Lidoderm 5% Patch

Manufacturer ENDO 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
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?

Lidoderm 5% Patch is a medicated patch that contains lidocaine, a numbing medicine. It's applied to the skin to help relieve pain, especially nerve pain like that from 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

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. Do not use bandages or dressings unless your doctor instructs you to do so.
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.

Wearing the Medication

Different products may have different wear times. Be sure to follow your doctor's instructions for how long to wear the medication.
Do not wear the medication for longer than recommended by your doctor.
If you have questions or concerns, talk to your doctor.
Do not apply more than one skin patch or system at a time, unless instructed to do so by your doctor.

Securing the Medication

If the skin patch or system loosens at the edges, press the edges firmly to secure it. If it comes off, 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 safe place, out of reach of children and pets.
Cut pieces of the medication should also be disposed of safely.

Important Safety Precautions

Some medications may be flammable. Do not use near an open flame or while smoking.

Storing and Disposing of Your Medication

Store your medication at room temperature in the 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 safely. 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 to see if there are any drug take-back programs 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 often than recommended by your doctor.
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Lifestyle & Tips

  • Apply the patch to clean, dry, intact skin. Do not apply to broken, cut, or irritated skin.
  • Do not apply more than 3 patches at one time.
  • Wear the patch for no more than 12 hours within a 24-hour period. Remove the patch for at least 12 hours before applying a new one.
  • Wash hands immediately after handling the patch.
  • Avoid exposing the application site to external heat sources (e.g., heating pads, electric blankets, heat lamps, saunas, hot tubs) as this can increase absorption and risk of side effects.
  • Do not cut the patch into smaller pieces unless specifically instructed by your doctor or pharmacist (some generic patches may be cut, but Lidoderm brand is not designed to be cut).
  • Fold used patches in half with the sticky sides together and dispose of them safely, out of reach of children and pets.
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Available Forms & Alternatives

Available Strengths:

Generic Alternatives:

Dosing & Administration

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Adult Dosing

Standard Dose: Apply up to 3 patches, once for up to 12 hours within a 24-hour period.
Dose Range: 1 - 3 mg

Condition-Specific Dosing:

postherpetic_neuralgia: Apply to the most painful area of intact skin. Patches should be removed after 12 hours of application, allowing a 12-hour patch-free interval.
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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 adjustment recommended due to minimal systemic absorption.
Moderate: No specific adjustment recommended due to minimal systemic absorption. Use with caution.
Severe: Use with caution; consider potential for increased systemic exposure in patients with severe renal impairment, though unlikely with topical patch.
Dialysis: No specific recommendations; minimal systemic absorption makes dialysis unlikely to be relevant for removal.

Hepatic Impairment:

Mild: No specific adjustment recommended due to minimal systemic absorption.
Moderate: Use with caution; consider potential for increased systemic exposure in patients with moderate hepatic impairment, though unlikely with topical patch.
Severe: Use with caution; significant systemic exposure is unlikely, but severe hepatic impairment could theoretically impair metabolism of absorbed lidocaine. Monitor for signs of systemic toxicity.

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: Low (<5% systemically absorbed from patch)
Tmax: Variable, typically 10-12 hours after patch application (for systemic levels)
FoodEffect: Not applicable (topical administration)

Distribution:

Vd: 0.7-2.7 L/kg (systemic)
ProteinBinding: 60-80% (primarily to alpha-1-acid glycoprotein)
CnssPenetration: Limited (with topical application, significant CNS penetration only with high systemic levels)

Elimination:

HalfLife: Approximately 7.6 hours (systemic, after patch removal)
Clearance: Not readily quantifiable for topical patch due to low systemic absorption
ExcretionRoute: Renal (primarily as metabolites)
Unchanged: <10% (systemic, excreted unchanged in urine)
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Pharmacodynamics

OnsetOfAction: Within 30 minutes to 1 hour
PeakEffect: Approximately 2-4 hours after application
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

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you experience 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 too much acid in the blood (acidosis), 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
Trouble breathing, slow breathing, or 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 experience any of the following side effects or any other symptoms that concern you, contact your doctor:

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

If you have questions about side effects or concerns about your symptoms, 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:

  • Signs of too much medicine in the body (systemic toxicity): dizziness, lightheadedness, drowsiness, confusion, ringing in the ears (tinnitus), blurred vision, numbness around the mouth, muscle twitching, tremors, or seizures. Seek immediate medical attention if these occur.
  • Severe skin reactions at the application site: severe redness, swelling, blistering, or itching. Remove the patch and contact your doctor.
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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. 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.
* If a large area requires treatment.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other drugs and health issues. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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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

This medication can cause a severe blood disorder 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 under 6 months old
If you have ever had methemoglobinemia, tell your doctor.

Using Other Medications and Products

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. When applying, avoid scratching or rubbing the skin while it is numb. Also, avoid exposing the treated area to extreme temperatures.

Skin Application Precautions

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 these can cause your body temperature to rise and lead to 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. When using this medication in children, exercise caution, as the risk of certain side effects may be higher.

Managing Skin Irritation

If you experience burning or other irritation where the medication is applied, remove it and wait for the irritation to resolve before reapplying.

