Lidocaine 2% Jelly Gel (uro-Jet)5ml

Manufacturer INTRNTL 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 1948
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Lidocaine 2% Jelly is a gel that contains a medicine to numb a specific area of your body. It's often used to numb the inside of the urethra (the tube that carries urine out of the body) before medical procedures like inserting a catheter or scope. It works by temporarily blocking nerve signals in that area, so you don't feel pain.
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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 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 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 that case, do not wash your hand after application.
Clean the affected area before applying the medication and make sure it is dry.
Apply the medication to clean, dry, 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 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. You may also want to explore 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 on an as-needed basis, do not use it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Do not apply to large areas of skin or to broken/irritated skin unless directed by a healthcare professional, as this can increase absorption and risk of side effects.
  • Avoid contact with eyes.
  • Wash hands thoroughly after handling the jelly.
  • Do not use more than the prescribed amount or more frequently than directed.

Dosing & Administration

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Adult Dosing

Standard Dose: For male urethral anesthesia: 6-10 mL (120-200 mg lidocaine HCl) instilled slowly into the urethra. For female urethral anesthesia: 3-5 mL (60-100 mg lidocaine HCl) instilled slowly into the urethra. Max dose: Do not exceed 600 mg (30 mL of 2% jelly) in a 12-hour period.
Dose Range: 60 - 200 mg

Condition-Specific Dosing:

urethral_anesthesia_male: 6-10 mL (120-200 mg)
urethral_anesthesia_female: 3-5 mL (60-100 mg)
max_single_dose: Not specified for single application, but generally keep below 300 mg for systemic absorption concerns.
max_24_hour_dose: 600 mg (30 mL of 2% jelly) in a 12-hour period.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Dosing should be calculated based on weight and age, typically not exceeding 4.5 mg/kg. Use with extreme caution and under strict medical supervision for urethral procedures. Consult specific pediatric guidelines.
Adolescent: Dosing should be calculated based on weight and age, typically not exceeding 4.5 mg/kg. Use with caution. Consult specific guidelines.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended for topical use with low systemic absorption.
Moderate: No specific adjustment recommended for topical use with low systemic absorption. Monitor for signs of systemic toxicity if large areas or damaged mucosa are treated.
Severe: No specific adjustment recommended for topical use with low systemic absorption. Monitor closely for signs of systemic toxicity due to potential accumulation of metabolites.
Dialysis: Considerations: Lidocaine is dialyzable. Monitor for systemic toxicity if significant absorption occurs.

Hepatic Impairment:

Mild: No specific adjustment recommended for topical use with low systemic absorption.
Moderate: Use with caution. Reduced metabolism may lead to increased systemic levels if significant absorption occurs. Monitor for systemic toxicity.
Severe: Use with extreme caution. Significant reduction in metabolism may lead to increased systemic levels and toxicity even with topical application. Monitor closely 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 the propagation of action potentials.
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Pharmacokinetics

Absorption:

Bioavailability: Variable; depends on site of application, duration of exposure, concentration, and integrity of the mucosal barrier. Systemic absorption occurs from mucous membranes.
Tmax: Variable; typically 10-60 minutes after mucosal application, depending on site and dose.
FoodEffect: Not applicable for topical jelly.

Distribution:

Vd: 0.7-2.7 L/kg (systemic)
ProteinBinding: 60-80% (primarily to alpha-1-acid glycoprotein and albumin)
CnssPenetration: Yes (readily crosses blood-brain barrier if systemic levels are high)

Elimination:

HalfLife: 1.5-2 hours (systemic)
Clearance: Approximately 10-20 mL/min/kg (systemic)
ExcretionRoute: Renal (less than 10% as unchanged drug)
Unchanged: <10%
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Pharmacodynamics

OnsetOfAction: 2-5 minutes (after mucosal application)
PeakEffect: 5-10 minutes
DurationOfAction: 20-30 minutes (for local anesthesia)
Confidence: Medium

Safety & Warnings

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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 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
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 may not experience any side effects or may only have 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.
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Seek Immediate Medical Attention If You Experience:

  • Feeling lightheaded or dizzy
  • Drowsiness or confusion
  • Ringing in the ears (tinnitus)
  • Blurred vision
  • Numbness or tingling around the mouth
  • Shaking or tremors
  • Muscle twitching
  • 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, 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 discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This includes:

All your current medications, to ensure safe use and potential interactions with this medication.
* Any health problems you have, as they may affect the safety or efficacy of this medication.

