Clinical Information
Gen. Code and Des.
5258 collagenase Clostridium hist. TOPICAL OINT. (G) 250 UNIT/G
GCN and Des.
21190 collagenase Clostridium hist. TOPICAL OINT. (G) 250 UNIT/G
Strength
250U/GM
Dose Form
OINTMENT (GRAM)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
84920000 SKIN AND MUCOUS MEMBRANE AGENTS, MISC.
Active Ingredients
1890 collagenase Clostridium histolyticum 9001121
COLLAGENASE SANTYL- collagenase clostridium histolyticum ointment
HEALTHPOINT, LTD
Rx only
DESCRIPTION
Collagenase Santyl� Ointment is a sterile enzymatic debriding ointment which contains 250 collagenase units per gram of white petrolatum USP. The enzyme collagenase is derived from the fermentation by Clostridium histolyticum. It possesses the unique ability to digest collagen in necrotic tissue.
CLINICAL PHARMACOLOGY
Since collagen accounts for 75% of the dry weight of skin tissue, the ability of collagenase to digest collagen in the physiological pH and temperature range makes it particularly effective in the removal of detritus. 1 Collagenase thus contributes towards the formation of granulation tissue and subsequent epithelization of dermal ulcers and severely burned areas. 2, 3, 4, 5, 6 Collagen in healthy tissue or in newly formed granulation tissue is not attacked. 2, 3, 4, 5, 6, 7, 8 There is no information available on collagenase absorption through skin or its concentration in body fluids associated with therapeutic and/or toxic effects, degree of binding to plasma proteins, degree of uptake by a particular organ or in the fetus, and passage across the blood brain barrier.
COLLAGENASE SANTYL Indications and Usage
Collagenase Santyl� Ointment is indicated for debriding chronic dermal ulcers 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 and severely burned areas. 3, 4, 5, 7, 16, 19, 20, 21
CONTRAINDICATIONS
Collagenase Santyl� Ointment is contraindicated in patients who have shown local or systemic hypersensitivity to collagenase.
PRECAUTIONS
The optimal pH range of collagenase is 6 to 8. Higher or lower pH conditions will decrease the enzyme's activity and appropriate precautions should be taken. The enzymatic activity is also adversely affected by certain detergents, and heavy metal ions such as mercury and silver which are used in some antiseptics. When it is suspected such materials have been used, the site should be carefully cleansed by repeated washings with normal saline before Collagenase Santyl� Ointment is applied. Soaks containing metal ions or acidic solutions should be avoided because of the metal ion and low pH. Cleansing materials such as Dakin's solution and normal saline are compatible with Collagenase Santyl� Ointment.
Debilitated patients should be closely monitored for systemic bacterial infections because of the theoretical possibility that debriding enzymes may increase the risk of bacteremia.
A slight transient erythema has been noted occasionally in the surrounding tissue, particularly when Collagenase Santyl� Ointment was not confined to the wound. Therefore, the ointment should be applied carefully within the area of the wound. Safety and effectiveness in pediatric patients have not been established.
Adverse Reactions to COLLAGENASE SANTYL
No allergic sensitivity or toxic reactions have been noted in clinical use when used as directed. However, one case of systemic manifestations of hypersensitivity to collagenase in a patient treated for more than one year with a combination of collagenase and cortisone has been reported.
OVERDOSAGE
No systemic or local reaction attributed to overdose has been observed in clinical investigations and clinical use. If deemed necessary the enzyme may be inactivated by washing the area with povidone iodine.
DOSAGE AND ADMINISTRATION
Collagenase Santyl� Ointment should be applied once daily (or more frequently if the dressing becomes soiled, as from incontinence). When clinically indicated, crosshatching thick eschar with a #10 blade allows Collagenase Santyl� Ointment more surface contact with necrotic debris. It is also desirable to remove, with forceps and scissors, as much loosened detritus as can be done readily. Use Collagenase Santyl
