Lidocaine 2% Topical Jelly 20ml

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
Amide-type Local Anesthetic; 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 numbing medicine used to make certain areas of your body, like the inside of your mouth, nose, or urinary tract, feel numb before medical procedures or to relieve pain. It works by temporarily blocking nerve signals in the area 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 is essential to use this medication only as directed.

Apply this medication to your skin only, as directed 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 you accidentally get it in any of these areas, rinse well 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, healthy skin.
Unless instructed by your doctor to do so, 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 properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of medications, and consider participating in drug take-back programs in your area.

Missed Dose

If you use this medication on a regular basis and miss a dose:
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 on an as-needed basis, do not use it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Apply only as directed by your healthcare provider.
  • Do not apply to large areas of the body or to broken, irritated, or inflamed skin unless specifically instructed by a doctor.
  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • Do not swallow the jelly. If swallowed, seek medical attention immediately.
  • Keep out of reach of children and pets.
  • Wash hands thoroughly after applying the jelly.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply 5-10 mL (100-200 mg lidocaine) for adequate anesthesia. Maximum recommended dose is 600 mg (30 mL of 2% jelly) in a 12-hour period.
Dose Range: 100 - 600 mg

Condition-Specific Dosing:

urethral_anesthesia_male: 6-30 mL (120-600 mg) as needed for adequate anesthesia. Insert slowly.
urethral_anesthesia_female: 3-5 mL (60-100 mg) into the urethra.
endoscopy: 5-10 mL (100-200 mg) applied to the instrument or directly to the area.
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Pediatric Dosing

Neonatal: Not established for routine use; use with extreme caution and reduced doses if clinically necessary, considering weight and surface area.
Infant: Not established for routine use; use with extreme caution and reduced doses if clinically necessary, considering weight and surface area. Max dose 4.5 mg/kg.
Child: Maximum recommended dose is 4.5 mg/kg (0.225 mL/kg of 2% jelly) not to exceed 300 mg (15 mL of 2% jelly) in a single application or 600 mg (30 mL) in a 12-hour period. Use lowest effective dose.
Adolescent: Maximum recommended dose is 4.5 mg/kg (0.225 mL/kg of 2% jelly) not to exceed 300 mg (15 mL of 2% jelly) in a single application or 600 mg (30 mL) in a 12-hour period. Use lowest effective dose.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment typically required for topical use, but monitor for systemic toxicity with extensive use.
Moderate: No specific adjustment typically required for topical use, but monitor for systemic toxicity with extensive use.
Severe: Use with caution; consider reduced doses and monitor closely for systemic toxicity due to potential accumulation of lidocaine and its metabolites.
Dialysis: Considerations: Lidocaine is not significantly removed by hemodialysis. Use with caution and monitor for systemic toxicity.

Hepatic Impairment:

Mild: No specific adjustment typically required for topical use, but monitor for systemic toxicity with extensive use.
Moderate: Use with caution; consider reduced doses and monitor closely for systemic toxicity due to impaired metabolism.
Severe: Use with extreme caution; significantly reduced doses may be necessary due to impaired metabolism and increased risk of systemic toxicity.

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 effecting local anesthetic action. It blocks voltage-gated sodium channels in the neuronal membrane, preventing the influx of sodium ions and thus inhibiting depolarization and nerve impulse propagation.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (depends on application site, duration, skin integrity); generally low from intact skin, higher from mucous membranes or broken skin.
Tmax: Variable (5-60 minutes, depending on site and formulation).
FoodEffect: Not applicable

Distribution:

Vd: 0.7-2.7 L/kg (systemic absorption)
ProteinBinding: 60-80% (primarily to alpha-1-acid glycoprotein and albumin)
CnssPenetration: Yes (if systemically absorbed, crosses blood-brain barrier)

Elimination:

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

OnsetOfAction: 2-5 minutes (topical)
PeakEffect: 5-10 minutes (topical)
DurationOfAction: 20-60 minutes (topical, depending on site and dose)

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:

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 too much acid in the blood (acidosis), 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. However, many people do not experience any side effects or only have mild ones. If you experience any of the following side effects or any other symptoms that concern you, contact your doctor:

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

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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
  • Ringing in the ears (tinnitus)
  • Blurred vision
  • Unusual drowsiness or confusion
  • Tremors or muscle twitching
  • Slow or irregular heartbeat
  • Difficulty breathing
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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 to this medication, its components, or other substances, including foods and drugs. 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.
If a large area requires treatment.

This medication may interact with other drugs or health conditions. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking.
Any natural products or vitamins you are using.
Your existing health problems.

