Santyl 250u/gm Ointment 30gm
It is used to promote healing of skin ulcers and wounds.It is used to treat burns.
Drug Class
Debriding agent
Pharmacologic Class
Proteolytic enzyme
Pregnancy Category
Category C
FDA Approved
Jan 1969
DEA Schedule
Not Controlled
Overview
What is this medicine?
Collagenase ointment is a medicine applied to wounds to help remove dead or unhealthy tissue. It works by breaking down the dead tissue, which helps the wound heal better. It's often used for bedsores, burns, and other skin ulcers.
How to Use This Medicine
Using Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions and the information provided with your prescription. This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. Avoid ingesting the medication or applying it to your mouth, nose, or eyes, as it may cause irritation or burning.
Before applying the medication, wash your hands thoroughly. If the affected area is on your hand, you do not need to wash that hand after application. Clean the affected area before applying the medication and make sure it is completely dry. Apply a thin layer of the medication to the affected area, taking care to avoid applying it to healthy skin.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from heat and moisture. Keep all medications in a secure location, out of the reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush medications down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, and consider participating in a drug take-back program in your area.
Missing a Dose
If you forget to apply a dose of your medication, apply it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular application schedule. Do not apply two doses at the same time or use extra doses to make up for a missed dose.
To use this medication safely and effectively, follow your doctor's instructions and the information provided with your prescription. This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. Avoid ingesting the medication or applying it to your mouth, nose, or eyes, as it may cause irritation or burning.
Before applying the medication, wash your hands thoroughly. If the affected area is on your hand, you do not need to wash that hand after application. Clean the affected area before applying the medication and make sure it is completely dry. Apply a thin layer of the medication to the affected area, taking care to avoid applying it to healthy skin.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from heat and moisture. Keep all medications in a secure location, out of the reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush medications down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, and consider participating in a drug take-back program in your area.
Missing a Dose
If you forget to apply a dose of your medication, apply it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular application schedule. Do not apply two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Clean the wound thoroughly before applying the ointment, as directed by your healthcare provider.
- Apply a thin layer of the ointment directly to the dead tissue in the wound.
- Cover the wound with a sterile dressing as instructed.
- Change the dressing and reapply the ointment daily, or as directed.
- Avoid using other topical medications or antiseptics on the wound at the same time as collagenase, unless specifically approved by your doctor, as they may inactivate the enzyme.
- Keep the ointment in the refrigerator (2-8°C or 36-46°F) as directed, and do not freeze.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply once daily
Condition-Specific Dosing:
woundDebridement:
Apply a thin layer (approximately 2 mm thick) directly to the wound bed once daily. Ensure the wound is clean and free of debris before application. Cover with a sterile dressing.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and efficacy not established, but generally used similarly to adults under medical supervision if indicated, due to minimal systemic absorption.
Adolescent:
Safety and efficacy not established, but generally used similarly to adults under medical supervision if indicated, due to minimal systemic absorption.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed; minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Collagenase is a proteolytic enzyme derived from Clostridium histolyticum. It selectively cleaves native and denatured collagen fibers in necrotic tissue, facilitating the removal of devitalized tissue (debridement) from chronic dermal ulcers and severely burned areas. It does not significantly harm viable tissue.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption
Tmax:
Not applicable (topical)
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable (topical)
ProteinBinding:
Not applicable (topical)
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (topical, local action)
Clearance:
Not applicable (topical)
ExcretionRoute:
Not applicable (local degradation)
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Debridement typically begins within hours to days
PeakEffect:
Continued debridement over several days to weeks depending on wound size and necrotic burden
DurationOfAction:
Approximately 24 hours (requires daily application)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
* Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you have side effects that bother you or do not go away, contact your doctor for advice.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, discuss them with your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical guidance on managing side effects.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
* Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you have side effects that bother you or do not go away, contact your doctor for advice.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, discuss them with your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical guidance on managing side effects.
Seek Immediate Medical Attention If You Experience:
- Signs of infection (increased redness, swelling, pain, warmth, pus, fever)
- Allergic reaction (rash, itching, hives, severe burning at the application site)
- No improvement in the wound or worsening of the wound after several days of use
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have a skin infection, as this may affect the use of this medication.
