Collagenase (Topical) (Monograph)

Brand name: Collagenase Santyl
Drug class: Basic Ointments and Protectants

Medically reviewed by Drugs.com on May 10, 2024. Written by ASHP.

Introduction

Enzymatic debriding agent derived from Clostridium histolyticum.^{a b}

Uses for Collagenase (Topical)

Wound Debridement

Used to promote debridement of necrotic tissue in the treatment of severe burns and dermal ulcers including decubitus ulcers.^{a b}

Collagenase (Topical) Dosage and Administration

Administration

Apply ointment topically to wound.^{a b}

Do not introduce ointment into major body cavities (e.g., pleural or peritoneal cavities).^a

Topical Administration

Apply ointment directly to the wound or to a sterile gauze pad which is then applied to the wound and properly secured.^{a b}

Use caution to restrict application to the lesion; avoid applying to healthy skin.^{a b} (See Local Effects under Cautions.)

Prior to each application, cleanse wound with a gauze pad saturated with 0.9% sodium chloride solution or a compatible cleansing agent to remove necrotic material and follow with a normal saline solution rinse.^b (See Compatibility under Stability.)

Avoid detergents, solutions containing heavy metal ions, or acidic solutions.^{a b} If such materials are used, carefully cleanse site with repeated normal saline solution rinses prior to application.^b (See Enzyme Inactivation under Cautions and see Compatibility under Stability.)

Remove as much loosened detritus as can be done readily with forceps and scissors.^{a b} If clinically indicated, cross-hatch thick eschar with a #10 scalpel blade.^{a b}

If infection is present, apply a topical antibiotic powder to the lesion prior to the application of collagenase.^{a b} (See Compatibility under Stability.) If infection does not respond to combined therapy, discontinue collagenase until infection has resolved.^{a b}

Dosage

Adults

Wound Debridement

Topical

Apply once daily to wound. ^{a b}

Apply more frequently if the dressing becomes soiled (e.g., due to incontinence).^{a b}

Discontinue when debridement of necrotic tissue is complete and granulation tissue is well established.^{a b}

Special Populations

No special population dosage recommendations at this time.^b

Cautions for Collagenase (Topical)

Contraindications

• Known local or systemic hypersensitivity to collagenase.^{a b}

Warnings/Precautions

General Precautions

Enzymatic Inactivation

Collagenase is potentially irreversibly inactivated at pH <5 and reversibly inactivated at pH ≥8.5; activity can be restored by return of pH to 7.4.^a

Collagenase can be destroyed by other proteolytic enzymes or by exposure to temperatures >56°C.^a

Enzymatic activity is adversely affected by detergents, heavy metal ions (e.g., mercury or silver), and povidone iodine.^{a b}

Infection Risk

Possible risk of systemic bacterial infection;^{a b} closely monitor debilitated patients for evidence of systemic bacterial infection (e.g., fever, chills, tachycardia).^{a b}

Local Effects

Slight erythema may develop in surrounding tissue, especially if ointment is not confined to lesion being treated.^b

Specific Populations

Lactation

Not known if distributed into human milk.^b

Pediatric Use

Safety and efficacy not established.^{a b}

Common Adverse Effects

Slight erythema.^a

Stability

Storage

Topical

Ointment

<25°C.^{a b}

Compatibility

Topical

For information on interactions resulting from concomitant use, see Enzymatic Inactivation under Cautions.

Solution Compatibility

Actions

• An enzymatic debriding agent capable of specifically hydrolyzing peptide bonds of undenatured and denatured collagen.^{a b}

• Liquefies necrotic tissue without damaging granulation tissue.^a

• Contributes towards the formation of granulation tissue and subsequent epithelization of dermal ulcers and severely burned areas.^b

• May remove substrates necessary for bacterial proliferation or may permit antibodies, leukocytes, and antibiotics better access to the infected area.^a

Advice to Patients

• Importance of using as directed and not applying to healthy skin.^{a b}

• Importance of informing clinicians immediately of any symptoms of serious infection (e.g., fever/chills, hyperventilation, rapid heartbeat).^{a b}

• Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.^a

• Importance of informing patients of other important precautionary information.^a (See Cautions.)

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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