Regenecare 2% Topical Gel 14gm
It is used to promote healing of skin ulcers and wounds.It is used to treat burns.
Drug Class
Local Anesthetic; Wound Healing Agent
Pharmacologic Class
Amide-type Local Anesthetic; Biologic Matrix Component; Emollient
Pregnancy Category
Category B
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Regenecare 2% Topical Gel is a skin gel that contains lidocaine to numb pain, collagen to help your skin heal, and aloe vera to soothe and moisturize. It's used for minor cuts, scrapes, burns, and skin irritations.
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
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 burning.
Before applying the medication, wash your hands thoroughly. Clean the affected area and dry it well to ensure the medication adheres properly. After applying the medication, cover the treated area with a clean dressing.
Hand Hygiene
Remember to wash your hands before and after applying the medication to prevent the spread of infection.
Storage and Disposal
Store this medication at room temperature, avoiding freezing temperatures.
Missed Dose
If you miss a dose, apply the medication 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
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 burning.
Before applying the medication, wash your hands thoroughly. Clean the affected area and dry it well to ensure the medication adheres properly. After applying the medication, cover the treated area with a clean dressing.
Hand Hygiene
Remember to wash your hands before and after applying the medication to prevent the spread of infection.
Storage and Disposal
Store this medication at room temperature, avoiding freezing temperatures.
Missed Dose
If you miss a dose, apply the medication as soon as you remember.
Lifestyle & Tips
- Clean the affected area gently before applying the gel.
- Wash hands thoroughly before and after applying the gel.
- Avoid contact with eyes, nose, mouth, and other mucous membranes.
- Do not apply to large areas of the body or to broken, blistered, or raw skin without consulting a healthcare professional.
- Do not use with occlusive dressings (e.g., bandages that don't breathe) unless directed by a doctor, as this can increase absorption.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to the affected area 2 to 3 times daily as needed.
Condition-Specific Dosing:
minor_cuts_burns_abrasions:
Apply a thin layer to the affected area, ensuring complete coverage. Do not exceed 3-4 applications per day.
Pediatric Dosing
Neonatal:
Not established. Use with extreme caution and under medical supervision due to increased risk of systemic absorption and toxicity.
Infant:
Not established. Use with extreme caution and under medical supervision due to increased risk of systemic absorption and toxicity.
Child:
Consult a physician for use in children under 12 years of age. If used, apply sparingly to small areas.
Adolescent:
Apply a thin layer to the affected area 2 to 3 times daily as needed. Do not exceed 3-4 applications per day.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment required for topical use with minimal systemic absorption.
Moderate:
No specific adjustment required for topical use with minimal systemic absorption.
Severe:
No specific adjustment required for topical use with minimal systemic absorption. Caution if applied to large areas or broken skin, as systemic absorption of lidocaine could occur.
Dialysis:
Considerations: Not typically relevant for topical application. If significant systemic absorption of lidocaine occurs, dialysis is not effective for removal.
Hepatic Impairment:
Mild:
No specific adjustment required for topical use with minimal systemic absorption.
Moderate:
No specific adjustment required for topical use with minimal systemic absorption. Caution if applied to large areas or broken skin, as systemic absorption of lidocaine could occur.
Severe:
No specific adjustment required for topical use with minimal systemic absorption. Caution if applied to large areas or broken skin, as systemic absorption of lidocaine could occur, potentially leading to increased lidocaine levels due to impaired metabolism.
Pharmacology
Mechanism of Action
Lidocaine is an amide-type local anesthetic that stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. Collagen provides a scaffold for cellular ingrowth, promotes fibroblast proliferation, and aids in wound contraction and re-epithelialization. Aloe vera gel possesses anti-inflammatory, moisturizing, and wound healing properties.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable for collagen/aloe (minimal systemic absorption). For lidocaine, bioavailability is variable and depends on the integrity of the skin barrier, surface area of application, duration of contact, and presence of occlusive dressings. Systemic absorption is generally low with intact skin but can increase significantly with broken or compromised skin.
Tmax:
Not precisely defined for topical application; local anesthetic effect typically within 2-5 minutes. Systemic Tmax for lidocaine, if absorbed, is variable (e.g., 30-60 minutes after topical application to mucous membranes).
FoodEffect:
Not applicable (topical administration).
Distribution:
Vd:
Not significant for collagen/aloe. For lidocaine, if systemically absorbed, Vd is approximately 1.1-2.1 L/kg.
ProteinBinding:
Not significant for collagen/aloe. For lidocaine, if systemically absorbed, approximately 60-80% is plasma protein bound (primarily to alpha-1-acid glycoprotein and albumin).
CnssPenetration:
Limited for topical application. If significant systemic absorption of lidocaine occurs, it can cross the blood-brain barrier.
Elimination:
HalfLife:
Not significant for collagen/aloe. For lidocaine, if systemically absorbed, the elimination half-life is approximately 1.5-2 hours (longer in patients with hepatic impairment).
Clearance:
Not significant for collagen/aloe. For lidocaine, if systemically absorbed, systemic clearance is approximately 0.95 L/min.
ExcretionRoute:
Not significant for collagen/aloe. For lidocaine, if systemically absorbed, primarily renal excretion of metabolites and less than 10% as unchanged drug.
Unchanged:
Less than 10% (for lidocaine, if systemically absorbed).
Pharmacodynamics
OnsetOfAction:
Local anesthetic effect: 2-5 minutes (for lidocaine). Wound healing/soothing effects: Gradual.
PeakEffect:
Local anesthetic effect: 10-20 minutes (for lidocaine).
DurationOfAction:
Local anesthetic effect: 30-60 minutes (for lidocaine), depending on application site and amount. Wound healing/soothing effects: Continuous with regular application.
