pharmacopeia
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Boxed warning

Life-threatening and fatal events in infants and young children Postmarketing cases of seizures, cardiopulmonary arrest, and death in patients under the age of 3 years have been reported with use of Lidocaine Viscous 2% when it was not administered in strict adherence to the dosing and administration recommendations. In the setting of teething pain, Lidocaine 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 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.

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Sodium Channel Interactions.

Indications

Sourced from openFDA
  • Lidocaine is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.

Contraindications

Sourced from openFDA
  • Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type, or to other components of the solution.contraindicated

Dosage & administration

Sourced from openFDA

Adult The maximum recommended single dose of lidocaine for healthy adults should be such that the dose of lidocaine does not exceed 4.5 mg/kg or 2 mg/lb body weight and does not in any case exceed a total of 300 mg. For symptomatic treatment of irritated or inflamed mucous membranes of the mouth and pharynx, the usual adult dose is 15 mL undiluted. For use in the mouth, the solution should be swished around in the mouth and spit out. For use in the pharynx, the undiluted solution should be gargled and may be swallowed. This dose should not be administered at intervals of less than three hours, and not more than eight doses should be given in a 24-hour period. The dosage should be adjusted commensurate with the patient’s age, weight and physical condition (see PRECAUTIONS ). Pediatric Care must be taken to ensure correct dosage in all pediatric patients as there have been cases of overdose due to inappropriate dosing. It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is determined by the child’s weight or age. For example: in a child of 5 years weighing 50 lbs., the dose of lidocaine should not exceed 75 to 100 mg (3.7 to 5 mL of lidocaine). For infants and in children under 3 years of age, the solution should be accurately measured and no more than 1.2 mL be applied to the immediate area with a cotton-tipped applicator.

Warnings & precautions

Sourced from openFDA

EXCESSIVE DOSAGE, OR SHORT INTERVALS BETWEEN DOSES, CAN RESULT IN HIGH PLASMA LEVELS AND SERIOUS ADVERSE EFFECTS. PATIENTS SHOULD BE INSTRUCTED TO STRICTLY ADHERE TO THE RECOMMENDED DOSAGE AND ADMINISTRATION GUIDELINES AS SET FORTH IN THIS PACKAGE INSERT. THE MANAGEMENT OF SERIOUS ADVERSE REACTIONS MAY REQUIRE THE USE OF RESUSCITATIVE EQUIPMENT, OXYGEN, AND OTHER RESUSCITATIVE DRUGS. Lidocaine should be used with extreme caution if the mucosa in the area of application has been traumatized, since under such conditions there is the potential for rapid systemic absorption. Life-threatening and fatal events in infants and young children Postmarketing cases of seizures, cardiopulmonary arrest, and death in patients under the age of 3 years have been reported with use of Lidocaine Viscous 2% when it was not administered in strict adherence to the dosing and administration recommendations. In the setting of teething pain, Lidocaine 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. Methemoglobinemia Cases of methemoglobinemia have been reported in association with local anesthetic use.

Adverse reactions

Sourced from openFDA

Adverse experiences following the administration of lidocaine are similar in nature to those observed with other amide local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage or rapid absorption, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported: Central Nervous System CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest. The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest. Drowsiness following the administration of lidocaine is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption. Cardiovascular System Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest. Allergic Allergic reactions are characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions.

Use in specific populations

Sourced from openFDA

Pregnancy Teratogenic Effects Pregnancy Category B: Reproduction studies have been performed in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed.

Overdosage

Sourced from openFDA

Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics. (See ADVERSE REACTIONS , WARNINGS , and PRECAUTIONS ) Management of Local Anesthetic Emergencies The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient’s state of consciousness after each local anesthetic administration. The first step in the management of convulsions consist of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen. In situations where trained personnel are readily available, ventilation should be maintained and oxygen should be delivered by a delivery system capable of permitting immediate positive airway pressure by mask. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated, keeping in mind that drugs used to treat convulsions sometimes depress the circulation when administered intravenously.

Approval history

Sourced from openFDA
  • Nov 19, 1948NDANDA006488Fresenius Kabi Usa
  • Mar 26, 1976NDANDA017584Fresenius Kabi Usa
  • Apr 22, 1981NDANDA018461Baxter Hlthcare
  • Apr 8, 1992NDANDA019830B Braun
  • Mar 19, 1999NDANDA020612Teikoku Pharma Usa
  • Dec 19, 2003NDANDA021451Dentsply Pharm
  • Jun 29, 2006NDANDA021717Crescita Therap
  • Oct 7, 2008NDANDA022221Thea Pharma

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Lidocaine, Patch, 5% (NDC 0591-2679-30)To be discontinued
    Sponsor: Actavis Pharma, Inc.
    Updated

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
94,207 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective13,04214%
  2. 2Off Label Use5,0995.4%
  3. 3Pain5,0975.4%
  4. 4Nausea4,8275.1%
  5. 5Fatigue4,7415.0%
  6. 6Headache4,3324.6%
  7. 7Product Quality Issue3,8974.1%
  8. 8Dyspnoea3,5503.8%
  9. 9Product Adhesion Issue3,4933.7%
  10. 10Diarrhoea3,2113.4%
  11. 11Condition Aggravated3,1813.4%
  12. 12Pneumonia3,0253.2%
  13. 13Vomiting2,9003.1%
  14. 14Dizziness2,8713.0%
  15. 15Sinusitis2,7532.9%

Literature

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Recent PubMed references pinned to Lidocaine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 3,993 ClinicalTrials.gov registrations naming Lidocaine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Lidocaine. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • G6PDCPIC B/C (provisional)

Frequently asked questions

How does Lidocaine work?
Mechanism-of-action class: Sodium Channel Interactions.
What is Lidocaine used for?
According to FDA labeling, Lidocaine carries indications including: Lidocaine is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Lidocaine?
Lidocaine is classified as Amides, Analgesics and anesthetics, Anesthetics for topical use, Anesthetics, local, Antiarrhythmics, class Ib, Local anesthetics, Amide Local Anesthetic, Antiarrhythmic, Sodium Channel Interactions, Cardiac Rhythm Alteration, Decreased Cardiac Muscle Organized Electrical Activity, Decreased Sensory-Somatic Nervous System Organized Electrical Activity, Local Anesthesia.
What are the brand names for Lidocaine?
Lidocaine is marketed under brand names including Abreva Rapid Pain Relief, Akten, Allercaine, Alocane, Alocane Max Strength, Alocane Plus, Ana-Lex, AneCream.
What are the contraindications for Lidocaine?
Lidocaine labeling lists contraindications including: Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type, or to other components of the solution.. Always consult the full prescribing information and a clinician.
Note. Data for lidocaine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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