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Lidocaine 2% Visc Oral Solution

Manufacturer ROXANE Active Ingredient Lidocaine Oral Solution (Viscous)(LYE doe kane) Pronunciation LYE doe kane
WARNING: Very bad health problems (like seizures and heart that stops working) and death have happened in children younger than 3 years old. In these cases, this drug was not used how it was recommended. Do not use this drug to treat infants and children with teething pain. Talk with the doctor.This drug must only be used in children younger than 3 years old when other treatments cannot be used. If using in a child younger than 3 years old for a reason other than teething pain, follow how to give as you were told by the doctor. Talk with the doctor. @ COMMON USES: 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.
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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% Viscous Oral Solution is a medicine that numbs the inside of your mouth and throat. It's used to relieve pain from conditions like mouth sores or sore throats, especially those caused by cancer treatments. You swish it around in your mouth and gargle, then either spit it out or swallow it, depending on your doctor's instructions.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication effectively, follow your doctor's instructions and read all accompanying information carefully.

If using as a mouth rinse, swish the medication in your mouth for as long as possible. Then, either swallow or spit it out as directed by your doctor or the label instructions.
 If applying with a cotton swab, place the medication on the affected area as instructed by your doctor or the label.
After using this medication, wait at least 60 minutes (1 hour) before eating.
 Before each use, shake the medication well. If you are taking a liquid dose, measure it carefully to ensure accuracy.

Storing and Disposing of Your Medication

Store the medication at room temperature, keeping it in a safe location.
 Ensure that all medications are out of reach of children and pets.
Dispose of any unused or expired medication. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your doctor or pharmacist. If you have questions about disposing of your medication, consult your pharmacist. You may also have access to drug take-back programs in your area.

What to Do If You Miss a Dose

 If you use this medication on a regular basis and miss a dose, take it as soon as you remember.
If the missed dose is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
 Do not apply two doses at once or take extra doses to make up for a missed dose.
* If you use this medication as needed, do not take it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Do not eat or drink for at least 60 minutes after using the solution to prevent choking or biting your tongue/cheek due to numbness.
  • Avoid hot foods or liquids immediately after use, as you may not feel the heat and could burn yourself.
  • Do not use more often or in larger amounts than prescribed.
  • Keep out of reach of children, especially infants and young children, due to the risk of serious harm or death from accidental ingestion.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: 15 mL (300 mg) swished in the mouth and gargled, then spit out or swallowed, every 3 hours as needed.

Condition-Specific Dosing:

oral_mucositis: 15 mL (300 mg) swished in the mouth and gargled, then spit out or swallowed, every 3 hours as needed. Do not exceed 8 doses (120 mL or 2400 mg) in a 24-hour period.
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Pediatric Dosing

Neonatal: Not established (contraindicated in infants and young children due to risk of systemic toxicity and death).
Infant: Not established (contraindicated in infants and young children due to risk of systemic toxicity and death).
Child: Not established (contraindicated in infants and young children due to risk of systemic toxicity and death). For children >3 years, dosing must be carefully individualized based on weight and severity of condition, typically 4-5 mg/kg/dose, not to exceed 4.5 mg/kg/dose or 300 mg/dose, whichever is less, every 3 hours as needed. Max 4 doses in 24 hours. Use with extreme caution and only if benefits outweigh risks.
Adolescent: Similar to adult dosing, but caution with weight-based limits. Max 4.5 mg/kg/dose, not to exceed 300 mg/dose, every 3 hours as needed. Max 4 doses in 24 hours.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended.
Moderate: Use with caution. Consider reduced frequency or dose.
Severe: Use with caution. Consider reduced frequency or dose due to accumulation of active metabolites.
Dialysis: Lidocaine is not significantly dialyzable. Use with caution, monitor for toxicity.

Hepatic Impairment:

Mild: Use with caution. Consider reduced dose.
Moderate: Reduce dose by 50% or extend dosing interval. Monitor for toxicity.
Severe: Reduce dose by 75% or extend dosing interval significantly. Monitor for toxicity. Contraindicated in severe hepatic impairment due to risk of accumulation and toxicity.

