A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Santyl Indications, Dosage, Storage, Stability - Collagenase
Santyl Indications, Dosage, Storage, Stability - Collagenase
INDICATIONS
Collagenase Santyl® 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® 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 4 micromoles of leucine.
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
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® is a
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