Regenecare Ha Spray, 120ml
It is used to manage pain.
Drug Class
Local Anesthetic
Pharmacologic Class
Voltage-gated sodium channel blocker
Pregnancy Category
Category B
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lidocaine is a medicine that numbs the skin. It works by temporarily blocking nerve signals in the area where it's applied, which helps to relieve pain or itching. Regenecare Ha Spray is a topical form of lidocaine used for temporary relief of minor pain and itching.
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 use this medication only as directed.
Application Instructions
Do not take this medication by mouth. It is for topical use on your skin only.
Avoid getting this medication in your mouth, nose, or eyes, as it may cause burning. If accidental contact occurs, rinse the affected area thoroughly with water.
Wash your hands before and after applying the medication, unless your hand is the treated area. In this case, do not wash your hand after application.
Clean the affected area before use and ensure it is dry. Apply the medication to clean, dry, healthy skin.
Unless instructed by your doctor, do not cover the treated area with bandages or dressings.
Important Safety Precautions
This medication may be flammable, so avoid using it near an open flame or while smoking.
If your medication requires shaking before use, make sure to do so before applying it.
Storage and Disposal
Store this medication at room temperature, away from heat or open flames. Do not freeze.
Keep all medications in a safe place, out of the reach of children and pets.
Missed Dose Instructions
If you use this medication on a regular basis and miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not apply two doses at the same time or use extra doses.
If you use this medication as needed, do not use it more frequently than directed by your doctor.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication only as directed.
Application Instructions
Do not take this medication by mouth. It is for topical use on your skin only.
Avoid getting this medication in your mouth, nose, or eyes, as it may cause burning. If accidental contact occurs, rinse the affected area thoroughly with water.
Wash your hands before and after applying the medication, unless your hand is the treated area. In this case, do not wash your hand after application.
Clean the affected area before use and ensure it is dry. Apply the medication to clean, dry, healthy skin.
Unless instructed by your doctor, do not cover the treated area with bandages or dressings.
Important Safety Precautions
This medication may be flammable, so avoid using it near an open flame or while smoking.
If your medication requires shaking before use, make sure to do so before applying it.
Storage and Disposal
Store this medication at room temperature, away from heat or open flames. Do not freeze.
Keep all medications in a safe place, out of the reach of children and pets.
Missed Dose Instructions
If you use this medication on a regular basis and miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not apply two doses at the same time or use extra doses.
If you use this medication as needed, do not use it more frequently than directed by your doctor.
Lifestyle & Tips
- Wash hands thoroughly before and after applying the spray.
- Do not apply to broken, irritated, or infected skin unless directed by a healthcare professional.
- Avoid contact with eyes, nose, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not use heating pads or tight bandages over the treated area, as this can increase absorption and risk of side effects.
- Do not exceed the recommended dose or frequency of application.
- Keep out of reach of children and pets.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected area not more than 3 to 4 times daily. Do not exceed recommended dosage or application area.
Condition-Specific Dosing:
generalPainRelief:
Apply a thin layer to the affected skin area as needed, typically every 6-8 hours, not exceeding 3-4 applications in 24 hours. Max total dose and application area should be adhered to as per product label to avoid systemic toxicity.
Pediatric Dosing
Neonatal:
Not established (Use with extreme caution, if at all, due to risk of systemic absorption and toxicity)
Infant:
Not established (Use with extreme caution, if at all, due to risk of systemic absorption and toxicity)
Child:
Consult physician. Dosing is typically weight-based and limited to small areas for short durations due to increased risk of systemic toxicity compared to adults.
Adolescent:
Similar to adult dosing, but caution advised for extensive use or broken skin.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment for topical use, but caution with extensive application.
Moderate:
No specific adjustment for topical use, but caution with extensive application.
Severe:
Use with caution, especially with extensive application or broken skin, due to potential for systemic accumulation of lidocaine and its metabolites. Monitor for signs of toxicity.
Dialysis:
Not well-studied for topical use. Use with caution, monitor for toxicity.
Hepatic Impairment:
Mild:
No specific adjustment for topical use, but caution with extensive application.
Moderate:
Use with caution, especially with extensive application or broken skin, due to potential for systemic accumulation of lidocaine and its metabolites. Monitor for signs of toxicity.
