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Collagenase (topical): Drug information

Collagenase (topical): Drug information
(For additional information see "Collagenase (topical): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Santyl
Brand Names: Canada
  • Santyl
Pharmacologic Category
  • Enzyme, Topical Debridement
Dosing: Adult
Dermal ulcers

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: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling; it is not known if collagenase is absorbed systemically following topical application.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling; it is not known if collagenase is absorbed systemically following topical application.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions are derived from product labeling unless otherwise specified.

Frequency not defined: Local: Localized erythema

Contraindications

Local or systemic hypersensitivity to collagenase or any component of the formulation.

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.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Ointment, External:

Santyl: 250 units/g (30 g, 90 g)

Generic Equivalent Available: US

No

Pricing: US

Ointment (Santyl External)

250 units/g (per gram): $12.09

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Ointment, External:

Santyl: 250 units/g (15 g, 30 g)

Administration: Adult

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.

Use: Labeled Indications

Dermal ulcers: Debriding chronic dermal ulcers and severely burned areas.

Medication Safety Issues
Sound-alike/look-alike issues:

Topical collagenase formulation (Santyl) may be confused with the injectable collagenase clostridium histolyticum (Xiaflex)

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

It is not known if collagenase is absorbed systemically following topical application.

Breastfeeding Considerations

It is not known if collagenase is absorbed systemically following topical application or if collagenase is excreted in breast milk.

Monitoring Parameters

Signs and symptoms of systemic bacterial infection

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 (Adult Data Unless Noted)

Absorption: Topical: Unknown

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (BE) Belgium: Iruxol mono;
  • (BG) Bulgaria: Iruxol mono;
  • (BR) Brazil: Iruxol mono | Kollagenase | Ktriz uno;
  • (CH) Switzerland: Iruxol mono;
  • (CN) China: Iruxol mono;
  • (CO) Colombia: Iruxol 1.2 | Iruxol simplex;
  • (DO) Dominican Republic: Kollagenase;
  • (EC) Ecuador: Iruxol simplex;
  • (EE) Estonia: Iruxol mono;
  • (FI) Finland: Iruxol mono;
  • (GR) Greece: Iruxol mono;
  • (IT) Italy: Noruxol;
  • (LT) Lithuania: Iruxol mono;
  • (LU) Luxembourg: Novuxol;
  • (LV) Latvia: Iruxol mono;
  • (MY) Malaysia: Iruxol mono;
  • (NL) Netherlands: Novuxol;
  • (PE) Peru: Iruxol simplex;
  • (PR) Puerto Rico: Santyl;
  • (PT) Portugal: Colagenase | Ulcerase;
  • (SI) Slovenia: Novuxol;
  • (TR) Turkey: Novuxol;
  • (TW) Taiwan: Collagenase abc;
  • (UY) Uruguay: Iruxol mono;
  • (VE) Venezuela, Bolivarian Republic of: Iruxol simplex
  1. Santyl (collagenase) [prescribing information]. Fort Worth, TX; Smith & Nephew; 2016.
Topic 9296 Version 144.0

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