Lidocaine 5% Topical Ointment 30gm
It is used to manage pain.It is used to treat mouth sores.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
Jun 1948
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lidocaine 5% Ointment is a medicine applied to the skin to numb an 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.
Application to the Skin:
Do not take this medication by mouth. It is for skin use only.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. If accidental contact occurs, rinse the area thoroughly with water.
Wash your hands before and after applying the medication, unless your hand is the treated area. In that case, do not wash your hand after application.
Clean the affected area before applying the medication and make sure it is dry.
Apply the medication to clean, dry, healthy skin.
Do not cover the treated area with bandages or dressings unless instructed to do so by your doctor.
Oral Application (if applicable):
If using a cotton swab to apply the medication, follow your doctor's or the label's instructions for application to the affected area.
Avoid eating for at least 60 minutes (1 hour) after applying the medication.
Storage and Disposal:
Store the medication at room temperature.
Do not freeze the medication.
Keep all medications in a safe place, out of the reach of children and pets.
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. Consult your pharmacist for guidance on the best disposal method. Your area may have drug take-back programs available.
Missed Dose:
If you use this medication on a regular basis and miss a dose, apply it as soon as you remember.
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 extra doses.
* If you use this medication as needed, do not apply it more frequently than directed by your doctor.
To use this medication correctly, follow your doctor's instructions and read all the information provided.
Application to the Skin:
Do not take this medication by mouth. It is for skin use only.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. If accidental contact occurs, rinse the area thoroughly with water.
Wash your hands before and after applying the medication, unless your hand is the treated area. In that case, do not wash your hand after application.
Clean the affected area before applying the medication and make sure it is dry.
Apply the medication to clean, dry, healthy skin.
Do not cover the treated area with bandages or dressings unless instructed to do so by your doctor.
Oral Application (if applicable):
If using a cotton swab to apply the medication, follow your doctor's or the label's instructions for application to the affected area.
Avoid eating for at least 60 minutes (1 hour) after applying the medication.
Storage and Disposal:
Store the medication at room temperature.
Do not freeze the medication.
Keep all medications in a safe place, out of the reach of children and pets.
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. Consult your pharmacist for guidance on the best disposal method. Your area may have drug take-back programs available.
Missed Dose:
If you use this medication on a regular basis and miss a dose, apply it as soon as you remember.
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 extra doses.
* If you use this medication as needed, do not apply it more frequently than directed by your doctor.
Lifestyle & Tips
- Wash hands thoroughly before and after applying the ointment.
- Apply only a thin layer to the affected area. Do not rub it in vigorously.
- Do not apply to large areas of the body, to broken or irritated skin, or to open wounds unless directed by a doctor.
- 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 ointment in your eyes, nose, mouth, or other mucous membranes. If it gets into these areas, rinse thoroughly with water.
- Keep out of reach of children and pets. Store at room temperature.
- Do not use for longer than directed or more frequently than prescribed.
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 every 6 to 8 hours.
Condition-Specific Dosing:
post-herpetic neuralgia:
Apply to intact skin to cover the most painful area. Maximum 3 applications per day, each application for up to 12 hours within a 24-hour period. (Note: This is for patch, ointment is generally for shorter duration/smaller areas). For ointment, typically 3-4 times daily, not exceeding 5g per application or 20g per 24 hours for large areas.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (use with extreme caution, lower concentrations preferred if necessary)
Child:
Not established (use with extreme caution, lower concentrations preferred if necessary, maximum dose should not exceed 3 mg/kg per application, not more than 4 times in 24 hours)
Adolescent:
Similar to adult dosing, but with caution regarding total dose and application area, especially if body weight is low.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended for topical use.
Moderate:
No specific adjustment recommended for topical use, but monitor for systemic effects if large areas or prolonged use.
Severe:
No specific adjustment recommended for topical use, but monitor for systemic effects if large areas or prolonged use. Increased risk of accumulation.
Dialysis:
Considerations: Lidocaine is not significantly dialyzable. Monitor for systemic effects.
Hepatic Impairment:
Mild:
No specific adjustment recommended for topical use.
Moderate:
Use with caution. Reduced metabolism may lead to increased systemic levels and toxicity, especially with large areas or prolonged use.
