L-M-x 5% Cream 30gm

Manufacturer FERNDALE LAB Active Ingredient Lidocaine Rectal Cream and Gel(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
Amide-type local anesthetic; 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?

Lidocaine 5% cream is a numbing medicine that you apply to your skin. It works by temporarily blocking nerve signals in the area where it's applied, 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

To use this medication correctly, follow your doctor's instructions and read all the information provided. Before and after applying the medication, wash your hands thoroughly. Clean the affected area before use and make sure it is completely dry. Apply the medication as directed by your doctor or according to the package labeling.

Storing and Disposing of Your Medication

Store the medication at room temperature, avoiding freezing. Keep all medications in a safe location, out of the 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 disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.

Missing a Dose

If you use this medication regularly, take a missed dose as soon as you remember. However, 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 take 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

  • Wash hands thoroughly before and after applying the cream.
  • Apply only to intact skin as directed by your healthcare provider. Avoid applying to broken, irritated, or mucous membranes unless specifically instructed.
  • Do not apply to large areas of the body or for longer than recommended, as this can increase the risk of serious side effects.
  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • Keep out of reach of children and pets. Store at room temperature.
  • Do not cover the treated area with tight bandages or heating pads unless specifically instructed by your doctor, as this can increase absorption.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thick layer to the intact skin for 30-60 minutes prior to procedure. Do not exceed 60 minutes of application. Maximum single application area: 200-600 cm². Maximum total dose: 60 grams per 24 hours.

Condition-Specific Dosing:

minorDermatologicalProcedures: Apply 2.5 grams (1/2 of a 5-gram tube) over 25 cm² for 20-30 minutes.
largerAreasOrLongerDuration: Apply up to 60 grams over 400 cm² for 1-2 hours under occlusive dressing.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (use with extreme caution, lower concentrations/smaller areas recommended if used off-label)
Child: For children 3 months and older: Apply 1.7 grams per 10 cm² for 30-60 minutes. Maximum dose: 10 grams or 0.1 g/kg, whichever is less, over 100 cm². Do not exceed 60 minutes of application. Not recommended for children under 3 months.
Adolescent: Same as adult dosing, but caution with total dose and application area based on body weight.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed for topical application due to minimal systemic absorption.
Moderate: No specific adjustment needed for topical application due to minimal systemic absorption.
Severe: Use with caution; monitor for signs of systemic toxicity if applied to large areas or broken skin, as metabolites may accumulate.
Dialysis: Considerations: Not dialyzable. Use with caution; monitor for signs of systemic toxicity.

Hepatic Impairment:

Mild: No specific adjustment needed for topical application due to minimal systemic absorption.
Moderate: Use with caution; monitor for signs of systemic toxicity if applied to large areas or broken skin, as lidocaine is primarily metabolized by the liver.
Severe: Use with extreme caution; significant reduction in clearance may occur. Monitor closely for systemic toxicity. Avoid large areas or prolonged application.

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 (dependent on application site, duration of application, skin integrity, and dose); up to 36% systemic absorption reported for intact skin, higher for compromised skin.
Tmax: Variable, typically 2-4 hours after topical application, but can be longer depending on formulation and application.
FoodEffect: Not applicable for topical formulation.

Distribution:

Vd: 0.7-2.7 L/kg (systemic)
ProteinBinding: 60-80% (primarily to alpha-1-acid glycoprotein and albumin)
CnssPenetration: Yes (if systemically absorbed, crosses blood-brain barrier)

Elimination:

HalfLife: 1.5-2 hours (systemic, parent drug); MEGX: 2.5-3 hours; GX: 10 hours
Clearance: Approximately 10 mL/min/kg (systemic)
ExcretionRoute: Renal (less than 10% unchanged drug)
Unchanged: Less than 10%
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Pharmacodynamics

OnsetOfAction: 3-5 minutes (initial numbing), full effect typically 20-60 minutes after application.
PeakEffect: Variable, typically 2-4 hours after application, depending on duration of application.
DurationOfAction: 1-2 hours after removal of cream, depending on dose and site.

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 acidosis (too much acid in the blood), 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
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
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 experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

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

This is not an exhaustive list of possible 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:

  • Dizziness or lightheadedness
  • Drowsiness or confusion
  • Numbness or tingling around the mouth
  • Unusual taste in mouth
  • Ringing in the ears (tinnitus)
  • Blurred vision
  • Tremors or muscle twitching
  • Slow or irregular heartbeat
  • Difficulty breathing
  • Unusual paleness or bluish discoloration of the skin (signs of methemoglobinemia, rare)
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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 symptoms you experienced as a result of the allergy.
The presence of an infection at the site where this medication will be applied.
Any broken skin or open wounds at the site where the medication will be used.
If you have swollen skin, numbness, or an inability to feel pain at the site where the medication will be applied.

This list is not exhaustive, and it is crucial to discuss all your medications (including 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 in conjunction with your other medications and health issues. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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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. Do not use this medication for a longer period than prescribed by your doctor. While your skin is numb, avoid scratching or rubbing the area, and do not expose it to extreme temperatures.

