Lidocaine 4% Topical Pain Patch

Manufacturer SOLA PHARMACEUTICALS Active Ingredient Lidocaine Patch(LYE doe kane) Pronunciation LYE doe kane
It is used to manage pain.It is used to treat painful nerve diseases.It is used to ease pain caused by shingles.It may be given to you for other reasons. Talk with the doctor.
đŸˇī¸
Drug Class
Local Anesthetic, Analgesic
đŸ§Ŧ
Pharmacologic Class
Amide-type Local Anesthetic, Voltage-gated Sodium Channel Blocker
🤰
Pregnancy Category
Category B
✅
FDA Approved
Jan 1970
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Lidocaine is a numbing medicine that works by blocking pain signals in the nerves where you apply the patch. It helps relieve minor aches and pains in muscles and joints.
📋

How to Use This Medicine

Using Your Medication Correctly

To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely.

Applying the Medication

Do not take this medication by mouth. It is for use on your skin only.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. If you accidentally get the medication in these areas, rinse well with water.
Before applying the medication, clean the affected area and dry it thoroughly.
Apply the medication to clean, dry, healthy skin.
Unless directed by your doctor, do not cover the treated area with bandages or dressings.
Wash your hands before and after applying the medication.
Apply the medication to the most painful areas of the skin.
Trim the medication to fit the affected area, if necessary.
Apply the medication at the same time every day.

Important Usage Instructions

Different products may have different wear times. Be sure to understand how long you can wear the medication before removing it and how long to wait before applying a new patch or skin system.
Do not wear the medication for longer than recommended by your doctor.
If you have questions or concerns, consult your doctor.
Do not apply more skin patches than directed by your doctor.
If the skin patch or system loosens at the edges, press the edges firmly to reattach. If it comes off completely, try to reapply it. If you cannot reapply it, use a new one.

Disposing of Used Medication

After removing a skin patch or system, fold the sticky sides together and dispose of it in a way that prevents children and pets from accessing it.
Some medications may be flammable, so keep them away from open flames or sparks, and do not smoke while using them.

Storing and Disposing of Your Medication

Store the medication at room temperature in its original envelope to protect it from children.
Do not open the envelope until you are ready to use the medication.
Keep all medications in a safe place, out of the 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 a drug take-back program in your area.

Missing a Dose

If you use this medication regularly 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 continue with your regular schedule.
Do not apply two doses at the same time or extra doses.
If you use this medication as needed, do not use it more frequently than directed by your doctor.
💡

Lifestyle & Tips

  • Apply the patch to clean, dry, intact skin. Do not apply to broken, cut, or irritated skin.
  • Wash your hands thoroughly after handling the patch.
  • Do not apply more than one patch at a time.
  • Remove the patch after 8-12 hours and allow a patch-free period (e.g., 12 hours) before applying a new one.
  • Avoid exposing the application site to external heat sources (e.g., heating pads, electric blankets, hot tubs) as this can increase absorption and risk of side effects.
  • Do not cut the patch unless specifically instructed by the manufacturer (some brands are designed to be cut, others are not).
  • Keep patches out of reach of children and pets. Accidental ingestion can be dangerous.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: Apply 1 patch to the affected area for up to 8-12 hours within a 24-hour period. Do not apply more than 1 patch at a time.
Dose Range: 1 - 1 mg

Condition-Specific Dosing:

general pain: Apply 1 patch to the affected area for up to 8-12 hours. Remove for at least 12 hours before applying a new patch.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (generally not recommended for children under 12 without medical supervision)
Adolescent: Not established (generally not recommended for children under 12 without medical supervision)
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended for topical use due to limited systemic absorption.
Moderate: No specific adjustment recommended for topical use due to limited systemic absorption.
Severe: Use with caution; monitor for signs of systemic toxicity, though significant accumulation is unlikely with proper topical use.
Dialysis: Considerations: No specific recommendations for topical use; systemic exposure is minimal.

Hepatic Impairment:

Mild: No specific adjustment recommended for topical use due to limited systemic absorption.
Moderate: No specific adjustment recommended for topical use due to limited systemic absorption.
Severe: Use with caution; monitor for signs of systemic toxicity, though significant accumulation is unlikely with proper topical use.

Pharmacology

đŸ”Ŧ

Mechanism of Action

Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby exerting a local anesthetic action. It blocks voltage-gated sodium channels in the neuronal cell membrane, preventing depolarization and propagation of action potentials.
📊

Pharmacokinetics

Absorption:

Bioavailability: Highly variable, typically 3-5% of applied dose for 5% patches; similar for 4% patches. Systemic absorption is limited through intact skin.
Tmax: Variable, typically 10-12 hours for systemic peak concentration after patch application.
FoodEffect: Not applicable (topical administration).