Severe:
Use with extreme caution. Significant reduction in metabolism. Avoid large areas or prolonged use. Monitor for 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, preventing depolarization and propagation of action potentials in nerve fibers.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (low, typically 3-10% systemically absorbed from intact skin, but can be higher with damaged skin, large areas, or occlusion)
Tmax:
Variable, typically 2-6 hours after topical application (systemic absorption)
FoodEffect:
Not applicable for topical ointment
Distribution:
Vd:
0.7-2.7 L/kg (systemic)
ProteinBinding:
60-80% (primarily to alpha-1-acid glycoprotein and albumin)
CnssPenetration:
Yes (if systemic absorption occurs)
Elimination:
HalfLife:
1.5-2 hours (systemic, in healthy adults)
Clearance:
Approximately 10 mL/min/kg (systemic)
ExcretionRoute:
Renal (primarily as metabolites, <10% unchanged drug)
Unchanged:
<10%
Pharmacodynamics
OnsetOfAction:
Within 30 minutes (topical)
PeakEffect:
Variable, typically 2-4 hours (topical)
DurationOfAction:
Approximately 6-8 hours (topical)
Confidence:
Medium
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 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
+ 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
Respiratory problems, such as:
+ Trouble breathing
+ Slow breathing
+ 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
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild side effects. If you experience any of the following side effects or any other side effects that bother you or do not go away, contact your doctor:
Irritation at the site of application
Swelling
Redness
Changes in skin color
This is not a comprehensive list of all 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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. 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
+ 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
Respiratory problems, such as:
+ Trouble breathing
+ Slow breathing
+ 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
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild side effects. If you experience any of the following side effects or any other side effects that bother you or do not go away, contact your doctor:
Irritation at the site of application
Swelling
Redness
Changes in skin color
This is not a comprehensive list of all 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
- Drowsiness or confusion
- Ringing in the ears (tinnitus)
- Blurred vision
- Numbness or tingling around the mouth
- Muscle twitching or tremors
- Slow heartbeat or feeling faint
- Difficulty breathing
- Seizures
- Severe redness, swelling, blistering, or rash 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 absorption or increase the risk of adverse reactions.
* If a large area of skin needs to be treated, as this may require special consideration or dosage adjustments.
Additionally, it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any existing health problems. This information will help your doctor and pharmacist assess potential interactions and ensure safe use of this medication. Never start, stop, or modify 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. Be sure to describe the allergic reaction and its symptoms.
The presence of an infection at the site where the medication will be applied.
Any broken skin or open wounds at the intended application site.
Swollen skin, numbness, or loss of sensation at the application site, as these conditions may affect the medication's absorption or increase the risk of adverse reactions.
* If a large area of skin needs to be treated, as this may require special consideration or dosage adjustments.
Additionally, it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any existing health problems. This information will help your doctor and pharmacist assess potential interactions and ensure safe use of this medication. Never start, stop, or modify 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.
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 skin products, such as 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 directed by your doctor, do not apply this medication to cuts, scrapes, or damaged skin.
To minimize the risk of increased drug absorption, 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 activities may cause your body temperature to rise.
If this medication is accidentally ingested, immediately contact a doctor or a poison control center.
When considering the use of this medication in children, it is crucial to consult with a doctor, as different brands may be suitable for different age groups. Children may be at a higher risk for certain side effects, so caution is advised.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of using this medication with your doctor to make an informed decision.
There is a risk of developing a severe blood condition called methemoglobinemia associated with this type of drug. Certain factors may increase this risk, including:
- Having a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD)
- Pre-existing heart or lung problems
- Taking 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.
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 directed by your doctor, do not apply this medication to cuts, scrapes, or damaged skin.
To minimize the risk of increased drug absorption, 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 activities may cause your body temperature to rise.
If this medication is accidentally ingested, immediately contact a doctor or a poison control center.
When considering the use of this medication in children, it is crucial to consult with a doctor, as different brands may be suitable for different age groups. Children may be at a higher risk for certain side effects, so caution is advised.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of using this medication with your doctor to make an informed decision.
Overdose Information
Overdose Symptoms:
- Severe dizziness, lightheadedness, or fainting
- Confusion, disorientation
- Slurred speech
- Tremors, muscle twitching, or seizures
- Slow or irregular heartbeat
- Low blood pressure
- Difficulty breathing, respiratory arrest
- Coma
What to Do:
If you suspect an overdose, seek immediate medical attention or call Poison Control at 1-800-222-1222. Remove the ointment immediately and wash the area with soap and water.
