L-M-x 4% Cream 30gm
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?
L-M-x 4% Cream is a topical cream containing lidocaine, a local anesthetic. It works by numbing the skin to reduce pain or discomfort from minor skin irritations, insect bites, or before certain medical procedures like injections or minor skin procedures.
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. Use it only on your skin.
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 way to dispose of medications. Local drug take-back programs may also be available.
Missing a Dose
If you use this medication regularly and miss a dose, apply it 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 use extra doses. If you use this medication as needed, do not use it more frequently than directed 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. Use it only on your skin.
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 way to dispose of medications. Local drug take-back programs may also be available.
Missing a Dose
If you use this medication regularly and miss a dose, apply it 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 use extra doses. If you use this medication as needed, do not use it more frequently than directed by your doctor.
Lifestyle & Tips
- Wash hands thoroughly before and after applying the cream.
- Apply only to intact, unbroken skin. Do not apply to open wounds, cuts, or irritated skin.
- Use the smallest amount needed to cover the affected area.
- Do not cover the treated area with bandages or plastic wrap unless specifically instructed by your doctor, as this can increase absorption and risk of side effects.
- Avoid contact with eyes, nose, mouth, or other mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not use heat (e.g., heating pads) on the treated area, as this can increase absorption.
- Keep out of reach of children and pets. Store at room temperature.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to the affected intact skin area up to 3-4 times daily. Do not exceed 0.5 g of cream per 5 cm x 5 cm area (25 cm²) or 60 g per day for adults.
Condition-Specific Dosing:
intact_skin:
Apply to intact skin only. Do not apply to broken, inflamed, or irritated skin.
maximum_area:
Do not apply to large skin areas or for prolonged periods without medical supervision.
occlusive_dressing:
Do not use with occlusive dressings unless directed by a healthcare professional, as this can increase systemic absorption.
Pediatric Dosing
Neonatal:
Not established. Use with extreme caution due to increased risk of systemic toxicity.
Infant:
Not established. Use with extreme caution due to increased risk of systemic toxicity. Consult a pediatrician.
Child:
For children 2-12 years: Apply a thin layer to the affected intact skin area. Do not exceed 0.1 g of cream per 10 cm² or 10 g per day. Max 3 applications in 24 hours. Use with caution due to increased risk of systemic toxicity.
Adolescent:
Similar to adult dosing, but caution advised regarding total dose and application area.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment for topical application, but caution if significant systemic absorption is anticipated.
Moderate:
No specific adjustment for topical application, but caution if significant systemic absorption is anticipated.
Severe:
No specific adjustment for topical application, but caution if significant systemic absorption is anticipated. Monitor for signs of systemic toxicity.
Dialysis:
Considerations: Minimal systemic absorption with proper topical use, but monitor for systemic toxicity if large areas or prolonged use.
Hepatic Impairment:
Mild:
No specific adjustment for topical application, but caution if significant systemic absorption is anticipated.
Moderate:
No specific adjustment for topical application, but caution if significant systemic absorption is anticipated. Monitor for signs of systemic toxicity.
Severe:
No specific adjustment for topical application, but caution if significant systemic absorption is anticipated. Lidocaine is primarily metabolized by the liver; severe impairment may increase risk of systemic toxicity if absorbed.
Pharmacology
Mechanism of Action
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 achieves 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.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (low for intact skin, increases with damaged skin, occlusive dressings, or large application areas). Systemic bioavailability from topical application is generally low but can range from 3% to 10% or higher depending on site, duration, and integrity of skin.
Tmax:
Approximately 2-4 hours after topical application, but can vary widely.
FoodEffect:
Not applicable (topical administration)
Distribution:
Vd:
Approximately 1.1 L/kg (systemic)
ProteinBinding:
Approximately 60-80% (primarily to alpha-1-acid glycoprotein and albumin) (systemic)
CnssPenetration:
Limited (with topical application, but can occur with systemic absorption leading to CNS effects)
Elimination:
HalfLife:
Approximately 1.5-2 hours (systemic, in healthy adults)
Clearance:
Approximately 10-20 mL/min/kg (systemic)
ExcretionRoute:
Renal (primarily as metabolites)
Unchanged:
Less than 10% (systemic)
Pharmacodynamics
OnsetOfAction:
3-5 minutes (topical)
PeakEffect:
20-60 minutes (topical)
DurationOfAction:
30-60 minutes (topical, depending on application site and duration)
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
+ 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
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
For rectal products: bleeding from the rectum or rectal pain
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor if you notice any of the following:
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 concerns or questions, 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.
