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Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride in water for injection for parenteral administration in various concentrations with characteristics as follows:
mg/mL lidocaine HCl (anhyd.)
mg/mL sodium chloride
Multiple-dose vials contain 0.1% of methylparaben added as preservative. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The pH is 6.5 (5.0 to 7.0). See HOW SUPPLIED section for various sizes and strengths.
Lidocaine is a local anesthetic of the amide type.
Lidocaine Hydrochloride, USP is chemically designated 2-(diethylamino)-N-(2,6-dimethylphenyl)-acetamide monohydrochloride monohydrate, a white powder freely soluble in water. The molecular weight is 288.82. It has the following structural formula:
The semi-rigid vial used for the plastic vials is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.
Systemic: Adverse experiences following the administration of lidocaine are similar in nature to those observed with other amide local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage, rapid absorption or inadvertent intravascular injection, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported:
Central Nervous System: CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest. The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest.
Drowsiness following the administration of lidocaine is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption.
Cardiovascular System: Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest.
Allergic: Allergic reactions are characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions. Allergic reactions may occur as a result of sensitivity either to local anesthetic agents or to the methylparaben used as a preservative in multiple dose vials. Allergic reactions as a result of sensitivity to lidocaine are extremely rare and, if they occur, should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.
Neurologic: The incidences of adverse reactions associated with the use of local anesthetics may be related to the total dose of local anesthetic administered and are also dependent upon the particular drug used, the route of administration and the physical status of the patient. In a prospective review of 10,440 patients who received lidocaine for spinal anesthesia, the incidences of adverse reactions were reported to be about 3 percent each for positional headaches, hypotension and backache; 2 percent for shivering; and less than 1 percent each for peripheral nerve symptoms, nausea, respiratory inadequacy and double vision. Many of these observations may be related to local anesthetic techniques, with or without a contribution from the local anesthetic.
In the practice of caudal or lumbar epidural block, occasional unintentional penetration of the subarachnoid space by the catheter may occur. Subsequent adverse effects may depend partially on the amount of drug administered subdurally.
These may include spinal block of varying magnitude (including total spinal block), hypotension secondary to spinal block, loss of bladder and bowel control, and loss of perineal sensation and sexual function. Persistent motor, sensory and/or autonomic (sphincter control) deficit of some lower spinal segments with slow recovery (several months) or incomplete recovery have been reported in rare instances when caudal or lumbar epidural block has been attempted. Backache and headache have also been noted following use of these anesthetic procedures.
There have been reported cases of permanent injury to extraocular muscles requiring surgical repair following retrobulbar administration.
Usual Adult Dose for Ventricular Fibrillation
Initial dose: 50 to 100 mg IV bolus once over 2 to 3 minutes; may repeat after 5 minutes if necessary not to exceed up to 300 mg in a 1-hour period
Following bolus administration: 1 to 4 mg/min continuous IV infusion
-Patients should be under constant ECG monitoring during administration of this drug.
-Sufficient time should be allowed to enable a slow circulation to carry this drug to the site of action.
-The rate of the IV infusion should be reassessed as soon as the patient's basic cardiac rhythm appears stable or at the earliest signs of toxicity.
Uses: For the acute management of ventricular arrhythmias occurring during cardiac manipulations, such as cardiac surgery; and for life-threatening arrhythmias which are ventricular in origin, such as those that occur during acute myocardial infarction
The American Heart Association (AHA) recommends:
-Initial dose: 1 to 1.5 mg/kg IV bolus once; may repeat if necessary at a dose of 0.5 to 0.75 mg/kg IV every 5 to 10 minutes up to a maximum cumulative dose of 3 mg/kg
-Following bolus administration: 1 to 4 mg/min continuous IV infusion (30 to 50 mcg/kg/min)
Endotracheal: May be administered endotracheally (bolus dose only) if IV access unavailable at a dose of 2 to 2.5 times the IV dose diluted in 5 to 10 mL NS or distilled water
Uses: For the treatment of ventricular fibrillation (VF) or pulseless ventricular tachycardia (pVT) unresponsive to CPR, defibrillation, and vasopressor therapy as an alternative to amiodarone
Usual Pediatric Dose for Ventricular Fibrillation
The manufacturer gives no specific dosing instructions.
The AHA recommends:
-Initial dose: 1 mg/kg IV or intraosseous once
-Maintenance infusion: 20 to 50 mcg/kg/min IV
Endotracheal: May be administered endotracheally (bolus dose only) if IV or intraosseous access unavailable at a dose of 2 to 3 times the dose (2 to 3 mg/kg) followed by a flush with at least 5 mL of NS and 5 consecutive positive-pressure ventilations
Use: For use in shock-refractory VF or pVT after resuscitation from cardiac arrest in infants and children
Renal Dose Adjustments
Use with caution; renal dysfunction may increase the accumulation of metabolites, leading to toxicity.