Lidocaine 3% Cream 28.35gm
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 3% cream is a numbing medicine that helps relieve pain and itching on the skin. It works by temporarily blocking nerve signals in the area where it's applied.
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 disposal method. Local drug take-back programs may also be available.
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 disposal method. Local drug take-back programs may also be available.
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 your hands before and after applying the cream.
- Apply a thin layer only to the affected skin area as directed by your doctor or pharmacist.
- Do not apply to large areas of skin, open wounds, or broken 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 tight dressings unless advised 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 using for a procedure, apply the cream about 30-60 minutes before the procedure for best effect.
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 as needed, typically up to 3-4 times daily. Do not exceed 0.5 g of cream per 10 cm² area. Maximum total dose should not exceed 600 mg (20 g of 3% cream) in a 24-hour period.
Condition-Specific Dosing:
minorPain:
Apply thinly to intact skin, covering the smallest area necessary. Do not apply to large areas or broken skin.
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:
Not established for routine use. If used, apply smallest effective amount to smallest area for shortest duration. Max dose and area must be strictly adhered to (e.g., < 7 mg/kg/dose, not exceeding 3-4 doses/day). Consult a pediatrician.
Adolescent:
Similar to adult dosing, but with caution regarding total dose and application area, especially in younger adolescents.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for topical use on intact skin.
Moderate:
No specific adjustment needed for topical use on intact skin. Monitor for signs of systemic toxicity if applied to large or compromised areas.
Severe:
No specific adjustment needed for topical use on intact skin. Monitor closely for signs of systemic toxicity if applied to large or compromised areas, as metabolites may accumulate.
Dialysis:
Considerations: Systemic absorption is minimal with proper topical use, but if significant absorption occurs, metabolites may accumulate. Use with caution.
Hepatic Impairment:
Mild:
No specific adjustment needed for topical use on intact skin.
Moderate:
No specific adjustment needed for topical use on intact skin. Monitor for signs of systemic toxicity if applied to large or compromised areas, as lidocaine is primarily metabolized by the liver.
Severe:
Use with caution. Monitor closely for signs of systemic toxicity if applied to large or compromised areas, as lidocaine clearance may be significantly reduced.
Confidence:
Medium
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, duration of application, and occlusive dressings). Systemic absorption can be up to 3-10% from intact skin, significantly higher from compromised skin.
Tmax:
Topical: 2-6 hours (systemic absorption peak after topical application)
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
0.7-2.7 L/kg (systemic)
ProteinBinding:
60-80% (primarily to alpha-1-acid glycoprotein and albumin)
CnssPenetration:
Yes (if systemically absorbed, crosses blood-brain barrier)
Elimination:
HalfLife:
1.5-2 hours (systemic, parent drug); MEGX: 2.5 hours; GX: 10 hours
Clearance:
Approximately 10 mL/min/kg (systemic)
ExcretionRoute:
Renal (less than 10% unchanged drug)
Unchanged:
<10%
Pharmacodynamics
OnsetOfAction:
Topical: 15-30 minutes
PeakEffect:
Topical: 30-60 minutes
DurationOfAction:
Topical: 1-3 hours (depending on concentration, area, and duration of application)
Confidence:
Medium
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of acidosis (too much acid in the blood), such as:
+ Confusion
+ Fast breathing
+ Fast heartbeat
+ 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
+ Heat
+ Swelling
+ Redness
+ Pain
Breathing difficulties, including slow 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 form of this medication, you may also experience:
Rectal bleeding or 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 have any concerns. Other possible side effects include:
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, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of acidosis (too much acid in the blood), such as:
+ Confusion
+ Fast breathing
+ Fast heartbeat
+ 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
+ Heat
+ Swelling
+ Redness
+ Pain
Breathing difficulties, including slow 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 form of this medication, you may also experience:
Rectal bleeding or 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 have any concerns. Other possible side effects include:
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:
- Dizziness or lightheadedness
- Drowsiness or confusion
- Ringing in the ears (tinnitus)
- Blurred vision
- Numbness or tingling around the mouth
- Unusual tiredness or weakness
- Tremors or muscle twitching
- Seizures
- Slow or irregular heartbeat
- Difficulty breathing
- Severe skin irritation, rash, or blistering at the application site
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
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 your body needs to be treated, as this may require special consideration.
Additionally, to ensure safe use, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your medical history, including any health problems
This information will help your doctor determine if it is safe for you to use this medication, especially when combined with other drugs or in the presence of certain health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
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 your body needs to be treated, as this may require special consideration.
Additionally, to ensure safe use, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your medical history, including any health problems
This information will help your doctor determine if it is safe for you to use this medication, especially when combined with other drugs or in the presence of certain health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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 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 adverse effects, 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 can cause your body temperature to rise, potentially leading to excessive absorption of the medication.
