Lidocaine 2% Topical Jelly 30ml

Manufacturer ARMAS PHARMACEUTICALS 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 applied to the skin or mucous membranes to numb the area. It works by temporarily blocking nerve signals in that specific area, reducing pain or discomfort.
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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. This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. Avoid getting it in your mouth, nose, or eyes, as it may cause burning. If accidental contact occurs, rinse the area thoroughly with water.

Before applying the medication, wash your hands and clean the affected area. Make sure the area is dry before application. Apply the medication to clean, dry, and healthy skin. Unless directed by your doctor, do not cover the treated area with bandages or dressings. If the treated area is on your hand, do not wash your hand after application.

Storage and Disposal

Store this medication at room temperature, avoiding freezing. Keep all medications in a safe location, 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 about disposal, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.

Missed Dose

If you use this medication on a regular schedule, apply the missed dose as soon as you remember. However, 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, follow your doctor's instructions and do not use it more frequently than recommended.
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Lifestyle & Tips

  • Wash hands thoroughly before and after applying the jelly.
  • Apply 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 under occlusive dressings unless specifically instructed by a healthcare professional, as this can increase absorption and risk of side effects.
  • Avoid contact with eyes.
  • Do not swallow the jelly.
  • Keep out of reach of children and pets. Accidental ingestion can be dangerous.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin layer to the affected area as needed. Max 300 mg (15 grams of 2% jelly) in a 12-hour period.

Condition-Specific Dosing:

mucousMembranes: Apply 5-10 mL (100-200 mg lidocaine) for adequate anesthesia, not exceeding 300 mg in 12 hours.
urethralAnesthesia: Males: 6-30 mL (120-600 mg) in divided doses. Females: 3-5 mL (60-100 mg). Max 300 mg in 12 hours.
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Pediatric Dosing

Neonatal: Not established for routine use; extreme caution due to higher risk of systemic toxicity.
Infant: Not established for routine use; extreme caution due to higher risk of systemic toxicity.
Child: Dosing should not exceed 4.5 mg/kg (0.225 mL/kg of 2% jelly) or 300 mg total, whichever is less, in a 12-hour period. Use with extreme caution, especially in children under 3 years or those with compromised skin/mucosa.
Adolescent: Dosing similar to adult, but not to exceed 4.5 mg/kg or 300 mg total, whichever is less, in a 12-hour period.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment generally needed for topical use with intact skin.
Moderate: Use with caution; monitor for signs of systemic toxicity if large areas or broken skin are involved.
Severe: Use with caution; consider reduced dose or frequency due to potential accumulation of active metabolites (MEGX, GX) which are renally excreted. Monitor for systemic toxicity.
Dialysis: Considerations: Lidocaine and its metabolites are dialyzable, but systemic absorption from topical use is usually low. Use with caution and monitor for toxicity.

Hepatic Impairment:

Mild: No specific adjustment generally needed for topical use with intact skin.
Moderate: Use with caution; monitor for signs of systemic toxicity due to reduced metabolism of lidocaine.
Severe: Use with caution; consider reduced dose or frequency due to significantly impaired metabolism. Monitor for systemic toxicity.
Confidence: Medium

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, preventing depolarization and propagation of action potentials.
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Pharmacokinetics

Absorption:

Bioavailability: Variable; generally low systemic absorption from intact skin (approx. 3-10%), but significantly higher from mucous membranes or broken skin (up to 60-70%).
Tmax: Topical: 10-60 minutes (onset of action). Systemic absorption Tmax: 1-3 hours (if significant absorption occurs).
FoodEffect: Not applicable for topical formulation.

Distribution:

Vd: 0.7-2.7 L/kg (systemic)
ProteinBinding: 60-80% (primarily to alpha-1-acid glycoprotein and albumin)
CnssPenetration: Limited with topical application; significant penetration occurs with systemic absorption, leading to CNS effects.

Elimination:

HalfLife: 1.5-2 hours (systemic, parent drug); MEGX: 2.5 hours; GX: 10 hours.
Clearance: Approximately 10-20 mL/min/kg (systemic)
ExcretionRoute: Renal (primarily as metabolites)
Unchanged: Less than 10% (systemic)
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Pharmacodynamics

OnsetOfAction: 2-5 minutes (topical)
PeakEffect: 5-10 minutes (topical)
DurationOfAction: 30-60 minutes (topical, depending on site and concentration)

Safety & Warnings

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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
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 excessively 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 for advice:

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, 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.
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Seek Immediate Medical Attention If You Experience:

  • Dizziness or lightheadedness
  • Feeling nervous or restless
  • Blurred vision or ringing in the ears (tinnitus)
  • Numbness or tingling around the mouth
  • Tremors or muscle twitching
  • Unusual drowsiness or confusion
  • Slow or irregular heartbeat
  • Difficulty breathing
  • Seizures
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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 medications or health conditions. Therefore, it is crucial to discuss the following with your doctor and pharmacist:

All prescription and over-the-counter medications you are taking.
Any natural products, vitamins, or supplements you are using.
Your overall health and any existing medical conditions.

To ensure safe use, do not start, stop, or change the dose of any medication without first consulting your doctor. It is your responsibility to verify that it is safe to take this medication with all your other medications 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.

