Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Ointment, External:
Santyl: 250 units/g (30 g, 90 g)
Pharmacology
Mechanism of Action
Collagenase is an enzyme derived from the fermentation by Clostridium histolyticum and differs from other proteolytic enzymes in that its enzymatic action has a high specificity for native and denatured collagen in necrotic tissue; collagenase will not attack collagen in healthy tissue or newly formed granulation tissue. Therefore, collagenase is effective for the removal of detritus, formation of granulation tissue, and subsequent epithelization of dermal ulcers and severely burned areas.
Pharmacokinetics/Pharmacodynamics
Absorption
Topical: Unknown
Use: Labeled Indications
Dermal ulcers: Debriding chronic dermal ulcers and severely burned areas.
Contraindications
Local or systemic hypersensitivity to collagenase or any component of the formulation.
Dosage and Administration
Dosing: Adult
Dermal ulcers: Topical: Apply once daily (or more frequently if the dressing becomes soiled) until debridement of necrotic tissue is complete and granulation tissue is well established. If infection is present, apply an appropriate topical antibiotic prior to the application of collagenase. If the infection persists despite treatment, discontinue use of collagenase until remission of the infection.
Dosing: Geriatric
Refer to adult dosing.
Administration
Prior to application, cleanse the wound of debris and digested material by gently rubbing with a gauze pad saturated with normal saline or another compatible cleansing solution (eg, Dakin’s solution) followed by a normal saline rinse; detergents and antiseptics or soaks containing heavy metal ions (eg, mercury, silver) may decrease the enzymatic activity of collagenase and should be avoided. The enzymatic activity is optimal at a pH range of 6 to 8; precautions should be taken to ensure optimal pH at the application site.
Apply collagenase directly to the wound or to a sterile gauze pad and then apply to the wound and secure. If a thick eschar is present, consider crosshatching with a #10 blade prior to application to allow for more surface contact with necrotic debris; remove as much loosened detritus as can be done readily with forceps and scissors. Application should be carefully confined to the area of the wound; transient erythema may occur in surrounding tissue when application is not confined to the wound.
Storage
Do not store above 25˚C (77˚F).
Drug Interactions
There are no known significant interactions.
Adverse Reactions
Frequency not defined.
Local: Application site burning, application site irritation, application site pain
<1%, postmarketing and/or case reports: Hypersensitivity reaction
Warnings/Precautions
Concerns related to adverse effects:
- Local effects: A slight transient erythema has been noted occasionally in the surrounding tissue, particularly when application was not confined to the wound.
Special populations:
- Debilitated patients: Debriding enzymes may increase the risk of bacteremia; monitor debilitated patients for systemic bacterial infections.
Monitoring Parameters
Signs and symptoms of systemic bacterial infection
Pregnancy
Pregnancy Considerations
It is not known if collagenase is absorbed systemically following topical application.
Patient Education
What is this drug used for?
- It is used to promote healing of skin ulcers and wounds.
- It is used to treat burns.
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Infection
- A significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
