Lidocaine 5% Topical Ointment 50gm
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
Amide-type local anesthetic; Voltage-gated sodium channel blocker
Pregnancy Category
Category B
FDA Approved
Jan 1980
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lidocaine 5% topical ointment is a medicine applied to the skin to numb the area and relieve pain or itching. It works by 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.
Skin Application:
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
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 and dry the affected area before applying the medication. Apply it to clean, dry, and healthy skin.
Do not cover the treated area with bandages or dressings unless your doctor instructs you to do so.
Oral Application (using a cotton swab):
Apply the medication to the affected area as directed by your doctor or the label instructions.
Wait at least 60 minutes (1 hour) after application before eating or drinking anything.
Storage and Disposal
Store this medication at room temperature, away from freezing temperatures.
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 by your pharmacist. Check with your pharmacist for guidance on the best disposal method, and consider participating in local drug take-back programs.
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 the same time or use 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.
Skin Application:
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
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 and dry the affected area before applying the medication. Apply it to clean, dry, and healthy skin.
Do not cover the treated area with bandages or dressings unless your doctor instructs you to do so.
Oral Application (using a cotton swab):
Apply the medication to the affected area as directed by your doctor or the label instructions.
Wait at least 60 minutes (1 hour) after application before eating or drinking anything.
Storage and Disposal
Store this medication at room temperature, away from freezing temperatures.
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 by your pharmacist. Check with your pharmacist for guidance on the best disposal method, and consider participating in local drug take-back programs.
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 the same time or use 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 skin area.
- Do not apply to large areas of the body, broken skin, or open wounds unless directed by a healthcare professional.
- Avoid contact with eyes, nose, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not cover the treated area with bandages or dressings unless specifically instructed by your doctor, as this can increase absorption and risk of side effects.
- Keep out of reach of children and pets. Store at room temperature.
- Do not use heat (e.g., heating pads) over the treated area, as this can increase absorption.
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, up to 3-4 times daily.
Condition-Specific Dosing:
post-herpetic neuralgia:
Apply a thin layer to the affected area, up to 3-4 times daily. Do not exceed 60g per day or application to more than 1/4 of body surface area.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Use with caution; dose should be calculated based on weight and body surface area to avoid systemic toxicity. Consult pediatric guidelines. Max 3 mg/kg per dose.
Adolescent:
Use with caution; dose should be calculated based on weight and body surface area to avoid systemic toxicity. Max 3 mg/kg per dose.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for topical use on intact skin, but use with caution if large areas or broken skin are involved due to potential for increased systemic absorption.
Moderate:
No specific adjustment needed for topical use on intact skin, but use with caution if large areas or broken skin are involved due to potential for increased systemic absorption.
Severe:
No specific adjustment needed for topical use on intact skin, but use with caution if large areas or broken skin are involved due0 to potential for increased systemic absorption.
Dialysis:
Considerations: Lidocaine is not significantly dialyzable. Use with caution if large areas or broken skin are involved.
Hepatic Impairment:
Mild:
No specific adjustment needed for topical use on intact skin, but use with caution if large areas or broken skin are involved due to potential for increased systemic absorption.
Moderate:
Use with caution; reduced hepatic metabolism may lead to increased systemic levels if significant absorption occurs. Monitor for signs of toxicity.
Severe:
Use with extreme caution; significantly impaired hepatic metabolism may lead to increased systemic levels and toxicity even with topical application if significant absorption occurs. Monitor closely for signs of toxicity.
Pharmacology
Mechanism of Action
Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. It blocks voltage-gated sodium channels in the neuronal cell membrane, preventing depolarization and propagation of action potentials.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (depends on skin integrity, area of application, duration of exposure, and dose). Generally low systemic absorption from intact skin.
Tmax:
Variable (typically 2-6 hours after topical application, but can be longer depending on formulation and application site).
FoodEffect:
Not applicable (topical administration).
Distribution:
Vd:
1.1-2.1 L/kg (systemic)
ProteinBinding:
60-80% (primarily to alpha-1-acid glycoprotein and albumin)
CnssPenetration:
Limited (with topical use on intact skin); significant with systemic absorption.