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
+ 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
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
For rectal products: bleeding from the rectum or rectal pain
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor if you notice any of the following:
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 concerns or questions, 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.
Seek Immediate Medical Attention If You Experience:
- Signs of too much medicine absorbed (systemic toxicity): lightheadedness, dizziness, nervousness, blurred vision, ringing in ears (tinnitus), numbness around the mouth, tremors, drowsiness, confusion, seizures, slow heartbeat, low blood pressure.
- Severe skin reactions: severe redness, swelling, blistering, or rash at the application site.
- Allergic reactions: hives, difficulty breathing, swelling of face/lips/tongue/throat.
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 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 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 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 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 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 developing a severe blood condition called methemoglobinemia associated 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 certain 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 to ensure safe use.
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, take the following precautions:
- Avoid scratching or rubbing the skin in the treated area, as it may be numb
- Protect the skin from extreme temperatures, whether hot or cold
- Unless instructed by your doctor, do not apply this medication to cuts, scrapes, or damaged skin
To minimize the risk of adverse effects, avoid exposure to heat sources such as:
- Sunlamps
- Tanning beds
- Heating pads
- Electric blankets
- Heat lamps
- Saunas
- Hot tubs
- Heated waterbeds
Additionally, refrain from taking long, hot baths or sunbathing, as these activities can cause your body temperature to rise, potentially leading to excessive absorption of the medication.
In the event that this medication is ingested, seek immediate medical attention or contact a 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.
There is a risk of developing a severe blood condition called methemoglobinemia associated 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 certain 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 to ensure safe use.
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, take the following precautions:
- Avoid scratching or rubbing the skin in the treated area, as it may be numb
- Protect the skin from extreme temperatures, whether hot or cold
- Unless instructed by your doctor, do not apply this medication to cuts, scrapes, or damaged skin
To minimize the risk of adverse effects, avoid exposure to heat sources such as:
- Sunlamps
- Tanning beds
- Heating pads
- Electric blankets
- Heat lamps
- Saunas
- Hot tubs
- Heated waterbeds
Additionally, refrain from taking long, hot baths or sunbathing, as these activities can cause your body temperature to rise, potentially leading to excessive absorption of the medication.
In the event that this medication is ingested, seek immediate medical attention or contact a 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.
Overdose Information
Overdose Symptoms:
- Severe dizziness or lightheadedness
- Nausea, vomiting
- Tremors, muscle twitching
- Seizures
- Slow or irregular heartbeat (bradycardia, arrhythmia)
- Low blood pressure (hypotension)
- Difficulty breathing, respiratory arrest
- Coma
- Cardiac arrest
What to Do:
If you suspect an overdose or experience severe symptoms, seek immediate medical attention or call a Poison Control Center (1-800-222-1222). Remove the cream immediately. Supportive care, including airway management, oxygen, IV fluids, and medications to manage seizures or cardiac effects, may be necessary.
Drug Interactions
Contraindicated Interactions
- Not applicable for topical lidocaine cream under normal use
Major Interactions
- Antiarrhythmics (Class I antiarrhythmics like mexiletine, tocainide, procainamide, quinidine, disopyramide): Increased risk of cardiac effects if significant systemic absorption occurs.
- Other local anesthetics: Increased risk of systemic toxicity (additive effects).
Moderate Interactions
- Beta-blockers (e.g., propranolol, metoprolol): May decrease hepatic clearance of lidocaine, increasing systemic levels if significant absorption occurs.
- Cimetidine: May inhibit lidocaine metabolism, increasing systemic levels if significant absorption occurs.
- CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin): May increase lidocaine levels.
- CYP3A4 inhibitors (e.g., ketoconazole, erythromycin): May increase lidocaine levels.