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate 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
Signs of skin infection, including:
+ Oozing
+ Heat
+ Swelling
+ Redness
+ Pain
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although 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 persist, contact your doctor for guidance:
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, don't hesitate to reach out to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate 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
Signs of skin infection, including:
+ Oozing
+ Heat
+ Swelling
+ Redness
+ Pain
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although 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 persist, contact your doctor for guidance:
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, don't hesitate to reach out to 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 redness, swelling, or pain at the application site.
- Rash, itching, or hives.
- Signs of infection (e.g., pus, fever).
- Unusual sensations like dizziness, lightheadedness, drowsiness, confusion, ringing in the ears, or blurred vision (these are rare but can indicate too much lidocaine has been absorbed).
- Irregular or fast heartbeat (very rare, but serious).
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 as a result of the allergy.
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, and vitamins, as well as any existing health problems. This is not an exhaustive list of potential interactions, and your doctor and pharmacist need to be aware of all your medications and health issues to verify the safety of taking this medication in conjunction with them.
Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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 as a result of the allergy.
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, and vitamins, as well as any existing health problems. This is not an exhaustive list of potential interactions, and your doctor and pharmacist need to be aware of all your medications and health issues to verify the safety of taking this medication in conjunction with them.
Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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 may 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 promptly. Your doctor will discuss the potential benefits and risks of this medication with you, considering the impact on both you and your baby.
Overdose Information
Overdose Symptoms:
- Numbness or tingling around the mouth
- Lightheadedness
- Dizziness
- Blurred vision
- Tinnitus (ringing in the ears)
- Drowsiness
- Confusion
- Tremors
- Muscle twitching
- Seizures (severe cases)
- Bradycardia (slow heart rate)
- Hypotension (low blood pressure)
- Cardiac arrest (severe cases)
What to Do:
If you suspect an overdose or experience severe symptoms, stop using the product immediately and seek emergency medical attention. Call 911 or your local emergency number. For non-emergencies, call Poison Control at 1-800-222-1222.
Drug Interactions
Monitoring
Baseline Monitoring
Skin integrity and wound assessment
Rationale: To determine suitability of application and potential for systemic absorption of lidocaine.
Timing: Prior to first application.
Routine Monitoring
Local skin reactions (e.g., redness, irritation, rash, swelling)
Frequency: Daily or with each application
Target: Absence of adverse reactions
Action Threshold: Discontinue use and consult healthcare provider if severe or persistent reactions occur.
Signs of systemic lidocaine toxicity (e.g., dizziness, drowsiness, confusion, tremors, blurred vision, tinnitus, irregular heartbeat)
Frequency: Monitor during and after application, especially if applied to large areas or broken skin
Target: Absence of systemic symptoms
Action Threshold: Seek immediate medical attention if any systemic symptoms develop.
Wound healing progress
Frequency: Regularly, as per clinical need
Target: Improvement in wound appearance (e.g., reduced pain, decreased inflammation, signs of tissue regeneration)
Action Threshold: Consult healthcare provider if wound worsens or shows no improvement.
Symptom Monitoring
- Local irritation
- Redness
- Swelling
- Rash
- Itching
- Burning sensation
- Dizziness (rare, systemic absorption)
- Drowsiness (rare, systemic absorption)
- Confusion (rare, systemic absorption)
- Tremors (rare, systemic absorption)
- Blurred vision (rare, systemic absorption)
- Tinnitus (rare, systemic absorption)
- Irregular heartbeat (rare, systemic absorption)
Special Patient Groups
Pregnancy
Lidocaine is Pregnancy Category B. Studies in animals have not shown risk, but human studies are limited. Topical use with minimal systemic absorption is generally considered low risk. Use only if clearly needed and the potential benefits outweigh the potential risks.
Trimester-Specific Risks:
First Trimester:
Low risk with topical application and minimal systemic absorption.
Second Trimester:
Low risk with topical application and minimal systemic absorption.
Third Trimester:
Low risk with topical application and minimal systemic absorption. Avoid large areas or prolonged use near term.
Lactation
Lidocaine is excreted in breast milk in small amounts. Given the minimal systemic absorption from topical application, the amount transferred to breast milk is expected to be very low, posing minimal risk to the nursing infant (Lactation Risk L2).
Infant Risk:
Low risk. Monitor infant for unusual drowsiness or feeding difficulties, though unlikely with typical topical use.
Pediatric Use
Use with caution in infants and young children, especially those under 2 years of age, due to their higher surface area to body weight ratio, which can increase the risk of systemic lidocaine absorption and toxicity. Consult a physician before use in this age group. Avoid applying to large areas or broken skin.
Geriatric Use
Generally safe for use in the elderly. No specific dose adjustments are typically required for topical application. However, elderly patients may be more sensitive to systemic effects if significant absorption occurs due to potential age-related decreases in hepatic function.
Clinical Information
Clinical Pearls
- For external use only. Do not ingest.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not apply to deep wounds, puncture wounds, animal bites, or serious burns without medical supervision.
- Discontinue use if irritation or rash develops or worsens.
- Keep out of reach of children.
- Store at room temperature, away from excessive heat or cold.
Alternative Therapies
- Oral analgesics (e.g., acetaminophen, NSAIDs) for pain relief
- Antiseptic creams/ointments for wound care
- Hydrogel dressings for wound healing
- Topical corticosteroids for inflammation (if appropriate)
Cost & Coverage
Average Cost:
Price varies per 14gm tube
Generic Available:
Yes
Insurance Coverage:
Often OTC, may not be covered by insurance. If prescribed, coverage varies by plan.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety and the effectiveness of your 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's a good idea to check with your pharmacist for more information. If you have any questions or concerns about your 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 medication taken, the amount, and the time it happened, as this information is crucial for proper treatment.