Lidocaine (oral topical)

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Lidocaine (oral topical)
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]

Disclaimer

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Black Box Warning

WARNING: LIFE-THREATENING AND FATAL EVENTS IN INFANTS AND YOUNG CHILDREN
See full prescribing information for complete Boxed Warning.
* Postmarketing cases of seizures, cardiopulmonary arrest, and death in patients under the age of 3 years have been reported with use of Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% when it was not administered in strict adherence to the dosing and administration recommendations. In the setting of teething pain, Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% should generally not be used. For other conditions, the use of the product in patients less than 3 years of age should be limited to those situations where safer alternatives are not available or have been tried but failed.
  • To decrease the risk of serious adverse events with use of Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, instruct caregivers to strictly adhere to the prescribed dose and frequency of administration and store the prescription bottle safely out of reach of children.

Overview

Lidocaine (oral topical) is an amino amide and local anesthetic agent that is FDA approved for the treatment of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include {{{adverseReactions}}}.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Lidocaine (oral topical) FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Lidocaine (oral topical) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Lidocaine (oral topical) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Lidocaine (oral topical) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Lidocaine (oral topical) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Lidocaine (oral topical) in pediatric patients.

Contraindications

There is limited information regarding Lidocaine (oral topical) Contraindications in the drug label.

Warnings

WARNING: LIFE-THREATENING AND FATAL EVENTS IN INFANTS AND YOUNG CHILDREN
See full prescribing information for complete Boxed Warning.
* Postmarketing cases of seizures, cardiopulmonary arrest, and death in patients under the age of 3 years have been reported with use of Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% when it was not administered in strict adherence to the dosing and administration recommendations. In the setting of teething pain, Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% should generally not be used. For other conditions, the use of the product in patients less than 3 years of age should be limited to those situations where safer alternatives are not available or have been tried but failed.
  • To decrease the risk of serious adverse events with use of Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, instruct caregivers to strictly adhere to the prescribed dose and frequency of administration and store the prescription bottle safely out of reach of children.

There is limited information regarding Lidocaine (oral topical) Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Lidocaine (oral topical) Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Lidocaine (oral topical) Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Lidocaine (oral topical) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Lidocaine (oral topical) in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Lidocaine (oral topical) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Lidocaine (oral topical) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Lidocaine (oral topical) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Lidocaine (oral topical) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Lidocaine (oral topical) in geriatric settings.

Gender

There is no FDA guidance on the use of Lidocaine (oral topical) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Lidocaine (oral topical) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Lidocaine (oral topical) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Lidocaine (oral topical) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Lidocaine (oral topical) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Lidocaine (oral topical) in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral Topical

Monitoring

There is limited information regarding Lidocaine (oral topical) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Lidocaine (oral topical) and IV administrations.

Overdosage

There is limited information regarding Lidocaine (oral topical) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Lidocaine (oral topical) Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Lidocaine (oral topical) Mechanism of Action in the drug label.

Structure

There is limited information regarding Lidocaine (oral topical) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Lidocaine (oral topical) Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Lidocaine (oral topical) Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Lidocaine (oral topical) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Lidocaine (oral topical) Clinical Studies in the drug label.

How Supplied

There is limited information regarding Lidocaine (oral topical) How Supplied in the drug label.

Storage

There is limited information regarding Lidocaine (oral topical) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Lidocaine (oral topical) Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Lidocaine (oral topical) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Lidocaine (oral topical) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Lidocaine (oral topical) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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