This drug can cause a severe blood disorder called methemoglobinemia, particularly in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency, heart problems, or lung problems. The risk may also be increased when taking certain other medications or in infants under 6 months of age. If you have a history of methemoglobinemia, notify your doctor.

Before using any other medications or skin products, including soaps, consult with your doctor. Do not use this medication for an extended period beyond what your doctor has prescribed.

While using this medication, avoid scratching or rubbing the treated skin area, and protect it from extreme temperatures. Do not apply this medication to cuts, scrapes, or damaged skin unless 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. Refrain from taking long, hot baths or sunbathing, as this can cause your body temperature to rise and lead to excessive absorption of the medication.

If this medication is ingested, it can be harmful. In the event of accidental ingestion, immediately contact a doctor or 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 of experiencing certain side effects. 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, inform your doctor. It is crucial to discuss the potential benefits and risks of using this medication during these situations to ensure the well-being of both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe dizziness or fainting
  • Seizures
  • Slow or irregular heartbeat
  • Low blood pressure
  • Difficulty breathing or respiratory arrest
  • Coma

What to Do:

If you suspect an overdose, seek immediate medical attention or call a Poison Control Center (1-800-222-1222). If the person has collapsed, had a seizure, has trouble breathing, or can't be awakened, call 911 immediately.

Drug Interactions

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Major Interactions

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

  • Beta-blockers (e.g., propranolol): May decrease hepatic blood flow, potentially reducing lidocaine clearance and increasing systemic levels if significant absorption occurs.
  • Cimetidine: May inhibit lidocaine metabolism, increasing systemic levels.
  • CYP3A4 inhibitors (e.g., macrolide antibiotics, azole antifungals): May increase lidocaine levels if significant systemic absorption occurs.
  • CYP1A2 inhibitors (e.g., fluvoxamine): May increase lidocaine levels if significant systemic absorption occurs.

Monitoring

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Baseline Monitoring

Allergy history (especially to amide-type anesthetics)

Rationale: To prevent hypersensitivity reactions.

Timing: Prior to first administration.

Skin/mucosal integrity of application site

Rationale: Broken or inflamed skin/mucosa increases systemic absorption and risk of toxicity.

Timing: Prior to each application.

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Routine Monitoring

Signs of systemic toxicity (CNS, cardiovascular)

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

Target: Absence of symptoms

Action Threshold: Any signs of dizziness, lightheadedness, tinnitus, blurred vision, tremors, drowsiness, confusion, bradycardia, hypotension, or seizures require immediate medical attention.

Local site reaction

Frequency: Visually inspect application site during and after use.

Target: Absence of excessive redness, swelling, itching, or irritation.

Action Threshold: Discontinue use if severe local reactions occur.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Tinnitus
  • Blurred vision
  • Numbness around mouth
  • Tremors
  • Drowsiness
  • Confusion
  • Bradycardia
  • Hypotension
  • Seizures
  • Cardiac arrest (rare, severe toxicity)

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, and there are no adequate and well-controlled studies in pregnant women. Topical use with limited systemic absorption is generally considered safe, but use only if clearly needed and potential benefits outweigh risks.

Trimester-Specific Risks:

First Trimester: Low risk with topical use and limited systemic absorption.
Second Trimester: Low risk with topical use and limited systemic absorption.
Third Trimester: Low risk with topical use and limited systemic absorption. Caution near term if used for labor/delivery due to potential for fetal bradycardia.
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Lactation

Lidocaine is excreted into breast milk in small amounts. The amount transferred to the infant is generally very low with topical application. It is considered L2 (safer) by Hale's Lactation Risk Category. Use with caution, especially if applied to large areas or for prolonged periods.

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

Children, especially those under 3 years of age, are more susceptible to systemic toxicity due to a higher ratio of surface area to body weight and potentially immature metabolic pathways. Dosing must be carefully calculated based on weight and not exceed recommended maximums. Avoid use on large areas or broken skin. Keep out of reach of children due to risk of accidental ingestion.

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Geriatric Use

Elderly patients may be more sensitive to the effects of lidocaine due to decreased hepatic function, reduced renal clearance of metabolites, or underlying cardiovascular disease. Use with caution and monitor for signs of systemic toxicity. Consider lower doses or less frequent application if needed.

Clinical Information

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Clinical Pearls

  • Always confirm the concentration of lidocaine product being used to prevent accidental overdose.
  • Systemic toxicity is rare with appropriate topical use on intact skin but can occur if applied to large areas, broken skin, or mucous membranes, or if occlusive dressings are used.
  • Symptoms of systemic toxicity often begin with CNS effects (e.g., dizziness, tinnitus, perioral numbness) before progressing to more severe cardiovascular effects.
  • Do not apply heat to the area after application, as this can increase systemic absorption.
  • Ensure patients understand that the numbing effect can mask pain, so caution should be exercised to avoid injury to the anesthetized area.
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Alternative Therapies

  • Benzocaine topical
  • Prilocaine topical
  • EMLA cream (lidocaine/prilocaine combination)
  • Tetracaine topical
  • Bupivacaine (injectable local anesthetic)
  • Cryotherapy (ice packs)
  • Oral analgesics (e.g., NSAIDs, acetaminophen)
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Cost & Coverage

Average Cost: $15 - $50 per 30ml 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'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 taken, the amount, and the time it happened.