Drug Interactions
Major Interactions
- Class I Antiarrhythmics (e.g., Mexiletine, Tocainide): 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
- Antiarrhythmics (Class III, e.g., Amiodarone, Sotalol): Potential for additive cardiac effects.
- Beta-blockers (e.g., Propranolol, Metoprolol): May reduce hepatic blood flow, potentially decreasing lidocaine clearance and increasing systemic levels.
- Cimetidine: May inhibit lidocaine metabolism, increasing systemic levels.
- Phenytoin: May alter lidocaine metabolism.
- Succinylcholine: Prolonged neuromuscular blockade.
Minor Interactions
- MAOIs, TCAs, Phenothiazines: Theoretical risk of increased systemic toxicity, but less significant with topical use.
Monitoring
Baseline Monitoring
Skin integrity of application site
Rationale: Damaged or broken skin increases systemic absorption and risk of toxicity.
Timing: Prior to first application
Patient's medical history (cardiac, hepatic, renal disease, allergies)
Rationale: Identifies risk factors for systemic toxicity or adverse reactions.
Timing: Prior to first application
Routine Monitoring
Application site for irritation/allergic reaction
Frequency: Daily or with each application
Target: Absence of redness, swelling, itching, rash
Action Threshold: Discontinue use if irritation or allergic reaction occurs.
Signs of systemic toxicity (CNS: dizziness, drowsiness, confusion, tinnitus, seizures; Cardiovascular: bradycardia, hypotension, arrhythmias)
Frequency: Periodically, especially with large area application or prolonged use
Target: Absence of symptoms
Action Threshold: Discontinue use immediately and seek medical attention if systemic toxicity symptoms appear.
Symptom Monitoring
- Dizziness
- Lightheadedness
- Drowsiness
- Confusion
- Tinnitus
- Blurred vision
- Numbness around mouth
- Muscle twitching
- Tremors
- Seizures
- Bradycardia
- Hypotension
- Shortness of breath
- Skin irritation (redness, itching, rash, swelling) at application site
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 use with limited systemic absorption is generally considered low risk, but caution is advised, especially with large areas or prolonged use.
Trimester-Specific Risks:
First Trimester:
Low risk, but use only if clearly needed.
Second Trimester:
Low risk, but use only if clearly needed.
Third Trimester:
Low risk, but use only if clearly needed. Avoid large areas or prolonged use near term due to potential for fetal bradycardia.
Lactation
Lidocaine is excreted into breast milk in small amounts. The amount transferred to the infant via breast milk after topical application is generally considered very low and unlikely to cause adverse effects. Use with caution, avoid applying to the breast area if breastfeeding.
Infant Risk:
L2 (Safer - limited data, but risk is low)
Pediatric Use
Use with extreme caution in infants and young children due to higher risk of systemic toxicity from increased surface area to body weight ratio and thinner skin. Lower concentrations and limited application areas are preferred if necessary. Not recommended for routine use in children under 12 years without specific medical guidance.
Geriatric Use
No specific dose adjustment is typically needed for topical use in the elderly. However, elderly patients may be more susceptible to systemic adverse effects due to decreased hepatic function, reduced protein binding, or underlying cardiac conditions. Use with caution, monitor for systemic toxicity, and consider lower doses or smaller application areas if frail or with comorbidities.
Clinical Information
Clinical Pearls
- Topical lidocaine is for external use only. Do not ingest.
- Systemic absorption can occur, especially with large application areas, prolonged use, damaged skin, or occlusion. This can lead to serious CNS and cardiovascular toxicity.
- Patients should be advised not to apply external heat (e.g., heating pads) over the treated area, as this significantly increases systemic absorption.
- Numbness from lidocaine can mask pain, potentially leading to injury if the treated area is subjected to trauma.
- Always start with the lowest effective dose and application area to minimize systemic exposure.
- Be aware of potential for methemoglobinemia, especially in infants or patients with G6PD deficiency, though rare with topical lidocaine.
Alternative Therapies
- Benzocaine topical
- Pramoxine topical
- Capsaicin topical
- Diclofenac topical (NSAID)
- Menthol/Camphor topical
- Oral analgesics (e.g., NSAIDs, Acetaminophen)
Cost & Coverage
Average Cost:
$20 - $50 per 30gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.