Lidocaine 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
Voltage-gated sodium channel blocker
Pregnancy Category
Category B
FDA Approved
Jan 1970
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
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Adhere to the guidelines below for the specific type of product you are 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.
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, in which case you should not wash it after application.
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.
Storage and Disposal
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. You may also want to explore drug take-back programs in your area.
Missed Dose
If you use this medication on a regular basis 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 correctly, follow your doctor's instructions and read all the information provided. Adhere to the guidelines below for the specific type of product you are 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.
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, in which case you should not wash it after application.
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.
Storage and Disposal
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. You may also want to explore drug take-back programs in your area.
Missed Dose
If you use this medication on a regular basis 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 skin. Do not apply to open wounds, broken skin, or mucous membranes (e.g., eyes, mouth, nose, genitals) unless directed by a doctor.
- Do not cover the treated area with bandages or plastic wrap unless specifically instructed by a healthcare professional, as this can increase absorption and risk of side effects.
- Do not use on large areas of the body or for prolonged periods without medical advice.
- Keep out of reach of children and pets. Store at room temperature.
- If using for a specific procedure (e.g., before an injection), follow your healthcare provider's instructions precisely regarding application time and duration.
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 no more than 3 to 4 times daily. Do not exceed 0.5 g of cream per application or 2 g per 24 hours for a 5gm tube.
Condition-Specific Dosing:
painRelief:
Apply to intact skin to relieve pain or itching.
Pediatric Dosing
Neonatal:
Not established (use with extreme caution, if at all, due to risk of systemic toxicity)
Infant:
Not established (use with extreme caution, if at all, due to risk of systemic toxicity)
Child:
For children 2 to 12 years of age, consult a physician. Use with caution, apply to small areas, and monitor closely for systemic toxicity. Max 0.5 g per application, not more than 3-4 times daily.
Adolescent:
Similar to adult dosing, but caution with large areas or prolonged use.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment typically required for topical use on intact skin.
Moderate:
No specific adjustment typically required for topical use on intact skin.
Severe:
Use with caution, especially if applied to large areas or broken skin, due to potential for increased systemic exposure.
Dialysis:
Considerations: Use with caution, monitor for systemic toxicity if significant absorption is anticipated.
Hepatic Impairment:
Mild:
No specific adjustment typically required for topical use on intact skin.
Moderate:
Use with caution, especially if applied to large areas or broken skin, due to potential for impaired metabolism and increased systemic exposure.
Severe:
Use with caution, monitor for systemic toxicity if significant absorption is anticipated.
Pharmacology
Mechanism of Action
Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby exerting a local anesthetic action. It blocks voltage-gated sodium channels in the neuronal cell membrane, preventing depolarization and propagation of action potentials.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (low for intact skin, increases with damaged skin, occlusion, or large surface areas)
Tmax:
Approximately 2-4 hours (for topical application, can vary)
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Approximately 1.1 L/kg (systemic)
ProteinBinding:
Approximately 60-80% (primarily to alpha-1-acid glycoprotein)
CnssPenetration:
Yes (if systemically absorbed, crosses blood-brain barrier)
Elimination:
HalfLife:
Approximately 1.5-2 hours (systemic, for parent drug)
Clearance:
Approximately 0.95 L/min (systemic)
ExcretionRoute:
Renal (less than 10% as unchanged drug)
Unchanged:
Less than 10%
Pharmacodynamics
OnsetOfAction:
Within 3-5 minutes (for topical application)
PeakEffect:
Variable, typically within 20-60 minutes
DurationOfAction:
Approximately 1-3 hours (can vary based 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 signs or 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
If you are using a rectal product, you may also experience:
Bleeding from the rectum
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 or seek medical attention if you notice any of the following:
Irritation at the site of application
Swelling
Redness
Changes in skin color
Reporting 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.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following signs or 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
If you are using a rectal product, you may also experience:
Bleeding from the rectum
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 or seek medical attention if you notice any of the following:
Irritation at the site of application
Swelling
Redness
Changes in skin color
Reporting 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.
