Regenecare Wound Gel
It is used to promote healing of skin ulcers and wounds.It is used to treat burns.
Drug Class
Wound healing agent, topical anesthetic
Pharmacologic Class
Local anesthetic (Lidocaine), Biologic/Wound matrix (Collagen), Botanical/Emollient (Aloe Gel)
Pregnancy Category
Category B (based on Lidocaine topical, generally considered low risk)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Regenecare Wound Gel is a topical gel used to help wounds heal and reduce pain. It contains lidocaine to numb the area, collagen to help new skin grow, and aloe vera to soothe and moisturize the skin.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to follow the instructions carefully.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands thoroughly before and after applying the medication.
Clean the affected area before application and make sure it is completely dry.
Cover the treated wound with a clean dressing.
Storage and Disposal
Store this medication at room temperature, away from freezing temperatures.
Missed Dose
* If you miss a dose, apply it as soon as you remember.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to follow the instructions carefully.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands thoroughly before and after applying the medication.
Clean the affected area before application and make sure it is completely dry.
Cover the treated wound with a clean dressing.
Storage and Disposal
Store this medication at room temperature, away from freezing temperatures.
Missed Dose
* If you miss a dose, apply it as soon as you remember.
Lifestyle & Tips
- Keep the wound clean and dry before applying the gel.
- Wash hands thoroughly before and after applying the gel.
- Avoid getting the gel in eyes, nose, or mouth. If contact occurs, rinse thoroughly with water.
- Do not apply to large areas of the body or for prolonged periods without consulting a healthcare professional, especially on broken skin, to avoid systemic absorption of lidocaine.
- Follow your healthcare provider's instructions for wound care, including dressing changes.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to the affected area 1-3 times daily or as directed by a healthcare professional.
Dose Range:
1 - 3 mg
Condition-Specific Dosing:
wound_care:
Cleanse the wound thoroughly before application. Apply a thin layer directly to the wound bed and surrounding skin. May be covered with a secondary dressing if desired.
Pediatric Dosing
Neonatal:
Not established (use with extreme caution, consult pediatrician due to potential for increased systemic absorption in infants)
Infant:
Not established (use with extreme caution, consult pediatrician due to potential for increased systemic absorption in infants)
Child:
Apply a thin layer to the affected area 1-3 times daily or as directed by a healthcare professional. Use lowest effective dose and monitor for systemic effects.
Adolescent:
Apply a thin layer to the affected area 1-3 times daily or as directed by a healthcare professional.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (systemic absorption is minimal with proper topical use)
Moderate:
No adjustment needed (systemic absorption is minimal with proper topical use)
Severe:
No adjustment needed (systemic absorption is minimal with proper topical use)
Dialysis:
No specific considerations for topical use; monitor for systemic lidocaine toxicity if large areas or broken skin are treated.
Hepatic Impairment:
Mild:
No adjustment needed (systemic absorption is minimal with proper topical use)
Moderate:
No adjustment needed (systemic absorption is minimal with proper topical use)
Severe:
No adjustment needed (systemic absorption is minimal with proper topical use)
Confidence:
High
Pharmacology
Mechanism of Action
Regenecare Wound Gel combines the local anesthetic action of Lidocaine with the wound healing properties of Collagen and the soothing effects of Aloe Gel. Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby producing local anesthetic action. Collagen provides a scaffold for cellular ingrowth, promoting granulation tissue formation, wound contraction, and epithelialization. Aloe Gel contributes anti-inflammatory, moisturizing, and soothing effects, aiding in skin repair and comfort.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (Lidocaine: Systemic absorption from topical application depends on dose, duration, skin integrity, and site of application. Generally low but can increase significantly on broken or inflamed skin. Collagen/Aloe: Primarily local action, minimal to no systemic absorption of intact components.)
Tmax:
Not applicable for topical collagen/aloe. For Lidocaine, systemic Tmax is variable, typically 1-4 hours after topical application to intact skin, but can be faster on compromised skin.
FoodEffect:
Not applicable (topical administration)
Distribution:
Vd:
Not applicable for topical collagen/aloe. For Lidocaine, approximately 1.1 L/kg (systemic).
ProteinBinding:
Not applicable for topical collagen/aloe. For Lidocaine, approximately 60-80% (systemic).
CnssPenetration:
Limited (Lidocaine can cross the blood-brain barrier if systemically absorbed in sufficient quantities, leading to CNS effects.)
Elimination:
HalfLife:
Approximately 1.5-2 hours (Lidocaine, systemic)
Clearance:
Approximately 10 mL/min/kg (Lidocaine, systemic)
ExcretionRoute:
Renal (Lidocaine and its metabolites)
Unchanged:
Less than 10% (Lidocaine, systemic)
Pharmacodynamics
OnsetOfAction:
Minutes (Lidocaine for local anesthetic effect)
PeakEffect:
Variable (Lidocaine: 1-4 hours for systemic absorption; Collagen/Aloe: Gradual, over days to weeks for wound healing effects)
DurationOfAction:
Hours (Lidocaine for local anesthetic effect; Collagen/Aloe: Continuous local action as long as applied)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of skin infection, including:
+ Oozing
+ Heat
+ Swelling
+ Redness
+ Pain
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor or seek medical help:
Skin irritation
Numb skin
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult 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, this medication can cause severe and potentially life-threatening side effects. If you experience 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of skin infection, including:
+ Oozing
+ Heat
+ Swelling
+ Redness
+ Pain
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor or seek medical help:
Skin irritation
Numb skin
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult 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, redness, swelling, or pus from the wound (signs of infection)
- Rash, itching, or hives at the application site (allergic reaction)
- Dizziness, lightheadedness, drowsiness, confusion, ringing in ears, metallic taste, numbness around the mouth, blurred vision, tremors, or muscle twitching (signs of too much lidocaine in the body)
- Slow or irregular heartbeat, difficulty breathing
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.
