Lidocaine Pain Relief 4% Patch

Manufacturer RUGBY LABORATORIES 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.
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Drug Class
Local anesthetic, topical analgesic
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Pharmacologic Class
Voltage-gated sodium channel blocker
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Pregnancy Category
Category B
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Lidocaine is a medicine that numbs the skin to help relieve pain. When applied as a patch, it works by blocking nerve signals in the area where it's placed, reducing the feeling of pain.
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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. This medication is for topical use only, meaning it should be applied directly to the skin. Avoid getting it in your mouth, nose, or eyes, as it may cause burning. If accidental contact occurs, rinse the area thoroughly with water.

Before applying the medication, clean the affected area and dry it completely. Apply the medication to clean, dry, and 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.

To apply, place the medication on 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. Different products may have varying wear times, so be sure to understand how long you can wear this medication before removing it. Also, know 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 with your doctor. Additionally, do not apply more skin patches than prescribed by your doctor.

If the skin patch or system loosens at the edges, press them firmly to reattach. If it comes off completely, try to reapply it. If you are unable to reapply the patch or system, use a new one.

After removing a skin patch or system, fold the sticky sides together and dispose of it properly. Keep used patches, systems, and cut pieces out of reach of children and pets.

Important Safety Precautions

Some of these medications may be flammable, so avoid using them near open flames or while smoking.

Storage and Disposal

Store this 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 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. If you have questions about disposal, consult with your pharmacist. You may also want to check if there are drug take-back programs in your area.

Missed 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.
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Lifestyle & Tips

  • Apply patch to clean, dry, intact skin. Do not apply to broken, irritated, or cut skin.
  • Do not apply heat (e.g., heating pads, hot baths) over the patch, as this can increase absorption and risk of side effects.
  • Wash hands thoroughly after handling the patch.
  • Avoid contact with eyes, nose, and mouth.
  • Do not wear more than the recommended number of patches or for longer than recommended.
  • Fold used patches in half with the sticky sides together and dispose of them out of reach of children and pets.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply 1 patch to the affected area for up to 12 hours within a 24-hour period. Do not apply more than 3 patches at one time.
Dose Range: 1 - 3 mg

Condition-Specific Dosing:

post-herpetic neuralgia (prescription strength): Apply up to 3 patches to the most painful area once for up to 12 hours within a 24-hour period. Patches should be removed after 12 hours of application and a 12-hour patch-free interval should follow.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (for OTC 4% patch, generally not recommended for children under 12 without physician consultation)
Adolescent: For ages 12 and older, follow adult dosing. Consult physician for use in younger adolescents.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed due to minimal systemic absorption.
Moderate: No specific adjustment needed due to minimal systemic absorption.
Severe: No specific adjustment needed due to minimal systemic absorption. Use with caution if significant skin barrier compromise exists.
Dialysis: No specific adjustment needed due to minimal systemic absorption.

Hepatic Impairment:

Mild: No specific adjustment needed due to minimal systemic absorption.
Moderate: No specific adjustment needed due to minimal systemic absorption.
Severe: No specific adjustment needed due to minimal systemic absorption. Use with caution if significant skin barrier compromise exists.
Confidence: Medium

Pharmacology

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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, preventing the generation and conduction of nerve impulses.
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Pharmacokinetics

Absorption:

Bioavailability: Low (<5% systemically absorbed from intact skin for topical patch)
Tmax: Highly variable, typically 4-12 hours for peak plasma concentration after topical patch application, but systemic levels are very low.
FoodEffect: Not applicable for topical administration.

Distribution:

Vd: 0.7-2.7 L/kg (for systemically absorbed lidocaine, not highly relevant for topical patch due to low absorption)
ProteinBinding: 60-80% (primarily to alpha-1-acid glycoprotein and albumin for systemically absorbed lidocaine)
CnssPenetration: Limited (for topical patch due to low systemic absorption; significant CNS penetration occurs with systemic administration)

Elimination:

HalfLife: Approximately 1.5-2 hours (for systemically absorbed lidocaine)
Clearance: Approximately 10-20 mL/min/kg (for systemically absorbed lidocaine)
ExcretionRoute: Renal (primarily as metabolites, <10% as unchanged drug)
Unchanged: <10%
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Pharmacodynamics

OnsetOfAction: Within 30-60 minutes
PeakEffect: Variable, typically within 2-4 hours for maximal pain relief, but can extend throughout the application period.
DurationOfAction: Up to 12 hours (while patch is applied)
Confidence: Medium

Safety & Warnings

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Side Effects

Urgent 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 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), including:
+ 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, including:
+ 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

This is not an exhaustive list of possible side effects. 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe skin irritation, rash, blistering, or swelling at the application site.
  • Signs of systemic absorption (rare): dizziness, lightheadedness, drowsiness, confusion, blurred vision, ringing in ears, numbness/tingling around mouth, unusual taste, tremors, seizures, irregular heartbeat, shortness of breath.
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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 these conditions 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, it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This includes:

All your current health problems, as they may interact with this medication.
* Any potential interactions between this medication and your other medications or health conditions.

Do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety. It is your responsibility to verify that it is safe to take this medication with all your other drugs and health conditions.
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Precautions & Cautions

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

A rare but serious blood condition called methemoglobinemia can occur with the use of this drug. Your risk may be increased if you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD), heart problems, or lung problems. Additionally, the risk may be higher 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 to ensure safe use.

