Get your patient on Collagenase Santyl - Collagenase Santyl ointment (Collagenase Santyl)

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Collagenase Santyl - Collagenase Santyl ointment prescribing information

Indications & Usage

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

Dosage & Administration

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.

Contraindications

CONTRAINDICATIONS

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

Adverse Reactions

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.

Description

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.

Pharmacology

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.

How Supplied/Storage & Handling

HOW SUPPLIED

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

Data SourceWe receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available
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