Lidocaine 3% Cream 85gm
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 is a medicine that numbs the skin. When applied to your skin, it blocks nerve signals in that area, which helps to reduce pain or discomfort. It's used for conditions like nerve pain or before minor skin procedures.
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 product.
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 affected 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 skin 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 location, 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 or to inquire about 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 product.
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 affected 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 skin 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 location, 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 or to inquire about 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 your hands thoroughly before and after applying the cream.
- Apply only a thin layer of cream to the affected area as directed by your doctor. Do not apply more than recommended.
- Do not apply to broken, cut, or irritated skin unless specifically instructed by your doctor.
- Avoid applying the cream to large areas of the body.
- Do not cover the treated area with bandages, plastic wrap, or heating pads unless specifically instructed by your doctor, as this can increase absorption and risk of side effects.
- Avoid getting the cream in your eyes, nose, mouth, or other mucous membranes. If it gets into these areas, rinse thoroughly with water.
- Keep the cream out of reach of children and pets. Accidental ingestion can be very dangerous.
- Store at room temperature, away from moisture and heat.
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 of cream to the affected area every 6 to 8 hours as needed. Do not exceed 3 applications in a 24-hour period. The maximum total dose should not exceed 60 grams per 24 hours.
Condition-Specific Dosing:
post-herpetic neuralgia:
Apply to intact skin covering the most painful area. Avoid application to broken or inflamed skin.
localized pain:
Apply to the affected area as directed by a healthcare professional.
Pediatric Dosing
Neonatal:
Not established (generally not recommended)
Infant:
Not established (generally not recommended)
Child:
Not generally recommended for children under 12 years of age due to increased risk of systemic toxicity. If used, apply a very small amount to a limited area under strict medical supervision. Dosing must be individualized based on weight and surface area, not exceeding 4.5 mg/kg per dose.
Adolescent:
Use with caution, similar to adult dosing but with careful monitoring for systemic toxicity, especially in younger adolescents.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment typically required for topical use on intact skin.
Moderate:
Use with caution, especially if applying to large areas or compromised skin, due to potential for systemic accumulation of lidocaine and its metabolites.
Severe:
Use with caution and reduced frequency/amount, or avoid, especially if applying to large areas or compromised skin, due to increased risk of systemic toxicity.
Dialysis:
Considerations: Lidocaine is not significantly dialyzable. Use with caution due to potential for systemic accumulation.
Hepatic Impairment:
Mild:
No specific adjustment typically required for topical use on intact skin.
Moderate:
Use with caution and reduced frequency/amount, especially if applying to large areas or compromised skin, due to impaired metabolism and increased risk of systemic toxicity.
Severe:
Use with extreme caution, reduced frequency/amount, or avoid, especially if applying to large areas or compromised skin, due to significantly impaired metabolism and high risk of systemic toxicity.
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 effecting local anesthetic action. It blocks voltage-gated sodium channels in the neuronal cell membrane, preventing depolarization and propagation of action potentials.
Pharmacokinetics
Absorption:
Bioavailability:
Highly variable (3-10% for intact skin, significantly higher with compromised skin, inflammation, or occlusion)
Tmax:
2-6 hours (topical application)
FoodEffect:
Not applicable for topical formulation
Distribution:
Vd:
0.8-1.3 L/kg (systemic)
ProteinBinding:
60-80% (primarily to alpha-1-acid glycoprotein)
CnssPenetration:
Yes (if systemic levels are high enough to cause toxicity)
Elimination:
HalfLife:
1.5-2 hours (systemic)
Clearance:
Not readily quantifiable for topical application due to variable absorption
ExcretionRoute:
Renal (primarily as metabolites)
Unchanged:
<10% (systemic)
Pharmacodynamics
OnsetOfAction:
Within 30 minutes (topical)
PeakEffect:
2-4 hours (topical)
DurationOfAction:
Up to 6-8 hours (topical)
Safety & Warnings
BLACK BOX WARNING
Accidental ingestion of lidocaine cream by children can result in serious adverse events, including seizures, cardiac arrest, and death. Keep out of reach of children. If ingested, seek emergency medical attention immediately.
