Lidocaine 5% Patch

Manufacturer TEVA /ACTAVIS 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, Analgesic
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Pharmacologic Class
Amide-type local anesthetic; Sodium channel blocker
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Pregnancy Category
Category B
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FDA Approved
Mar 1999
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Lidocaine 5% patch is a medicated patch that contains a numbing medicine called lidocaine. It is applied to the skin to help relieve nerve pain, especially after shingles (postherpetic neuralgia). The medicine works by blocking pain signals in the nerves where the patch is applied.
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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 instructed 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 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 have access to 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 resume your regular schedule. Do not apply two doses at once or use extra doses. If you use this medication as needed, do not use it more frequently than recommended by your doctor.
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Lifestyle & Tips

  • Apply the patch to clean, dry, intact, and non-irritated skin. Avoid applying to broken or damaged skin.
  • Do not apply to areas with cuts, wounds, or rashes.
  • Wash your hands immediately after handling the patch.
  • Do not apply heat (e.g., heating pads, electric blankets) over the patch, as this can increase absorption and risk of side effects.
  • Avoid bathing, showering, or swimming while wearing the patch.
  • If the patch does not stick well, you may secure it with medical tape, but do not cover it with bandages that prevent air circulation.
  • Fold used patches in half with the sticky sides together and dispose of them safely, out of reach of children and pets.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply to the most painful area of intact skin. Up to 3 patches may be applied at one time. Patches should be worn for no more than 12 hours within a 24-hour period.
Dose Range: 1 - 3 mg

Condition-Specific Dosing:

Postherpetic Neuralgia (PHN): Apply to the most painful area of intact skin. Up to 3 patches may be applied at one time. Patches should be worn for no more than 12 hours within a 24-hour period.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, but use with caution.
Moderate: Use with caution; monitor for systemic toxicity.
Severe: Use with caution; monitor for systemic toxicity. Consider reducing application area or duration.
Dialysis: Considerations: Lidocaine is not significantly dialyzable. Use with caution due to potential for accumulation of metabolites.

Hepatic Impairment:

Mild: No specific dose adjustment recommended, but use with caution.
Moderate: Use with caution; monitor for systemic toxicity. Consider reducing application area or duration.
Severe: Contraindicated or use with extreme caution; monitor for systemic toxicity. Significant dose reduction or avoidance may be necessary due to impaired metabolism.

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 in the neuronal cell membrane, preventing depolarization and propagation of action potentials.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 3% to 5% of the applied dose is systemically absorbed from the patch.
Tmax: Approximately 10-12 hours (for systemic absorption from patch).
FoodEffect: Not applicable for topical administration.

Distribution:

Vd: 0.7-2.7 L/kg (systemic lidocaine).
ProteinBinding: 60-80% (primarily to alpha-1-acid glycoprotein and albumin).
CnssPenetration: Limited (from topical application, but can occur with high systemic levels).

Elimination:

HalfLife: Approximately 1.5-2 hours (systemic lidocaine).
Clearance: Approximately 0.95 L/min (systemic lidocaine).
ExcretionRoute: Renal (metabolites and unchanged drug).
Unchanged: <10% (of systemic lidocaine).
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Pharmacodynamics

OnsetOfAction: Within 30-60 minutes.
PeakEffect: Approximately 10-12 hours (due to sustained release from patch).
DurationOfAction: Up to 12 hours (while patch is applied).
Confidence: High

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 immediately or seek emergency 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
+ Difficulty 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
+ Rapid breathing
+ Rapid heartbeat
+ Abnormal 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
+ Abnormal 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:
+ Difficulty 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 extremely hot or cold
Shakiness
Twitching
Slow heartbeat
Chest 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 contact your doctor if you notice any of the following:

Irritation at the site of application
Other side effects that bother you or do not go away

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.
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Seek Immediate Medical Attention If You Experience:

  • Severe skin reactions (blistering, peeling, severe redness, swelling)
  • Signs of allergic reaction (hives, difficulty breathing, swelling of face/lips/tongue/throat)
  • Signs of systemic toxicity: severe dizziness, lightheadedness, confusion, blurred vision, ringing in ears (tinnitus), unusual tiredness, tremors, muscle twitching, seizures, slow or irregular heartbeat, shortness of breath, fainting.
  • If you experience any of these, remove the patch immediately and seek emergency medical attention.
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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, 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 reactions.
If a large area of your body needs to be treated, as this may require special consideration.

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

Your doctor will assess the safety of taking this medication in conjunction with your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
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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

A severe blood disorder called methemoglobinemia has been associated with drugs like this one. Your risk may be increased 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 a history of methemoglobinemia, notify your doctor.

Using Other Products on Your Skin

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

Proper Use and Application

Do not use this medication for a longer period than prescribed by your doctor. Avoid scratching or rubbing the skin while it is numb, and do not expose it to extreme temperatures.

Applying to Damaged Skin

Only apply this medication to cuts, scrapes, or damaged skin if your doctor instructs you to do so.

Avoiding Heat Sources

Avoid using heat sources such as:
Sunlamps
Tanning beds
Heating pads
Electric blankets
Heat lamps
Saunas
Hot tubs
* Heated waterbeds
Also, avoid taking long, hot baths or sunbathing, as your body temperature may rise and cause excessive absorption of the medication.

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

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 sensations, 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.

Wearing Clothing

You can wear clothing over the area where the medication is applied.

Accidental Ingestion

This medication can be harmful if chewed or swallowed, including used patches. If the medication has been ingested, contact a doctor or poison control center immediately.

