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Santyl

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Santyl

Indications
Dosage
How Supplied

INDICATIONS

Collagenase Santyl (collagenase) ® Ointment is indicated for debriding chronic dermal ulcers 2-6,8-18 and severely burned areas. 3-5,7,16,19-21

DOSAGE AND ADMINISTRATION

Collagenase Santyl (collagenase) ® 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 (collagenase) ® 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 (collagenase) ® 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 (collagenase) ® Ointment. Should the infection not respond, therapy with Collagenase Santyl (collagenase) ® Ointment should be discontinued until remission of the infection.

3 - Collagenase Santyl (collagenase) ® 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 (collagenase) ® 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 4 micromoles of leucine.

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

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

REFERENCES

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

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

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

4. Zimmerman, WE.,in "Collagenase:" I. Mandl, ed., Gordon & Breach, Science Publishers, New York, 1971, p. 131, p. 185.

5. Vetra, H. Whittaker, D., Geriatrics 30:53, 1975.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Manufactured by
ADVANCE BIOFACTURES CORPORATION

A Subsidiary of
BIOSPECIFICS TECHNOLOGIES CORP.
35 Wilbur Street Lynbrook, New York 11563

Distributed by
Ross Products Division, Abbott Laboratories Inc.
625 Cleveland Ave. Columbus, OH 43215-1724
©2003 Abbott Laboratories SANTYL® (collagenase) is a registered trademark of Abbott Laboratories
All rights reserved Revised: July 2003 Printed in U.S.A.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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