Side Effects
Serious Side Effects: Seek Medical Help Immediately
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 right away:
Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of acidosis (too much acid in the blood): confusion, fast breathing, fast heartbeat, irregular heartbeat, severe stomach pain, upset stomach, vomiting, excessive sleepiness, shortness of breath, or feeling extremely tired or weak
Signs of methemoglobinemia: blue or gray discoloration of the lips, nails, or skin, irregular heartbeat, seizures, severe dizziness or fainting, severe headache, excessive sleepiness, feeling tired or weak, or shortness of breath (this rare effect can be life-threatening if it occurs)
Signs of skin infection: oozing, heat, swelling, redness, or pain
Respiratory problems: 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
Upset stomach 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, be aware of the following additional side effects:
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 help if you experience any of the following:
Irritation at the site of application
Swelling
Redness
Changes in skin color
Reporting Side Effects
This is not an exhaustive list of possible 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 right away:
Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of acidosis (too much acid in the blood): confusion, fast breathing, fast heartbeat, irregular heartbeat, severe stomach pain, upset stomach, vomiting, excessive sleepiness, shortness of breath, or feeling extremely tired or weak
Signs of methemoglobinemia: blue or gray discoloration of the lips, nails, or skin, irregular heartbeat, seizures, severe dizziness or fainting, severe headache, excessive sleepiness, feeling tired or weak, or shortness of breath (this rare effect can be life-threatening if it occurs)
Signs of skin infection: oozing, heat, swelling, redness, or pain
Respiratory problems: 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
Upset stomach 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, be aware of the following additional side effects:
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 help if you experience any of the following:
Irritation at the site of application
Swelling
Redness
Changes in skin color
Reporting Side Effects
This is not an exhaustive list of possible 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
- Feeling confused or drowsy
- Blurred vision or ringing in your ears
- Tremors or muscle twitching
- Numbness or tingling around your mouth
- Slow or irregular heartbeat
- Trouble breathing
- Unusual tiredness or weakness
- Severe skin irritation, redness, swelling, 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 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 efficacy or increase the risk of adverse reactions.
If a large area of skin needs to be treated, as this may require special consideration.
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 or vitamins you are using
Your existing health problems
Your doctor will assess the safety of taking this medication in conjunction with your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
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 efficacy or increase the risk of adverse reactions.
If a large area of skin needs to be treated, as this may require special consideration.
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 or vitamins you are using
Your existing health problems
Your doctor will assess the safety of taking this medication in conjunction with your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
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 duration than prescribed by your doctor. While your skin is numb, avoid scratching or rubbing it, 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 ingested, it can be harmful. In the event of ingestion, immediately contact a doctor or poison control center. Note that different brands of this medication may be suitable for children of various 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 duration than prescribed by your doctor. While your skin is numb, avoid scratching or rubbing it, 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 ingested, it can be harmful. In the event of ingestion, immediately contact a doctor or poison control center. Note that different brands of this medication may be suitable for children of various 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 fainting
- Seizures (convulsions)
- Slow or irregular heartbeat
- Very low blood pressure
- Difficulty breathing or stopping breathing
- Coma
What to Do:
If you suspect an overdose, seek emergency medical attention immediately or call a Poison Control Center at 1-800-222-1222.
Drug Interactions
Major Interactions
- Class I Antiarrhythmics (e.g., mexiletine, tocainide): Additive cardiac effects, increased risk of CNS and cardiovascular toxicity.
- Other Local Anesthetics: Additive systemic toxicity.
Moderate Interactions
- Beta-blockers (e.g., propranolol, metoprolol): May reduce hepatic blood flow, decreasing lidocaine clearance and increasing systemic levels.
- Cimetidine: Inhibits CYP enzymes, potentially increasing lidocaine plasma concentrations.
- Succinylcholine: Lidocaine may prolong the neuromuscular blockade of succinylcholine.
- Phenytoin: May increase lidocaine clearance; conversely, lidocaine may increase phenytoin levels.
Minor Interactions
- Not many clinically significant minor interactions for topical lidocaine.
