Lidocaine 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 1948
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lidocaine 4% cream is a medicine applied to the skin to numb the area and relieve pain or itching. It works by temporarily blocking nerve signals in the skin.
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 burning. 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 a missed dose as soon as you remember.
- If the next dose is near, 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.
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 burning. 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 a missed dose as soon as you remember.
- If the next dose is near, 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.
Lifestyle & Tips
- Wash your hands thoroughly before and after applying the cream.
- Apply only a thin layer to the affected area as directed by your doctor or pharmacist.
- Do not apply to broken, irritated, or inflamed skin unless specifically instructed by a healthcare professional.
- Avoid contact with eyes, nose, mouth, and other mucous membranes.
- Do not cover the treated area with bandages or plastic wrap unless directed by your doctor, as this can increase absorption and risk of side effects.
- Keep out of reach of children and pets. Accidental ingestion can be dangerous.
- If you miss a dose, apply it as soon as you remember, but do not apply more than the recommended amount or more frequently than advised.
Available Forms & Alternatives
Available Strengths:
- Lidocaine 4% Top Soln 50ml
- Lidocaine 2% Visc Oral Solution
- Lidocaine 1% Inj, 10ml
- Lidocaine 2% Inj, 2ml
- Lidocaine 4% Injection, 5ml
- Lidocaine 1% Inj, 5ml
- Lidocaine 1% Inj, 20ml
- Lidocaine 2% Inj, 20ml
- Lidocaine 1% Inj, 2ml
- Lidocaine 1% Inj, 50ml
- Lidocaine 2% Inj, 5ml
- Lidocaine 2% Inj, 10ml
- Lidocaine 1% Inj, 30ml
- Lidocaine 2% Inj, 50ml
- Lidocaine 2% Inj, 5ml
- Lidocaine 10mg/ml Inj, 5ml
- Lidocaine 3% Cream 28.35gm
- Lidocaine 3% Cream 85gm
- Lidocaine 2% Topical Jelly 5ml
- Lidocaine 2% Topical Jelly 10ml
- Lidocaine 2% Topical Jelly 20ml
- Lidocaine 20mg/ml Inj, 5ml
- Lidocaine 2% Jelly Gel (uro-Jet)5ml
- Lidocaine 0.5% Inj, 50ml
- Lidocaine 5% Patch
- Lidocaine 5% Topical Ointment 30gm
- Lidocaine 5% Topical Oint 35.44gm
- Lidocaine 5% Topical Ointment 50gm
- Lidocaine 1.5% Inj, 1 Ampule
- Lidocaine 5% Top/oral Oint 50gm
- Lidocaine 4% Cream 15gm
- Lidocaine 4% Cream 30gm
- Lidocaine 4% Cream 5gm
- Lidocaine 3% Cream 85gm
- Lidocaine Pain Relief 4% Patch
- Lidocaine 5% Top/oral Oint (sprmt)
- Lidocaine 5% Anorectal Cream
- Lidocaine 4% Cream 15gm
- Lidocaine 5% Topical Ointment 30gm
- Lidocaine 5% Anorectal Cream 15gm
- Lidocaine Pain Relief 4% Patch
- Lidocaine 5% Cream 30gm
- Lidocaine 2% Inj 25ml
- Lidocaine 5% Ointment 50gm
- Lidocaine 4% Cream 15gm
- Lidocaine 4% Topical Pain Patch
- Lidocaine 3%/hc 0.5% Cream 28.3gm
- Lidocaine 2% Topical Jelly 30ml
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to the affected area every 6 to 8 hours as needed.
Condition-Specific Dosing:
generalPainRelief:
Apply to intact skin to cover the most painful area. Do not exceed 3 applications in a 24-hour period. Maximum recommended dose is 0.5 g of cream per 5 cm x 5 cm area, not to exceed 50 g total per 24 hours.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Use with caution. Consult a healthcare professional. Dosing should be based on weight and surface area to avoid systemic toxicity. Generally, lower concentrations and smaller application areas are recommended.
Adolescent:
Similar to adult dosing, but caution advised regarding total dose and application area, especially for younger adolescents.
Dose Adjustments
Renal Impairment:
Mild:
Not typically adjusted for topical use unless significant systemic absorption is anticipated or prolonged use.
