Santyl 250u/gm Ointment 90gm
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
C
FDA Approved
Jun 1975
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 contains an enzyme that breaks down the dead tissue, allowing the wound to heal better. It's important to apply it exactly as directed by your doctor or nurse.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication as directed.
Application Instructions
Apply this medication only to the affected area of your skin. Do not ingest it or apply it to your mouth, nose, or eyes, as it may cause burning.
Before applying the medication, wash your hands thoroughly. If the treated area is on your hand, do not wash that hand after application.
Clean the affected area before applying the medication and ensure it is completely dry.
Apply a thin layer of the medication to the affected area, avoiding healthy skin.
Storage and Disposal
Store this medication at room temperature, away from heat and moisture.
Keep all medications in a secure location, out of reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
Check with your pharmacist for guidance on disposing of medications, and consider participating in local drug take-back programs.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular application schedule.
* Do not apply two doses at once or use extra doses to make up for a missed dose.
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication as directed.
Application Instructions
Apply this medication only to the affected area of your skin. Do not ingest it or apply it to your mouth, nose, or eyes, as it may cause burning.
Before applying the medication, wash your hands thoroughly. If the treated area is on your hand, do not wash that hand after application.
Clean the affected area before applying the medication and ensure it is completely dry.
Apply a thin layer of the medication to the affected area, avoiding healthy skin.
Storage and Disposal
Store this medication at room temperature, away from heat and moisture.
Keep all medications in a secure location, out of reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
Check with your pharmacist for guidance on disposing of medications, and consider participating in local drug take-back programs.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular application schedule.
* Do not apply two doses at once 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.
- Avoid using other topical agents (especially those containing heavy metals like silver, or strong antiseptics like iodine) on the wound simultaneously with collagenase, as they can inactivate the enzyme. If other agents are necessary, discuss timing with your doctor.
- Cover the wound with a sterile dressing after application, as instructed.
- Maintain good hygiene and follow all wound care instructions to prevent infection.
- Report any signs of infection or worsening of the wound to your healthcare provider immediately.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer of ointment (approximately 2 mm thick) once daily to the necrotic tissue.
Condition-Specific Dosing:
pressureUlcers:
Apply once daily.
diabeticUlcers:
Apply once daily.
burns:
Apply once daily to second and third-degree burns with necrotic tissue.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and efficacy not fully established, but generally used with caution similar to adult dosing if clinically indicated due to minimal systemic absorption.
Adolescent:
Safety and efficacy not fully established, but generally used with caution similar to adult dosing if clinically indicated due to minimal systemic absorption.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Collagenase is a proteolytic enzyme derived from Clostridium histolyticum. It selectively digests native and denatured collagen in necrotic tissue, facilitating the removal of devitalized tissue from wounds. It does not significantly harm viable tissue.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption
Tmax:
Not applicable (topical)
FoodEffect:
Not applicable (topical)
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 (topical)
Unchanged:
Not applicable (topical)
Pharmacodynamics
OnsetOfAction:
Debridement typically begins within hours to days, with visible results often within 1-2 weeks.
PeakEffect:
Variable, depends on wound size and amount of necrotic tissue.
DurationOfAction:
Applied once daily, continuous action over 24 hours.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
- 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, or swelling of the mouth, face, lips, tongue, or throat.
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many individuals do not experience any side effects or only have mild ones. If you have side effects that bother you or persist, contact your doctor for advice. It's essential to note that this list may not include all possible side effects. If you have questions or concerns about side effects, discuss them with your doctor.
Reporting Side Effects
For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
- 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, or swelling of the mouth, face, lips, tongue, or throat.
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many individuals do not experience any side effects or only have mild ones. If you have side effects that bother you or persist, contact your doctor for advice. It's essential to note that this list may not include all possible side effects. If you have questions or concerns about side effects, discuss them with your doctor.
Reporting Side Effects
For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Increased pain or tenderness in the wound area
- Redness, swelling, or warmth spreading from the wound
- Foul-smelling or increased drainage from the wound
- Fever or chills
- New rash, itching, or severe irritation at the application site
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 symptoms you experienced.
