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U.S. Department of Health and Human Services

Safety

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Lidocaine Hydrochloride and 5% Dextrose Injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

January 2014

Summary View

CONTRAINDICATIONS

  • Lidocaine hydrochloride is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.
  • Lidocaine should not be used in patients with Stokes-Adams syndrome, Wolff-Parkinson-White Syndrome, or with severe degrees of sinoatrial, atrioventricular, or intraventricular block.
  • Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

WARNINGS

  • Constant monitoring with an electrocardiograph is essential to the proper administration of lidocaine hydrochloride intravenously. Signs of excessive depression of cardiac conductivity, such as prolongation of the PR interval, widening of the QRS interval or appearance or aggravation of arrhythmias, should be followed by prompt cessation of the intravenous infusion of this agent. It is mandatory to have emergency resuscitative equipment and drugs immediately available to manage adverse reactions involving cardiovascular, respiratory, or central nervous systems. Occasional acceleration of ventricular rate may occur when lidocaine hydrochloride is administered to patients with atrial fibrillation. Evidence for proper usage in pediatric patients is limited. Anaphylactic reactions may occur following administration of lidocaine hydrochloride. In the case of severe reaction, discontinue the use of the drug. Because dosages of this drug are titrated to response (see DOSAGE AND ADMINISTRATION), no additives should be made to Lidocaine Hydrochloride and 5% Dextrose Injection USP.

PRECAUTIONS

General
  • Caution should be employed in the repeated use of lidocaine hydrochloride in patients with severe liver or renal disease because accumulation may occur and lead to toxic phenomena, since lidocaine hydrochloride is metabolized mainly in the liver and excreted by the kidneys. The drug should also be used with caution in patients with hypovolemia and shock, and in all forms of heart block (see CONTRAINDICATIONS and WARNINGS).
  • In patients with sinus bradycardia or incomplete heart block, the administration of lidocaine hydrochloride intravenously for the elimination of ventricular ectopic beats without prior acceleration in heart rate (e.g., by isoproterenol or by electric pacing) may promote more frequent and serious ventricular arrhythmias or complete heart block (see CONTRAINDICATIONS).
  • Most potent anesthetic agents, local anesthetics of the amide type which includes lidocaine, and muscle relaxants of both depolarizing and nondepolarizing types have been associated with malignant hyperthermia.
  • Care should be taken in the administration of intravenous fluids in patients with compromised myocardial function to avoid fluid overload or disturbances of serum electrolyte  concentrations which might interfere with cardiac conduction or result in congestive heart failure.
  • If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. If administration is not controlled by a pumping device, refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container.
  • These solutions are intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours. Use only if solution is clear and container and seals are intact.
Drug Interactions
  • Added ..... potential interactions with cimetidine and amiodarone.
Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Long term animal studies have not been performed to evaluate carcinogenic potential of lidocaine; nor have studies been conducted to assess the mutagenic potential of lidocaine or its potential to affect fertility.

ADVERSE REACTIONS

Systemic reactions of the following types have been reported:

  1. Central Nervous System: Light-headedness; drowsiness; dizziness; apprehension; euphoria; tinnitus; blurred or double vision; vomiting; sensation of heat, cold or numbness; twitching; tremors; convulsions; unconsciousness; respiratory depression and arrest.
  2. Cardiovascular System: Hypotension; cardiovascular arrest; and bradycardia which may lead to cardiac arrest.
  3. Hematologic Effects: methemoglobinemia.
  4. Allergic reactions, including anaphylactic reactions, may occur but are infrequent. There have been no reports of cross-sensitivity between lidocaine hydrochloride and procainamide or between lidocaine hydrochloride and quinidine.

  

February 2013

Summary View

 

WARNINGS

  • Anaphylactic reactions may occur following administration of lidocaine hydrochloride. In the case of severe reaction, discontinue the use of the drug.
 

ADVERSE REACTIONS

  • Hematologic Effects: methemoglobinemia
  • Allergic reactions, including anaphylactic reactions