If this medication is accidentally ingested, seek immediate medical attention or contact a poison control center.
Note that different brands of this medication may be suitable for children of varying ages. Before administering this medication to a child, consult with your doctor to ensure the correct dosage and potential risks are understood.
When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this age group.
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 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 adverse effects, 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 can cause your body temperature to rise, potentially leading to excessive absorption of the medication.
If this medication is accidentally ingested, seek immediate medical attention or contact a poison control center.
Note that different brands of this medication may be suitable for children of varying ages. Before administering this medication to a child, consult with your doctor to ensure the correct dosage and potential risks are understood.
When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this age group.
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 and vomiting
- Tremors, muscle twitching, or seizures
- Difficulty breathing or shallow breathing
- Slow or irregular heartbeat
- Low blood pressure
- Coma
What to Do:
If you suspect an overdose, seek immediate medical attention. Call 911 or your local emergency number. In the US, you can also contact a poison control center at 1-800-222-1222.
Drug Interactions
Major Interactions
- Class I Antiarrhythmics (e.g., Tocainide, Mexiletine): Increased risk of cardiac effects if significant systemic absorption occurs.
- Other Local Anesthetics: Increased risk of systemic toxicity (additive effects).
Moderate Interactions
- Antiarrhythmics (e.g., Amiodarone, Beta-blockers): May potentiate cardiac depression if significant systemic absorption occurs.
- CYP3A4 Inhibitors (e.g., Ketoconazole, Erythromycin): May increase lidocaine plasma levels if significant systemic absorption occurs.
- CYP1A2 Inhibitors (e.g., Cimetidine, Fluvoxamine): 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
Signs and symptoms 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, tinnitus, blurred vision, tremors, seizures, bradycardia, hypotension, or cardiac arrest require immediate medical attention.
Application site reaction
Frequency: Daily or with each application
Target: Absence of severe redness, swelling, blistering, or irritation
Action Threshold: Discontinue use if severe irritation or allergic reaction occurs.
Symptom Monitoring
- Dizziness
- Drowsiness
- Confusion
- Tinnitus
- Blurred vision
- Numbness around mouth
- Tremors
- Muscle twitching
- Seizures
- Bradycardia
- Hypotension
- Shortness of breath
- Skin irritation (redness, swelling, rash, itching)
Special Patient Groups
Pregnancy
Lidocaine is Pregnancy Category B. Animal studies have not shown harm to the fetus, and there are no adequate and well-controlled studies in pregnant women. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Low risk based on animal data, but use with caution.
Second Trimester:
Low risk based on animal data, but use with caution.
Third Trimester:
Low risk based on animal data, but use with caution. Avoid large areas or prolonged use near term.
Lactation
Lidocaine is excreted into breast milk in small amounts. The amount transferred to the infant is generally considered low with topical application. Lactation risk is L2 (safer). Monitor the infant for signs of sedation or feeding difficulties.
Infant Risk:
Low risk with proper topical use. Observe infant for unusual drowsiness or feeding changes.
Pediatric Use
Children, especially infants and young children, are more susceptible to systemic toxicity from lidocaine due to their higher surface area to body weight ratio and immature metabolic pathways. Use with extreme caution, if at all, and strictly adhere to recommended doses and application areas. Not recommended for routine use in very young children without specific medical guidance.
Geriatric Use
Elderly patients may be more sensitive to the systemic effects of lidocaine due to decreased hepatic function, reduced renal clearance of metabolites, and potential for underlying cardiac conditions. Use the lowest effective dose for the shortest duration. Monitor closely for signs of systemic toxicity.
Clinical Information
Clinical Pearls
- Always apply to intact skin. Application to broken, inflamed, or compromised skin significantly increases systemic absorption and risk of toxicity.
- Avoid occlusive dressings unless specifically instructed by a healthcare provider, as they can enhance absorption.
- Educate patients on the signs of systemic toxicity (e.g., dizziness, tinnitus, numbness around mouth) and to seek immediate medical attention if they occur.
- The 3% concentration is generally for minor localized pain or itching; higher concentrations (e.g., 4%, 5%) or patches are available for more intense or prolonged pain.
- Consider the total amount of lidocaine applied over 24 hours, especially if patients are using multiple lidocaine-containing products (e.g., cream, patch, spray).
Alternative Therapies
- Benzocaine topical
- Tetracaine topical
- Capsaicin topical
- Diclofenac topical (NSAID)
- Menthol/Camphor topical
- Oral analgesics (e.g., acetaminophen, NSAIDs)
Cost & Coverage
Average Cost:
$20 - $60 per 28.35gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 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.