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Lidocaine 2% Topical Jelly 10ml

Manufacturer INTRNTL MEDICATION SYSTEM Active Ingredient Lidocaine Gel(LYE doe kane) Pronunciation LYE doe kane
It is used to manage pain.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Local Anesthetic
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Pharmacologic Class
Voltage-gated sodium channel blocker
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Pregnancy Category
Category B
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Lidocaine 2% Topical Jelly is a medicine that numbs a specific area of your body to relieve pain or discomfort. It works by temporarily blocking nerve signals in the skin or mucous membranes where it's applied.
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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. It's essential to use this medication only as directed.

Apply this medication directly to your skin, as instructed by your doctor. Do not take it by mouth.
 Avoid getting this medication in your mouth, nose, or eyes, as it may cause burning. If accidental contact occurs, rinse the affected area thoroughly with water.
Wash your hands before and after applying the medication, unless your hand is the treated area. In this case, do not wash your hand after application.
 Before applying the medication, clean the affected area and dry it thoroughly. Apply the medication to clean, dry, and healthy skin.
Unless instructed by your doctor, do not cover the treated area with bandages or dressings.

Storage and Disposal

To store this medication properly:

 Keep it at room temperature.
Do not freeze the medication.
 Store all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications responsibly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your doctor or pharmacist. You can also check with your pharmacist for guidance on the best disposal method or inquire about drug take-back programs in your area.

Missed Dose Instructions

If you use this medication on a regular basis and miss a dose:

 Apply the missed dose as soon as you remember.
If it's 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, follow your doctor's instructions and do not use it more frequently than recommended.
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Lifestyle & Tips

  • Wash your hands before and after applying the jelly.
  • Apply only a thin layer to the affected area as directed by your healthcare provider.
  • Do not apply to large areas of the body, to broken or irritated skin, or for prolonged periods unless specifically instructed by a doctor, as this can increase the risk of side effects.
  • Avoid getting the jelly in your eyes. If it gets into your eyes, rinse thoroughly with water.
  • Do not swallow the jelly. If accidentally swallowed, especially by a child, seek immediate medical attention.
  • Keep out of reach of children and pets.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin layer to the affected area as needed. Maximum recommended dose varies by site and formulation, typically not exceeding 300 mg (15 mL of 2% jelly) in a 12-hour period for mucous membranes, or 4.5 mg/kg (not exceeding 300 mg) for skin.

Condition-Specific Dosing:

mucousMembranes: Up to 15 mL (300 mg) of 2% jelly in a 12-hour period.
skinIntact: Apply sparingly, typically 1-2 times daily. Max 4.5 mg/kg or 300 mg total dose in 24 hours.
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Pediatric Dosing

Neonatal: Not established. Use with extreme caution, if at all, due to risk of systemic toxicity.
Infant: Not established. Use with extreme caution, if at all, due to risk of systemic toxicity. Max 1.2-2 mg/kg per dose.
Child: Use with caution. Max 4.5 mg/kg per dose, not to exceed 300 mg total dose in 24 hours. Apply smallest effective amount.
Adolescent: Use with caution. Max 4.5 mg/kg per dose, not to exceed 300 mg total dose in 24 hours. Apply smallest effective amount.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed for topical use with intact skin, but monitor for systemic effects if large areas or broken skin are involved.
Moderate: No specific adjustment needed for topical use with intact skin, but monitor for systemic effects if large areas or broken skin are involved.
Severe: No specific adjustment needed for topical use with intact skin, but monitor for systemic effects if large areas or broken skin are involved.
Dialysis: Consider reduced frequency or dose if significant systemic absorption is anticipated, as metabolites may accumulate.

Hepatic Impairment:

Mild: No specific adjustment needed for topical use with intact skin, but monitor for systemic effects if large areas or broken skin are involved.
Moderate: Use with caution. Consider reduced dose or frequency if significant systemic absorption is anticipated, as lidocaine is primarily metabolized by the liver.
Severe: Use with caution. Consider reduced dose or frequency if significant systemic absorption is anticipated, as lidocaine is primarily metabolized by the liver.

Pharmacology

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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, preventing depolarization and propagation of action potentials.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (low for intact skin, higher for mucous membranes or broken skin)
Tmax: Variable (5-10 minutes for mucous membranes, longer for skin)
FoodEffect: Not applicable for topical formulation

Distribution:

Vd: 0.7-2.7 L/kg (if systemically absorbed)
ProteinBinding: 60-80%
CnssPenetration: Yes (if systemically absorbed)

Elimination:

HalfLife: 1.5-2 hours (systemic)
Clearance: 10-20 mL/min/kg (systemic)
ExcretionRoute: Renal
Unchanged: Less than 10% (systemic)
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Pharmacodynamics

OnsetOfAction: 2-5 minutes (mucous membranes), 15-30 minutes (intact skin)
PeakEffect: 5-10 minutes (mucous membranes), 30-60 minutes (intact skin)
DurationOfAction: 30-60 minutes (mucous membranes), 1-3 hours (intact skin)

Safety & Warnings

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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
+ Difficulty 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
+ Rapid breathing
+ Rapid heartbeat
+ Irregular heartbeat
+ Severe stomach pain, nausea, or vomiting
+ Excessive sleepiness
+ Shortness of breath
+ Feeling extremely tired or weak
Signs of methemoglobinemia, a rare but potentially life-threatening condition, such as:
+ Blue or gray discoloration of the lips, nails, or skin
+ Irregular heartbeat
+ Seizures
+ Severe dizziness or fainting
+ Severe headache
+ Excessive sleepiness
+ Feeling extremely tired or weak
+ Shortness of breath
 Signs of skin infection, such as:
+ Oozing
+ Heat
+ Swelling
+ Redness
+ Pain
Respiratory problems, such as:
+ Difficulty 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 extremely hot or cold
Shakiness
 Twitching
Slow heartbeat
 Chest pain

Other Possible Side Effects

Like all medications, this drug can cause side effects. However, 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 or seek medical attention if they bother you or persist:

Irritation at the site of application
 Swelling
Redness
 Changes in skin color

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Dizziness or lightheadedness
  • Numbness or tingling around the mouth
  • Blurred vision or ringing in the ears
  • Unusual drowsiness or confusion
  • Tremors or muscle twitching
  • Slow or irregular heartbeat
  • Difficulty breathing
  • Severe skin irritation, rash, or swelling at the application site
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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 site where the medication will be used.
 Swollen skin, numbness, or loss of sensation at the site where the medication will be applied.
* If a large area of skin needs to be treated with this medication.

