tients 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.

ng 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 avoid potential overdosage and toxicity. intravenous infusion should be terminated as soon as the patient’s basic cardiac rhythm appears to be stable or at the earliest signs of toxicity (see overdosage). it should rarely be necessary to continue intravenous infusions beyond 24 hours. as soon as possible and when indicated, patients should be changed to an oral antiarrhythmic agent for maintenance therapy. caution: when administering lidocaine hydrochloride by continuous infusion, it is advisable to closely monitor the infusion rate. administer lidocaine hydrochloride and 5% dextrose injection, usp only with a calibrated infusion device. pediatric: clinical studies to establish pediatric dosing schedules have not been conducted. the usual dosage is a bolus dose of 1 mg/kg followed by an infusion rate of 20 mcg to 50 mcg/kg/min. the bolus dose should be repeated if infusion is not initiated within 15 minutes of the initial bolus dose. hepatic impairment is likely to decrease clearance and increase exposure level of lidocaine. administer lidocaine at lower maintenance infusion rate with close monitoring of toxicity in patients with hepatic impairment. renal impairment: in patients with severe renal impairment (egfr less than 30 ml/min/1.73 m2), administer lidocaine at lower maintenance infusion rate with close monitoring of toxicity. lidocaine is incompatible with the following due to precipitate formation (includes but is not limited to): • amphotericin • cephazolin sodium • phenytoin sodium parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. do not administer unless solution is clear, the seal is intact, and the container is undamaged. some opacity of the container plastic due to moisture absorption during the sterilization process may be observed. this is normal and does not affect solution quality or safety. the opacity will diminish gradually. use of a final filter is recommended during administration of all parenteral solutions, where possible. lidocaine must not be infused simultaneously through the same tubing with other medicinal products without first verifying their compatibility. set the vent to the close position on a vented intravenous administration set to prevent air embolism. all injections in viaflex plus plastic containers are intended for intravenous administration using sterile equipment. because dosages of this drug are titrated to response, no additives should be made to lidocaine hydrochloride and 5% dextrose injection, usp.

metabolites, and less than 10% is excreted unchanged. biotransformation includes oxidative n-dealkylation, ring hydroxylation, cleavage of the amide linkage, and conjugation. cyp1a2 and cyp3a4 mediated n-dealkylation, a major pathway of biotransformation, yields the metabolites monoethyl glycine xylidide (megx) and glycine xylidide (gx). the pharmacological/toxicological actions of these metabolites are similar to, but less potent than, those of lidocaine. the primary metabolite in urine is a conjugate of 4-hydroxy-2,6-dimethylaniline. the elimination half-life of lidocaine following an intravenous bolus injection is typically 1.5 to 2.0 hours. specific populations hepatic impairment because of the rapid rate at which lidocaine is metabolized, any condition that affects liver function may alter lidocaine kinetics. the half-life may be prolonged two-fold or more in patients with liver dysfunction. renal impairment mild or moderate renal impairment does not affect lidocaine kinetics; while in patients with severe renal dysfunction, lidocaine clearance is decreased by half and the accumulation of gx increased 1.5-fold. lidocaine toxicity is related to systemic blood levels. the decreased clearance and longer half-life of lidocaine should be taken into consideration with prolonged (24 hour) infusions. constant rate of infusion may result in toxic accumulation of lidocaine.