Distribution:

Vd: 0.7-2.7 L/kg (systemic)
ProteinBinding: 60-80% (primarily to alpha-1-acid glycoprotein and albumin)
CnssPenetration: Limited (with therapeutic topical use); Yes (if systemic levels are elevated due to excessive absorption).

Elimination:

HalfLife: 1.5-2 hours (systemic)
Clearance: Not available (for topical)
ExcretionRoute: Renal (metabolites and less than 10% unchanged drug)
Unchanged: <10%
âąī¸

Pharmacodynamics

OnsetOfAction: 30-60 minutes (for local analgesic effect)
PeakEffect: 2-4 hours (for local analgesic effect)
DurationOfAction: Up to 8-12 hours (while patch is applied)

Safety & Warnings

âš ī¸

Side Effects

Serious Side Effects: Seek Medical Help Right Away

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 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 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. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Irritation at the site of application
Other side effects not listed here

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, rash, or blistering at the application site.
  • Dizziness, lightheadedness, or feeling faint.
  • Drowsiness or confusion.
  • Ringing in the ears (tinnitus).
  • Blurred vision or double vision.
  • Tremors or muscle twitching.
  • Numbness or tingling around the mouth.
  • Unusual tiredness or weakness.
  • Difficulty breathing or shortness of breath.
  • Bluish or grayish discoloration of the skin, lips, or fingernails (signs of methemoglobinemia).
📋

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 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 these conditions may affect the medication's absorption or increase the risk of adverse effects.
If a large area of skin needs to be treated, as this may require special consideration or dose adjustment.

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 existing health problems

Your doctor will help you determine whether it is safe to take this medication with your other drugs and health conditions. Do not initiate, stop, or modify the dose of any medication without first consulting your doctor to ensure your safety.
âš ī¸

Precautions & Cautions

Important Warnings and Precautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Risk of Methemoglobinemia

Drugs like this one can cause a severe blood problem called methemoglobinemia. Your risk may be higher if you have:
Glucose-6-phosphate dehydrogenase (G6PD) deficiency
Heart problems
Lung problems
Are taking certain other medications
* Are an infant younger than 6 months of age
If you have ever had methemoglobinemia, tell your doctor.

Using Other Products on Your Skin

Before using other drugs or products on your skin, including soaps, consult with your doctor.

Proper Use and Application

Do not use this medication for longer than prescribed by your doctor. Avoid scratching or rubbing the skin while it is numb, and do not expose it to extreme temperatures. Do not apply this medication to cuts, scrapes, or damaged skin unless instructed to do so by your doctor.

Avoiding Heat Sources

Avoid using heat sources such as sunlamps, tanning beds, heating pads, electric blankets, heat lamps, saunas, hot tubs, and heated waterbeds. Also, avoid taking long, hot baths or sunbathing, as your body temperature may rise and cause too much medication to be absorbed.

Use in Children

Different brands of this medication may be suitable for different age groups of children. Consult with your doctor before giving this medication to a child. If the patient is a child, use this medication with caution, as the risk of certain side effects may be higher in children.

Skin Reactions and Irritation

If you experience burning or other irritation where the medication is applied, remove it and wait until the irritation resolves before reapplying. Skin reactions, such as blisters, bruising, burning, or abnormal feelings, are common during or after treatment. These reactions usually resolve within a few minutes to hours. If any of these effects are severe, bothersome, or persistent, contact your doctor.

General Precautions

You may wear clothing over the area where the medication is applied. However, be aware that this medication can cause harm if chewed or swallowed, including used patches. If the medication is ingested, call a doctor or poison control center immediately. Keep the medication dry, as it may not adhere properly if it gets wet. Avoid bathing, swimming, or showering while wearing the medication.

Special Considerations

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks with your doctor.
🆘

Overdose Information

Overdose Symptoms:

  • Severe dizziness or lightheadedness
  • Nausea and vomiting
  • Tremors or muscle twitching
  • Seizures
  • Slow or irregular heartbeat
  • Difficulty breathing
  • Loss of consciousness

What to Do:

If you suspect an overdose, remove the patch immediately and seek emergency medical attention. Call 911 or your local poison control center (e.g., 1-800-222-1222 in the US).

Drug Interactions

🔴

Major Interactions

  • Class I Antiarrhythmics (e.g., mexiletine, tocainide): Theoretical risk of additive cardiac effects if significant systemic absorption occurs.
  • Other Local Anesthetics: Increased risk of systemic toxicity if used concurrently with other lidocaine-containing products or other local anesthetics.
🟡

Moderate Interactions

  • Drugs associated with Methemoglobinemia (e.g., dapsone, nitrates, nitrites, sulfonamides, antimalarials, phenobarbital, phenytoin, nitroprusside): Increased risk of methemoglobinemia, especially in susceptible individuals or with excessive absorption.

