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

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

3. Indications and Usage

Collagenase Santyl Ointment is indicated for debriding chronic dermal ulcers2,3,4,5,6,8,9,10,11,12,13,14,15,16,17,18 and severely burned areas.3,4,5,7,16,19,20,21

10. 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.

9. 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.

12. Storage and Handling

Do not store above 25°C (77°F). Sterility guaranteed until tube is opened.

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