INDICATIONS & USAGE Lidocaine Hydrochloride Injection, USP administered intravenously is specifically indicated in the acute management of 1) ventricular arrhythmias occurring during cardiac manipulation such as cardiac surgery, and 2) life-threatening arrhythmias, particularly those which are ventricular in origin, such as those which occur during acute myocardial infarction.

WARNINGS Constant monitoring of the electrocardiogram and blood pressure is essential in the proper administration of Lidocaine Hydrochloride Injection, USP intravenously.

If hypotension or excessive depression of cardiac conductivity (such as prolongation of the PR interval and QRS complex and the appearance of aggravation of arrhythmias) is seen, administration of Lidocaine Hydrochloride Injection, USP should be discontinued.

Emergency resuscitative equipment and drugs must be immediately available to manage possible adverse reactions involving the cardiovascular, respiratory, or central nervous system.

Occasional acceleration of ventricular rate may occur when Lidocaine Hydrochloride Injection, USP is administered to patients with atrial fibrillation.

Toxicity may be manifest as 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 the problem.

Should convulsions persist despite ventilatory support, small doses of anticonvulsant drugs may be used intravenously.

Examples of such drugs include benzodiazepines (e.g., diazepam, lorazepam), or an ultrashort acting barbiturate (e.g., thiopental or thiamylal).

If the patient is under anesthesia, a short-acting muscle relaxant (succinylcholine) may be used.

Longer acting drugs should be used only when recurrent convulsions are evidenced.

ADVERSE REACTIONS Most adverse reactions accompanying administration of Lidocaine Hydrochloride Injection, USP result from systemic toxicity affecting primarily the central nervous system and the cardiovascular system.

Systemic reactions of the following types have been reported: 1.

Central Nervous System Light-headedness; drowsiness; dizziness; apprehension; euphoria; tinnitus; blurred vision or double vision; vomiting; sensations of heat; cold or numbness; twitching; tremors; convulsions; unconsciousness; respiratory depression and arrest.

2.

Cardiovascular System Hypotension; cardiovascular collapse; and bradycardia which may lead to cardiac arrest.

Continuous monitoring of blood pressure and the electrocardiogram are essential to prevent these events.

3.

Allergic reactions may occur but are infrequent.

There have been no reports of cross-sensitivity between lidocaine hydrochloride and procainamide or between lidocaine and quinidine.