L-M-x 4% Cream 15gm

Manufacturer FERNDALE LAB Active Ingredient Lidocaine Cream(LYE doe kane) Pronunciation LYE-doe-kane
It is used to manage pain.It is used to treat signs of hemorrhoids or rectal irritation. It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Local Anesthetic
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Pharmacologic Class
Voltage-gated sodium channel blocker
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Pregnancy Category
Category B
FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

L-M-x 4% Cream is a numbing cream that contains lidocaine. It works by temporarily blocking nerve signals in the skin, which helps to reduce pain or discomfort during minor medical procedures, injections, or for certain skin conditions.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication safely and effectively, follow your doctor's instructions and read all the information provided.

Using Rectal Products

1. Wash your hands before and after applying the medication.
2. Apply the medication to clean, dry skin as directed by your doctor or according to the package labeling.

Using Skin Products

1. Do not ingest this medication. It is for skin use only.
2. Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation. If accidental contact occurs, rinse the area thoroughly with water.
3. Wash your hands before and after applying the medication, unless your hand is the treated area.
4. Clean and dry the affected area before applying the medication.
5. Apply the medication to clean, dry, healthy skin.
6. Do not cover the treated area with bandages or dressings unless instructed to do so by your doctor.

Storing and Disposing of Your Medication

1. Store the medication at room temperature.
2. Do not freeze the medication.
3. Keep all medications in a safe place, out of the reach of children and pets.
4. 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.
5. Consult your pharmacist for guidance on the best disposal method. Local drug take-back programs may also be available.

Missing a Dose

If you use this medication regularly:
- Take a missed dose as soon as you remember.
- If the next dose is soon, 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:
- Follow your doctor's instructions regarding frequency of use.
- Do not use the medication more often than recommended by your doctor.
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Lifestyle & Tips

  • Clean and dry the skin area before applying the cream.
  • Apply a thick layer of cream to the skin as directed by your healthcare provider or the product instructions.
  • Do not rub the cream in; it should sit on top of the skin.
  • Cover the area with an occlusive dressing (e.g., plastic wrap) if recommended, to enhance absorption and prevent removal.
  • Wash your hands thoroughly after applying the cream.
  • Remove the cream completely with a clean cloth or tissue before the procedure.
  • Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
  • Do not apply to broken, irritated, or inflamed skin unless specifically instructed by a doctor.
  • Keep out of reach of children and pets.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thick layer to intact skin for 20-60 minutes prior to procedure. Do not exceed 60 minutes. Maximum single application area: 400 cm². Maximum total dose: 60 grams per 24 hours.

Condition-Specific Dosing:

minorProcedures: Apply for 20-30 minutes.
majorProcedures: Apply for 30-60 minutes.
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Pediatric Dosing

Neonatal: Not established. Use with extreme caution due to risk of systemic toxicity.
Infant: Not established. Use with extreme caution due to risk of systemic toxicity. Max dose and area must be strictly adhered to based on weight and age.
Child: Not established. Use with extreme caution due to risk of systemic toxicity. Max dose and area must be strictly adhered to based on weight and age. For children 3-12 years, typically 0.5-1 g per 10 cm² for up to 1 hour, not exceeding 10 g total.
Adolescent: Similar to adult dosing, but caution with total dose and application area, especially for smaller adolescents.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed for topical application.
Moderate: No specific adjustment needed for topical application, but monitor for signs of systemic toxicity if large areas or prolonged use.
Severe: Use with caution; monitor for signs of systemic toxicity due to potential accumulation of metabolites.
Dialysis: Considerations: Lidocaine and its metabolites are dialyzable to some extent. Use with caution and monitor for systemic toxicity.

Hepatic Impairment:

Mild: No specific adjustment needed for topical application.
Moderate: Use with caution; monitor for signs of systemic toxicity due to reduced metabolism.
Severe: Use with extreme caution; significant reduction in metabolism can lead to increased systemic levels and toxicity.
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 effecting 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: Variable (low for intact skin, increases with damaged skin, occlusion, or prolonged application). Systemic absorption can occur.
Tmax: Topical: 2-4 hours (systemic absorption peak)
FoodEffect: Not applicable (topical)

Distribution:

Vd: 0.7-2.7 L/kg (systemic)
ProteinBinding: 60-80% (primarily to alpha-1-acid glycoprotein)
CnssPenetration: Yes (if systemic absorption occurs)

Elimination:

HalfLife: 1.5-2 hours (systemic)
Clearance: 10-20 mL/min/kg (systemic)
ExcretionRoute: Renal (less than 10% as unchanged drug)
Unchanged: <10%
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Pharmacodynamics

OnsetOfAction: Topical: 20-60 minutes
PeakEffect: Topical: 60 minutes
DurationOfAction: Topical: 1-2 hours after removal of cream
Confidence: Medium

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:

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 unusually hot or cold
Shakiness
Twitching
Slow heartbeat
Chest pain

Additional Side Effects of Rectal Products

If you are using a rectal form of this medication, be aware of the following additional side effects:
Rectal bleeding or 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 are bothered by any of the following side effects or if they do not go away, contact your doctor:
Irritation at the site of application
Swelling
Redness
* Skin color changes

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:

  • Dizziness or lightheadedness
  • Numbness or tingling around the mouth
  • Blurred vision or ringing in the ears (tinnitus)
  • Unusual drowsiness or confusion
  • Tremors or muscle twitching
  • Slow or irregular heartbeat
  • Difficulty breathing
  • Severe skin irritation, rash, or blistering at the application site
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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 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, vitamins, or supplements you are using.
Your medical history, including any health problems or conditions.