Elimination:
HalfLife:
1.5-2 hours (systemic)
Clearance:
Not available (highly variable with topical use)
ExcretionRoute:
Renal (metabolites)
Unchanged:
<10% (systemic)
Pharmacodynamics
OnsetOfAction:
2-5 minutes (topical)
PeakEffect:
Variable (depends on application site and duration, typically within 30-60 minutes for maximal effect)
DurationOfAction:
Up to 6-8 hours (depending on formulation and application site)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of acidosis (too much acid in the blood), such as:
+ Confusion
+ Fast breathing
+ Fast heartbeat
+ Irregular heartbeat
+ Severe stomach pain, nausea, or vomiting
+ Excessive sleepiness
+ Shortness of breath
+ Feeling extremely tired or weak
Signs of methemoglobinemia, a rare but potentially life-threatening condition, such as:
+ Blue or gray discoloration of the lips, nails, or skin
+ Irregular heartbeat
+ Seizures
+ Severe dizziness or fainting
+ Severe headache
+ Excessive sleepiness
+ Feeling extremely tired or weak
+ Shortness of breath
Signs of skin infection, such as:
+ Oozing
+ Heat
+ Swelling
+ Redness
+ Pain
Trouble breathing, slow breathing, or shallow breathing
Severe numbness and tingling
Feeling lightheaded, sleepy, confused, or experiencing blurred vision
Seizures
Changes in vision
Feeling nervous and excitable
Dizziness or fainting
Ringing in the ears
Nausea or vomiting
Feeling hot or cold
Shakiness
Twitching
Slow heartbeat
Chest pain
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 ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Irritation at the site of application
Swelling
Redness
Changes in skin color
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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 notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of acidosis (too much acid in the blood), such as:
+ Confusion
+ Fast breathing
+ Fast heartbeat
+ Irregular heartbeat
+ Severe stomach pain, nausea, or vomiting
+ Excessive sleepiness
+ Shortness of breath
+ Feeling extremely tired or weak
Signs of methemoglobinemia, a rare but potentially life-threatening condition, such as:
+ Blue or gray discoloration of the lips, nails, or skin
+ Irregular heartbeat
+ Seizures
+ Severe dizziness or fainting
+ Severe headache
+ Excessive sleepiness
+ Feeling extremely tired or weak
+ Shortness of breath
Signs of skin infection, such as:
+ Oozing
+ Heat
+ Swelling
+ Redness
+ Pain
Trouble breathing, slow breathing, or shallow breathing
Severe numbness and tingling
Feeling lightheaded, sleepy, confused, or experiencing blurred vision
Seizures
Changes in vision
Feeling nervous and excitable
Dizziness or fainting
Ringing in the ears
Nausea or vomiting
Feeling hot or cold
Shakiness
Twitching
Slow heartbeat
Chest pain
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 ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Irritation at the site of application
Swelling
Redness
Changes in skin color
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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
- Numbness or tingling around the mouth
- Blurred vision or ringing in the ears (tinnitus)
- Unusual tiredness or weakness
- Slow or irregular heartbeat
- Difficulty breathing
- Seizures
- 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 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.
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 medical history, including any health problems or conditions
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure safe use and minimize potential interactions.
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.
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 medical history, including any health problems or conditions
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure safe use and minimize potential interactions.
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 problems
- Pre-existing 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, 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 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. Exercise caution when using this medication in children, as they may be at a higher risk for certain side effects.
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.
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 problems
- Pre-existing 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, 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 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. Exercise caution when using this medication in children, as they may be at a higher risk for certain side effects.
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.
Overdose Information
Overdose Symptoms:
- Severe dizziness or lightheadedness
- Nausea and vomiting
- Tremors or muscle twitching
- Seizures
- Slow or irregular heartbeat
- Low blood pressure
- Difficulty breathing
- Coma
What to Do:
If you suspect an overdose, seek immediate medical attention or call a Poison Control Center (1-800-222-1222). Remove the ointment immediately and wash the area thoroughly. Supportive care for symptoms may be necessary.
Drug Interactions
Major Interactions
- Class I Antiarrhythmics (e.g., tocainide, mexiletine): Increased risk of cardiac adverse effects due to additive effects on cardiac conduction.