The presence of an infection at the site where this medication will be administered.
To ensure safe use, it is crucial to disclose all of your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
* Vitamins
Additionally, inform your doctor about any existing health problems. This information will help your doctor determine if it is safe for you to take this medication with your other medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all of your other medications and health problems.
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.
The presence of an infection at the site where this medication will be administered.
To ensure safe use, it is crucial to disclose all of your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
* Vitamins
Additionally, inform your doctor about any existing health problems. This information will help your doctor determine if it is safe for you to take this medication with your other medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all of your other medications and health problems.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. While using this drug, avoid scratching or rubbing the treated skin, as it will be numb. Additionally, protect the area from extreme temperatures, avoiding exposure to very hot or very cold conditions. If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe dizziness or lightheadedness
- Nausea, vomiting
- Tremors, muscle twitching, seizures
- Difficulty breathing, slow or irregular heartbeat
- Loss of consciousness
What to Do:
Immediately wash off the gel from the skin. Seek emergency medical attention or call a Poison Control Center (1-800-222-1222). Bring the product packaging with you.
Drug Interactions
Moderate Interactions
- Class I antiarrhythmics (e.g., tocainide, mexiletine): Increased risk of additive cardiac effects if significant systemic lidocaine absorption occurs.
- Other local anesthetics: Increased risk of systemic toxicity if used concurrently over large areas.
Monitoring
Baseline Monitoring
Wound assessment (size, depth, exudate, signs of infection)
Rationale: To establish baseline wound status and guide treatment.
Timing: Prior to first application
Skin integrity around wound
Rationale: To assess risk of increased systemic lidocaine absorption.
Timing: Prior to first application
Routine Monitoring
Signs of local irritation (redness, itching, rash)
Frequency: Daily or with each dressing change
Target: Absence of irritation
Action Threshold: Discontinue use if irritation persists or worsens.
Signs of systemic lidocaine toxicity (dizziness, drowsiness, confusion, tinnitus, perioral numbness, metallic taste, blurred vision, tremors, seizures, bradycardia)
Frequency: Daily, especially if applied to large or compromised areas
Target: Absence of symptoms
Action Threshold: Seek immediate medical attention if any systemic symptoms occur.
Wound healing progress (reduction in size, granulation tissue formation, epithelialization)
Frequency: Weekly or as clinically indicated
Target: Positive wound progression
Action Threshold: Re-evaluate treatment if no improvement or wound worsens.
Symptom Monitoring
- Local irritation (redness, itching, rash, swelling)
- Allergic reaction (hives, difficulty breathing, swelling of face/lips/tongue/throat)
- Signs of systemic lidocaine toxicity (dizziness, lightheadedness, drowsiness, confusion, tinnitus, metallic taste, perioral numbness, blurred vision, tremors, muscle twitching, seizures, slow heart rate, difficulty breathing)
Special Patient Groups
Pregnancy
Use with caution. While topical lidocaine is generally considered low risk due to limited systemic absorption, large areas or prolonged use, especially on broken skin, should be avoided. Consult a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Low risk, but systemic absorption should be minimized.
Second Trimester:
Low risk, but systemic absorption should be minimized.
Third Trimester:
Low risk, but systemic absorption should be minimized.
Lactation
Use with caution. Lidocaine is excreted in breast milk in small amounts. While unlikely to cause harm to a nursing infant with typical topical use, monitor the infant for unusual drowsiness or feeding difficulties. Avoid applying to areas where the infant may ingest the gel.
Infant Risk:
Low (L2)
Pediatric Use
Use with caution, especially in infants and young children, due to potentially increased systemic absorption of lidocaine through immature or compromised skin. Use the lowest effective dose for the shortest duration. Monitor closely for signs of systemic toxicity.
Geriatric Use
Generally safe for use in the elderly. However, elderly patients may have thinner skin or comorbidities that could increase systemic absorption of lidocaine. Use the lowest effective dose and monitor for adverse effects.
Clinical Information
Clinical Pearls
- Ensure the wound is clean and free of debris before applying the gel to maximize efficacy and prevent infection.
- A thin layer is usually sufficient; applying more gel does not necessarily increase efficacy but may increase the risk of systemic lidocaine absorption.
- Avoid using on large body surface areas or for prolonged periods, especially if the skin is broken or inflamed, to minimize the risk of systemic lidocaine toxicity.
- This product is for external use only. Do not ingest.
- If signs of infection (increased redness, swelling, pain, pus) develop or worsen, discontinue use and consult a healthcare professional.
Alternative Therapies
- Topical antiseptics (e.g., povidone-iodine, chlorhexidine)
- Antibiotic ointments (e.g., bacitracin, neomycin)
- Hydrogel dressings
- Alginate dressings
- Foam dressings
- Silver-containing dressings (for infected wounds)
- Oral analgesics (for pain management)
Cost & Coverage
Average Cost:
Varies widely, typically $15-$50 per tube/jar
Generic Available:
Yes
Insurance Coverage:
Not typically covered by insurance (OTC product)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.