Lidocaine 5% Topical Oint 35.44gm
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% topical ointment is a numbing cream used to relieve pain and itching from certain skin conditions, such as minor burns, insect bites, or scrapes. 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.
Skin Application:
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 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 (with a cotton swab):
Apply the medication to the affected area as directed by your doctor or the label instructions.
Do not eat anything for at least 60 minutes (1 hour) after applying the medication.
Storage and Disposal
Store the medication at room temperature and do not freeze it.
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. You may also have access to drug take-back programs in your area.
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 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:
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 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 (with a cotton swab):
Apply the medication to the affected area as directed by your doctor or the label instructions.
Do not eat anything for at least 60 minutes (1 hour) after applying the medication.
Storage and Disposal
Store the medication at room temperature and do not freeze it.
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. You may also have access to drug take-back programs in your area.
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 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 as directed by your doctor or pharmacist.
- Do not apply to large areas of the body, to broken or irritated skin, or for prolonged periods without medical supervision, as this can increase the risk of serious side effects.
- Avoid contact with eyes, nose, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not use with occlusive dressings (e.g., bandages, plastic wrap) unless specifically instructed by a healthcare professional, as this can increase absorption.
- Keep out of reach of children and pets. Store at room temperature.
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 every 6 to 8 hours as needed. Do not exceed 60 grams in a 24-hour period.
Condition-Specific Dosing:
post-herpetic neuralgia:
Not specifically indicated for PHN, but may be used off-label for localized pain. Lidocaine 5% patch is indicated for PHN.
Pediatric Dosing
Neonatal:
Not established. Use with extreme caution due to increased risk of systemic toxicity.
Infant:
Not established. Use with extreme caution due to increased risk of systemic toxicity.
Child:
Not established. Use with extreme caution due to increased risk of systemic toxicity. Max dose typically 3 mg/kg per application, not exceeding 4 applications in 24 hours. Consult a physician.
Adolescent:
Similar to adult dosing, but caution advised regarding total applied area and frequency to minimize systemic absorption.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended for topical use with intact skin.
Moderate:
Use with caution. Monitor for signs of systemic toxicity if applied to large areas or broken skin.
Severe:
Use with caution. Monitor for signs of systemic toxicity if applied to large areas or broken skin. Reduced clearance of lidocaine and its metabolites may occur.
Dialysis:
Considerations: Lidocaine is not significantly dialyzable. Use with caution and monitor for systemic toxicity.
Hepatic Impairment:
Mild:
No specific adjustment recommended for topical use with intact skin.
Moderate:
Use with caution. Monitor for signs of systemic toxicity, especially with extensive application, as lidocaine is primarily metabolized by the liver.
Severe:
Use with extreme caution. Significant reduction in lidocaine clearance may occur, increasing risk of systemic toxicity. 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 in the neuronal cell membrane, preventing depolarization and propagation of action potentials.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (depends on skin integrity, area, duration of application, and presence of occlusive dressings). Systemic absorption is generally low from intact skin.
Tmax:
2-4 hours (for topical application, can vary widely)
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
0.7-2.7 L/kg (systemic)
ProteinBinding:
60-80% (primarily to alpha-1-acid glycoprotein and albumin)
CnssPenetration:
Yes (if significant systemic absorption occurs)
Elimination:
HalfLife:
1.5-2 hours (systemic)
Clearance:
Approximately 10-20 mL/min/kg (systemic)
ExcretionRoute:
Renal (primarily as metabolites)
Unchanged:
<10% (in urine)
Pharmacodynamics
OnsetOfAction:
Within 30 minutes (topical)
PeakEffect:
2-4 hours (topical)
DurationOfAction:
Up to 6-8 hours (topical)
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 immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of acidosis (too much acid in the blood), such as:
+ Confusion
+ Fast breathing
+ Fast heartbeat
+ Abnormal heartbeat
+ Severe stomach pain, nausea, or vomiting
+ Excessive sleepiness
+ Shortness of breath
+ Feeling extremely tired or weak
Signs of methemoglobinemia, a rare but potentially life-threatening condition, such as:
+ Blue or gray discoloration of the lips, nails, or skin
+ Abnormal heartbeat
+ Seizures
+ Severe dizziness or fainting
+ Severe headache
+ Excessive sleepiness
+ Feeling extremely tired or weak
+ Shortness of breath
Signs of skin infection, such as:
+ Oozing
+ Heat
+ Swelling
+ Redness
+ Pain
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 experience no side effects or only 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, 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 immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of acidosis (too much acid in the blood), such as:
+ Confusion
+ Fast breathing
+ Fast heartbeat
+ Abnormal heartbeat
+ Severe stomach pain, nausea, or vomiting
+ Excessive sleepiness
+ Shortness of breath
+ Feeling extremely tired or weak
Signs of methemoglobinemia, a rare but potentially life-threatening condition, such as:
+ Blue or gray discoloration of the lips, nails, or skin
+ Abnormal heartbeat
+ Seizures
+ Severe dizziness or fainting
+ Severe headache
+ Excessive sleepiness
+ Feeling extremely tired or weak
+ Shortness of breath
Signs of skin infection, such as:
+ Oozing
+ Heat
+ Swelling
+ Redness
+ Pain
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 experience no side effects or only 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, 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
- Blurred vision or ringing in the ears (tinnitus)
- Numbness or tingling around the mouth
- Unusual drowsiness or confusion
- Tremors or muscle twitching
- Slow or irregular heartbeat
- Difficulty breathing
- Seizures
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 application site.
Swollen skin, numbness, or loss of sensation at the application site.