Pharmacology

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Mechanism of Action

Lidocaine is an amide-type local anesthetic. It stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of nerve impulses, thereby blocking the propagation of pain signals. It does this by reversibly binding to and blocking voltage-gated sodium channels in the neuronal cell membrane, preventing the influx of sodium ions and subsequent depolarization.
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Pharmacokinetics

Absorption:

Bioavailability: Low (oral ingestion due to extensive first-pass metabolism); however, significant systemic absorption can occur from mucous membranes.
Tmax: Variable, typically 10-20 minutes for topical effect, systemic absorption Tmax can be 30-60 minutes.
FoodEffect: Not directly applicable to topical effect, but swallowing can lead to systemic absorption.

Distribution:

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

Elimination:

HalfLife: 1.5-2 hours (parent drug); MEGX: 2.5 hours; GX: 10 hours
Clearance: Approximately 10 mL/min/kg
ExcretionRoute: Renal (metabolites)
Unchanged: <10% (parent drug)
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Pharmacodynamics

OnsetOfAction: 2-5 minutes (topical effect)
PeakEffect: 5-10 minutes (topical effect)
DurationOfAction: 30-60 minutes (topical effect)

Safety & Warnings

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BLACK BOX WARNING

Cases of severe adverse events, including seizures, cardiopulmonary arrest, and death, have been reported in patients who were administered Lidocaine Viscous 2% Solution, including infants and children. Lidocaine Viscous 2% Solution is contraindicated in infants and children younger than 3 years of age. In young children, Lidocaine Viscous 2% Solution should be used with extreme caution and only if the potential benefits outweigh the risks. Accidental ingestion or inappropriate use (e.g., exceeding recommended dose, frequent administration, or administration to infants and young children) can result in systemic toxicity.
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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
+ 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
 Breathing difficulties, including slow 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 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 may not experience any side effects or may only have mild ones. If you are bothered by any of the following side effects or if they persist, contact your doctor:

 Irritation at the site of application

This is not an exhaustive list of possible side effects. 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
  • Drowsiness or confusion
  • Ringing in the ears (tinnitus)
  • Blurred or double vision
  • Tremors or muscle twitching
  • Seizures
  • Slow or irregular heartbeat
  • Feeling unusually tired or weak
  • 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, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
 All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. 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 problems
- Pre-existing 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.

Note that different brands of this medication may be suitable for children of varying ages. Before administering this drug to a child, consult with their doctor to ensure the correct brand and dosage are used.

When giving this medication to a child, exercise caution, as the risk of certain side effects may be higher in pediatric patients.

To avoid accidental injury, do not eat until the numbness in your mouth has resolved, as you may inadvertently bite your tongue.

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

If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe dizziness or lightheadedness
  • Nausea and vomiting
  • Slurred speech
  • Confusion, disorientation
  • Tremors, muscle twitching, seizures
  • Slow or irregular heartbeat
  • Low blood pressure
  • Difficulty breathing, 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). In severe cases, emergency medical services may be required to manage seizures, support breathing, and stabilize cardiovascular function.

Drug Interactions

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Major Interactions

  • Class I antiarrhythmics (e.g., mexiletine, tocainide, flecainide, propafenone) - increased risk of cardiac depression and CNS effects.
  • Other local anesthetics - increased risk of systemic toxicity.
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Moderate Interactions

  • Beta-blockers (e.g., propranolol, metoprolol) - may decrease lidocaine clearance, increasing plasma levels and risk of toxicity.
  • Cimetidine - may decrease lidocaine clearance, increasing plasma levels and risk of toxicity.
  • Phenytoin - may increase lidocaine metabolism (CYP3A4 induction) but also has additive cardiac effects.
  • Amiodarone - additive cardiac effects, increased risk of arrhythmias.
  • CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) - may increase lidocaine plasma concentrations.
  • CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin) - may increase lidocaine plasma concentrations.