Remember, 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.

There is a risk of developing a severe blood condition called methemoglobinemia with this type of drug. Certain factors can increase this risk, including:
- Having a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD)
- 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 skin products, 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 area, as it may be numb. Additionally, protect the area from extreme temperatures.

Unless instructed by your doctor, do not apply this medication to cuts, scrapes, or damaged skin.

To minimize the risk of increased drug absorption, avoid exposure to heat sources such as:
- Sunlamps
- Tanning beds
- Heating pads
- Electric blankets
- Heat lamps
- Saunas
- Hot tubs
- Heated waterbeds
Also, avoid taking long, hot baths or sunbathing, as these can cause your body temperature to rise and lead to excessive drug absorption.

If this medication is accidentally ingested, seek immediate medical attention or contact a poison control center.

When considering the use of this medication in children, it is crucial to consult with your 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 lightheadedness
  • Nausea and vomiting
  • Tremors or muscle twitching
  • Seizures
  • Difficulty breathing
  • Slow or irregular heartbeat
  • 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). Symptoms of overdose can be serious and life-threatening.

Drug Interactions

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Major Interactions

  • Antiarrhythmics (Class I, e.g., mexiletine, tocainide): Increased risk of cardiac adverse effects.
  • Other local anesthetics: Additive systemic toxicity.
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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, increasing systemic levels.
  • Phenytoin: May alter lidocaine metabolism.
  • Succinylcholine: Prolonged neuromuscular blockade.

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 administration

Integrity of mucosal surface

Rationale: Damaged or inflamed mucosa can increase systemic absorption and risk of toxicity.

Timing: Prior to administration

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Routine Monitoring

Signs of systemic toxicity (CNS and cardiovascular)

Frequency: During and immediately after application, especially with higher doses or prolonged exposure.

Target: Absence of symptoms

Action Threshold: Any signs of dizziness, drowsiness, confusion, tinnitus, blurred vision, tremors, muscle twitching, seizures, bradycardia, hypotension, or cardiac arrest require immediate intervention.

Effectiveness of anesthesia

Frequency: As needed

Target: Adequate local anesthesia

Action Threshold: Inadequate anesthesia may indicate need for re-application (within max dose limits) or alternative methods.

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Symptom Monitoring

  • Lightheadedness
  • Dizziness
  • Drowsiness
  • Confusion
  • Tinnitus
  • Blurred vision
  • Numbness or tingling around the mouth
  • Tremors
  • Muscle twitching
  • Seizures
  • Bradycardia
  • Hypotension
  • Cardiac arrest (severe toxicity)

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 during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Systemic absorption from topical use is generally low.

Trimester-Specific Risks:

First Trimester: Low risk, but use with caution and only if clearly needed.
Second Trimester: Low risk, but use with caution and only if clearly needed.
Third Trimester: Low risk, but use with caution and only if clearly needed. Avoid large doses near term due to potential effects on the neonate.
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Lactation

Lidocaine is excreted into breast milk in small amounts. However, due to its short half-life and low oral bioavailability in the infant, adverse effects on the breastfed infant are unlikely with typical topical use. Considered L2 (likely compatible).

Infant Risk: Low risk
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Pediatric Use

Use with extreme caution in pediatric patients, especially infants and young children, as they may be more susceptible to systemic toxicity due to higher absorption rates relative to body weight and immature metabolic pathways. Dosing must be carefully calculated based on weight (not to exceed 4.5 mg/kg).

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Ensure the patient is positioned correctly for optimal jelly instillation and retention in the urethra.
  • Allow adequate time (5-10 minutes) for the anesthetic effect to develop before proceeding with the procedure.
  • Warn patients about the temporary numbness and potential for urinary retention post-procedure due to the anesthetic effect.
  • Always adhere to maximum dose limits to prevent systemic toxicity, especially when applying to inflamed or traumatized mucous membranes.
  • Keep out of reach of children; accidental ingestion can be dangerous.
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Alternative Therapies

  • Other topical local anesthetics (e.g., benzocaine, prilocaine)
  • Injectable local anesthetics (for deeper anesthesia)
  • Systemic analgesics (for pain management not requiring local anesthesia)
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Cost & Coverage

Average Cost: Varies, typically $10-$50 per 5ml syringe/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. 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.