Severe:
Use with extreme caution or avoid, especially with extensive application or broken skin, due to significantly impaired metabolism and increased risk of systemic toxicity. Monitor for signs of toxicity.
Confidence:
Medium
Pharmacology
Mechanism of Action
Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. It blocks voltage-gated sodium channels in the neuronal cell membrane, preventing depolarization and propagation of action potentials.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (0-10% for intact skin, significantly higher with damaged skin, occlusion, or large application areas)
Tmax:
Variable (typically 2-10 minutes for onset of action, peak plasma levels can be reached within 30-60 minutes after extensive topical application)
FoodEffect:
Not applicable (topical administration)
Distribution:
Vd:
Not applicable (primarily local action, systemic distribution is limited from topical application)
ProteinBinding:
60-80% (for systemically absorbed lidocaine)
CnssPenetration:
Limited (from topical application, but can occur with systemic absorption)
Elimination:
HalfLife:
1.5-2 hours (for systemically absorbed lidocaine)
Clearance:
Not applicable (primarily local action, systemic clearance is hepatic)
ExcretionRoute:
Renal (less than 10% as unchanged drug)
Unchanged:
Less than 10%
Pharmacodynamics
OnsetOfAction:
2-5 minutes (for topical application)
PeakEffect:
Variable (peak pain relief within 15-30 minutes, peak systemic absorption can be 30-60 minutes)
DurationOfAction:
30-60 minutes (for local anesthetic effect, can be longer depending on formulation and 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 medical attention immediately:
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 acidosis (too much acid in the blood), such as:
+ Confusion
+ Fast breathing
+ Fast heartbeat
+ Irregular heartbeat
+ Severe stomach pain, nausea, or vomiting
+ Excessive sleepiness
+ Shortness of breath
+ Feeling extremely tired or weak
Signs of methemoglobinemia, a rare but potentially life-threatening condition, such as:
+ Blue or gray discoloration of the lips, nails, or skin
+ Irregular heartbeat
+ Seizures
+ Severe dizziness or fainting
+ Severe headache
+ Excessive sleepiness
+ Feeling extremely tired or weak
+ Shortness of breath
Signs of skin infection, such as:
+ Oozing
+ Heat
+ Swelling
+ Redness
+ Pain
Respiratory problems, such as:
+ Trouble breathing
+ Slow breathing
+ Shallow breathing
Severe numbness and tingling
Feeling lightheaded, sleepy, confused, or experiencing blurred vision
Seizures
Changes in vision
Feeling nervous and excitable
Dizziness or fainting
Ringing in the ears
Nausea or vomiting
Feeling hot or cold
Shakiness
Twitching
Slow heartbeat
Chest pain
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Irritation at the site of application
Swelling
Redness
Changes in skin color
Reporting Side Effects
If you have questions or concerns 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.
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 medical attention immediately:
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 acidosis (too much acid in the blood), such as:
+ Confusion
+ Fast breathing
+ Fast heartbeat
+ Irregular heartbeat
+ Severe stomach pain, nausea, or vomiting
+ Excessive sleepiness
+ Shortness of breath
+ Feeling extremely tired or weak
Signs of methemoglobinemia, a rare but potentially life-threatening condition, such as:
+ Blue or gray discoloration of the lips, nails, or skin
+ Irregular heartbeat
+ Seizures
+ Severe dizziness or fainting
+ Severe headache
+ Excessive sleepiness
+ Feeling extremely tired or weak
+ Shortness of breath
Signs of skin infection, such as:
+ Oozing
+ Heat
+ Swelling
+ Redness
+ Pain
Respiratory problems, such as:
+ Trouble breathing
+ Slow breathing
+ Shallow breathing
Severe numbness and tingling
Feeling lightheaded, sleepy, confused, or experiencing blurred vision
Seizures
Changes in vision
Feeling nervous and excitable
Dizziness or fainting
Ringing in the ears
Nausea or vomiting
Feeling hot or cold
Shakiness
Twitching
Slow heartbeat
Chest pain
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Irritation at the site of application
Swelling
Redness
Changes in skin color
Reporting Side Effects
If you have questions or concerns 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:
- Severe skin irritation or allergic reaction (rash, hives, itching, swelling, blistering)
- Signs of systemic toxicity: dizziness, lightheadedness, blurred vision, ringing in ears (tinnitus), numbness or tingling around the mouth, confusion, drowsiness, tremors, muscle twitching, seizures, slow or irregular heartbeat, difficulty breathing.
