRIPTION Each gram of SANTYL Ointment contains 250 units of collagenase enzyme per gram of white petrolatum U.S.P. The potency assay of collagenase is based on the digestion of undenatured collagen (from bovine Achilles tendon) at pH 7.2 and 37°C for 24 hours. The number of peptides cleaved are measured by reaction with ninhydrin. Peptides released by a trypsin digestion control are subtracted. One net collagenase unit will solubilize ninhydrin reactive material equivalent to 4 micromoles of leucine. ACTION Collagenase digests collagen in the physiologic pH and temperature range. Since collagen accounts for 75% of the dry weight of skin tissue, collagenase is useful in the removal of detritus from the craters of dermal ulcers or skin burns. Rapid debridement contributes toward the formation of Read the complete document