Monitoring

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Baseline Monitoring

Liver function tests (LFTs)

Rationale: Lidocaine is extensively metabolized by the liver; hepatic impairment increases risk of toxicity.

Timing: Prior to initiation, especially in patients with suspected hepatic dysfunction.

Renal function tests (RFTs)

Rationale: Metabolites are renally excreted; severe renal impairment can lead to metabolite accumulation.

Timing: Prior to initiation, especially in patients with suspected renal dysfunction.

Cardiac status (ECG, heart rate, blood pressure)

Rationale: Lidocaine can cause cardiovascular effects, especially with systemic absorption.

Timing: Prior to initiation, especially in patients with pre-existing cardiac conditions.

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Routine Monitoring

Signs and symptoms of systemic toxicity (CNS and cardiovascular)

Frequency: Continuously during treatment, especially after initial doses or dose increases.

Target: Absence of symptoms

Action Threshold: Any signs of dizziness, drowsiness, confusion, seizures, tinnitus, blurred vision, bradycardia, hypotension, or arrhythmias require immediate medical evaluation and potential discontinuation.

Heart rate and blood pressure

Frequency: Regularly, especially in patients at risk for systemic absorption.

Target: Within normal limits for the patient

Action Threshold: Significant bradycardia or hypotension.

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Symptom Monitoring

  • Dizziness
  • Drowsiness
  • Confusion
  • Disorientation
  • Tinnitus
  • Blurred vision
  • Tremors
  • Muscle twitching
  • Seizures
  • Bradycardia
  • Hypotension
  • Arrhythmias
  • Numbness of lips/tongue (beyond local effect)
  • Metallic taste

Special Patient Groups

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Pregnancy

Lidocaine is considered Category B. Animal studies have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed.

Trimester-Specific Risks:

First Trimester: Low risk, but use with caution.
Second Trimester: Low risk, but use with caution.
Third Trimester: Low risk, but use with caution.
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Lactation

Lidocaine is excreted into breast milk in small amounts. The amount ingested by the infant is generally considered too small to cause adverse effects. Use with caution, monitor infant for sedation or feeding difficulties.

Infant Risk: Low risk (L2)
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Pediatric Use

Contraindicated in infants and children younger than 3 years of age due to risk of systemic toxicity, seizures, cardiopulmonary arrest, and death. In children >3 years, use with extreme caution, only if benefits outweigh risks, and with strict adherence to weight-based dosing and monitoring for systemic toxicity. Accidental ingestion or inappropriate use is a significant risk.

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Geriatric Use

Use with caution. Elderly patients may be more susceptible to systemic toxicity due to decreased hepatic blood flow, reduced hepatic metabolism, and/or reduced renal function. Lower doses or extended dosing intervals may be necessary. Monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Emphasize the Black Box Warning to caregivers of pediatric patients; this drug is NOT for routine use in infants and young children.
  • Instruct patients to measure doses accurately using a dosing spoon or cup, not a household spoon.
  • Advise patients to swish and gargle thoroughly to maximize local effect before spitting or swallowing.
  • Warn patients about the risk of choking or biting their tongue/cheek due to numbness, especially when eating or drinking after use.
  • Systemic absorption can occur even with spitting out the solution, especially if mucous membranes are compromised (e.g., severe mucositis).
  • Monitor for CNS effects (dizziness, drowsiness, confusion, seizures) and cardiovascular effects (bradycardia, hypotension) as signs of systemic toxicity.
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Alternative Therapies

  • Benzydamine oral rinse (e.g., Tantum Verde)
  • Diphenhydramine/Maalox/Lidocaine (Magic Mouthwash - compounded)
  • Sucralfate suspension (for coating/protection)
  • Systemic analgesics (e.g., NSAIDs, opioids) for severe pain
  • Cryotherapy (ice chips) for mucositis prevention
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Cost & Coverage

Average Cost: Varies widely, typically $20-$50 per 100 mL bottle
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 this 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 overdose, including the medication taken, the amount, and the time it occurred.