If a large area of your body needs to be treated with this medication.
Additionally, this is not an exhaustive list of potential interactions. Therefore, it is crucial to discuss all of your:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
* Health problems
with your doctor and pharmacist to ensure safe use. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm it is safe to do so.
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 application site.
Swollen skin, numbness, or loss of sensation at the application site.
If a large area of your body needs to be treated with this medication.
Additionally, this is not an exhaustive list of potential interactions. Therefore, it is crucial to discuss all of your:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
* Health problems
with your doctor and pharmacist to ensure safe use. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm it is safe to do so.
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 the area, and protect it from extreme temperatures.
Do not apply this medication to cuts, scrapes, or damaged skin unless specifically instructed to do so by your doctor. 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 and lead to excessive absorption of the medication.
If this medication is accidentally swallowed, immediately contact a doctor or a 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 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.
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 the area, and protect it from extreme temperatures.
Do not apply this medication to cuts, scrapes, or damaged skin unless specifically instructed to do so by your doctor. 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 and lead to excessive absorption of the medication.
If this medication is accidentally swallowed, immediately contact a doctor or a 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 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, muscle twitching, or seizures
- Difficulty breathing
- Slow or irregular heartbeat (bradycardia)
- Low blood pressure (hypotension)
- Coma
- Cardiac arrest
What to Do:
If you suspect an overdose, seek immediate medical attention or call a Poison Control Center (1-800-222-1222). Symptoms of systemic toxicity require prompt intervention, including airway management, oxygen, IV fluids, vasopressors for hypotension, and benzodiazepines for seizures. Lipid emulsion therapy may be considered for severe systemic toxicity.
Drug Interactions
Major Interactions
- Class I Antiarrhythmics (e.g., tocainide, mexiletine): Increased risk of additive cardiac effects.
- Other local anesthetics: Increased risk of systemic toxicity.
Moderate Interactions
- Beta-blockers (e.g., propranolol): May reduce hepatic blood flow, potentially decreasing lidocaine clearance and increasing systemic levels.
- Cimetidine: May inhibit lidocaine metabolism (CYP1A2, CYP3A4), increasing systemic levels.
- Phenytoin: May alter lidocaine metabolism.
- Amiodarone: Increased risk of cardiac adverse effects.
Monitoring
Baseline Monitoring
Skin integrity of application site
Rationale: Broken or compromised skin increases systemic absorption and risk of toxicity.
Timing: Prior to first application
Patient's medical history (cardiac, hepatic, renal conditions)
Rationale: Identifies risk factors for systemic toxicity or altered metabolism/excretion.
Timing: Prior to first application
Routine Monitoring
Signs and symptoms of systemic toxicity (CNS, cardiovascular)
Frequency: During and after application, especially with large areas or prolonged use.
Target: Absence of symptoms
Action Threshold: Any signs of dizziness, lightheadedness, blurred vision, tinnitus, tremors, drowsiness, confusion, bradycardia, hypotension, or seizures require immediate medical attention.
Application site reaction
Frequency: Daily, or with each application
Target: Minimal to no irritation
Action Threshold: Severe redness, swelling, blistering, or pain at the application site.
Symptom Monitoring
- Dizziness
- Lightheadedness
- Blurred vision
- Tinnitus
- Numbness around the mouth
- Tremors
- Drowsiness
- Confusion
- Bradycardia
- Hypotension
- Seizures
- Cardiac arrest
Special Patient Groups
Pregnancy
Lidocaine is classified as 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 with limited systemic absorption is generally considered low risk, but use only if clearly needed and potential benefits outweigh risks.
Trimester-Specific Risks:
First Trimester:
Low risk based on animal data and limited systemic absorption from topical use.
Second Trimester:
Low risk.
Third Trimester:
Low risk.
Lactation
Lidocaine is excreted into breast milk in small amounts. The amount transferred to the infant via breast milk is generally considered too small to cause adverse effects, especially with topical application. Classified as L2 (Safer). Use with caution, avoid applying to the breast area if breastfeeding.
Infant Risk:
Low risk of adverse effects in breastfed infants with typical topical use.
Pediatric Use
Children, especially infants and young children, are more susceptible to systemic toxicity from lidocaine due to their higher surface area to body weight ratio and immature metabolic pathways. Use with extreme caution, if at all, and under strict medical supervision. Dosing must be carefully calculated based on weight and applied area. Avoid use on large areas or broken skin.
Geriatric Use
Elderly patients may be more sensitive to the systemic effects of lidocaine due to decreased hepatic and renal function, reduced cardiac output, and altered body composition. Use with caution, starting with lower doses or less frequent application, and monitor closely for signs of systemic toxicity.
Clinical Information
Clinical Pearls
- Always apply the thinnest effective layer to minimize systemic absorption.
- Do not apply to large body areas, open wounds, or mucous membranes unless specifically directed by a healthcare professional.
- Avoid using heating pads or occlusive dressings over the application site, as this can significantly increase systemic absorption and risk of toxicity.
- Educate patients on the signs and symptoms of systemic lidocaine toxicity (e.g., dizziness, tinnitus, numbness around the mouth, tremors) and to seek immediate medical attention if they occur.
- This ointment is for external use only. Do not ingest.
Alternative Therapies
- Topical corticosteroids (for inflammation/itching)
- Oral analgesics (e.g., NSAIDs, acetaminophen)
- Cold packs/ice
- Antihistamines (for itching)
- Capsaicin cream (for neuropathic pain, different mechanism)
Cost & Coverage
Average Cost:
Varies, typically $20-$50 per 35.44gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.