LIDOCAINE HYDROCHLORIDE AND DEXTROSE

FDA Drug Profile — LIDOCAINE HYDROCHLORIDE AND DEXTROSE

Drug Details

Generic Name
LIDOCAINE HYDROCHLORIDE AND DEXTROSE
Brand Names
LIDOCAINE HYDROCHLORIDE AND DEXTROSE
Application Number
NDA018461
Sponsor
HF Acquisition Co LLC, DBA HealthFirst
NDC Codes
1
Dosage Forms
INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients
LIDOCAINE HYDROCHLORIDE

Indications and Usage

Lidocaine hydrochloride administered intravenously is specifically indicated in the acute management of (1) ventricular arrhythmias occurring during cardiac manipulations, such as cardiac surgery and (2) life-threatening arrhythmias which are ventricular in origin, such as occur during acute myocardial infarction.

Warnings

Constant monitoring with an electrocardiograph is essential to the administration of lidocaine hydrochloride intravenously. Signs of excessive depression of cardiac conductivity, such as prolongation of the PR interval, widening of the QRS interval and the 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. Central nervous system adverse reactions are associated with venous plasma levels above 6.0 μg free base per mL (see ADVERSE REACTIONS). Hypersensitivity, including anaphylaxis, has been reported with lidocaine-containing solutions. Stop the infusion immediately if signs of hypersensitivity develop. Acceleration of ventricular rate may occur in patients with atrial fibrillation or flutter treated with lidocaine. 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 r ate (e.g., by isoproterenol or by electric pacing) may promote more frequent and serious ventricular arrhythmias or complete heart block (see Contraindications). Because lidocaine is metabolized mainly in the liver and excreted by the kidneys, patients with renal or hepatic insufficiency may be at increased risk for toxicity.