LIDOCAINE HCI

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.

DOAAGE & ADMINISTRATION Adult For Direct Injection–The usual dose is 50 to 100 mg administered intravenously under ECG monitoring. This dose may be administered at the rate of approximately 25 to 50 mg/min. Sufficient time should be allowed to enable a slow circulation to carry the drug to the site of action. If the initial injection of 50 to 100 mg does not produce a desired response, a second dose may be repeated after 5 minutes. NO MORE THAN 200 TO 300 MG OF LIDOCAINE HYDROCHLORIDE INJECTION, USP SHOULD BE ADMINISTERED DURING A ONE HOUR PERIOD. This product is for DIRECT INJECTION ONLY. For continuous infusion protocol, see prescribing information for lidocaine hydrochloride, USP for infusion solution. Pediatric Although controlled clinical studies to establish pediatric dosing schedules have not been conducted, the American Heart Association’s Standards and Guidelines recommends a bolus dose of 1 mg/kg followed by an infusion rate of 30 mcg/kg/min. This product is for DIRECT INJECTION ONLY. For continuous infusion protocol, see prescribing information for lidocaine hydrochloride, USP for infusion solution. Sterilization, Storage and Technical Procedures It is recommended that chemical disinfection be accomplished by wiping the vial thoroughly with cotton or gauze that has been moistened with either 91% isopropyl alcohol or 70% ethyl alcohol, just prior to use. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

CONTRAINDICATIONS Lidocaine Hydrochloride Injection, USP is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type. Lidocaine Hydrochloride Injection, USP should not be used in patients with STOKES-ADAMS syndrome, Wolff-Parkinson-White syndrome, or with severe degrees of sinoatrial, atrioventricular or intraventricular block.

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.