Lmx 4% Cream 5gm
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.
Drug Class
Local Anesthetic
Pharmacologic Class
Amide-type local anesthetic; Voltage-gated sodium channel blocker
Pregnancy Category
Category B
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lidocaine cream is a medicine applied to the skin to numb it. It works by temporarily blocking nerve signals in the area where it's applied, which helps to reduce pain or discomfort during minor procedures or for certain skin conditions.
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 topical use only.
2. Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation. If accidental exposure occurs, rinse the affected 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 skin area before application.
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 the 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 extra doses.
If you use this medication as needed:
- Do not use it more frequently than recommended by your doctor.
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 topical use only.
2. Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation. If accidental exposure occurs, rinse the affected 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 skin area before application.
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 the 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 extra doses.
If you use this medication as needed:
- Do not use it more frequently than recommended by your doctor.
Lifestyle & Tips
- Apply only to intact skin as directed by your doctor or the product label. Do not apply to broken, irritated, or wounded skin unless specifically instructed by a healthcare professional.
- Do not apply to large areas of the body.
- Do not use heat (e.g., heating pads, electric blankets) over the area where the cream is applied, as this can increase absorption and risk of side effects.
- Wash hands thoroughly before and after applying the cream.
- Avoid contact with eyes, nose, mouth, and other mucous membranes.
- Keep out of reach of children and pets. Even small amounts can be dangerous if ingested by a child.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thick layer to intact skin for 30-60 minutes prior to procedure. Do not exceed 0.5 g per 5 cm² or 60 g total per 24 hours.
Condition-Specific Dosing:
minorDermatologicalProcedures:
Apply 1.25 g (approx. 1/2 inch bead) per 25 cm² (10 in²) for 30 minutes to 1 hour. Max 60 g/24 hours.
painRelief:
Apply to affected area as needed, up to 3-4 times daily. Do not exceed 7 g per application or 28 g per day over a 24-hour period for general pain relief. For specific products like LMX 4%, refer to product-specific instructions for maximum application area and duration.
Pediatric Dosing
Neonatal:
Not established (increased risk of systemic toxicity due to immature skin barrier and higher surface area to weight ratio).
Infant:
Not established (increased risk of systemic toxicity). Use with extreme caution and under medical supervision if absolutely necessary, with strict adherence to minimal dose and area. Max 0.1 g/kg.
Child:
For children 3 months and older: Apply 1.25 g per 25 cm² for 30 minutes to 1 hour. Max 10 g total for children 3 months to 7 years (or <20 kg). Max 20 g total for children 8-17 years (or >20 kg). Do not exceed 3 applications in a 24-hour period. Monitor closely for signs of systemic toxicity.
Adolescent:
Same as adult dosing, but monitor for signs of systemic toxicity, especially if large areas or prolonged application.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for topical application on intact skin.
Moderate:
No specific adjustment needed for topical application on intact skin. Use with caution if large areas or prolonged application, as systemic absorption may lead to accumulation of metabolites.
Severe:
No specific adjustment needed for topical application on intact skin. Use with caution if large areas or prolonged application, as systemic absorption may lead to accumulation of metabolites.
Dialysis:
Considerations: Minimal systemic absorption with proper use, so dialysis is unlikely to significantly impact drug levels. However, caution is advised if significant systemic absorption is anticipated.
Hepatic Impairment:
Mild:
No specific adjustment needed for topical application on intact skin.
Moderate:
No specific adjustment needed for topical application on intact skin. Use with caution if large areas or prolonged application, as lidocaine is primarily metabolized by the liver.
Severe:
No specific adjustment needed for topical application on intact skin. Use with caution if large areas or prolonged application, as lidocaine is primarily metabolized by the liver. Increased risk of systemic toxicity.
Pharmacology
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.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (topical); Systemic absorption is variable (dependent on dose, duration, application area, skin integrity, and vascularity).
Tmax:
Variable (typically 2-4 hours for systemic absorption after topical application, but onset of local effect is within minutes).
FoodEffect:
Not applicable (topical).
Distribution:
Vd:
0.7-2.7 L/kg (systemic)
ProteinBinding:
60-80% (primarily to alpha-1-acid glycoprotein and albumin, systemic)
CnssPenetration:
Yes (if systemically absorbed, crosses blood-brain barrier)
Elimination:
HalfLife:
1.5-2 hours (systemic, in healthy adults)
Clearance:
Not readily quantifiable for topical application; Systemic clearance is approximately 10-20 mL/min/kg.
