COLLAGENASE SANTYL

COLLAGENASE SANTYL is an FDA-registered drug product whose active ingredient is COLLAGENASE SANTYL. It is labelled by SMITH & NEPHEW, INC taken by topical and marketed as a human prescription drug product. Identifiers on file: NDC 50484-010, application BLA101995, label effective 20190517. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing COLLAGENASE SANTYL are most often described in connection with: usage collagenase, santyl ointment, debriding chronic, dermal ulcers, severely burned. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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 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.

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

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.

1 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

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

Who makes COLLAGENASE SANTYL?
SMITH & NEPHEW, INC is the labeler of record for COLLAGENASE SANTYL.

What form does COLLAGENASE SANTYL come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is COLLAGENASE SANTYL prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has COLLAGENASE SANTYL been recalled?
1 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.