Lidocaine 5% Top/oral Oint (sprmt)
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
Mar 1960
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lidocaine 5% ointment is a medicine that numbs the skin or the inside of the mouth to relieve pain or itching. It works by blocking nerve signals in the area where it's applied.
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 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 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 anything 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. If you have questions, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
Missed Dose:
If you use this medication on a regular basis and miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and continue with your regular schedule.
Do not apply two doses at the same time or extra doses.
If you use this medication as needed, do not use it more frequently than directed by your doctor.
To use this medication correctly, follow your doctor's instructions and read all the information provided.
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 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 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 anything 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. If you have questions, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
Missed Dose:
If you use this medication on a regular basis and miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and continue with your regular schedule.
Do not apply two doses at the same time or extra doses.
If you use this medication as needed, do not use 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 use more than directed.
- Do not apply to large areas of the body, open wounds, or severely damaged skin unless specifically instructed by a doctor.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- For oral use, do not swallow large amounts. Spit out excess after application.
- Do not cover the treated area with bandages or plastic wrap unless advised by your doctor, as this can increase absorption and risk of side effects.
- Keep out of reach of children and pets.
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:
topical_skin:
Apply a thin layer to the affected area. Do not exceed 5 grams per application or 20 grams in a 24-hour period. Maximum 3-4 applications per day.
oral_mucosa:
Apply a thin layer to the affected oral mucous membranes. Do not exceed 5 grams per application or 20 grams in a 24-hour period. Maximum 3-4 applications per day. For oral use, apply with a cotton swab or finger, do not swallow large amounts.
Pediatric Dosing
Neonatal:
Not established. Use with extreme caution due to risk of systemic toxicity.
Infant:
Not established. Use with extreme caution due to risk of systemic toxicity. Dosing must be individualized and based on weight, not to exceed 3 mg/kg per application.
Child:
Not established. Use with extreme caution due to risk of systemic toxicity. Dosing must be individualized and based on weight, not to exceed 3 mg/kg per application. Max 3-4 applications per day.
Adolescent:
Similar to adult dosing, but with caution regarding total daily dose and application area, especially in younger adolescents. Do not exceed 5 grams per application or 20 grams in a 24-hour period.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment typically needed for topical use, but caution with large or prolonged applications.
Moderate:
No specific adjustment typically needed for topical use, but caution with large or prolonged applications due to potential for accumulation of metabolites.
Severe:
Use with caution. Reduced clearance of lidocaine and its metabolites may occur, increasing risk of systemic toxicity, especially with large or prolonged applications.
Dialysis:
Use with caution. Lidocaine is not significantly dialyzable. Monitor for signs of systemic toxicity.
Hepatic Impairment:
Mild:
No specific adjustment typically needed for topical use, but caution with large or prolonged applications.
Moderate:
Use with caution. Reduced hepatic metabolism may increase systemic lidocaine levels. Monitor for signs of systemic toxicity, especially with large or prolonged applications.
Severe:
Use with extreme caution. Significantly impaired hepatic metabolism can lead to toxic systemic levels. Reduce dose and frequency, or avoid use if possible, especially with large or prolonged applications.
Pharmacology
Mechanism of Action
Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby exerting a 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 application site, duration, skin integrity, and total dose). Systemic absorption can occur, especially from mucous membranes or broken skin. Up to 60% absorption from mucous membranes.
Tmax:
Variable, typically 2-10 minutes for onset of action, peak systemic levels can occur within 30-60 minutes after topical application.
FoodEffect:
Not applicable for topical/oral ointment.
Distribution:
Vd:
0.7-2.7 L/kg (systemic absorption)
ProteinBinding:
60-80% (primarily to alpha-1-acid glycoprotein and albumin)
CnssPenetration:
Yes (if absorbed systemically, crosses blood-brain barrier)
Elimination:
HalfLife:
1.5-2 hours (systemic, in healthy adults); prolonged in hepatic impairment or heart failure.
Clearance:
Approximately 10 mL/min/kg (systemic)
ExcretionRoute:
Renal (primarily as metabolites)
Unchanged:
Less than 10% (systemic)
Pharmacodynamics
OnsetOfAction:
2-5 minutes (topical/oral)
PeakEffect:
5-10 minutes (topical/oral)
DurationOfAction:
30-60 minutes (topical/oral), depending on site and dose.
Safety & Warnings
Side Effects
Urgent 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 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), including:
+ 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, including:
+ 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. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you notice any of the following:
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 concerns or questions, 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.
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 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), including:
+ 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, including:
+ 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. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you notice any of the following:
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 concerns or questions, 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, lightheadedness, or drowsiness
- Numbness or tingling around the mouth
- Blurred vision or ringing in the ears (tinnitus)
- Tremors or muscle twitching
- Feeling unusually anxious or restless
- 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, 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 change the dosage of any medication without consulting your doctor first.
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, 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 change 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.
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 do not expose it to extreme temperatures.
Apply this medication only to intact skin, unless your doctor specifically instructs you to use it on cuts, scrapes, or damaged skin. Avoid using heat sources such as sunlamps, tanning beds, heating pads, electric blankets, heat lamps, saunas, hot tubs, or 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 ingested, immediately contact a doctor or poison control center, as it can cause harm. 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 of experiencing certain side effects.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant or breastfeeding women, or those planning to become pregnant, should discuss the potential benefits and risks of using this medication with their 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 do not expose it to extreme temperatures.
