NDC 50484-010 Collagenase Santyl

Collagenase Santyl

NDC Product Code 50484-010

NDC 50484-010-30

Package Description: 1 TUBE in 1 CARTON > 30 g in 1 TUBE

NDC 50484-010-90

Package Description: 1 TUBE in 1 CARTON > 90 g in 1 TUBE

NDC Product Information

Collagenase Santyl with NDC 50484-010 is a a human prescription drug product labeled by Smith & Nephew, Inc. The generic name of Collagenase Santyl is collagenase santyl. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Smith & Nephew, Inc

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Collagenase Santyl Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • COLLAGENASE CLOSTRIDIUM HISTOLYTICUM 250 [arb'U]/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • PETROLATUM (UNII: 4T6H12BN9U)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Collagenases - [Chemical/Ingredient]
  • Collagen-specific Enzyme - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Smith & Nephew, Inc
Labeler Code: 50484
FDA Application Number: BLA101995 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: BLA - A product marketed under an approved Biologic License Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 10-18-2006 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Collagenase Santyl Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Collagenase Santyl◊ Ointment is a sterile enzymatic debriding ointment which contains 250 collagenase units per gram of white petrolatum USP. The enzyme collagenase is derived from the fermentation by Clostridium histolyticum. It possesses the unique ability to digest collagen in necrotic tissue.

Clinical Pharmacology

Since collagen accounts for 75% of the dry weight of skin tissue, the ability of collagenase to digest collagen in the physiological pH and temperature range makes it particularly effective in the removal of detritus.
1
  Collagenase thus contributes towards the formation of granulation tissue and subsequent epithelization of dermal ulcers and severely burned areas.
2, 3, 4, 5, 6
Collagen in healthy tissue or in newly formed granulation tissue is not attacked.
2, 3, 4, 5, 6, 7, 8
There is no information available on collagenase absorption through skin or its concentration in body fluids associated with therapeutic and/or toxic effects, degree of binding to plasma proteins, degree of uptake by a particular organ or in the fetus, and passage across the blood brain barrier.

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

Contraindications

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

Precautions

The optimal pH range of collagenase is 6 to 8. Higher or lower pH conditions will decrease the enzyme’s activity and appropriate precautions should be taken. The enzymatic activity is also adversely affected by certain detergents, and heavy metal ions such as mercury and silver which are used in some antiseptics. When it is suspected such materials have been used, the site should be carefully cleansed by repeated washings with normal saline before Collagenase Santyl◊ Ointment is applied. Soaks containing metal ions or acidic solutions should be avoided because of the metal ion and low pH. Cleansing materials such as Dakin’s solution and normal saline are compatible with Collagenase Santyl◊ Ointment.Debilitated patients should be closely monitored for systemic bacterial infections because of the theoretical possibility that debriding enzymes may increase the risk of bacteremia.A slight transient erythema has been noted occasionally in the surrounding tissue, particularly when Collagenase Santyl◊ Ointment was not confined to the wound. Therefore, the ointment should be applied carefully within the area of the wound. Safety and effectiveness in pediatric patients have not been established.

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.

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.

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.

How Supplied

Collagenase Santyl◊ Ointment contains 250 units of collagenase enzyme per gram of white petrolatum USP.Do not store above 25°C (77°F). Sterility guaranteed until tube is opened.Collagenase Santyl◊ Ointment is available in the following sizes:30 g tube NDC 50484-010-3090 g tube NDC 50484-010-90REFERENCES1 – Mandl, I., Adv Enzymol. 23:163, 1961.2 – Boxer, A.M., Gottesman, N., Bernstein, H., & Mandl, I., Geriatrics. 24:75, 1969.3 – Mazurek, I., Med. Welt. 22:150, 1971.4 – Zimmermann, WE., in “Collagenase,” Mandl, I., ed., Gordon & Breach, Science Publishers, New York, 1971, p. 131, p. 185.5 – Vetra, H., & Whittaker, D., Geriatrics. 30:53, 1975.6 – Rao, D.B., Sane, P.G., & Georgiev, E.L., J. Am. Geriatrics Soc. 23:22, 1975.7 – Vrabec, R., Moserova, J., Konickova, Z., Behounkova, E., & Blaha, J., J. Hyg. Epidemiol. Microbiol. Immunol. 18:496, 1974.8 – Lippmann, H.I., Arch. Phys. Med. Rehabil. 54:588, 1973.9 – German, F. M., in “Collagenase,” Mandl, I., ed., Gordon & Breach, Science Publishers, New York, 1971, p. 165.10 – Haimovici, H. & Strauch, B., in “Collagenase,” Mandl, I., ed., Gordon & Breach, Science Publishers, New York, 1971, p. 177.11 – Lee, L.K., & Ambrus, J.L., Geriatrics. 30:91, 1975.12 – Locke, R.K., & Heifitz, N.M., J. Am. Pod. Assoc. 65:242, 1975.13 – Varma, A.O., Bugatch, E., & German, F.M., Surg. Gynecol. Obstet. 136:281, 1973.14 – Barrett, D., Jr., & Klibanski, A., Am. J. Nurs. 73:849, 1973.15 – Bardfeld, L.A., J. Pod. Ed. 1:41, 1970.16 – Blum, G., Schweiz, Rundschau Med Praxis. 62:820, 1973. Abstr. in Dermatology Digest, Feb. 1974, p. 36.17 – Zaruba, F., Lettl, A., Brozkova, L., Skrdlantova, H., & Krs, V., J. Hyg. Epidemiol. Microbiol. Immunol. 18:499, 1974.18 – Altman, M.I., Goldstein, L., & Horwitz, S., J. Am. Pod. Assoc. 68:11, 1978.19 – Rehn, V.J., Med. Klin. 58:799, 1963.20 – Krauss, H., Koslowski, L., & Zimmermann, W. E., Langenbecks Arch. Klin. Chir. 303:23, 1963.21 – Gruenagel, H.H., Med. Klin. 58:442, 1963.Manufactured by: SMITH & NEPHEW, INCFort Worth, Texas 76109US Gov’t License #2004Marketed by: Smith & Nephew◊1-800-441-8227Smith & Nephew, Inc., Fort Worth, Texas 76109© 2016 Smith & Nephew, Inc.SANTYL is a registered trademark of Smith & Nephew, Inc.140749-0316

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