Moderate:
Not typically adjusted for topical use unless significant systemic absorption is anticipated or prolonged use.
Severe:
Use with caution due to potential for accumulation of lidocaine and its metabolites if significant systemic absorption occurs. Monitor for signs of systemic toxicity.
Dialysis:
Considerations: Lidocaine is not significantly removed by hemodialysis. Use with caution if significant systemic absorption is expected.
Hepatic Impairment:
Mild:
Not typically adjusted for topical use unless significant systemic absorption is anticipated or prolonged use.
Moderate:
Use with caution. Hepatic impairment can reduce lidocaine clearance, increasing risk of systemic toxicity if significant absorption occurs. Monitor for signs of systemic toxicity.
Severe:
Use with extreme caution. Significant hepatic impairment can severely reduce lidocaine clearance. Consider lower doses and smaller application areas. Monitor closely for 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 the influx of sodium ions and thus inhibiting depolarization and nerve impulse propagation.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (depends on application site, skin integrity, duration of application, and total dose applied); generally low for intact skin.
Tmax:
Variable (typically 2-6 hours after topical application, but can vary widely).
FoodEffect:
Not applicable
Distribution:
Vd:
0.7-2.7 L/kg (systemic absorption)
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)
Clearance:
Approximately 10-20 mL/min/kg (systemic)
ExcretionRoute:
Renal (primarily as metabolites)
Unchanged:
<10% (systemic)
Pharmacodynamics
OnsetOfAction:
Within 30 minutes (topical)
PeakEffect:
Variable (typically 2-6 hours after topical application)
DurationOfAction:
Approximately 4-8 hours (topical)
Safety & Warnings
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 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
Additional Side Effects of Rectal Products:
Bleeding from the rectum
Rectal pain
Other Possible Side Effects:
While many people may not experience any side effects or only minor ones, it's essential to be aware of the following:
Irritation at the site of application
Swelling
Redness
Changes in skin color
If you experience any of these side effects or any other unusual symptoms, contact your doctor for advice. Not all side effects are listed here. If you have questions or concerns, don't hesitate to reach out to your doctor.
Reporting Side Effects:
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when 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
Additional Side Effects of Rectal Products:
Bleeding from the rectum
Rectal pain
Other Possible Side Effects:
While many people may not experience any side effects or only minor ones, it's essential to be aware of the following:
Irritation at the site of application
Swelling
Redness
Changes in skin color
If you experience any of these side effects or any other unusual symptoms, contact your doctor for advice. Not all side effects are listed here. If you have questions or concerns, don't hesitate to reach out to your doctor.
Reporting Side Effects:
You can 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): Dizziness, lightheadedness, drowsiness, confusion, ringing in the ears, metallic taste, numbness around the mouth, blurred vision, tremors, muscle twitching, or seizures. Seek immediate medical attention if these occur.
- Signs of allergic reaction: Rash, itching, hives, severe dizziness, trouble breathing, swelling of face/tongue/throat. Seek immediate medical attention.
- Severe skin irritation at the application site: Excessive redness, swelling, blistering, or oozing. Discontinue use and consult a healthcare professional.
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 to this medication, its components, or other substances, including foods and drugs. 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.
* If a large area requires treatment.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other drugs and health issues. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
It is essential to inform your doctor about the following:
Any allergies you have to this medication, its components, or other substances, including foods and drugs. 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.
* If a large area requires treatment.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other drugs and health issues. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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 protect it from extreme temperatures.
Apply this medication only to intact skin, unless your doctor specifically instructs you to use it on cuts, scrapes, or damaged skin. Avoid exposure to heat sources such as sunlamps, tanning beds, heating pads, electric blankets, heat lamps, saunas, hot tubs, and heated waterbeds. Also, avoid taking long, hot baths or sunbathing, as these can cause your body temperature to rise, leading to increased 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 approved for use in children of varying 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.
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 protect it from extreme temperatures.
Apply this medication only to intact skin, unless your doctor specifically instructs you to use it on cuts, scrapes, or damaged skin. Avoid exposure to heat sources such as sunlamps, tanning beds, heating pads, electric blankets, heat lamps, saunas, hot tubs, and heated waterbeds. Also, avoid taking long, hot baths or sunbathing, as these can cause your body temperature to rise, leading to increased 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 approved for use in children of varying 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.