ExcretionRoute:
Renal (primarily as metabolites)
Unchanged:
<10% (systemic, excreted unchanged in urine)
Pharmacodynamics
OnsetOfAction:
3-5 minutes (for local anesthetic effect)
PeakEffect:
20-60 minutes (for local anesthetic effect)
DurationOfAction:
1-2 hours (for local anesthetic effect, depending on concentration and application)
Safety & Warnings
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 or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or 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 or 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 or discharge
+ Increased heat or swelling
+ Redness or pain
Respiratory problems, such as:
+ Difficulty breathing
+ Slow or shallow breathing
Severe numbness or tingling
Feeling lightheaded, sleepy, confused, or experiencing blurred vision
Seizures
Changes in vision
Feeling nervous or excitable
Dizziness or fainting
Ringing in the ears
Nausea or vomiting
Feeling excessively hot or cold
Shakiness or tremors
Twitching
Slow heartbeat
Chest pain
Additional Side Effects
As with any medication, some people may experience side effects. If you notice any of the following symptoms or any other unusual effects, contact your doctor:
Irritation or discomfort at the site of application
Swelling
Redness
Changes in skin color
Reporting Side Effects
If you experience any side effects that bother you or do not go away, contact your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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 medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or 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 or 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 or discharge
+ Increased heat or swelling
+ Redness or pain
Respiratory problems, such as:
+ Difficulty breathing
+ Slow or shallow breathing
Severe numbness or tingling
Feeling lightheaded, sleepy, confused, or experiencing blurred vision
Seizures
Changes in vision
Feeling nervous or excitable
Dizziness or fainting
Ringing in the ears
Nausea or vomiting
Feeling excessively hot or cold
Shakiness or tremors
Twitching
Slow heartbeat
Chest pain
Additional Side Effects
As with any medication, some people may experience side effects. If you notice any of the following symptoms or any other unusual effects, contact your doctor:
Irritation or discomfort at the site of application
Swelling
Redness
Changes in skin color
Reporting Side Effects
If you experience any side effects that bother you or do not go away, contact your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Dizziness or lightheadedness
- Drowsiness or confusion
- Unusual tiredness
- Blurred vision or ringing in the ears (tinnitus)
- Numbness or tingling around the mouth
- Metallic taste in the mouth
- Tremors or muscle twitching
- Seizures
- Slow or irregular heartbeat
- Difficulty breathing
- Pale, gray, or blue-colored skin (methemoglobinemia, rare but serious)
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 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 dosage adjustments.
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 complete medical history, including any health problems or conditions.
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety and the effectiveness of your treatment plan.
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 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 dosage adjustments.
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 complete medical history, including any health problems or conditions.
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety and the effectiveness of your treatment plan.
Precautions & Cautions
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 a severe blood condition called methemoglobinemia associated with this type of drug. Certain factors may increase this risk, including:
- Having glucose-6-phosphate dehydrogenase (G6PD) deficiency
- 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 products on your skin, 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 may cause your body temperature to rise, leading to excessive drug absorption.
If this medication is ingested, it can be harmful. In the event of accidental ingestion, immediately contact a doctor or a poison control center.
When administering this medication to children, be aware that different brands may have specific age restrictions. 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 this age group.
For individuals 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, inform your doctor. It is crucial to discuss the potential benefits and risks of using this medication during these situations to ensure the well-being of both you and your baby.
There is a risk of a severe blood condition called methemoglobinemia associated with this type of drug. Certain factors may increase this risk, including:
- Having glucose-6-phosphate dehydrogenase (G6PD) deficiency
- 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 products on your skin, 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 may cause your body temperature to rise, leading to excessive drug absorption.
If this medication is ingested, it can be harmful. In the event of accidental ingestion, immediately contact a doctor or a poison control center.
When administering this medication to children, be aware that different brands may have specific age restrictions. 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 this age group.
