LIDOCAINE HCI

Lidocaine hydrochloride, chemical name: acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride has the following structural formula: Lidocaine Hydrochloride Injection, USP intravenous for cardiac arrhythmias, is a sterile, nonpyrogenic solution prepared from lidocaine with the aid of hydrochloric acid in Water for Injection. Each mL contains: Lidocaine HCl 20 mg; Sodium Chloride 6 mg; Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (pH 5.0 to 7.0). The container is for single use; solution contains no preservative. STRUCTURE

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.

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.

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.