Overdose Information
Overdose Symptoms:
- Severe dizziness or lightheadedness
- Nausea, vomiting
- Tremors, muscle twitching, seizures
- Slow or irregular heartbeat (bradycardia, arrhythmias)
- Low blood pressure (hypotension)
- Difficulty breathing
- Coma
What to Do:
If overdose is suspected, seek immediate medical attention or call a Poison Control Center (1-800-222-1222). Management is supportive and may include airway management, oxygen, IV fluids, vasopressors for hypotension, and benzodiazepines for seizures. Lipid emulsion therapy may be considered for severe systemic toxicity.
Drug Interactions
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.
Moderate Interactions
- Beta-blockers (e.g., propranolol): May decrease lidocaine clearance, increasing systemic levels and risk of toxicity.
- Cimetidine: May inhibit lidocaine metabolism, increasing systemic levels and risk of toxicity.
- 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.
Monitoring
Baseline Monitoring
Skin integrity
Rationale: To assess suitability for application and risk of increased systemic absorption.
Timing: Prior to first application
Area of application
Rationale: To ensure adherence to recommended maximum area and minimize systemic absorption.
Timing: Prior to each application
Routine Monitoring
Signs of systemic toxicity (CNS, cardiovascular)
Frequency: During and 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 medical attention.
Local skin reactions
Frequency: Daily or with each application
Target: Absence of severe redness, swelling, blistering, or irritation.
Action Threshold: Discontinue use if severe local reactions occur.
Symptom Monitoring
- Dizziness
- Lightheadedness
- Drowsiness
- Confusion
- Numbness around mouth
- Metallic taste
- Tinnitus (ringing in ears)
- Blurred vision
- Tremors
- Muscle twitching
- Seizures
- Bradycardia (slow heart rate)
- Hypotension (low blood pressure)
- Skin irritation (redness, swelling, blistering, rash) at application site
Special Patient Groups
Pregnancy
Lidocaine is considered Category B for pregnancy. 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 human data limited.
Second Trimester:
Low risk based on animal data, but human data limited.
Third Trimester:
Low risk based on animal data, but human data limited. Consider potential for systemic absorption and effects on fetal heart rate if used extensively near term.
Lactation
Lidocaine is excreted into breast milk in small amounts. The amount transferred to the infant is generally considered too small to cause harm, especially with topical application. Considered L2 (likely compatible).
Infant Risk:
Low risk. Monitor infant for unusual drowsiness or feeding difficulties, though unlikely with typical topical use.
Pediatric Use
Use with extreme caution in children, especially those under 2 years of age. Children have a larger surface area to body weight ratio and thinner skin, which can lead to increased systemic absorption and a higher risk of systemic toxicity (e.g., seizures, cardiac arrest). Dosing must be carefully calculated based on weight and surface area, and the smallest effective amount should be used for the shortest duration. Avoid application to large areas or broken skin.
Geriatric Use
Use with caution in elderly patients. They may be more susceptible to the systemic effects of lidocaine due to decreased hepatic and renal function, which can affect lidocaine metabolism and excretion. Start with lower doses and monitor closely for signs of systemic toxicity.
Clinical Information
Clinical Pearls
- Always apply to intact skin. Application to broken, inflamed, or abraded skin can significantly increase systemic absorption and the risk of toxicity.
- Do not exceed the recommended dose, frequency, or application area. More is not better with topical lidocaine, and can lead to serious systemic side effects.
- Educate patients on the signs of systemic toxicity (e.g., dizziness, metallic taste, numbness around mouth, tremors) and instruct them to seek immediate medical attention if these occur.
- Avoid heat (e.g., heating pads, hot baths) over the application area, as this can increase systemic absorption.
- Lidocaine cream is for external use only. Do not ingest.
Alternative Therapies
- Topical NSAIDs (e.g., diclofenac gel)
- Capsaicin cream
- Menthol/Camphor topical analgesics
- Oral analgesics (e.g., acetaminophen, ibuprofen)
- Ice/Heat therapy
- Physical therapy
Cost & Coverage
Average Cost:
$15 - $40 per 30gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about your 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.