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 use this medication in conjunction with your other treatments and health status. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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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 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 products on your skin, 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, and protect it from extreme temperatures. Unless instructed by your doctor, do not apply this medication to 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
Additionally, refrain from taking long, hot baths or sunbathing, as these activities can cause your body temperature to rise, potentially leading to excessive absorption of the medication.

In the event that this medication is swallowed, immediately contact a doctor or a poison control center, as it can cause harm.

When considering the use of this medication in children, it is crucial to consult with a doctor, as different brands may be suitable for different age groups. Children may be at a higher risk for certain side effects, so caution is advised.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of using this medication with your doctor to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Severe dizziness or fainting
  • Seizures (convulsions)
  • Slow or irregular heartbeat
  • Very low blood pressure
  • Difficulty breathing or stopping breathing
  • Coma

What to Do:

If you suspect an overdose, seek immediate emergency medical attention or call Poison Control at 1-800-222-1222.

Drug Interactions

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Major Interactions

  • Class I antiarrhythmics (e.g., tocainide, mexiletine) - increased risk of cardiac effects if significant systemic absorption occurs.
  • Other local anesthetics - additive systemic toxicity.
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Moderate Interactions

  • Beta-blockers (e.g., propranolol) - may reduce hepatic clearance of lidocaine, increasing systemic levels.
  • Cimetidine - may reduce hepatic clearance of lidocaine, increasing systemic levels.
  • Antiarrhythmics (e.g., amiodarone) - increased risk of cardiac effects.
  • CNS depressants (e.g., opioids, benzodiazepines) - additive CNS depression if systemic absorption occurs.

Monitoring

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Baseline Monitoring

Allergy history

Rationale: To identify hypersensitivity reactions to lidocaine or other amide-type local anesthetics.

Timing: Prior to first application

Skin/mucosal integrity

Rationale: Broken skin or mucous membranes can increase systemic absorption and risk of toxicity.

Timing: Prior to application

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Routine Monitoring

Local site reaction (redness, swelling, irritation)

Frequency: During and after application

Target: Absence of significant reaction

Action Threshold: Discontinue if severe irritation or allergic reaction occurs.

Signs of systemic toxicity (CNS: dizziness, drowsiness, confusion, tremors, seizures; Cardiovascular: bradycardia, hypotension, arrhythmias)

Frequency: During and after application, especially with large areas, prolonged use, or broken skin

Target: Absence of symptoms

Action Threshold: Discontinue immediately and seek medical attention if symptoms appear.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Numbness around the mouth
  • Tingling sensations
  • Blurred vision
  • Ringing in the ears (tinnitus)
  • Drowsiness
  • Confusion
  • Tremors
  • Muscle twitching
  • Seizures
  • Slow heart rate (bradycardia)
  • Low blood pressure (hypotension)
  • Difficulty breathing

Special Patient Groups

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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. Use only if clearly needed and the potential benefits outweigh the potential risks.

Trimester-Specific Risks:

First Trimester: Generally considered low risk for topical use due to limited systemic absorption.
Second Trimester: Generally considered low risk for topical use due to limited systemic absorption.
Third Trimester: Generally considered low risk for topical use due to limited systemic absorption.
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Lactation

Lidocaine is excreted into breast milk in small amounts. The amount transferred to the infant is generally very low, especially with topical application. It is considered L2 (likely compatible) by LactMed. Use with caution, especially with large or prolonged applications.

Infant Risk: Low risk of adverse effects in breastfed infants with typical topical use. Monitor infant for drowsiness or feeding difficulties.
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Pediatric Use

Use with extreme caution in infants and young children due to their higher susceptibility to systemic toxicity from local anesthetics. Their skin surface area to body weight ratio is higher, and their metabolic pathways may be immature. Strict adherence to dosing guidelines and monitoring for signs of toxicity are crucial. Not recommended for routine use in neonates or very young infants.

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Geriatric Use

Elderly patients may be more susceptible to the systemic effects of lidocaine due to decreased hepatic function, reduced renal clearance, or underlying cardiovascular disease. Use the lowest effective dose and monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Always use the smallest effective amount for the shortest duration necessary to achieve desired effect.
  • Avoid applying to large areas, broken skin, or mucous membranes for prolonged periods to minimize systemic absorption and risk of toxicity.
  • Educate patients on signs of systemic toxicity (e.g., dizziness, perioral numbness, tinnitus) and to seek immediate medical attention if they occur.
  • Not for ophthalmic use. Avoid contact with eyes.
  • Consider non-pharmacological pain relief methods as adjuncts or alternatives where appropriate.
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Alternative Therapies

  • Benzocaine topical
  • Prilocaine topical
  • Tetracaine topical
  • EMLA cream (lidocaine/prilocaine combination)
  • Topical NSAIDs (e.g., diclofenac gel)
  • Topical capsaicin
  • Cold/heat therapy
  • Oral analgesics (e.g., acetaminophen, ibuprofen)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 10ml tube
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist 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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.