Thursday, 1 March 2012

Collagenase Santyl


Generic Name: Collagenase
Class: Skin and Mucous Membrane Agents, Miscellaneous
ATC Class: D03BA02
VA Class: DE900
CAS Number: 9001-12-1

Introduction

Enzymatic debriding agent derived from Clostridium histolyticum.a b


Uses for Collagenase Santyl


Wound Debridement


Used to promote debridement of necrotic tissue in the treatment of severe burns and dermal ulcers including decubitus ulcers.a b


Collagenase Santyl Dosage and Administration


Administration


Apply ointment topically to wound.a b


Do not introduce ointment into major body cavities (e.g., pleural or peritoneal cavities).a


Topical Administration


Apply ointment directly to the wound or to a sterile gauze pad which is then applied to the wound and properly secured.a b


Use caution to restrict application to the lesion; avoid applying to healthy skin.a b (See Local Effects under Cautions.)


Prior to each application, cleanse wound with a gauze pad saturated with 0.9% sodium chloride solution or a compatible cleansing agent to remove necrotic material and follow with a normal saline solution rinse.b (See Compatibility under Stability.)


Avoid detergents, solutions containing heavy metal ions, or acidic solutions.a b If such materials are used, carefully cleanse site with repeated normal saline solution rinses prior to application.b (See Enzyme Inactivation under Cautions and see Compatibility under Stability.)


Remove as much loosened detritus as can be done readily with forceps and scissors.a b If clinically indicated, cross-hatch thick eschar with a #10 scalpel blade.a b


If infection is present, apply a topical antibiotic powder to the lesion prior to the application of collagenase.a b (See Compatibility under Stability.) If infection does not respond to combined therapy, discontinue collagenase until infection has resolved.a b


Dosage


Adults


Wound Debridement

Topical

Apply once daily to wound. a b


Apply more frequently if the dressing becomes soiled (e.g., due to incontinence).a b


Discontinue when debridement of necrotic tissue is complete and granulation tissue is well established.a b


Special Populations


No special population dosage recommendations at this time.b


Cautions for Collagenase Santyl


Contraindications



  • Known local or systemic hypersensitivity to collagenase.a b



Warnings/Precautions


General Precautions


Enzymatic Inactivation

Collagenase is potentially irreversibly inactivated at pH <5 and reversibly inactivated at pH ≥8.5; activity can be restored by return of pH to 7.4.a


Collagenase can be destroyed by other proteolytic enzymes or by exposure to temperatures >56°C.a


Enzymatic activity is adversely affected by detergents, heavy metal ions (e.g., mercury or silver), and povidone iodine.a b


Infection Risk

Possible risk of systemic bacterial infection;a b closely monitor debilitated patients for evidence of systemic bacterial infection (e.g., fever, chills, tachycardia).a b


Local Effects

Slight erythema may develop in surrounding tissue, especially if ointment is not confined to lesion being treated.b


Specific Populations


Lactation

Not known if distributed into human milk.b


Pediatric Use

Safety and efficacy not established.a b


Common Adverse Effects


Slight erythema.a


Stability


Storage


Topical


Ointment

<25°C.a b


Compatibility


For information on systemic interactions resulting from concomitant use, see Interactions.


Topical


For information on interactions resulting from concomitant use, see Enzymatic Inactivation under Cautions.










Drug and Chemical Compatibility

Compatiblea



Bacitracin



Polymyxin B



Incompatibleb



Detergents



Heavy metal ions (e.g., mercury, silver)



Povidone iodine


Solution Compatibility






Compatible



Dakin's Solution



Hydrogen peroxide



Sodium chloride 0.9%


ActionsActions



  • An enzymatic debriding agent capable of specifically hydrolyzing peptide bonds of undenatured and denatured collagen.a b




  • Liquefies necrotic tissue without damaging granulation tissue.a




  • Contributes towards the formation of granulation tissue and subsequent epithelization of dermal ulcers and severely burned areas.b




  • May remove substrates necessary for bacterial proliferation or may permit antibodies, leukocytes, and antibiotics better access to the infected area.a



Advice to Patients



  • Importance of using as directed and not applying to healthy skin.a b




  • Importance of informing clinicians immediately of any symptoms of serious infection (e.g., fever/chills, hyperventilation, rapid heartbeat).a b




  • Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.a




  • Importance of informing patients of other important precautionary information.a (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.













Collagenase

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Topical



Ointment



250 units/g



Collagenase Santyl (in white petrolatum)



Health Point



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions January 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References



a. AHFS drug information 2007. McEvoy GK, ed. Collagenase. Bethesda, MD: American Society of Health-System Pharmacists; 2007: pages [3565-3566]



b. Health Point, Ltd. Collagenase Santyl ointment prescribing information. Fort Worth, TX; 2006.



More Collagenase Santyl resources


  • Collagenase Santyl Side Effects (in more detail)
  • Collagenase Santyl Use in Pregnancy & Breastfeeding
  • Collagenase Santyl Drug Interactions
  • Collagenase Santyl Support Group
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