Monitoring
Baseline Monitoring
Cardiac status (ECG)
Rationale: To assess baseline cardiac function, especially if large areas are treated or in patients with pre-existing cardiac conditions, due to potential for systemic absorption and cardiac effects.
Timing: Prior to initiation of therapy for extensive or prolonged use.
Liver function tests (LFTs)
Rationale: Lidocaine is primarily metabolized by the liver; baseline assessment is prudent in patients with known hepatic impairment.
Timing: Prior to initiation of therapy in patients with suspected or known hepatic impairment.
Routine Monitoring
Signs and symptoms of systemic toxicity (CNS and cardiovascular)
Frequency: Regularly during treatment, especially during initial applications or dose adjustments.
Target: Absence of symptoms
Action Threshold: Any signs of dizziness, lightheadedness, confusion, drowsiness, blurred vision, tinnitus, tremors, muscle twitching, bradycardia, hypotension, or difficulty breathing warrant immediate medical attention and discontinuation of the cream.
Application site reaction
Frequency: Daily
Target: Absence of severe irritation, redness, swelling, or blistering
Action Threshold: Discontinue use if severe skin reactions occur.
Symptom Monitoring
- Dizziness
- Lightheadedness
- Confusion
- Drowsiness
- Blurred vision
- Tinnitus (ringing in ears)
- Tremors
- Muscle twitching
- Numbness or tingling around the mouth
- Slow heart rate (bradycardia)
- Low blood pressure (hypotension)
- Difficulty breathing
- Seizures
- Unusual fatigue
Special Patient Groups
Pregnancy
Lidocaine is classified as Pregnancy Category B. Studies in animals have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Topical lidocaine is generally considered safe for use during pregnancy when used as directed and on intact skin, but use the lowest effective dose and avoid large application areas.
Trimester-Specific Risks:
First Trimester:
Low risk with topical use; systemic absorption is minimal.
Second Trimester:
Low risk with topical use; systemic absorption is minimal.
Third Trimester:
Low risk with topical use; systemic absorption is minimal. Caution near term as systemic absorption could affect fetal heart rate.
Lactation
Lidocaine is excreted into breast milk in small amounts. However, due to low systemic absorption from topical application and extensive first-pass metabolism, the amount transferred to breast milk is generally considered too small to cause harm to a nursing infant. It is rated L2 (Safer) by LactMed.
Infant Risk:
Low risk. Monitor infant for drowsiness or feeding difficulties, though unlikely with typical topical use.
Pediatric Use
Children, especially those under 12 years, are at higher risk of systemic toxicity due to their higher surface area to body weight ratio and potentially immature hepatic metabolism. Use with extreme caution, if at all, and only under strict medical supervision with precise dosing and limited application area. Accidental ingestion is a significant risk.
Geriatric Use
Elderly patients may be more susceptible to systemic toxicity due to age-related decreases in hepatic metabolism, reduced renal clearance, and potential for underlying cardiac or hepatic conditions. Use lower doses, apply to smaller areas, and monitor closely for signs of systemic toxicity.
Clinical Information
Clinical Pearls
- Always ensure the skin is clean and dry before application.
- Do not apply to open wounds, broken skin, or mucous membranes unless specifically instructed by a healthcare professional.
- Avoid using heating pads or occlusive dressings over the treated area, as this can significantly increase systemic absorption and risk of toxicity.
- Patients should be educated on the signs of systemic toxicity (e.g., dizziness, confusion, tremors) and instructed to seek immediate medical attention if these occur.
- For neuropathic pain, consistent application as prescribed is key to achieving optimal pain relief.
- The cream is for external use only. Emphasize the danger of accidental ingestion, especially in households with children.
Alternative Therapies
- Capsaicin cream (for neuropathic pain)
- NSAID topical gels/creams (e.g., diclofenac gel)
- Oral analgesics (e.g., acetaminophen, NSAIDs)
- Oral neuropathic pain medications (e.g., gabapentin, pregabalin)
- Physical therapy
- Acupuncture
Cost & Coverage
Average Cost:
$20 - $80 per 85gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic formulations)
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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened.