COLLAGENASE SANTYL ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

COLLAGENASE CLOSTRIDIUM HISTOLYTICUM (UNII: 9X7O8V25IT) (COLLAGENASE CLOSTRIDIUM HISTOLYTICUM - UNII:9X7O8V25IT)

Available from:

SMITH & NEPHEW, INC

INN (International Name):

COLLAGENASE CLOSTRIDIUM HISTOLYTICUM

Composition:

COLLAGENASE CLOSTRIDIUM HISTOLYTICUM 250 [arb'U] in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 Collagenase Santyl◊  Ointment is contraindicated in patients who have shown local or systemic hypersensitivity to collagenase.

Product summary:

Collagenase Santyl◊  Ointment contains 250 units of collagenase enzyme per gram of white petrolatum USP. Do not store above 25°C (77°F). Sterility guaranteed until tube is opened. Collagenase Santyl◊  Ointment is available in the following sizes: 30 g tube NDC 50484-010-30 90 g tube NDC 50484-010-90 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 – Zimmermann, WE., in “Collagenase,” Mandl, I., 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. Epidemiol. Microbiol. Immunol. 18:496, 1974. 8 – Lippmann, H.I., Arch. Phys. Med. Rehabil. 54:588, 1973. 9 – German, F. M., in “Collagenase,” Mandl, I., ed., Gordon & Breach, Science Publishers, New York, 1971, p. 165. 10 – Haimovici, H. & Strauch, B., in “Collagenase,” Mandl, I., 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: SMITH & NEPHEW, INC Fort Worth, Texas 76109 US Gov’t License #2004 Marketed by: Smith & Nephew◊ 1-800-441-8227 Smith & Nephew, Inc., Fort Worth, Texas 76109 © 2016 Smith & Nephew, Inc. SANTYL is a registered trademark of Smith & Nephew, Inc. 140749-0316

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

COLLAGENASE SANTYL- COLLAGENASE SANTYL OINTMENT
SMITH & NEPHEW, INC
----------
COLLAGENASE SANTYL OINTMENT
250 UNITS/G
[SMITH & NEPHEW, INC]
R 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.
Collagenase thus contributes towards the formation of granulation
tissue and subsequent
epithelization of dermal ulcers and severely burned areas.
Collagen in healthy tissue or in
newly formed granulation tissue is not attacked.
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
and severely burned areas.
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