Apply this medication only to intact skin, unless your doctor specifically instructs you to use it on cuts, scrapes, or damaged skin. Avoid using heat sources such as sunlamps, tanning beds, heating pads, electric blankets, heat lamps, saunas, hot tubs, or 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 ingested, immediately contact a doctor or poison control center, as it can cause harm. 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 of experiencing certain side effects.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant or breastfeeding women, or those planning to become pregnant, should discuss the potential benefits and risks of using this medication with their doctor.
Overdose Information
Overdose Symptoms:
- Severe dizziness or lightheadedness
- Nausea and vomiting
- Tremors, muscle twitching, or seizures
- Difficulty breathing or slow breathing
- Slow or irregular heartbeat
- Low blood pressure
- Loss of consciousness
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. Be prepared to provide information about the amount applied and when.
Drug Interactions
Major Interactions
- Class I Antiarrhythmics (e.g., tocainide, mexiletine, procainamide, quinidine, disopyramide): Increased risk of cardiac adverse effects due to additive effects on cardiac conduction.
- Other Local Anesthetics: Increased risk of systemic toxicity (CNS, cardiovascular depression) due to additive effects.
Moderate Interactions
- Beta-blockers (e.g., propranolol, metoprolol): May reduce hepatic blood flow, potentially decreasing lidocaine clearance and increasing systemic levels.
- Cimetidine: May inhibit lidocaine metabolism (CYP3A4, CYP1A2), increasing systemic levels.
- Amiodarone: Increased risk of cardiac adverse effects.
- Phenytoin: May alter lidocaine metabolism or increase risk of cardiac effects.
- Drugs that induce or inhibit CYP1A2 or CYP3A4 (e.g., rifampin, carbamazepine, macrolide antibiotics, azole antifungals): Can alter lidocaine metabolism and systemic levels.
- Succinylcholine: Prolonged neuromuscular blockade.
Minor Interactions
- Not available
Monitoring
Routine Monitoring
Signs and symptoms of systemic toxicity (CNS, cardiovascular)
Frequency: During and after application, especially with large or prolonged use.
Target: Absence of symptoms
Action Threshold: Any signs of dizziness, drowsiness, confusion, tinnitus, blurred vision, tremors, seizures, bradycardia, hypotension. Discontinue use and seek medical attention.
Efficacy of pain relief
Frequency: As needed
Target: Adequate pain control
Action Threshold: Lack of efficacy may indicate need for alternative treatment or re-evaluation.
Skin/mucosal integrity at application site
Frequency: Before each application
Target: Intact skin/mucosa
Action Threshold: Do not apply to severely damaged or infected skin/mucosa without medical advice.
Symptom Monitoring
- Lightheadedness
- Dizziness
- Drowsiness
- Confusion
- Tinnitus
- Blurred vision
- Numbness of lips/tongue
- Tremors
- Muscle twitching
- Seizures
- Bradycardia
- Hypotension
- Cardiac arrest
- Respiratory depression
Special Patient Groups
Pregnancy
Lidocaine is considered Category B for pregnancy. Animal studies have not shown harm to the fetus, and there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed and the potential benefits outweigh the potential risks.
Trimester-Specific Risks:
First Trimester:
Generally considered low risk, but use with caution.
Second Trimester:
Generally considered low risk, but use with caution.
Third Trimester:
Generally considered low risk, but use with caution. Avoid large doses near term due to potential for neonatal toxicity.
Lactation
Lidocaine is excreted into breast milk in small amounts. It is considered L2 (safer) by Hale's Lactation Risk Category. Systemic absorption from topical application is generally low. Monitor infant for drowsiness or feeding difficulties.
Infant Risk:
Low risk. Small amounts excreted into breast milk are unlikely to cause adverse effects in a nursing infant, especially with limited topical application.
Pediatric Use
Use with extreme caution in infants and children, especially those under 3 years of age. Children are more susceptible to systemic toxicity due to higher surface area to weight ratio and potentially immature metabolic pathways. Dosing must be carefully calculated based on weight, and the smallest effective amount should be used for the shortest duration. Avoid application to large areas or broken skin.
Geriatric Use
Use with caution in elderly patients. They may be more susceptible to systemic toxicity due to age-related decreases in hepatic and renal function, which can affect lidocaine metabolism and excretion. Start with lower doses and monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- Topical lidocaine 5% ointment is effective for localized pain and pruritus, including conditions like post-herpetic neuralgia (off-label for ointment, but common for patch), insect bites, minor burns, and oral mucositis.
- Emphasize the importance of applying a thin layer and not exceeding the recommended dose or frequency to minimize systemic absorption and toxicity.
- Patients should be educated on the signs and symptoms of systemic lidocaine toxicity (CNS and cardiovascular effects) and instructed to seek immediate medical attention if they occur.
- Avoid applying to large areas, broken skin, or mucous membranes for prolonged periods, as this significantly increases the risk of systemic absorption.
- For oral use, ensure the patient understands not to swallow large amounts and to spit out excess after application to minimize systemic absorption.
Alternative Therapies
- Other topical anesthetics (e.g., benzocaine, prilocaine, tetracaine)
- Topical corticosteroids (for pruritus/inflammation)
- Oral analgesics (e.g., NSAIDs, acetaminophen)
- Topical capsaicin (for neuropathic pain)
- Oral rinses (for oral mucositis, e.g., 'magic mouthwash' components)
Cost & Coverage
Average Cost:
$15 - $50 per 30g 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 for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may have additional patient information leaflets, so it is a good idea to consult with your pharmacist for more information. If you have any questions or concerns about this medication, do not 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.