Seek Immediate Medical Attention If You Experience:
- Severe skin irritation, redness, swelling, or rash at the application site.
- Signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.
- Signs of systemic toxicity (rare with 4% cream but possible if misused): dizziness, lightheadedness, drowsiness, confusion, metallic taste, ringing in ears (tinnitus), blurred vision, numbness or tingling around the mouth, tremors, muscle twitching, slurred speech, seizures, slow heart rate, low blood pressure, difficulty breathing, unusual tiredness.
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. Be sure to describe the allergic reaction and its symptoms.
The presence of an infection at the site where the medication will be applied.
Any broken skin or open wounds at the intended application site.
Swollen skin, numbness, or loss of sensation at the application site, as these conditions may affect the medication's absorption or increase the risk of adverse reactions.
If a large area of skin needs to be treated, as this may require special consideration or dose adjustment.
Additionally, it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This includes:
All your current medications, to ensure safe use and potential interactions.
* Any health problems you have, as they may affect the safety and efficacy of this medication.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor. This will help ensure your safety and the effectiveness of your treatment.
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. Be sure to describe the allergic reaction and its symptoms.
The presence of an infection at the site where the medication will be applied.
Any broken skin or open wounds at the intended application site.
Swollen skin, numbness, or loss of sensation at the application site, as these conditions may affect the medication's absorption or increase the risk of adverse reactions.
If a large area of skin needs to be treated, as this may require special consideration or dose adjustment.
Additionally, it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This includes:
All your current medications, to ensure safe use and potential interactions.
* Any health problems you have, as they may affect the safety and efficacy of this medication.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor. This will help ensure your safety and the effectiveness of your treatment.
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 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 skin products, such as soaps, consult with your doctor to ensure safe use.
Adhere to your doctor's instructions regarding the duration of treatment with this medication. Do not exceed the recommended treatment period.
While using this medication, take the following precautions:
- Avoid scratching or rubbing the skin while it is numb
- Protect the skin from extreme temperatures
- Only apply the medication to intact skin, unless your doctor advises otherwise
Avoid exposure to heat sources, including:
- Sunlamps
- Tanning beds
- Heating pads
- Electric blankets
- Heat lamps
- Saunas
- Hot tubs
- Heated waterbeds
Also, avoid taking long, hot baths or sunbathing, as this may cause your body temperature to rise and lead to excessive absorption of the medication.
If this medication is ingested, it can be harmful. In the event of accidental ingestion, immediately contact a doctor or 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, as the risk of certain side effects may be higher in pediatric patients.
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 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 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 skin products, such as soaps, consult with your doctor to ensure safe use.
Adhere to your doctor's instructions regarding the duration of treatment with this medication. Do not exceed the recommended treatment period.
While using this medication, take the following precautions:
- Avoid scratching or rubbing the skin while it is numb
- Protect the skin from extreme temperatures
- Only apply the medication to intact skin, unless your doctor advises otherwise
Avoid exposure to heat sources, including:
- Sunlamps
- Tanning beds
- Heating pads
- Electric blankets
- Heat lamps
- Saunas
- Hot tubs
- Heated waterbeds
Also, avoid taking long, hot baths or sunbathing, as this may cause your body temperature to rise and lead to excessive absorption of the medication.
If this medication is ingested, it can be harmful. In the event of accidental ingestion, immediately contact a doctor or 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, as the risk of certain side effects may be higher in pediatric patients.
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 to make an informed decision.
Overdose Information
Overdose Symptoms:
- Numbness or tingling around the mouth
- Lightheadedness, dizziness
- Tinnitus (ringing in ears)
- Blurred vision
- Tremors, muscle twitching
- Seizures
- Drowsiness, confusion
- Slurred speech
- Bradycardia (slow heart rate)
- Hypotension (low blood pressure)
- Respiratory depression or arrest
- Cardiac arrest
What to Do:
Immediately wash off the cream with soap and water. Call 911 or your local poison control center (1-800-222-1222 in the US) right away. Seek emergency medical attention.