Minor Interactions
- Not typically significant for topical application.
Monitoring
Baseline Monitoring
Skin integrity of application site
Rationale: To ensure application to intact skin and minimize systemic absorption.
Timing: Prior to first application
Patient's medical history (especially cardiac, hepatic, renal conditions, and medications)
Rationale: To identify risk factors for systemic toxicity or drug interactions.
Timing: Prior to first application
Routine Monitoring
Signs and symptoms of systemic toxicity (e.g., lightheadedness, dizziness, nervousness, blurred vision, tremors, drowsiness, tinnitus, perioral numbness, seizures, bradycardia, hypotension)
Frequency: During and after each application, especially with large areas or prolonged use.
Target: Absence of symptoms
Action Threshold: Any appearance of these symptoms requires immediate discontinuation and medical evaluation.
Local skin reactions (e.g., redness, swelling, itching, rash, irritation)
Frequency: During and after each application.
Target: Absence of severe reactions
Action Threshold: Persistent or severe reactions require discontinuation.
Symptom Monitoring
- Lightheadedness
- Dizziness
- Nervousness
- Blurred vision
- Tremors
- Drowsiness
- Tinnitus
- Perioral numbness
- Seizures
- Bradycardia
- Hypotension
- Cardiac arrest
- Respiratory depression
- Methemoglobinemia (rare, but possible with high doses or prolonged use)
Special Patient Groups
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 absorption is generally low, making it relatively safe for localized use when medically necessary. Use with caution and only if the potential benefit outweighs the potential risk.
Trimester-Specific Risks:
First Trimester:
Low risk with topical use, but caution advised.
Second Trimester:
Low risk with topical use.
Third Trimester:
Low risk with topical use, but caution advised near term due to potential for neonatal effects if significant systemic absorption occurs.
Lactation
Lidocaine is excreted in breast milk in small amounts following systemic administration. However, due to low systemic absorption from topical application, the amount transferred to breast milk is expected to be minimal and unlikely to cause adverse effects in a breastfed infant. Use with caution, especially avoiding application to the breast area to prevent direct infant ingestion.
Infant Risk:
Low risk (L2)
Pediatric Use
Children, especially infants and young children, are more susceptible to systemic toxicity from lidocaine due to their higher surface area to weight ratio and immature metabolic pathways. Dosing must be carefully calculated based on weight and surface area, and application should be limited to small areas for short durations. Avoid use in children under 2 years unless specifically directed by a physician. Monitor closely for signs of systemic toxicity.
Geriatric Use
Elderly patients may be more susceptible to systemic toxicity due to potential age-related decreases in hepatic and renal function, which can affect lidocaine metabolism and excretion. Use the lowest effective dose and monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- Always apply to intact skin only. Application to broken, inflamed, or irritated skin significantly increases systemic absorption and risk of toxicity.
- Educate patients on the signs of systemic lidocaine toxicity (e.g., lightheadedness, perioral numbness, tinnitus, tremors) and to seek immediate medical attention if they occur.
- Avoid using occlusive dressings (e.g., plastic wrap, bandages) over the treated area unless specifically instructed by a healthcare provider, as this can dramatically increase systemic absorption.
- Do not apply to large body areas or for prolonged periods, especially in children or patients with hepatic impairment, due to the risk of systemic toxicity.
- This cream is for external use only. Do not ingest or apply to mucous membranes (eyes, mouth, nose, genitals) unless specifically formulated for those areas and directed by a healthcare professional.
- Consider alternative pain relief methods for widespread or chronic pain, as topical lidocaine is best suited for localized, temporary pain relief.
Alternative Therapies
- Topical NSAIDs (e.g., diclofenac gel)
- Topical capsaicin cream
- Oral analgesics (e.g., acetaminophen, ibuprofen)
- Ice/cold packs
- Counterirritants (e.g., menthol, camphor)
Cost & Coverage
Average Cost:
Varies widely, typically $15 - $50 per 30gm tube
Generic Available:
Yes
Insurance Coverage:
Often covered by most insurance plans, typically Tier 1 or 2 for generic versions.
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.