For individuals 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, inform your doctor. It is crucial to discuss the potential benefits and risks of using this medication during these situations to ensure the well-being of both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe dizziness, lightheadedness, or fainting
- Extreme drowsiness or loss of consciousness
- Seizures
- Slow or irregular heartbeat (bradycardia, arrhythmias)
- Low blood pressure (hypotension)
- Difficulty breathing or respiratory arrest
- 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
Major Interactions
- Antiarrhythmics (Class I, e.g., mexiletine, tocainide): 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.
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 (CYP1A2, CYP3A4), increasing systemic levels.
- CYP3A4 inhibitors (e.g., macrolide antibiotics, azole antifungals, protease inhibitors): May increase lidocaine systemic exposure.
- CYP1A2 inhibitors (e.g., fluvoxamine): May increase lidocaine systemic exposure.
Minor Interactions
- Phenytoin: May alter lidocaine metabolism.
- Skeletal muscle relaxants (e.g., succinylcholine): Prolonged neuromuscular blockade.
Monitoring
Baseline Monitoring
Skin integrity and area of application
Rationale: To assess risk of systemic absorption and guide appropriate dosing.
Timing: Prior to first application
Patient's medical history (cardiac, hepatic, renal disease, allergies)
Rationale: To identify contraindications or increased risk of adverse effects.
Timing: Prior to first application
Routine Monitoring
Signs and symptoms 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, tremors, seizures, bradycardia, hypotension, or metallic taste warrant immediate discontinuation and medical evaluation.
Effectiveness of pain relief/anesthesia
Frequency: As needed
Target: Adequate pain control/anesthesia
Action Threshold: Inadequate effect may indicate need for re-evaluation of application technique or alternative therapy.
Symptom Monitoring
- Lightheadedness
- Dizziness
- Drowsiness
- Confusion
- Disorientation
- Tremors
- Muscle twitching
- Seizures
- Tinnitus (ringing in ears)
- Blurred vision
- Numbness around the mouth (perioral numbness)
- Metallic taste
- Bradycardia (slow heart rate)
- Hypotension (low blood pressure)
- Cardiac arrest (severe cases)
Special Patient Groups
Pregnancy
Lidocaine is classified as 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 use with minimal systemic absorption is generally considered low risk, but use only if clearly needed and potential benefits outweigh risks.
Trimester-Specific Risks:
First Trimester:
Low risk with topical application and minimal systemic absorption.
Second Trimester:
Low risk with topical application and minimal systemic absorption.
Third Trimester:
Low risk with topical application and minimal systemic absorption. Caution near term as systemic absorption could affect fetal heart rate.
Lactation
Lidocaine is excreted in breast milk in small amounts. Due to low systemic absorption from topical application and low oral bioavailability in the infant, the risk to a nursing infant is considered low (Lactation Risk L2). Use with caution, especially avoiding application to the breast area.
Infant Risk:
Low risk
Pediatric Use
Children, especially infants and those under 3 months, are at increased risk of systemic toxicity due to a higher surface area to weight ratio and immature skin barrier. Dosing must be carefully calculated based on weight and application area. Close monitoring for signs of systemic toxicity is crucial. Not recommended for routine use in neonates.
Geriatric Use
Elderly patients may be more susceptible to systemic adverse effects due to decreased hepatic function, reduced renal clearance, and potential for polypharmacy. Use with caution, consider lower doses or smaller application areas, and monitor closely for signs of toxicity.
Clinical Information
Clinical Pearls
- Topical lidocaine is for external use only. Do not ingest.
- The risk of systemic toxicity increases with larger application areas, longer application times, higher concentrations, and application to broken or inflamed skin.
- Occlusive dressings (e.g., plastic wrap) can significantly increase systemic absorption and should only be used if specifically directed by a healthcare professional.
- Patients should be advised not to apply the cream to mucous membranes or around the eyes.
- Be aware of the potential for methemoglobinemia, especially in infants or patients with certain genetic predispositions, though rare with topical lidocaine.
- Always use the smallest effective amount for the shortest duration necessary.
Alternative Therapies
- Benzocaine topical
- Tetracaine topical
- Bupivacaine topical (less common)
- Cryotherapy (ice packs)
- Non-pharmacological pain relief methods (e.g., distraction, relaxation techniques)
- Oral analgesics (e.g., NSAIDs, acetaminophen) for systemic pain.
Cost & Coverage
Average Cost:
Varies widely, typically $15-$50 per 5gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 (brand)
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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.