This is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to discuss all of your:
Medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins
Health problems
with your doctor and pharmacist. They will help you determine whether it is safe to take this medication in combination with your other medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have a skin infection, as this may affect the use of this medication.
This is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to discuss all of your:
Medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins
Health problems
with your doctor and pharmacist. They will help you determine whether it is safe to take this medication in combination with your other medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before using any other medications or products on your skin, such as soaps, consult with your doctor to discuss potential interactions. If you are pregnant, planning to become pregnant, or are breast-feeding, notify your doctor to carefully weigh the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Systemic overdose is highly unlikely due to minimal systemic absorption. Local irritation or allergic reaction may occur with excessive application.
What to Do:
Discontinue use, clean the area, and seek medical attention if severe local reaction occurs. For accidental ingestion, call a poison control center (1-800-222-1222) or seek medical attention, though systemic toxicity is not expected.
Drug Interactions
Moderate Interactions
- Antiseptics (e.g., hexachlorophene, iodine, silver sulfadiazine, hydrogen peroxide): May inactivate collagenase. Avoid concomitant use or ensure thorough rinsing before application.
Monitoring
Baseline Monitoring
Wound assessment (size, depth, presence of necrotic tissue, signs of infection)
Rationale: To establish baseline wound characteristics and guide treatment plan.
Timing: Prior to initiation of therapy
Routine Monitoring
Wound assessment (reduction in necrotic tissue, wound size, presence of granulation tissue, signs of infection, local irritation)
Frequency: Daily or at each dressing change
Target: Progressive debridement, decrease in necrotic tissue, increase in healthy granulation tissue
Action Threshold: Lack of debridement, worsening wound, signs of infection (redness, swelling, purulent discharge, pain), severe local irritation (burning, itching, rash) warrant re-evaluation of therapy.
Symptom Monitoring
- Increased wound pain
- Redness or swelling around the wound
- Purulent drainage from the wound
- Fever
- Chills
- Unusual odor from the wound
- Local irritation (burning, itching, rash) at the application site
Special Patient Groups
Pregnancy
Collagenase is classified as Pregnancy Category C. While animal reproduction studies have not been conducted, systemic absorption is minimal. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Minimal systemic absorption suggests low risk, but data are limited.
Second Trimester:
Minimal systemic absorption suggests low risk, but data are limited.
Third Trimester:
Minimal systemic absorption suggests low risk, but data are limited.
Lactation
It is not known whether collagenase is excreted in human milk. Due to minimal systemic absorption, excretion into breast milk is unlikely, and adverse effects on a breastfed infant are not expected. Use with caution.
Infant Risk:
Low risk (L3)
Pediatric Use
Safety and efficacy in pediatric patients have not been established. However, due to minimal systemic absorption, it may be used in children under close medical supervision when indicated, with careful monitoring of the wound.
Geriatric Use
No specific dosage adjustments are necessary for geriatric patients. Efficacy and safety are generally similar to those in younger adults, given the topical nature and minimal systemic absorption.
Clinical Information
Clinical Pearls
- Collagenase is most effective when applied to a clean wound bed free of debris and eschar. Surgical debridement or sharp debridement may be necessary before initiating collagenase therapy for heavily necrotic wounds.
- The wound should be moist for optimal enzyme activity. If the wound is dry, it may be moistened with normal saline before application.
- Avoid contact with the eyes and mucous membranes.
- Discontinue use once debridement is complete and healthy granulation tissue is present.
- Store in the refrigerator to maintain enzyme activity.
Alternative Therapies
- Surgical debridement
- Sharp debridement
- Autolytic debridement (e.g., hydrogels, transparent films)
- Mechanical debridement (e.g., wet-to-dry dressings, wound irrigation)
- Enzymatic debridement (other enzymes, though collagenase is unique in its specificity for collagen)
- Biologic debridement (e.g., maggot therapy)
Cost & Coverage
Average Cost:
Varies, typically $200-$400 per 30gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization or step therapy)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.