Before starting, stopping, or adjusting the dose of any medication, including this one, consult with your doctor to ensure your safety. Verify that it is safe to take this medication with your other drugs and health conditions.
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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. This risk may be increased in individuals with certain medical conditions, such as glucose-6-phosphate dehydrogenase (G6PD) deficiency, 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 products on your skin, including soaps, consult with your doctor. It is crucial to follow 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, as it may be numb. Also, be cautious not to expose the treated area to extreme temperatures. Do not apply this medication to cuts, scrapes, or damaged skin unless specifically instructed to do so by your doctor.

To minimize potential risks, avoid using heat sources such as sunlamps, tanning beds, heating pads, electric blankets, heat lamps, saunas, hot tubs, or heated waterbeds. Refrain from taking long, hot baths or sunbathing, as this may cause your body temperature to rise and lead to excessive absorption of the medication.

In case of accidental ingestion, this medication can be harmful. If swallowed, immediately contact a doctor or poison control center.

When using this medication in children, it is essential to follow the recommended guidelines for their age group. Different brands of this medication may be suitable for different ages, so consult with your doctor before administering it to a child. Children may be at a higher risk of experiencing certain side effects, so careful monitoring is necessary.

If you are 65 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 ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe dizziness or fainting
  • Seizures (convulsions)
  • Slow or irregular heartbeat
  • Trouble breathing
  • Coma

What to Do:

If you suspect an overdose, seek immediate medical attention or call a Poison Control Center (1-800-222-1222). Symptoms of overdose require urgent medical intervention, including supportive care for respiratory and cardiovascular depression, and anticonvulsants for seizures.

Drug Interactions

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Major Interactions

  • Class I Antiarrhythmics (e.g., tocainide, mexiletine): Increased risk of cardiac adverse effects.
  • Other Local Anesthetics: Additive systemic toxicity.
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Moderate Interactions

  • Beta-blockers (e.g., propranolol): May decrease lidocaine clearance, increasing systemic levels.
  • Cimetidine: May decrease lidocaine clearance, increasing systemic levels.
  • CYP3A4 inhibitors (e.g., macrolide antibiotics, azole antifungals, protease inhibitors): May increase lidocaine plasma concentrations.
  • Antiarrhythmics (e.g., amiodarone): Increased risk of cardiac effects.

Monitoring

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Routine Monitoring

Signs and symptoms of systemic toxicity (CNS and cardiovascular)

Frequency: During and immediately after application, especially with large doses or extensive areas.

Target: Absence of symptoms

Action Threshold: Any signs of toxicity (e.g., dizziness, tinnitus, perioral numbness, seizures, bradycardia, hypotension) require immediate cessation and supportive care.

Local site reaction

Frequency: During and after application

Target: Absence of irritation, redness, swelling

Action Threshold: Discontinue if irritation or allergic reaction occurs.

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Symptom Monitoring

  • Lightheadedness
  • Dizziness
  • Tinnitus
  • Blurred vision
  • Numbness of lips/tongue
  • Drowsiness
  • Confusion
  • Tremors
  • Muscle twitching
  • Seizures
  • Bradycardia
  • Hypotension
  • Cardiac arrest

Special Patient Groups

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Pregnancy

Lidocaine is considered Category B for pregnancy. 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, 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 fetal bradycardia or CNS depression.
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Lactation

Lidocaine is excreted into breast milk in small amounts. It is generally considered compatible with breastfeeding when used topically at recommended doses. Monitor the infant for signs of adverse effects.

Infant Risk: Low risk. Monitor for drowsiness or feeding difficulties in the infant, though unlikely with typical topical use.
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Pediatric Use

Children, especially infants and young children, are more susceptible to systemic toxicity due to higher absorption rates relative to body weight and immature metabolic pathways. Use the lowest effective dose and adhere strictly to weight-based dosing guidelines. Avoid application to large areas or broken skin.

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Geriatric Use

Elderly patients may be more susceptible to systemic toxicity due to decreased hepatic function, reduced renal clearance, and potential for polypharmacy. Use the lowest effective dose and monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Topical lidocaine jelly is primarily for mucous membrane anesthesia, not for large surface areas of intact skin.
  • The risk of systemic toxicity increases with the area of application, duration of exposure, and integrity of the skin/mucosa.
  • Always use the smallest effective amount to minimize systemic absorption.
  • Patients should be advised not to eat or drink until the numbness wears off if applied to the mouth or throat, to prevent aspiration.
  • Be aware of potential for methemoglobinemia, though rare with lidocaine, especially in infants or patients with certain genetic predispositions.
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Alternative Therapies

  • Benzocaine topical
  • Tetracaine topical
  • Bupivacaine topical (less common for jelly)
  • EMLA cream (lidocaine/prilocaine combination for intact skin)
  • Other local anesthetic sprays or solutions
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Cost & Coverage

Average Cost: $10 - $50 per 20ml 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 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 it's a good idea 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.