L-M-x 4%/10 Tegaderm (prev Ela-Max)

Lidocaine is an amide-type local anesthetic. It stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of nerve impulses, thereby blocking the conduction of pain signals. It does this by reversibly binding to and blocking voltage-gated sodium channels in the neuronal cell membrane, preventing the influx of sodium ions necessary for depolarization and action potential propagation.

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 immediate medical attention:

Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of acidosis (too much acid in the blood): confusion, fast breathing, fast heartbeat, irregular heartbeat, severe stomach pain, nausea, vomiting, excessive sleepiness, shortness of breath, or feeling extremely tired or weak
Signs of methemoglobinemia: blue or gray discoloration of the lips, nails, or skin, irregular heartbeat, seizures, severe dizziness or fainting, severe headache, excessive sleepiness, feeling tired or weak, or shortness of breath (this rare effect can be life-threatening if it occurs)
Signs of skin infection: oozing, heat, swelling, redness, or pain
Respiratory problems: 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

Additional Side Effects of Rectal Products:

Bleeding from the rectum or rectal pain

Other Possible Side Effects:

While many people may not experience side effects or may only have mild side effects, it's essential to be aware of the following:

Irritation at the site of application
Swelling
Redness
* Changes in skin color

If you experience any of these side effects or any other unusual symptoms that bother you or do not go away, contact your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

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 application site.
Swollen skin, numbness, or loss of sensation at the application site.
* If a large area of skin needs to be treated.

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 use this medication in conjunction with your other treatments. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

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

There is a risk of developing a severe blood condition called methemoglobinemia with this type of drug. Certain factors may increase this risk, including:
- Having a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD)
- Pre-existing heart or lung problems
- Taking specific other medications
- Being an infant 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.

Adhere to your doctor's instructions regarding the duration of use for this medication. Do not exceed the recommended treatment period.

While using this medication, avoid scratching or rubbing the treated skin area, as it may be numb. Additionally, protect the area from extreme temperatures.

Unless instructed by your doctor, do not apply this medication to cuts, scrapes, or damaged skin.

To minimize the risk of increased drug absorption, avoid exposure to 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 these activities can cause your body temperature to rise.

If this medication is accidentally ingested, seek immediate medical attention by calling a doctor or poison control center.

When considering the use of this medication in children, it is crucial to consult with a doctor, as different brands may be suitable for different age groups. Children may be at a higher risk for certain side effects, so cautious use is advised.

If you are 65 years 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 make an informed decision.

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

• Methemoglobinemia-inducing agents (e.g., dapsone, nitrates, sulfonamides, phenobarbital, phenytoin, acetaminophen, antimalarials): Increased risk of methemoglobinemia, especially in infants or patients with G6PD deficiency.
• CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, ketoconazole, ritonavir): May increase lidocaine systemic levels if significant absorption occurs.
• CYP1A2 inhibitors (e.g., cimetidine, fluvoxamine): May increase lidocaine systemic levels if significant absorption occurs.

• Local irritation (redness, itching, rash, swelling, burning)
• Signs of systemic toxicity (dizziness, lightheadedness, blurred vision, tinnitus, numbness/tingling around mouth, tremors, confusion, drowsiness, anxiety, slurred speech, seizures, slow heart rate, low blood pressure, difficulty breathing, unusual paleness or bluish skin/lips/nail beds (methemoglobinemia))

Generally considered safe for topical use during pregnancy when used as directed due to minimal systemic absorption. Consult a healthcare provider before use.

Lidocaine is excreted in breast milk in small amounts after systemic administration. With topical use and minimal systemic absorption, the amount transferred to breast milk is expected to be very low, posing minimal risk to the infant. Use with caution and avoid applying to areas where the infant might ingest it.

Use with extreme caution in children, especially those under 2 years of age, due to increased risk of systemic toxicity and methemoglobinemia. Dosing must be carefully calculated based on weight and surface area, and application should be limited to small areas for short durations. Avoid use on broken skin. Consult a physician.

No specific dose adjustment is typically needed for topical use. However, elderly patients may have thinner skin, reduced hepatic/renal function, or be on multiple medications, potentially increasing sensitivity to systemic effects if significant absorption occurs. Use with caution and monitor for adverse reactions.

• Occlusion (e.g., with Tegaderm) significantly enhances the penetration and effectiveness of topical lidocaine.
• Always apply to intact skin to minimize systemic absorption and reduce the risk of toxicity.
• The maximum recommended application area and duration should not be exceeded, especially in children or patients with compromised skin/organ function.
• Patients should be advised that the numbing effect may mask pain that would otherwise signal injury (e.g., burns from heat sources).
• Be aware of the potential for methemoglobinemia, especially in infants, patients with G6PD deficiency, or those concurrently using other methemoglobin-inducing agents. Symptoms include bluish skin/lips/nail beds, shortness of breath, and fatigue.

• Benzocaine topical (e.g., Solarcaine, Lanacane)
• Tetracaine topical
• Cryotherapy (ice packs)
• Oral analgesics (e.g., acetaminophen, NSAIDs) for systemic pain relief
• Non-pharmacological pain management techniques (e.g., distraction, relaxation)

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 for more information. 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 emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.