Collagenase Santyl® Ointment 250 units/g

COLLAGENASE SANTYL  - collagenase ointment 
Healthpoint, Ltd.

----------

Collagenase Santyl®
Ointment 250 units/g

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.

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 hydrogen peroxide, 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

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® Ointment in the following manner:

  1. – Prior to application the wound should be cleansed of debris and digested material by gently rubbing with a gauze pad saturated with normal saline solution, or with the desired cleansing agent compatible with Collagenase Santyl® Ointment (See PRECAUTIONS), followed by a normal saline solution rinse.
  2. – Whenever infection is present, it is desirable to use an appropriate topical antibiotic powder. The antibiotic should be applied to the wound prior to the application of Collagenase Santyl® Ointment. Should the infection not respond, therapy with Collagenase Santyl® Ointment should be discontinued until remission of the infection.
  3. – Collagenase Santyl® Ointment may be applied directly to the wound or to a sterile gauze pad which is then applied to the wound and properly secured.
  4. – Use of Collagenase Santyl® Ointment should be terminated when debridement of necrotic tissue is complete and granulation tissue is well established.

HOW SUPPLIED

Collagenase Santyl® Ointment contains 250 units of collagenase enzyme per gram of white petrolatum USP. 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 peptide bonds cleaved are measured by reaction with ninhydrin. Amino groups released by a trypsin digestion control are subtracted. One net collagenase unit will solubilize ninhydrin reactive material equivalent to 1 nanomole of leucine equivalents per minute.

Do not store above 25°C (77°F). Sterility guaranteed until tube is opened.

Collagenase Santyl® Ointment is available in 15 gram and 30 gram tubes.

REFERENCES

- Mandl, I., Adv Enzymol. 23:163, 1961.

- Boxer, A.M., Gottesman, N., Bernstein, H., & Mandl, I., Geriatrics. 24:75, 1969.

- Mazurek, I., Med. Welt. 22:150, 1971.

- Zimmerman, WE., in “Collagenase,” Mandl, I., ed., Gordon & Breach, Science Publishers, New York, 1971, p. 131, p. 185.

- Vetra, H., & Whittaker, D., Geriatrics 30:53, 1975.

- Rao, D.B., Sane, P.G., & Georgiev, E.L., J. Am. Geriatrics Soc. 23:22, 1975.

- Vrabec, R., Moserova, J., Konickova, Z., Behounkova, E., & Blaha, J., J. Hyg. Epidemiol. Microbiol. Immunol. 18:496, 1974.

- Lippmann, H.I., Arch. Phys. Med. Rehabil. 54:588, 1973.

- German, F.M., in “Collagenase,” Mandl, I., ed., Gordon & Breach, Science Publishers, New York, 1971, p. 165.

- Haimovici, H. & Strauch, B., in “Collagenase,” Mandl, I., ed., Gordon & Breach, Science Publishers, New York, 1971, p. 177.

- Lee, L.K., & Ambrus, J.L., Geriatrics. 30:91, 1975

- Locke, R.K., & Heifitz, N.M., J. Am. Pod. Assoc. 65:242, 1975.

- Varma, A.O., Bugatch, E., & German, F.M., Surg. Gynecol. Obstet. 136:281, 1973.

- Barrett D., Jr., & Klibanski, A., Am. J. Nurs. 73:849, 1973.

- Bardfeld, L.A., J. Pod. Ed. 1:41, 1970.

- Blum, G., Schweiz. Rundschau Med. Praxis 62:820, 1973. Abstr. in Dermatology Digest, Feb. 1974, p. 36.

- Zaruba, F., Lettl, A., Brozkova, L., Skrdlantova, H., & Krs, V., J. Hyg. Epidemiol. Microbiol. Immunol. 18:499, 1974.

- Altman, M.I., Goldstein, L., & Horwitz, S., J. Am. Pod. Assoc. 68:11, 1978.

- Rehn, V.J., Med. Klin. 58:799, 1963.

- Krauss, H., Koslowski, L., & Zimmermann W.E., Langenbecks Arch. Klin. Chir. 303:23, 1963.

- Gruenagel, H.H., Med. Klin, 58:442, 1963.

Marketed by:
HEALTHPOINT®
A DFB COMPANY
Healthpoint, Ltd.
Fort Worth, Texas 76107
Manufactured for DFB Biotech, Inc.
Fort Worth, Texas 76107
US Gov’t License #1745

Distributed by:
DPT Laboratories, Ltd.
San Antonio, Texas 78215

Reorder Nos.
0064-5010-15 (15g tube)
0064-5010-30 (30g tube)

© 2008 Healthpoint, Ltd.
SANTYL is a registered trademark of Healthpoint, Ltd.

128671-0808

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

38f72bdd-figure-01

COLLAGENASE SANTYL 
collagenase santyl   ointment
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0064-5010
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COLLAGENASE (COLLAGENASE) COLLAGENASE250 U  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
Product Characteristics
ColorWHITE (to off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
10064-5010-1515 g In 1 TUBENone
20064-5010-3030 g In 1 TUBENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10199510/18/2006

Labeler - Healthpoint, Ltd. (965634504)
Revised: 07/2010Healthpoint, Ltd.