LIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATE

FDA Drug Profile — Lidocaine Hydrochloride and Dextrose

Drug Details

Generic Name
LIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATE
Brand Names
Lidocaine Hydrochloride and Dextrose
Application Number
NDA019830
Sponsor
ProPharma Distribution
NDC Codes
3
Dosage Forms
INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients
DEXTROSE MONOHYDRATE, LIDOCAINE HYDROCHLORIDE ANHYDROUS

Indications and Usage

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

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 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. 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 .