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.

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

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.

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 registered trademark of Abbott Laboratories
All rights reserved Revised: July 2003 Printed in U.S.A.

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.

No information provided.

No information provided

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 should be avoided because of the metal ion and low pH. Cleansing materials such as hydrogen peroxide, Dakin's solution, and normal saline are compatible with Collagenase Santyl^® Ointment.

Debilitated patients should be closely monitored for systemic bacterial infections because of the theoretical possibility that debriding enzymes may increase the risk of bacteremia.

A slight transient erythema has been noted occasionally in the surrounding tissue, particularly when Collagenase Santyl^® Ointment was not confined to the wound. Therefore, the ointment should be applied carefully within the area of the wound. Safety and effectiveness in pediatric patients have not been established.

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.

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

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. ^2-6 Collagen in healthy tissue or in newly formed granulation tissue is not attacked. ^2-8 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.

See PRECAUTIONS and CONTRAINDICATIONS.

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

COLLAGENASE OINTMENT - TOPICAL

(coal-ADGE-ih-naze)

COMMON BRAND NAME(S): Santyl

USES: This product is used to help the healing of burns and skin ulcers. Collagenase is an enzyme. It works by helping to break up and remove dead skin and tissue. This effect may also help antibiotics to work better and speed up your body's natural healing process.

HOW TO USE: This medication is for use on the skin only. It is usually applied once daily or as directed by your doctor. If the dressing becomes soiled, collagenase may be applied more frequently.

To apply, wash hands first. Clean the area as directed by your doctor. Cleaning solutions such as hydrogen peroxide, normal saline, or Dakin's solution may be used. If your doctor has directed you to use an antibiotic powder, apply it first before applying this medication. Use a wooden spatula or a gauze pad to carefully apply the collagenase ointment directly to the affected area. Bandage securely. If you are unclear about how to clean the affected area or apply this medication, consult your doctor.

Avoid applying near the eyes. Be careful to apply the ointment only within the affected area. Wash hands thoroughly after applying the ointment.

SIDE EFFECTS: Pain or a burning feeling at the affected area may occur. Temporary redness/irritation may also occur in the skin around the affected area. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. To avoid redness/irritation in the surrounding skin, be careful to apply the ointment only within the affected area.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Treatment of burns and skin ulcers by breaking up and removing dead skin and tissue may infrequently increase the risk for serious infection (sepsis). Tell your doctor immediately if you notice any symptoms of serious infection, including: fever/chills, fast breathing (hyperventilation), fast heartbeat, warm skin, weakness.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using collagenase, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history.

Avoid using solutions that contain acid or metal as soaking liquids because these will decrease the effect of collagenase ointment (see also Drug Interactions section).

It is not known whether this medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: antiseptic skin products (especially those containing heavy metals such as lead, mercury, silver).

Skin products containing heavy metals may decrease the effect of collagenase. If the affected area has been exposed to one of these products, wash the area well with normal saline solution before applying this ointment.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature at or below 77 degrees F (25 degrees C) away from light and moisture. Do not freeze. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.