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.
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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.

This drug can cause a severe blood condition called methemoglobinemia, which may be more likely to occur in individuals with certain health conditions, such as glucose-6-phosphate dehydrogenase (G6PD) deficiency, heart problems, or lung problems. Additionally, the risk may be increased 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. Do not use this medication for an extended period beyond what your doctor has prescribed.

While using this medication, avoid scratching or rubbing the treated skin, and do not expose it to extreme temperatures. Do not apply this medication to cuts, scrapes, or damaged skin unless your doctor instructs you to do so.

Avoid using heat sources such as sunlamps, tanning beds, heating pads, electric blankets, heat lamps, saunas, hot tubs, or heated waterbeds, as they can cause your body temperature to rise, leading to excessive absorption of the medication. Also, avoid taking long, hot baths or sunbathing.

If this medication is ingested, it can be harmful, so if swallowed, immediately contact a doctor or poison control center. Note that different brands of this medication may be suitable for children of various ages, so consult with your doctor before administering it to a child.

When using this medication in children, exercise caution, as they may be more susceptible to certain side effects. Similarly, if you are 65 or older, use this medication with caution, as you may be more prone to experiencing 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 ensure the best outcome for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe dizziness or fainting
  • Seizures
  • Difficulty breathing or stopping breathing
  • Very slow or irregular heartbeat
  • Coma

What to Do:

Immediately remove the cream from the skin. Seek emergency medical attention or call Poison Control at 1-800-222-1222. Overdose can be life-threatening.

Drug Interactions

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Major Interactions

  • Class I Antiarrhythmics (e.g., Tocainide, Mexiletine): Increased risk of cardiac adverse effects.
  • Other Local Anesthetics: Increased risk of systemic toxicity.
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Moderate Interactions

  • Antiarrhythmics (e.g., Amiodarone, Beta-blockers): Additive cardiac effects, monitor ECG.
  • CYP3A4 Inhibitors (e.g., Ketoconazole, Macrolides): May increase lidocaine systemic levels.
  • CYP1A2 Inhibitors (e.g., Cimetidine, Fluvoxamine): May increase lidocaine systemic levels.
  • Skeletal Muscle Relaxants (e.g., Succinylcholine): Prolonged neuromuscular blockade.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Skin integrity

Rationale: Ensure skin is intact to minimize systemic absorption and reduce irritation.

Timing: Prior to application

Patient weight (pediatric)

Rationale: To calculate appropriate maximum dose and application area.

Timing: Prior to application

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Routine Monitoring

Signs of systemic toxicity (CNS, cardiovascular)

Frequency: During and immediately after application, especially with large areas or prolonged use.

Target: Absence of symptoms

Action Threshold: Any signs of dizziness, drowsiness, confusion, tinnitus, blurred vision, tremors, seizures, bradycardia, hypotension, or arrhythmias require immediate medical attention.

Local skin reactions

Frequency: During and after application

Target: Minimal redness or irritation

Action Threshold: Severe redness, swelling, blistering, or allergic reactions require discontinuation.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Numbness around the mouth
  • Tingling sensations
  • Blurred vision
  • Tinnitus (ringing in ears)
  • Drowsiness
  • Confusion
  • Tremors
  • Muscle twitching
  • Seizures
  • Bradycardia (slow heart rate)
  • Hypotension (low blood pressure)
  • Arrhythmias (irregular heart beat)

Special Patient Groups

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Pregnancy

Lidocaine is generally considered safe for topical use during pregnancy (Category B). Systemic absorption is minimal with proper use. Use the lowest effective dose for the shortest duration.

Trimester-Specific Risks:

First Trimester: Low risk, but use only if clearly needed.
Second Trimester: Low risk.
Third Trimester: Low risk.
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Lactation

Lidocaine is excreted in breast milk in small amounts. Topical application results in minimal systemic absorption, making infant exposure low (L2). Use with caution, avoid applying to breast area if breastfeeding.

Infant Risk: Low risk of adverse effects to the infant with proper topical use.
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Pediatric Use

Use with extreme caution, especially in infants and young children, due to higher risk of systemic toxicity from greater surface area to volume ratio and thinner skin. Strict adherence to weight-based dosing and application area limits is crucial. Monitor closely for signs of systemic toxicity.

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Geriatric Use

Generally safe for topical use in the elderly. However, elderly patients may be more susceptible to systemic adverse effects due to decreased hepatic function, reduced protein binding, or underlying cardiac conditions. Use the lowest effective dose and monitor for toxicity.

Clinical Information

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Clinical Pearls

  • Always apply to intact skin to minimize systemic absorption and reduce irritation.
  • Occlusion (e.g., with plastic wrap) can significantly increase absorption and onset, but also increases risk of systemic toxicity if not used carefully.
  • Ensure the cream is completely removed before any procedure to prevent interference or transfer.
  • Educate patients on signs of systemic toxicity (e.g., dizziness, tinnitus, numbness around mouth) and to seek immediate medical attention if they occur.
  • For pediatric patients, precise dosing based on weight and surface area is critical to prevent overdose.
  • Avoid applying to large body areas or for prolonged periods, especially in patients with compromised skin barrier or hepatic impairment.
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Alternative Therapies

  • Benzocaine topical
  • Bupivacaine topical (less common)
  • Cryoanesthesia (ice packs)
  • Non-pharmacological pain management techniques (e.g., distraction, relaxation)
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Cost & Coverage

Average Cost: Varies widely, typically $20-$100+ per 15gm tube
Generic Available: Yes
Insurance Coverage: Tier 1-3, often covered by most insurance plans with a co-pay.
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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 this 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.