Do not use this medication for a longer duration than prescribed by your doctor. While using this medication, avoid scratching or rubbing the treated skin, and protect it from extreme temperatures.

Apply this medication only to intact skin, unless your doctor specifically instructs you to use it on cuts, scrapes, or damaged skin.

Avoid exposure to 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 these can cause your body temperature to rise, leading to increased absorption of the medication.

When using this medication in children, it is crucial to follow the doctor's instructions, as different brands may be suitable for different age groups. Children may be at a higher risk for certain side effects, so careful monitoring is necessary.

If you experience burning or irritation at the application site, remove the medication and wait for the irritation to resolve before reapplying.

Common skin reactions at the application site may include blisters, bruising, burning, abnormal sensations, color changes, swelling, redness, pain, itching, peeling, flaking, or pimples. These reactions usually resolve within minutes to hours. However, if any of these effects are severe, bothersome, or persistent, contact your doctor.

You can wear clothing over the treated area if needed.

It is crucial to keep this medication out of the mouth, as it can be harmful if chewed or swallowed, including used patches. If accidental ingestion occurs, immediately contact a doctor or poison control center.

To ensure the medication adheres properly, keep it dry. Avoid bathing, swimming, or showering while wearing the medication.

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 with your doctor to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Severe dizziness or drowsiness
  • Confusion
  • Blurred vision or ringing in ears
  • Numbness or tingling around the mouth
  • Tremors or muscle twitching
  • Seizures
  • Slow or irregular heartbeat
  • Difficulty breathing
  • Loss of consciousness

What to Do:

Immediately remove patches. Seek emergency medical attention or call Poison Control (1-800-222-1222).

Drug Interactions

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Moderate Interactions

  • Class I antiarrhythmics (e.g., tocainide, mexiletine): Theoretical risk of additive systemic effects if significant lidocaine absorption occurs, leading to increased cardiac depression or neurological effects. (Very low risk with topical patch)
  • Other local anesthetics: Additive systemic effects if significant absorption occurs. (Very low risk with topical patch)

Monitoring

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Routine Monitoring

Pain level

Frequency: Daily or as needed

Target: Reduction in pain score

Action Threshold: Lack of efficacy after appropriate trial period, consider alternative therapy.

Application site reaction

Frequency: Daily, upon patch removal

Target: No significant redness, swelling, blistering, or irritation

Action Threshold: Persistent or severe skin irritation, discontinue use and consult healthcare provider.

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Symptom Monitoring

  • Skin irritation (redness, itching, rash, swelling, blistering) at application site
  • Signs of systemic toxicity (rare with topical patch): dizziness, lightheadedness, drowsiness, confusion, blurred vision, ringing in ears, numbness/tingling around mouth, unusual taste, tremors, seizures, irregular heartbeat, shortness of breath.

Special Patient Groups

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Pregnancy

Lidocaine is Pregnancy Category B. Studies in animals have not shown harm to the fetus, and there are no adequate and well-controlled studies in pregnant women. Topical use with minimal systemic absorption is generally considered low risk, but use only if clearly needed and under medical advice.

Trimester-Specific Risks:

First Trimester: Low risk, but consult physician.
Second Trimester: Low risk, but consult physician.
Third Trimester: Low risk, but consult physician.
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Lactation

Lidocaine is excreted in breast milk in small amounts. Due to low systemic absorption from topical patches, the amount transferred to breast milk is expected to be very low, posing minimal risk to the infant. Considered L2 (safer).

Infant Risk: Low risk
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Pediatric Use

Not recommended for children under 12 years of age for OTC use without consulting a doctor. Children may be more susceptible to systemic toxicity due to higher surface area to weight ratio and thinner skin. Use with extreme caution and under medical supervision if prescribed for specific conditions.

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Geriatric Use

No specific dose adjustment is typically needed. However, elderly patients may have thinner skin or reduced hepatic/renal function (though less relevant for topical use), increasing theoretical risk of systemic absorption. Monitor for skin reactions and systemic symptoms. Use with caution in frail elderly.

Clinical Information

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Clinical Pearls

  • Ensure skin is clean, dry, and free of cuts or irritation before applying the patch.
  • Do not cut the patch unless specifically instructed by the manufacturer (some brands allow cutting, others do not).
  • Avoid applying external heat (e.g., heating pads, electric blankets, hot showers/baths) over the patch, as this can significantly increase lidocaine absorption and risk of systemic toxicity.
  • Remove the patch after 12 hours of application and allow a 12-hour patch-free interval to minimize systemic exposure and reduce the risk of tachyphylaxis or skin irritation.
  • If pain relief is insufficient, do not apply more patches or wear them longer than recommended; consult a healthcare professional.
  • Store patches safely out of reach of children and pets, as ingestion or improper application can be dangerous.
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Alternative Therapies

  • Topical NSAIDs (e.g., diclofenac gel)
  • Topical capsaicin cream/patch
  • Topical counterirritants (e.g., menthol, methyl salicylate)
  • Oral analgesics (e.g., acetaminophen, NSAIDs)
  • Physical therapy
  • Heat/cold therapy
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Cost & Coverage

Average Cost: $10 - $30 per 5-6 patches (OTC)
Generic Available: Yes
Insurance Coverage: Generally not covered by insurance as an OTC product, but may be eligible for FSA/HSA reimbursement.
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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 happened.