- If pain or condition worsens or does not improve within 7 days.
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 to this medication, its components, or other substances, including foods and drugs. Be sure to describe the allergic reaction and its symptoms.
The presence of an infection at the site where the medication will be applied.
Any broken skin or open wounds at the intended application site.
Swollen skin, numbness, or loss of sensation at the application site, as this may affect the medication's absorption or increase the risk of adverse reactions.
If a large area of your body needs to be treated, as this may require special consideration and dosing adjustments.
Additionally, this medication may interact with other drugs or health conditions. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your medical history, including any health problems or conditions
Do not start, stop, or change the dose of any medication without first consulting your doctor to ensure safe use and minimize potential interactions.
It is essential to inform your doctor about the following:
Any allergies you have to this medication, its components, or other substances, including foods and drugs. Be sure to describe the allergic reaction and its symptoms.
The presence of an infection at the site where the medication will be applied.
Any broken skin or open wounds at the intended application site.
Swollen skin, numbness, or loss of sensation at the application site, as this may affect the medication's absorption or increase the risk of adverse reactions.
If a large area of your body needs to be treated, as this may require special consideration and dosing adjustments.
Additionally, this medication may interact with other drugs or health conditions. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your medical history, including any health problems or conditions
Do not start, stop, or change the dose of any medication without first consulting your doctor to ensure safe use and minimize potential interactions.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
This drug can cause a severe blood disorder called methemoglobinemia, which may be more likely to occur in individuals with certain conditions, such as glucose-6-phosphate dehydrogenase (G6PD) deficiency, heart problems, or lung problems. The risk may also be increased when taking certain other medications or in infants under 6 months of age. If you have a history of methemoglobinemia, be sure to discuss this with your doctor.
Before using any other medications or skin products, including soaps, consult with your doctor. Do not use this medication for an extended period beyond what your doctor has prescribed.
While using this medication, avoid scratching or rubbing the treated skin, and do not expose it to extreme temperatures. Do not apply this medication to cuts, scrapes, or damaged skin unless your doctor instructs you to do so.
Avoid using heat sources such as sunlamps, tanning beds, heating pads, electric blankets, heat lamps, saunas, hot tubs, or heated waterbeds, as they can cause your body temperature to rise, leading to excessive absorption of the medication. Also, avoid taking long, hot baths or sunbathing.
If this medication is accidentally swallowed, immediately contact a doctor or poison control center, as it can be harmful. Note that different brands of this medication may be suitable for children of various ages, so consult with your doctor before administering it to a child.
When using this medication in children, exercise caution, as they may be at a higher risk of experiencing certain side effects. If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of using this medication with your doctor to ensure the best outcome for you and your baby.
This drug can cause a severe blood disorder called methemoglobinemia, which may be more likely to occur in individuals with certain conditions, such as glucose-6-phosphate dehydrogenase (G6PD) deficiency, heart problems, or lung problems. The risk may also be increased when taking certain other medications or in infants under 6 months of age. If you have a history of methemoglobinemia, be sure to discuss this with your doctor.
Before using any other medications or skin products, including soaps, consult with your doctor. Do not use this medication for an extended period beyond what your doctor has prescribed.
While using this medication, avoid scratching or rubbing the treated skin, and do not expose it to extreme temperatures. Do not apply this medication to cuts, scrapes, or damaged skin unless your doctor instructs you to do so.
Avoid using heat sources such as sunlamps, tanning beds, heating pads, electric blankets, heat lamps, saunas, hot tubs, or heated waterbeds, as they can cause your body temperature to rise, leading to excessive absorption of the medication. Also, avoid taking long, hot baths or sunbathing.
If this medication is accidentally swallowed, immediately contact a doctor or poison control center, as it can be harmful. Note that different brands of this medication may be suitable for children of various ages, so consult with your doctor before administering it to a child.
