Drugs Details

Drugs Info of Santyl
Drugs Details
  • Drugs Type  : FDA
  • Date : 27th Mar 2015 11:24 pm
  • Brand Name : Santyl
  • Generic Name : collagenase topical (Pronunciation: KOL a JEN ase TOP ik al)
Descriptions

Collagenase Santyl® (collagenase) 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 byClostridium histolyticum. It possesses the unique ability to digest collagen innecrotic tissue.

 

What are the possible side effects of collagenase topical (Santyl)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if your skin condition gets worse, or you have new symptoms of illness or infection.

Less serious side effects may include redness of the skin around the treated area where collagenase topical was applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at...

Read All Potential Side Effects and See Pictures of Santyl »

What are the precautions when taking collagenase (Santyl)?

Before using collagenase, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

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...

Read All Potential Precautions of Santyl »

 

This monograph has been modified to include the generic and brand name in many instances.

Indications

Collagenase Santyl (collagenase) ® Ointment is indicated for debridingchronic dermal ulcers 2-6,8-18 and severely burned areas. 3-5,7,16,19-21

 
 

Dosage Administration

Collagenase Santyl (collagenase) ® 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 (collagenase) ® Ointment more surface contact withnecrotic debris. It is also desirable to remove, with forceps and scissors, as much loosened detritus as can be done readily. Use Collagenase Santyl (collagenase) ® 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 salinesolution, 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 topicalantibiotic powder. The antibiotic should be applied to the wound prior to the application of Collagenase Santyl (collagenase) ® Ointment. Should the infection not respond, therapy with Collagenase Santyl (collagenase) ®Ointment should be discontinued until remission of the infection.

3 - Collagenase Santyl (collagenase) ® 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 (collagenase) ® Ointment should be terminated when debridement of necrotic tissue is complete and granulationtissue is well established.

How Supplied

Collagenase Santyl® Ointment contains 250 units of collagenase enzymeper 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 (collagenase) ® 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, SciencePublishers, 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 DermatologyDigest, 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® (collagenase) is a registered trademark of Abbott Laboratories 
All rights reserved Revised: July 2003 Printed in U.S.A.

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

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.

Read the Santyl (collagenase) Side Effects Center for a complete guide to possible side effects

Learn More »
 
 
 

Interactions

No information provided.

Read the Santyl Drug Interactions Center for a complete guide to possible interactions

Learn More »
 

This monograph has been modified to include the generic and brand name in many instances.G

Warnings

No information provided

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 normalsaline before Collagenase Santyl (collagenase) ® 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 (collagenase) ® Ointment.

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

A slight transient erythema has been noted occasionally in the surroundingtissue, particularly when Collagenase Santyl (collagenase) ® Ointment was not confined to the wound. Therefore, the ointment should be applied carefully within the area of the wound. Safety and effectiveness in pediatricpatients have not been established.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

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.

ContrainDications

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

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Since collagen accounts for 75% of the dry weight of skin tissue, the ability of collagenase to digest collagen in the physiological pH and temperaturerange 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. 2-8There 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.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

See PRECAUTIONS and CONTRAINDICATIONS.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

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.

Consumer Overview Side Effect

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 (especially of the face/tongue/throat), 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.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Santyl (collagenase) Side Effects Center for a complete guide to possible side effects

Learn More »
 

PRECAUTIONS: Before using collagenase, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

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.

Consumer Overview Missed Dose

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 a poison control center or emergency room immediately. US residents can call their local poison control center 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 March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Santyl

Generic Name: collagenase topical (Pronunciation: KOL a JEN ase TOP ik al)

  • What is collagenase topical (Santyl)?
  • What are the possible side effects of collagenase topical (Santyl)?
  • What is the most important information I should know about collagenase topical (Santyl)?
  • What should I discuss with my health care provider before using collagenase topical (Santyl)?
  • How should I use collagenase topical (Santyl)?
  • What happens if I miss a dose (Santyl)?
  • What happens if I overdose (Santyl)?
  • What should I avoid while using collagenase topical (Santyl)?
  • What other drugs will affect collagenase topical (Santyl)?
  • Where can I get more information?

What is collagenase topical (Santyl)?

 

Collagenase is an enzyme that breaks down collagen in damaged tissues within the skin and helps the body generate new healthy tissue. Collagen is a type of protein that connects and supports fibers in body tissues such as skin, tendons, muscles, and bone.

Collagenase topical (for the skin) is applied to severe burns or skin ulcers to help remove dead skin tissue and aid in wound healing.

Collagenase topical may also be used for other purposes not listed in this medication guide.

What are the possible side effects of collagenase topical (Santyl)?

 

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if your skin condition gets worse, or you have new symptoms of illness or infection.

Less serious side effects may include redness of the skin around the treated area where collagenase topical was applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Santyl (collagenase) Side Effects Center for a complete guide to possible side effects

Learn More »
 

What is the most important information I should know about collagenase topical (Santyl)?

 

You should not use collagenase topical if you are allergic to it.

To make sure you can safely use this medication, tell your doctor about all of your medical conditions, and if you are pregnant or breast-feeding.

Apply this medication only to the affected skin wound. Try not to get any ointment on the healthy skin around the wound.

The enzymes in collagenase topical may increase your risk of a bacterial infection in your blood stream. Call your doctor at once if you have any signs of infection such as fever, chills, rapid heartbeats, nausea, vomiting, stomach pain, or feeling very ill.

Side Effects Centers
  • Santyl

Patient Detailed How Take

What should I discuss with my health care provider before using collagenase topical (Santyl)?

 

You should not use collagenase topical if you are allergic to it.

To make sure you can safely use this medication, tell your doctor about all of your medical conditions.

It is not known whether collagenase topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether collagenase topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use collagenase topical (Santyl)?

 

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Apply this medication only to the affected skin wound. Try not to get any ointment on the healthy skin around the wound.

Collagenase topical is usually applied once daily. You may need to apply it more often if the wound area becomes soiled.

You may apply collagenase topical directly to the wound, or apply it to a sterile gauze pad and then to the wound.

Before applying collagenase topical, rinse the skin area several times with normal saline solution or other cleanser recommended by your doctor. Collagenase topical may be less effective if you apply it to skin that has been treated with certain cleansers or antiseptic solutions.

Remove as much of the loose tissue as possible before applying the medication. Soak a gauze pad with the cleansing solution recommended by your doctor. Gently rub the wound to remove the loose skin and debris.

Your doctor may recommend using an antibiotic powder on the affected skin before you apply collagenase topical. Follow your doctor's instructions about the type and amount of antibiotic powder to use.

The enzymes in collagenase topical may increase your risk of a bacterial infection in your blood stream. Call your doctor right away if you have any signs of infection such as fever, chills, rapid heartbeats, nausea, vomiting, stomach pain, or feeling very ill.

Store at room temperature away from moisture and heat.

Side Effects Centers
  • Santyl

Patient Detailed Avoid Taking

What happens if I miss a dose (Santyl)?

 

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Santyl)?

 

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of collagenase topical is not expected to be dangerous. If you think you have applied too much of this medication, you may wash off the enzyme with povidone iodine.

What should I avoid while using collagenase topical (Santyl)?

 

Avoid using other medications on the areas you treat with collagenase topical unless your doctor tells you to.

What other drugs will affect collagenase topical (Santyl)?

 

There may be other drugs that can interact with collagenase topical. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

 

Your doctor or pharmacist can provide more information about collagenase topical.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 1.03. Revision date: 5/7/2012.

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