Keeping the Medication Dry

Avoid getting the medication wet, as it may not adhere properly. Do not bathe, swim, or shower while wearing the medication.

Use in Older Adults

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

Pregnancy and Breastfeeding

Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. You will need to discuss the benefits and risks of using this medication with your doctor.
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Overdose Information

Overdose Symptoms:

  • Numbness or tingling around the mouth
  • Lightheadedness, dizziness
  • Tinnitus (ringing in ears)
  • Blurred or double vision
  • Tremors, muscle twitching
  • Seizures
  • Drowsiness, confusion
  • Bradycardia (slow heart rate)
  • Hypotension (low blood pressure)
  • Respiratory depression or arrest
  • Cardiac arrest

What to Do:

If overdose is suspected, remove the patch immediately and call 911 or Poison Control (1-800-222-1222) right away. Seek immediate medical attention. Management may include supportive care, airway management, and treatment of seizures or cardiac arrhythmias.

Drug Interactions

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Major Interactions

  • Class I antiarrhythmics (e.g., tocainide, mexiletine): Increased risk of additive cardiac effects and systemic toxicity.
  • Other local anesthetics: Increased risk of systemic toxicity.
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Moderate Interactions

  • CYP3A4 inhibitors (e.g., erythromycin, itraconazole, ketoconazole, ritonavir): May increase lidocaine plasma concentrations, leading to increased risk of systemic toxicity.
  • CYP1A2 inhibitors (e.g., cimetidine, fluvoxamine): May increase lidocaine plasma concentrations.
  • Succinylcholine: May prolong neuromuscular blockade.
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Minor Interactions

  • Phenytoin: May increase lidocaine metabolism (less relevant for topical).

Monitoring

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Baseline Monitoring

Pain level assessment

Rationale: To establish baseline efficacy and guide treatment.

Timing: Prior to initiation of therapy.

Skin integrity at application site

Rationale: To ensure patch is applied to intact, non-irritated skin.

Timing: Prior to each application.

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Routine Monitoring

Local skin reactions (e.g., erythema, edema, pruritus, rash)

Frequency: Daily, with each patch application/removal.

Target: Minimal to no reaction.

Action Threshold: Discontinue use if severe or persistent reactions occur.

Signs/symptoms of systemic lidocaine toxicity (e.g., dizziness, drowsiness, confusion, blurred vision, tinnitus, tremor, seizures, bradycardia, hypotension)

Frequency: Periodically, especially if applying multiple patches or to compromised skin.

Target: Absence of systemic symptoms.

Action Threshold: Discontinue use immediately and seek medical attention if symptoms occur.

Pain level reassessment

Frequency: As needed, to assess treatment efficacy.

Target: Reduction in pain score.

Action Threshold: Consider alternative therapies if no significant pain relief.

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Symptom Monitoring

  • Skin irritation (redness, swelling, itching, burning) at application site
  • Dizziness
  • Lightheadedness
  • Drowsiness
  • Confusion
  • Blurred vision
  • Tinnitus (ringing in ears)
  • Tremors
  • Muscle twitching
  • Seizures
  • Bradycardia (slow heart rate)
  • Hypotension (low blood pressure)
  • Shortness of breath

Special Patient Groups

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Pregnancy

Lidocaine is Pregnancy Category B. Studies in animals have shown no evidence of harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed and the potential benefits outweigh the potential risks.

Trimester-Specific Risks:

First Trimester: Low risk based on animal data, but human data limited. Use only if clearly indicated.
Second Trimester: Low risk based on animal data, but human data limited. Use only if clearly indicated.
Third Trimester: Low risk based on animal data, but human data limited. Use only if clearly indicated. Consider potential for systemic absorption and effects on labor/delivery if applied to large areas.
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Lactation

Lidocaine is excreted into breast milk in small amounts. The amount transferred to the infant via topical application is expected to be very low. Lactation Risk Category L2 (Safer).

Infant Risk: Low risk of adverse effects to the breastfed infant. Monitor infant for drowsiness or feeding difficulties, though unlikely with topical use.
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Pediatric Use

Safety and effectiveness in pediatric patients (under 18 years of age) have not been established for postherpetic neuralgia. Use is generally not recommended in this population.

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Geriatric Use

Use with caution in elderly patients, as they may be more susceptible to systemic adverse effects due to decreased hepatic or renal function, or concomitant medications. Monitor closely for signs of systemic toxicity. No specific dose adjustment is typically required based on age alone, but individual patient factors should be considered.

Clinical Information

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Clinical Pearls

  • Instruct patients to apply the patch to the least hairy areas of the skin to ensure good adhesion and minimize discomfort upon removal.
  • The patch can be cut into smaller sizes to fit the painful area, but ensure the cut edges are not frayed.
  • Avoid applying the patch to the same skin site consecutively to prevent skin irritation; rotate application sites if possible.
  • Patients should be advised to remove the patch immediately if they experience any signs of systemic toxicity (e.g., dizziness, confusion, heart rate changes).
  • Proper disposal of used patches is crucial to prevent accidental exposure to children or pets, as significant amounts of lidocaine may remain in used patches.
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Alternative Therapies

  • Gabapentin (oral)
  • Pregabalin (oral)
  • Tricyclic antidepressants (e.g., amitriptyline, nortriptyline) (oral)
  • Capsaicin patch (8%)
  • Topical NSAIDs (e.g., diclofenac gel)
  • Opioid analgesics (generally reserved for severe, refractory pain)
  • Tramadol (oral)
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Cost & Coverage

Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (for brand), Tier 1 or Tier 2 (for generic)
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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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.