- Other Local Anesthetics: Increased risk of systemic toxicity (CNS, cardiovascular) due to additive effects.
Moderate Interactions
- Antiarrhythmics (e.g., amiodarone, beta-blockers): Potential for additive cardiac effects, monitor ECG.
- CYP3A4 Inhibitors (e.g., macrolide antibiotics, azole antifungals, protease inhibitors): May increase lidocaine systemic levels if significant absorption occurs, increasing risk of toxicity.
- CYP1A2 Inhibitors (e.g., cimetidine, fluvoxamine): May increase lidocaine systemic levels if significant absorption occurs, increasing risk of toxicity.
Monitoring
Baseline Monitoring
Skin integrity and area of application
Rationale: To assess risk of systemic absorption and local irritation.
Timing: Prior to first application
Patient's medical history (especially cardiac, hepatic, renal conditions, and other medications)
Rationale: To identify contraindications or increased risk of adverse effects.
Timing: Prior to first application
Routine Monitoring
Signs and symptoms of systemic toxicity (CNS: dizziness, drowsiness, confusion, tremors, seizures; Cardiovascular: bradycardia, hypotension, arrhythmias)
Frequency: During and after application, especially if large areas or broken skin are treated.
Target: Absence of symptoms
Action Threshold: Any new or worsening CNS/cardiovascular symptoms; discontinue use and seek medical attention.
Local skin reactions (e.g., redness, swelling, itching, rash, blistering)
Frequency: Daily, or with each application
Target: Absence of severe irritation
Action Threshold: Severe or persistent local reactions; discontinue use.
Symptom Monitoring
- Dizziness
- Drowsiness
- Confusion
- Tremors
- Muscle twitching
- Seizures
- Lightheadedness
- Numbness around the mouth
- Blurred vision
- Tinnitus
- Bradycardia
- Hypotension
- Arrhythmias
- Skin redness
- Swelling
- Itching
- Rash
- Blistering
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. It is generally considered safe for use during pregnancy when used topically as directed and systemic absorption is minimal. Use only if clearly needed.
Trimester-Specific Risks:
First Trimester:
Low risk, but use with caution and only if clearly indicated.
Second Trimester:
Low risk, generally considered safe for topical use.
Third Trimester:
Low risk, generally considered safe for topical use.
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 adverse effects in a breastfed infant. It is rated L2 (likely compatible).
Infant Risk:
Low risk of adverse effects to the infant.
Pediatric Use
Use with extreme caution in children, especially those under 3 years of age. Children are more susceptible to systemic toxicity due to a higher surface area to weight ratio and immature metabolic pathways. Dosing must be carefully calculated based on weight and body surface area, and the smallest effective amount should be used. Monitor closely for signs of systemic toxicity.
Geriatric Use
Elderly patients may be more susceptible to systemic toxicity due to age-related decreases in hepatic and renal function, and potential for polypharmacy. Use the lowest effective dose and monitor for signs of systemic toxicity (CNS and cardiovascular effects).
Clinical Information
Clinical Pearls
- Topical lidocaine ointment is for external use only. Do not ingest.
- Avoid applying to large areas, broken skin, or mucous membranes to minimize systemic absorption and risk of toxicity.
- Do not use occlusive dressings (bandages) over the treated area unless specifically instructed by a healthcare provider, as this can significantly increase systemic absorption.
- Patients should be advised to wash their hands thoroughly after applying the ointment to avoid accidental transfer to eyes or other sensitive areas.
- Educate patients on the signs and symptoms of systemic lidocaine toxicity (e.g., dizziness, confusion, tremors, ringing in ears, slow heart rate) and to seek immediate medical attention if these occur.
- The 5% ointment is often used for localized pain, itching, or discomfort, such as from hemorrhoids, insect bites, or minor burns.
Alternative Therapies
- Other topical analgesics (e.g., capsaicin cream, diclofenac gel)
- Oral analgesics (e.g., NSAIDs, acetaminophen)
- Cold/heat therapy
- Corticosteroid creams (for itching/inflammation)
Cost & Coverage
Average Cost:
$20 - $50 per 50gm 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 details. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.