Drugplain

Lidocaine Hydrochloride and Dextrose 5 g/100mL

LIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATE · INJECTION, SOLUTION · ProPharma Distribution

No Recall HistoryCurrently in Shortage
Plain English

Lidocaine Hydrochloride and Dextrose is a injection, solution containing lidocaine hydrochloride anhydrous and dextrose monohydrate at 5 g/100mL, taken intravenous. Manufactured by ProPharma Distribution.

Key Facts

Brand Name
Lidocaine Hydrochloride and Dextrose
Generic Name
LIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATE
NDC Code (Product)
84549-594
Manufacturer
ProPharma Distribution
Strength
5 g/100mL
Dosage Form
INJECTION, SOLUTION
Route
INTRAVENOUS
Marketing Status
Application #
NDA019830
Marketing Start
04/08/1992

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

infusion site pain682 reports
drug ineffective536 reports
nausea474 reports
infusion site erythema422 reports
headache419 reports
dyspnoea410 reports
off label use404 reports
diarrhoea398 reports
fatigue350 reports
pain332 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & 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.

Dosage & Administration

Therapy of ventricular arrhythmias is often initiated with a single IV bolus of 1.0 to 1.5 mg/kg at a rate of 25 to 50 mg/min. of lidocaine hydrochloride injection. Following acute treatment by bolus in patients in whom arrhythmias tend to recur and who are incapable of receiving oral antiarrhythmic agents, intravenous infusion of Lidocaine Hydrochloride and 5% Dextrose Injection, USP is administered continuously at the rate of 1 to 4 mg/min (0.020 to 0.050 mg/kg/min in the average 70 kg adult). The 0.4% solution (4 mg/mL) can be given at a rate of 15 to 60 mL/hr (0.25 to 1 mL/min). The 0.8% solution (8 mg/mL) can be given at a rate of 7.5 to 30 mL/hr (0.12 to 0.5 mL/min). Precise dosage regimen is determined by patient characteristics and response. Infusion rate should be reduced by approximately one-half to compensate for decreased rate of clearance after prolonged infusion (24 hours) (see Clinical Pharmacology). Failure to adjust the rate of infusion in keeping with this altered ability to eliminate lidocaine may result in toxic accumulation of the drug in the patient’s serum. Intravenous infusions of lidocaine hydrochloride must be administered under constant ECG monitoring to

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.

Contraindications

Hypersensitivity reactions, including anaphylactic reactions, have been reported with lidocaine. Lidocaine hydrochloride is contraindicated in patients with a history of hypersensitivity to local anesthetics of the amide type. Lidocaine is contraindicated in patients with Stokes-Adams syndrome, Wolff-Parkinson-White syndrome, or with severe degrees of sinoatrial, atrioventricular, or intraventricular block.

Adverse Reactions

Systemic reactions of the following types have been reported: Nervous System Disorders: respiratory depression and arrest; unconsciousness; convulsions; tremors; twitching; vomiting; blurred or double vision; drowsiness; dizziness; light-headedness; tinnitus; sensation of heat, cold or numbness; euphoria; apprehension; agitation; confused state; paresthesia; dysarthria. Cardiovascular System: cardiovascular arrest; bradycardia which may lead to cardiac arrest; hypotension, Ventricular fibrillation, Ventricular tachycardia, Ventricular arrhythmia, Asystole. Gastrointestinal Disorders: Hypoesthesia oral, Nausea, Hematologic Effects: methemoglobinemia. Psychiatric Disorders: Disorientation Allergic reactions, including anaphylactic reactions, may occur but are infrequent. There have been no reports of cross sensitivity between lidocaine hydrochloride and procainamide or between lidocaine hydrochloride and quinidine.

Frequently Asked Questions

What is Lidocaine Hydrochloride and Dextrose used for?

Lidocaine Hydrochloride and Dextrose contains LIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATE. It is a injection, solution taken intravenous. Consult your doctor for specific uses.

Is Lidocaine Hydrochloride and Dextrose a controlled substance?

Lidocaine Hydrochloride and Dextrose is not classified as a controlled substance by the DEA.

What is the generic name for Lidocaine Hydrochloride and Dextrose?

The generic name for Lidocaine Hydrochloride and Dextrose is LIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATE. There are no other listed brand versions of LIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATE.

What is the NDC code for Lidocaine Hydrochloride and Dextrose 5 g/100mL?

The NDC (National Drug Code) for Lidocaine Hydrochloride and Dextrose 5 g/100mL is 84549-594, listed by ProPharma Distribution.

Product NDC

84549-594

Package NDC

84549-594-20

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)