When using this medication in children, exercise caution, as they may be at a higher risk of experiencing certain side effects. If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of using this medication with your doctor to ensure the best outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Nervousness, dizziness, blurred vision, tremors, drowsiness, seizures, unconsciousness
- Bradycardia (slow heart rate), hypotension (low blood pressure), cardiac arrest
- Respiratory depression, apnea
What to Do:
Immediately stop use and seek emergency medical attention. Call 911 or Poison Control at 1-800-222-1222. Management is supportive, including airway management, oxygen, IV fluids, vasopressors for hypotension, and benzodiazepines for seizures. Lipid emulsion therapy may be considered for severe systemic toxicity.
Drug Interactions
Major Interactions
- Class I antiarrhythmics (e.g., tocainide, mexiletine): Increased risk of cardiac adverse effects if significant systemic absorption occurs.
- Other local anesthetics: Increased risk of systemic toxicity (additive effects).
Moderate Interactions
- Antiarrhythmics (e.g., amiodarone, beta-blockers): Potential for additive cardiac effects if significant systemic absorption occurs.
- CYP1A2 inhibitors (e.g., cimetidine, fluvoxamine): May increase lidocaine plasma levels if significant systemic absorption occurs.
- CYP3A4 inhibitors (e.g., macrolide antibiotics, azole antifungals, protease inhibitors): May increase lidocaine plasma levels if significant systemic absorption occurs.
Confidence Interactions
Monitoring
Symptom Monitoring
- Local skin reactions (redness, itching, rash, swelling, irritation)
- Signs of systemic toxicity (dizziness, lightheadedness, blurred vision, tinnitus, numbness/tingling around mouth, confusion, drowsiness, tremors, muscle twitching, seizures)
- Cardiovascular effects (bradycardia, hypotension, arrhythmias)
- Respiratory depression
Special Patient Groups
Pregnancy
Lidocaine is generally considered safe for topical use during pregnancy when used as directed and for limited areas. Systemic absorption is minimal. Consult a healthcare provider before use.
Trimester-Specific Risks:
First Trimester:
Low risk with topical use.
Second Trimester:
Low risk with topical use.
Third Trimester:
Low risk with topical use.
Lactation
Lidocaine is considered compatible with breastfeeding when used topically and as directed. Minimal amounts are excreted into breast milk, and infant exposure is expected to be low.
Infant Risk:
Low risk
Pediatric Use
Use with extreme caution in infants and young children due to their higher surface area to volume ratio, thinner skin, and immature metabolic pathways, which can lead to increased systemic absorption and higher risk of toxicity. Dosing must be carefully calculated and monitored by a healthcare professional. Not recommended for children under 2 years unless specifically advised by a doctor.
Geriatric Use
No specific dose adjustment is typically needed for topical lidocaine in the elderly, but caution is advised due to potential for decreased hepatic function and increased sensitivity to systemic effects. Start with lower doses and monitor for adverse reactions.
Clinical Information
Clinical Pearls
- Topical lidocaine is for external use only. Do not ingest.
- The risk of systemic toxicity increases with the amount of product applied, the duration of application, the integrity of the skin (broken skin increases absorption), and the use of occlusive dressings.
- Patients should be advised to wash their hands thoroughly after applying the product to avoid accidental transfer to eyes or mucous membranes.
- Educate patients on the signs and symptoms of systemic lidocaine toxicity and when to seek immediate medical attention.
- Regenecare Ha Spray contains hyaluronic acid (HA), which may aid in skin hydration and healing, potentially enhancing the overall soothing effect alongside lidocaine's anesthetic action.
Alternative Therapies
- Benzocaine (topical anesthetic)
- Pramoxine (topical anesthetic)
- Menthol/Camphor (counterirritants)
- Capsaicin (topical analgesic)
- NSAID topical gels (e.g., diclofenac gel)
- Oral analgesics (e.g., acetaminophen, ibuprofen)
Cost & Coverage
Average Cost:
Not available (varies widely by product, concentration, and dispenser) per 120ml spray
Generic Available:
Yes
Insurance Coverage:
Often covered by insurance, but may require prior authorization or be subject to formulary restrictions depending on specific product and plan.
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 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 occurred.