Lidocaine 5% Top/oral Oint 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 1948
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lidocaine ointment is a medicine applied to the skin or mucous membranes to numb the area and relieve pain or itching. It works by blocking nerve signals in the body.
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 this happens, rinse the area thoroughly with water.
Wash your hands before and after applying the medication, unless your hand is the area being treated.
Clean and dry the affected area before application. Apply the medication 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.
Do not eat or drink anything for at least 60 minutes (1 hour) after applying the medication.
Storage and Disposal:
Store the 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. Consult 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 regularly, apply the missed dose 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.
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 this happens, rinse the area thoroughly with water.
Wash your hands before and after applying the medication, unless your hand is the area being treated.
Clean and dry the affected area before application. Apply the medication 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.
Do not eat or drink anything for at least 60 minutes (1 hour) after applying the medication.
Storage and Disposal:
Store the 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. Consult 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 regularly, apply the missed dose 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 your hands thoroughly before and after applying the ointment.
- Apply only a thin layer to the affected area. Do not apply to large areas of the body or to broken, irritated, or infected skin unless directed by a doctor.
- Do not cover the treated area with bandages or plastic wrap unless specifically instructed by your doctor, as this can increase absorption and risk of side effects.
- Avoid getting the ointment in your eyes, nose, or mouth (unless it's for oral use as directed). If it gets into these areas, rinse thoroughly with water.
- Do not use heat (e.g., heating pads) on the treated area, as this can increase absorption.
- Keep out of reach of children and pets. Store safely.
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 6 times a day.
Condition-Specific Dosing:
mucousMembranes:
Apply to affected area, not exceeding 0.5 g per application (approx. 1 inch of ointment), up to 4 times a day. Max 5 g in 24 hours.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Use with caution. For children <12 years, consult a physician. Dosing should be based on weight and surface area, not exceeding 3 mg/kg per application. Max 4 applications in 24 hours.
Adolescent:
Similar to adult dosing, but with caution regarding total daily dose and systemic absorption.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment for topical use due to low systemic absorption.
Moderate:
No specific adjustment for topical use due to low systemic absorption, but use with caution in extensive application.
Severe:
Use with caution, especially with extensive application or compromised skin, due to potential for increased systemic exposure and accumulation of metabolites.
Dialysis:
Considerations: Use with caution. While systemic absorption is low, metabolites may accumulate. Monitor for signs of systemic toxicity.
Hepatic Impairment:
Mild:
No specific adjustment for topical use due to low systemic absorption.
Moderate:
Use with caution, especially with extensive application or compromised skin, due to potential for increased systemic exposure and reduced metabolism.
Severe:
Use with extreme caution. Significant hepatic impairment can reduce lidocaine clearance, increasing risk of systemic toxicity. Limit application area and frequency. Monitor closely for adverse effects.
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 the propagation of action potentials.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (low for intact skin, higher for denuded skin or mucous membranes); up to 3% for intact skin, significantly higher for damaged skin or mucous membranes.
Tmax:
Variable; typically 2-10 minutes for onset, peak systemic levels can occur within 30-60 minutes after extensive application.
FoodEffect:
Not applicable for topical ointment.
Distribution:
Vd:
0.7-2.7 L/kg (systemic absorption)
ProteinBinding:
60-80% (primarily to alpha-1-acid glycoprotein and albumin) (systemic absorption)
CnssPenetration:
Yes (systemic absorption, crosses blood-brain barrier)
Elimination:
HalfLife:
1.5-2 hours (systemic absorption)
Clearance:
Approximately 10-20 mL/min/kg (systemic absorption)
ExcretionRoute:
Renal (primarily as metabolites)
Unchanged:
<10% (systemic absorption)
Pharmacodynamics
OnsetOfAction:
2-5 minutes (topical)
PeakEffect:
Variable; 10-60 minutes (topical)
DurationOfAction:
30-60 minutes (topical), depending on site and application.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following 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. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor if you notice any of the following:
Irritation at the site of application
Swelling
Redness
Changes in skin color
If you experience any side effects that bother you or do not go away, contact your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following 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. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor if you notice any of the following:
Irritation at the site of application
Swelling
Redness
Changes in skin color
If you experience any side effects that bother you or do not go away, contact your doctor for advice. 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:
- Signs of allergic reaction: Hives, rash, itching, swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
- Signs of too much medicine absorbed into the body (systemic toxicity): Dizziness, drowsiness, confusion, ringing in the ears (tinnitus), blurred vision, tremors, muscle twitching, slurred speech, feeling numb around the mouth, unusual tiredness, slow heart rate, low blood pressure, seizures.
- Severe irritation 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 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 list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication in combination with your other treatments and health status. Never start, stop, 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, including allergies to this medication, its components, or other substances, such as foods or 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 list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication in combination with your other treatments and health status. Never start, stop, 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.
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 to ensure safe use.
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, take the following precautions:
- Avoid scratching or rubbing the skin in the treated area, as it may be numb
- Protect the skin from extreme temperatures
- Only apply the medication to intact skin, unless your doctor specifically instructs you to use it on 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, limit your time in long, hot baths and avoid sunbathing, as these can cause your body temperature to rise and potentially lead to excessive absorption of the medication.
In case of accidental ingestion, seek medical attention immediately by calling a doctor or poison control center.
When considering use in children, note that different brands of this medication may be approved for different age groups. Consult with your doctor before administering this medication to a child, as they may be more susceptible to certain side effects.
If you are 65 years or older, use this medication with caution, as you may be more prone to experiencing 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 to ensure safe use.