Drug Interactions
Moderate Interactions
- Class I antiarrhythmics (e.g., tocainide, mexiletine): Increased risk of additive cardiac effects if significant systemic absorption occurs.
- Other local anesthetics: Increased risk of systemic toxicity if significant absorption occurs.
- Drugs that inhibit CYP1A2 or CYP3A4 (e.g., cimetidine, beta-blockers, macrolide antibiotics): May increase lidocaine plasma levels if significant systemic absorption occurs.
Monitoring
Baseline Monitoring
Skin integrity and area to be treated
Rationale: To assess risk of systemic absorption and guide appropriate application.
Timing: Prior to first application
Routine Monitoring
Local skin reactions (redness, swelling, itching, rash)
Frequency: Daily or with each application
Target: Absence of significant irritation
Action Threshold: Discontinue use if severe irritation or allergic reaction occurs.
Signs of systemic toxicity (dizziness, drowsiness, confusion, metallic taste, tinnitus, blurred vision, tremors, muscle twitching, seizures, bradycardia, hypotension)
Frequency: During and after application, especially with large areas or prolonged use
Target: Absence of symptoms
Action Threshold: Seek immediate medical attention if any systemic symptoms occur.
Symptom Monitoring
- Local irritation (redness, swelling, itching, rash, burning)
- Allergic reactions (hives, difficulty breathing, swelling of face/lips/tongue/throat)
- Signs of systemic toxicity (dizziness, lightheadedness, drowsiness, confusion, disorientation, metallic taste, ringing in ears (tinnitus), blurred vision, numbness/tingling around mouth, tremors, muscle twitching, slurred speech, seizures, slow heart rate, low blood pressure, difficulty breathing, unusual tiredness)
Special Patient Groups
Pregnancy
Generally considered safe for topical use during pregnancy when used as directed on intact skin and for limited areas. Systemic absorption is low. Consult a healthcare provider before use.
Trimester-Specific Risks:
First Trimester:
Low risk with appropriate topical use.
Second Trimester:
Low risk with appropriate topical use.
Third Trimester:
Low risk with appropriate topical use.
Lactation
Lidocaine is excreted in breast milk in small amounts. 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, avoid applying to the breast area if breastfeeding.
Infant Risk:
Low risk (L2)
Pediatric Use
Use with extreme caution in children, especially those under 2 years of age, due to increased risk of systemic toxicity from higher absorption relative to body weight. Apply to the smallest possible area for the shortest duration. Consult a pediatrician before use.
Geriatric Use
Elderly patients may be more susceptible to systemic adverse effects due to decreased hepatic metabolism or underlying cardiac conditions. Use with caution, consider lower doses or smaller application areas, and monitor for systemic toxicity.
Clinical Information
Clinical Pearls
- Topical lidocaine 4% cream is primarily for temporary relief of pain and itching on intact skin.
- Avoid applying to large areas, broken skin, or mucous membranes to minimize systemic absorption and potential toxicity.
- Occlusive dressings (bandages, plastic wrap) can significantly increase systemic absorption; avoid unless specifically instructed by a healthcare provider.
- Patients should be educated on the signs of systemic lidocaine toxicity (e.g., dizziness, metallic taste, tinnitus, numbness around mouth) and instructed to seek immediate medical attention if they occur.
- This formulation is generally considered safer than higher concentration lidocaine products or those intended for deeper penetration, but misuse can still lead to adverse events.
Alternative Therapies
- Topical corticosteroids (for itching/inflammation)
- Topical antihistamines (for itching)
- Oral analgesics (e.g., acetaminophen, NSAIDs)
- Cold packs/ice
- Counterirritants (e.g., menthol, camphor)
Cost & Coverage
Average Cost:
$5 - $20 per 5gm tube
Generic Available:
Yes
Insurance Coverage:
Often OTC, may be covered by some plans with prescription or as a Tier 1/2 generic.
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 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.