Collagenase Santyl
FDA Drug Information • Also known as: Collagenase Santyl
- Brand Names
- Collagenase Santyl
- Route
- TOPICAL
- Dosage Form
- OINTMENT
- Product Type
- HUMAN PRESCRIPTION DRUG
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.
What Is Collagenase Santyl Used For?
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 and 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.
Side Effects (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.
Contraindications
CONTRAINDICATIONS Collagenase Santyl ◊ Ointment is contraindicated in patients who have shown local or systemic hypersensitivity to collagenase.
Overdosage
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.
How Supplied
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....
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
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Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.