Apply this medication only to intact skin, unless your doctor instructs you to use it on cuts, scrapes, or damaged skin. Avoid using heat sources such as sunlamps, tanning beds, heating pads, electric blankets, heat lamps, saunas, hot tubs, or heated waterbeds. Also, avoid taking long, hot baths or sunbathing, as this can cause your body temperature to rise and lead to excessive absorption of the medication.

If this medication is accidentally swallowed, immediately contact a doctor or a 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 at a higher risk for certain side effects. 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 of using this medication with your doctor.
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Overdose Information

Overdose Symptoms:

  • Severe dizziness, lightheadedness, or fainting
  • Seizures
  • Difficulty breathing or stopping breathing
  • Slow or irregular heartbeat
  • Very low blood pressure
  • Coma

What to Do:

If you suspect an overdose, seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222.

Drug Interactions

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Major Interactions

  • Class I Antiarrhythmics (e.g., tocainide, mexiletine): Increased risk of cardiac adverse effects due to additive effects on cardiac conduction.
  • Other Local Anesthetics: Increased risk of systemic toxicity (CNS, cardiovascular) due to additive effects.
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Moderate Interactions

  • Beta-blockers (e.g., propranolol): May decrease hepatic blood flow, potentially reducing lidocaine clearance and increasing systemic levels.
  • Cimetidine: May inhibit lidocaine metabolism, increasing systemic levels.
  • Phenytoin: May alter lidocaine metabolism.
  • Succinylcholine: Prolonged neuromuscular blockade.

Monitoring

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Baseline Monitoring

Skin integrity and area to be treated

Rationale: To assess risk of systemic absorption and determine appropriate dose/application area.

Timing: Prior to first application

Patient's medical history (cardiac, hepatic, renal disease, allergies)

Rationale: To identify contraindications or conditions requiring dose adjustment/increased monitoring.

Timing: Prior to first application

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Routine Monitoring

Signs and symptoms of systemic toxicity (CNS, cardiovascular)

Frequency: During and immediately after application, and for several hours post-application, especially with large areas or prolonged use.

Target: Absence of symptoms

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

Application site reaction

Frequency: During and after application

Target: Minimal redness or swelling

Action Threshold: Severe erythema, edema, blistering, or allergic reactions require discontinuation.

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Symptom Monitoring

  • Lightheadedness
  • Dizziness
  • Drowsiness
  • Confusion
  • Disorientation
  • Tinnitus (ringing in ears)
  • Blurred vision
  • Numbness or tingling around the mouth
  • Tremors
  • Muscle twitching
  • Seizures
  • Bradycardia (slow heart rate)
  • Hypotension (low blood pressure)
  • Cardiac arrest (severe toxicity)
  • Methemoglobinemia (rare, cyanosis, shortness of breath, fatigue)

Special Patient Groups

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Pregnancy

Lidocaine is classified as Pregnancy Category B. Animal studies have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed and the potential benefits outweigh the potential risks.

Trimester-Specific Risks:

First Trimester: Low risk based on animal data, but caution advised.
Second Trimester: Low risk based on animal data, but caution advised.
Third Trimester: Low risk based on animal data, but caution advised. Avoid large doses near term due to potential for fetal bradycardia.
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Lactation

Lidocaine is excreted in breast milk in small amounts. The amount transferred to the infant is generally considered too small to cause adverse effects when used topically at recommended doses. L2 (likely compatible) classification.

Infant Risk: Low risk. Monitor infant for unusual drowsiness or feeding difficulties, though unlikely with topical use.
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Pediatric Use

Use with extreme caution, especially in infants and young children (under 3 months). Children are more susceptible to systemic toxicity due to higher surface area to body weight ratio and thinner skin, leading to increased absorption. Dosing must be carefully calculated based on weight and surface area, and application time/area strictly limited. Not recommended for children under 3 months.

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Geriatric Use

Use with caution. Elderly patients may be more susceptible to systemic toxicity due to decreased hepatic and renal function, reduced protein binding, and potential for underlying cardiac disease. Start with lower doses and monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Always apply to intact skin. Application to broken, inflamed, or mucous membranes significantly increases systemic absorption and risk of toxicity.
  • Occlusive dressings (e.g., plastic wrap) enhance absorption and should only be used as directed, and for the minimum effective duration.
  • Be aware of the total amount of lidocaine applied, especially when treating large areas or using multiple lidocaine-containing products concurrently.
  • Systemic toxicity symptoms can be delayed. Monitor patients for several hours after application, particularly if large doses or areas were treated.
  • Patients should be advised not to scratch or rub the treated area while it is numb, to avoid accidental injury.
  • Methemoglobinemia is a rare but serious side effect, especially in infants or patients with G6PD deficiency. Look for cyanosis, shortness of breath, and fatigue.
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Alternative Therapies

  • Benzocaine topical
  • Bupivacaine topical (less common)
  • Cryoanesthesia (ice packs)
  • Non-pharmacological pain management techniques
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Cost & Coverage

Average Cost: $20 - $50 per 30gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic)
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General Drug Facts

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. 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 information about the medication taken, the amount, and the time it happened.