Monitoring

đŸ”Ŧ

Baseline Monitoring

Skin integrity

Rationale: To ensure patch is applied to intact, non-irritated skin to minimize systemic absorption and local irritation.

Timing: Prior to first application

Pain level and characteristics

Rationale: To establish baseline for assessing treatment efficacy.

Timing: Prior to first application

📊

Routine Monitoring

Local skin reactions (redness, itching, swelling, rash)

Frequency: Daily, with each patch application/removal

Target: Absence of significant irritation

Action Threshold: Discontinue use if severe irritation or allergic reaction occurs.

Signs of systemic toxicity (dizziness, drowsiness, confusion, tinnitus, blurred vision, tremors, seizures, cardiac arrhythmias)

Frequency: Periodically, especially during initial use or if applying to large/damaged areas

Target: Absence of symptoms

Action Threshold: Seek immediate medical attention if any signs of systemic toxicity appear.

Pain relief

Frequency: Daily

Target: Acceptable reduction in pain score

Action Threshold: Re-evaluate treatment if inadequate pain relief or worsening pain.

đŸ‘ī¸

Symptom Monitoring

  • Pain level
  • Skin irritation (redness, itching, rash, swelling, blistering)
  • Dizziness
  • Lightheadedness
  • Drowsiness
  • Confusion
  • Tinnitus (ringing in ears)
  • Blurred vision
  • Tremors
  • Muscle twitching
  • Numbness or tingling around the mouth
  • Unusual tiredness or weakness
  • Shortness of breath
  • Bluish or grayish skin discoloration (methemoglobinemia)

Special Patient Groups

🤰

Pregnancy

Lidocaine is Pregnancy Category B. While systemic absorption from topical patches is limited, use during pregnancy should be done with caution and only if clearly needed, after consulting a healthcare provider.

Trimester-Specific Risks:

First Trimester: Generally considered low risk due to limited systemic absorption, but caution advised.
Second Trimester: Generally considered low risk due to limited systemic absorption, but caution advised.
Third Trimester: Generally considered low risk due to limited systemic absorption, but caution advised.
🤱

Lactation

Lidocaine is considered L2 (Safer) for lactation. Minimal amounts are excreted into breast milk after topical application, and adverse effects on the infant are unlikely. Use with caution and avoid applying to the breast area.

Infant Risk: Low risk of adverse effects on the breastfed infant.
đŸ‘ļ

Pediatric Use

Not generally recommended for children under 12 years of age without medical supervision. Children may be more susceptible to systemic toxicity due to a higher surface area to body weight ratio and potentially thinner skin, leading to increased absorption.

👴

Geriatric Use

Use with caution in elderly patients, as they may be more sensitive to the systemic effects of lidocaine, although significant systemic absorption from topical patches is uncommon. Monitor for signs of systemic toxicity.

Clinical Information

💎

Clinical Pearls

  • Ensure the skin is clean, dry, and intact before applying the patch. Do not apply to open wounds, damaged, or irritated skin.
  • Instruct patients to remove the patch after 8-12 hours and allow a patch-free period (e.g., 12 hours) to minimize the risk of systemic accumulation and skin irritation.
  • Emphasize the importance of keeping patches out of reach of children and pets due to the risk of accidental ingestion and systemic toxicity.
  • Advise patients to avoid external heat sources (e.g., heating pads, electric blankets, hot baths/showers) over the patch, as heat can increase lidocaine absorption.
  • Monitor for signs of systemic toxicity (e.g., dizziness, confusion, tinnitus, tremors) especially if applying to large areas or for prolonged periods, though rare with 4% patches.
🔄

Alternative Therapies

  • Other topical analgesics (e.g., NSAID creams like diclofenac gel, capsaicin cream, menthol/methyl salicylate rubs)
  • Oral analgesics (e.g., acetaminophen, NSAIDs like ibuprofen or naproxen)
  • Physical therapy
  • Heat or cold therapy
  • Transcutaneous Electrical Nerve Stimulation (TENS)
  • Acupuncture
💰

Cost & Coverage

Average Cost: Variable, typically $15-$40 per 5-6 patches (OTC pack)
Generic Available: Yes
Insurance Coverage: Generally OTC, may not be covered by insurance unless prescribed by a physician.
📚

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, 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. If you have any questions or concerns about this medication, don't 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 medical attention. When seeking help, be prepared to provide information about what was taken, the amount, and the time it happened.