COLLAGENASE SANTYL Ointment Ref.[10783] Active ingredients: Collagenase

Source: FDA, National Drug Code (US)  Revision Year: 2019 

4. Contraindications

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

7. 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.

6. 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 should be avoided because of the metal ion and low pH. Cleansing materials such as 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.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.