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, take the following precautions:
- Avoid scratching or rubbing the skin in the treated area, as it may be numb
- Protect the skin from extreme temperatures
- Only apply the medication to intact skin, unless your doctor specifically instructs you to use it on 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, limit your time in long, hot baths and avoid sunbathing, as these can cause your body temperature to rise and potentially lead to excessive absorption of the medication.
In case of accidental ingestion, seek medical attention immediately by calling a doctor or poison control center.
When considering use in children, note that different brands of this medication may be approved for different age groups. Consult with your doctor before administering this medication to a child, as they may be more susceptible to certain side effects.
If you are 65 years or older, use this medication with caution, as you may be more prone to experiencing 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, vomiting
- Tremors, muscle twitching
- Slurred speech
- Confusion, disorientation
- Ringing in the ears (tinnitus)
- Blurred or double vision
- Numbness or tingling around the mouth
- Seizures
- Slow or irregular heartbeat
- Low blood pressure
- Difficulty breathing
- Loss of consciousness
What to Do:
If you suspect an overdose, seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222.
Drug Interactions
Major Interactions
- Class I Antiarrhythmics (e.g., tocainide, mexiletine): Increased risk of cardiac adverse effects due to additive sodium channel blockade if significant systemic absorption occurs.
- Other Local Anesthetics: Increased risk of systemic toxicity (CNS, cardiovascular) due to additive effects.
Moderate Interactions
- Beta-blockers (e.g., propranolol): May reduce hepatic blood flow, potentially decreasing lidocaine clearance and increasing systemic levels if significant absorption occurs.
- Cimetidine: May inhibit lidocaine metabolism (CYP1A2, CYP3A4), potentially increasing systemic levels if significant absorption occurs.
- Phenytoin: May alter lidocaine metabolism or increase risk of cardiac depression.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Skin integrity of application site
Rationale: Damaged or inflamed skin can increase 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
Signs of local irritation (redness, swelling, itching)
Frequency: With each application and periodically during treatment
Target: Absence of significant irritation
Action Threshold: Discontinue use if severe irritation or allergic reaction occurs.
Signs of systemic toxicity (CNS: dizziness, drowsiness, confusion, tremors, seizures; Cardiovascular: bradycardia, hypotension, arrhythmias)
Frequency: Periodically, especially with extensive application or compromised skin
Target: Absence of systemic symptoms
Action Threshold: Discontinue use immediately and seek medical attention if systemic symptoms develop.
Total amount applied per 24 hours
Frequency: Daily
Target: Within recommended maximum dose
Action Threshold: Reduce frequency or amount if exceeding recommended limits to minimize systemic absorption.
Symptom Monitoring
- Local: Redness, swelling, itching, rash, burning, stinging, tenderness.
- Systemic (CNS): Dizziness, lightheadedness, drowsiness, confusion, disorientation, tinnitus, blurred vision, tremors, muscle twitching, slurred speech, numbness/tingling around mouth, seizures.
- Systemic (Cardiovascular): Bradycardia, hypotension, pallor, arrhythmias, cardiac arrest.
- Allergic reactions: Hives, difficulty breathing, swelling of face/lips/tongue/throat.
Special Patient Groups
Pregnancy
Lidocaine is Pregnancy Category B. Studies in animals have not shown harm to the fetus, and there are no adequate and well-controlled studies in pregnant women. Topical use is generally considered safe when used as directed due to limited systemic absorption.
Trimester-Specific Risks:
First Trimester:
Low risk, but use only if clearly needed.
Second Trimester:
Low risk.
Third Trimester:
Low risk.
Lactation
Lidocaine is excreted into breast milk in small amounts. However, due to low systemic absorption from topical application and rapid metabolism, the amount transferred to breast milk is generally considered too small to cause harm to a nursing infant. Use with caution, avoid applying to the breast area.
Infant Risk:
Low risk (L2)
Pediatric Use
Use with extreme caution in infants and young 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 potentially immature metabolic pathways. Dosing must be carefully calculated based on weight, and the total amount applied should be strictly limited. Avoid application to large areas or broken skin.
Geriatric Use
Use with caution. Elderly patients may be more sensitive to the systemic effects of lidocaine due to potential age-related decreases in hepatic and renal function, which can affect metabolism and excretion. Start with lower doses and monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- Lidocaine ointment is for external use only. Do not ingest.
- Avoid applying to large areas of the body, especially if the skin is broken, inflamed, or denuded, as this significantly increases systemic absorption and the risk of toxicity.
- Do not use occlusive dressings (bandages, plastic wrap) over the treated area unless specifically instructed by a healthcare professional, as this can enhance systemic absorption.
- Patients should be advised to wash their hands thoroughly after applying the ointment to avoid accidental transfer to eyes or mucous membranes.
- Be aware of the potential for systemic toxicity, even with topical application, particularly in pediatric patients, elderly patients, or those with compromised hepatic/renal function.
- For oral/mucosal use, ensure the patient understands not to exceed the recommended dose and to avoid swallowing large amounts.
Alternative Therapies
- Benzocaine (topical anesthetic)
- Tetracaine (topical anesthetic)
- Prilocaine (often in combination with lidocaine, e.g., EMLA cream)
- Diclofenac topical (NSAID for pain)
- Capsaicin topical (counterirritant)
- Oral analgesics (e.g., acetaminophen, NSAIDs)
- Cold/hot packs
Cost & Coverage
Average Cost:
$15 - $40 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 information. 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.