If you have a skin infection, as this may affect the use of this medication.
This is not an exhaustive list of potential interactions. Therefore, 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 determine whether it is safe to take this medication in conjunction with your other medications and health conditions. Do not initiate, discontinue, or modify the dosage 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 symptoms you experienced.
If you have a skin infection, as this may affect the use of this medication.
This is not an exhaustive list of potential interactions. Therefore, 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 determine whether it is safe to take this medication in conjunction with your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all of 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 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 absorption.
- Excessive local application may theoretically increase local irritation, but no specific overdose symptoms are known.
What to Do:
Discontinue use, clean the area, and seek medical advice if severe local reaction occurs. For general poisoning concerns, call 1-800-222-1222.
Drug Interactions
Moderate Interactions
- Antiseptics containing heavy metal ions (e.g., silver sulfadiazine, mercury, lead)
- Detergents (e.g., benzalkonium chloride)
- Hexachlorophene
- Povidone-iodine
Monitoring
Baseline Monitoring
Wound assessment (size, depth, type of tissue, exudate, signs of infection)
Rationale: To establish baseline for monitoring debridement progress and identify potential complications.
Timing: Prior to initiation of therapy
Routine Monitoring
Wound appearance (reduction in necrotic tissue, presence of granulation tissue)
Frequency: Daily or every dressing change
Target: Progressive removal of necrotic tissue, increase in healthy granulation tissue
Action Threshold: Lack of progress, worsening wound, or signs of infection warrant re-evaluation.
Signs of local irritation or allergic reaction
Frequency: Daily or every dressing change
Target: Absence of erythema, edema, pain, or rash beyond expected wound healing.
Action Threshold: Presence of significant irritation or allergic reaction may require discontinuation.
Symptom Monitoring
- Increased wound pain
- Redness or warmth around the wound
- Increased swelling
- Purulent drainage
- Fever or chills (systemic infection signs)
- Rash or itching at application site
Special Patient Groups
Pregnancy
Collagenase topical is Pregnancy Category C. Animal reproduction studies have not been conducted. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemic absorption is minimal, which may reduce risk.
Trimester-Specific Risks:
First Trimester:
Risk unknown, minimal systemic absorption suggests low risk.
Second Trimester:
Risk unknown, minimal systemic absorption suggests low risk.
Third Trimester:
Risk unknown, minimal systemic absorption suggests low risk.
Lactation
It is not known whether collagenase is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when collagenase is administered to a nursing woman. However, due to minimal systemic absorption, risk to the infant is considered low.
Infant Risk:
Low
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Use with caution and only if clearly indicated, considering minimal systemic absorption.
Geriatric Use
No specific dosage adjustments are necessary for geriatric patients. Clinical studies have not identified differences in responses between elderly and younger patients. Use with caution in patients with compromised skin integrity.
Clinical Information
Clinical Pearls
- Ensure the wound is clean and free of debris before applying collagenase. Saline irrigation is often recommended.
- Avoid concomitant use of heavy metal-containing antiseptics (e.g., silver sulfadiazine, povidone-iodine) as they can inactivate the enzyme. If these are necessary, apply them, rinse thoroughly, and then apply collagenase.
- Collagenase is specific for collagen and will not harm viable tissue, making it a gentle debriding agent.
- Debridement progress should be monitored regularly. If no improvement is seen within 14 days, re-evaluate the treatment plan.
- A cross-hatching technique on eschar can facilitate penetration of the enzyme.
Alternative Therapies
- Surgical debridement
- Mechanical debridement (e.g., wet-to-dry dressings, hydrotherapy)
- Autolytic debridement (e.g., hydrogels, hydrocolloids)
- Other enzymatic debriding agents (e.g., papain-urea)
- Biologic debridement (e.g., maggot therapy)
Cost & Coverage
Average Cost:
$500 - $1000+ per 90gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 3 or 4 (Specialty/Non-Preferred Brand), may require prior authorization
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.