Common Skin Reactions

It is common to experience skin reactions, such as blisters, bruising, burning, abnormal feelings, color changes, swelling, redness, pain, itching, peeling, flaking, or pimples, at the application site 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 and Avoiding Moisture

You can wear clothing over the area where the medication is applied. However, keep the medication dry, as moisture may cause it to lose its adhesive properties. Avoid bathing, swimming, or showering while wearing the medication.

Ingestion Warning

This medication can be harmful if chewed or swallowed, including used patches. If ingestion occurs, contact a doctor or poison control center immediately.

Special Considerations for 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

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe dizziness or lightheadedness
  • Nausea, vomiting
  • Tremors, muscle twitching, seizures
  • Confusion, disorientation
  • Slow or irregular heartbeat (bradycardia, arrhythmias)
  • Low blood pressure (hypotension)
  • Difficulty breathing
  • Coma

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

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Major Interactions

  • Class I antiarrhythmics (e.g., tocainide, mexiletine): Increased risk of additive systemic toxicity (cardiac, neurological) if significant systemic absorption occurs.
  • Other local anesthetics: Increased risk of additive systemic toxicity.
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Moderate Interactions

  • Drugs that induce or inhibit CYP1A2 or CYP3A4 (e.g., cimetidine, beta-blockers, phenytoin, barbiturates): May alter systemic lidocaine levels if significant absorption occurs, though unlikely with topical patch.
  • Antiarrhythmics (e.g., amiodarone, propafenone): Potential for additive cardiac effects.

Monitoring

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Baseline Monitoring

Pain assessment (intensity, location, quality)

Rationale: To establish baseline pain level and guide treatment effectiveness.

Timing: Prior to initiation of therapy

Skin integrity at application site

Rationale: To ensure patch is applied to intact, non-irritated skin to prevent increased systemic absorption and local adverse reactions.

Timing: Prior to first application

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Routine Monitoring

Pain relief

Frequency: Daily or as needed

Target: Patient-reported reduction in pain score

Action Threshold: Lack of adequate pain relief may indicate need for re-evaluation of therapy or alternative treatments.

Application site reactions (e.g., erythema, edema, pruritus, vesicles)

Frequency: Daily, upon patch removal

Target: Absence of significant skin irritation

Action Threshold: Persistent or severe reactions may require discontinuation or change in application site.

Signs of systemic lidocaine toxicity (e.g., dizziness, drowsiness, confusion, tinnitus, blurred vision, muscle twitching, tremors, seizures, bradycardia, hypotension)

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

Target: Absence of these symptoms

Action Threshold: Presence of any systemic toxicity symptoms requires immediate patch removal and medical evaluation.

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Symptom Monitoring

  • Dizziness
  • Drowsiness
  • Confusion
  • Tinnitus
  • Blurred vision
  • Numbness around mouth
  • Muscle twitching
  • Tremors
  • Seizures
  • Bradycardia
  • Hypotension
  • Skin irritation (redness, swelling, itching, blisters) at application site

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 application results in minimal systemic absorption, making the risk to the fetus low. Use only if clearly needed.

Trimester-Specific Risks:

First Trimester: Low risk due to minimal systemic absorption.
Second Trimester: Low risk due to minimal systemic absorption.
Third Trimester: Low risk due to minimal systemic absorption.
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Lactation

Lidocaine is excreted in breast milk in small amounts. Due to minimal systemic absorption from topical application, the amount transferred to breast milk is expected to be very low, posing a low risk to the nursing infant (Lactation Risk L2).

Infant Risk: Low risk. Monitor infant for sedation or feeding difficulties, though unlikely.
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Pediatric Use

Safety and effectiveness in pediatric patients (under 18 years of age) have not been established. Not recommended for use in this population.

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Geriatric Use

No overall differences in effectiveness or safety were observed between elderly and younger patients. However, elderly patients may be more sensitive to the effects of lidocaine, and caution should be exercised, especially in those with impaired hepatic or renal function, or those taking other medications that may interact. Use the lowest effective dose.

Clinical Information

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Clinical Pearls

  • Lidoderm patches are specifically designed for postherpetic neuralgia (PHN) but are often used off-label for other localized neuropathic pain conditions.
  • Ensure the skin is intact and free of cuts, rashes, or irritation before applying the patch to prevent increased systemic absorption and local adverse reactions.
  • Patients should be instructed to remove the patch after 12 hours of application and allow a 12-hour patch-free interval to minimize the risk of systemic accumulation and toxicity.
  • Avoid external heat sources (e.g., heating pads, hot baths) over the patch, as this can significantly increase lidocaine absorption and the risk of systemic side effects.
  • Proper disposal of used patches is crucial to prevent accidental exposure to children or pets, as even used patches contain residual lidocaine.
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Alternative Therapies

  • Capsaicin topical (patch or cream)
  • NSAID topical (e.g., diclofenac gel)
  • Oral neuropathic pain medications (e.g., gabapentin, pregabalin, tricyclic antidepressants, SNRIs)
  • Opioid analgesics (for severe pain, with caution)
  • Physical therapy
  • Nerve blocks
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Cost & Coverage

Average Cost: $200 - $600 per 30 patches
Generic Available: Yes
Insurance Coverage: Varies by plan, often Tier 2 or 3 for brand, Tier 1 for generic. May require prior authorization.
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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.