Lidocaine warnings and precautions

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Lidocaine
XYLOCAINE® FDA Package Insert
Indications and Usage
Dosage and Administration
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
How Supplied/Storage and Handling
Labels and Packages
Clinical Trials on Lidocaine
ClinicalTrials.gov

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

Warnings

IN ORDER TO MANAGE POSSIBLE ADVERSE REACTIONS, RESUSCITATIVE EQUIPMENT, OXYGEN AND OTHER RESUSCITATIVE DRUGS SHOULD BE IMMEDIATELY AVAILABLE WHEN XYLOCAINE (LIDOCAINE HCl INJECTION, USP) IS USED.

Systemic toxicity may result in manifestations of central nervous system depression (sedation) or irritability (twitching), which may progress to frank convulsions accompanied by respiratory depression and/or arrest. Early recognition of premonitory signs, assurance of adequate oxygenation and, where necessary, establishment of artificial airway with ventilatory support are essential to management of this problem. Should convulsions persist despite ventilatory therapy with oxygen, small increments of anticonvulsant drugs may be used intravenously. Examples of such agents include benzodiazepines (eg, diazepam), ultrashort-acting barbiturates (eg, thiopental or thiamylal), or a short-acting barbiturate (eg, pentobarbital or secobarbital). If the patient is under anesthesia, a short-acting muscle relaxant (eg, succinylcholine) may be used. Longer-acting drugs should be used only when recurrent convulsions are evidenced.

Should circulatory depression occur, vasopressors may be used.

Constant electrocardiographic monitoring is essential to the proper administration of Xylocaine. Signs of excessive depression of cardiac electrical activity such as sinus node dysfunction, prolongation of the P-R interval and QRS complex or the appearance or aggravation of arrhythmias, should be followed by flow adjustment and, if necessary, prompt cessation of the intravenous infusion of this agent. Occasionally, acceleration of ventricular rate may occur when Xylocaine is administered to patients with atrial flutter or fibrillation.

Precautions

General

Caution should be employed in the use of Xylocaine in patients with severe liver or kidney disease because accumulation of the drug or metabolites may occur. Xylocaine should be used with caution in the treatment of patients with hypovolemia, severe congestive heart failure, shock, and all forms of heart block. In patients with sinus bradycardia or incomplete heart block, the administration of Xylocaine intravenously for the elimination of ventricular ectopic beats, without prior acceleration in heart rate (eg, by atropine, isoproterenol or electric pacing), may promote more frequent and serious ventricular arrhythmias or complete heart block (see CONTRAINDICATIONS).

Dosage should be reduced for pediatric patients and for debilitated and/or elderly patients, commensurate with their age and physical status.

The safety of amide local anesthetic agents in patients with genetic predisposition to malignant hyperthermia has not been fully assessed; therefore, lidocaine should be used with caution in such patients.

In hospital environments where drugs known to be triggering agents for malignant hyperthermia (fulminant hypermetabolism) are administered, it is suggested that a standard protocol for management should be available.

It is not known whether lidocaine may trigger this reaction; however, large doses resulting in significant plasma concentrations, as may be achieved by intravenous infusion, pose potential risk to these individuals. Recognition of early unexplained signs of tachycardia, tachypnea, labile blood pressure and metabolic acidosis may precede temperature elevation. Successful outcome is dependent on early diagnosis, prompt discontinuance of the triggering agent and institution of treatment including oxygen therapy, supportive measures and dantrolene (for details see dantrolene package insert).[1]

References

  1. "XYLOCAINE (LIDOCAINE HYDROCHLORIDE) INJECTION [ASTRAZENECA LP]".

Adapted from the FDA Package Insert.