Lidocaine Hydrochloride (Page 2 of 4)

PRECAUTIONS

1. General:

Caution should be employed in the use of lidocaine hydrochloride in patients with severe liver or kidney disease because accumulation of the drug or metabolites may occur.

Lidocaine Hydrochloride Injection, USP should be used with caution in the treatment of patients with hypovolemia, severe congestive heart failure, shock and all forms of heart block. 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 rate (e.g., by atropine, isoproterenol or electric pacing) may promote more frequent and serious ventricular arrhythmias or complete heart block (see CONTRAINDICATIONS).

Dosage should be reduced for pediatric patients and for debilitated and/or elderly patients, commensurate with their age and physical status.

The safety of amide local anesthetic agents in patients with genetic predisposition of malignant hyperthermia has not been fully assessed; therefore, lidocaine should be used with caution in such patients.

In hospital environments where drugs known to be triggering agents for malignant hyperthermia (fulminant hypermetabolism) are administered, it is suggested that a standard protocol for management should be available.

It is not known whether lidocaine may trigger this reaction; however, large doses resulting in significant plasma concentrations, as may be achieved by intravenous infusion, pose potential risk to these individuals. Recognition of early unexplained signs of tachycardia, tachypnea, labile blood pressure and metabolic acidosis may precede temperature elevation. Successful outcome is dependent on early diagnosis, prompt discontinuance of the triggering agent and institution of treatment including oxygen therapy, supportive measures and dantrolene (for details see dantrolene package insert).

2. Patient Information:

The patient should be advised of the possible occurrence of the experiences listed under ADVERSE REACTIONS.

3. Laboratory Tests:

None known.

4. Drug Interactions:

Lidocaine Hydrochloride Injection, USP should be used with caution in patients with digitalis toxicity accompanied by atrioventricular block. Concomitant use of beta-blocking agents or cimetidine may reduce hepatic blood flow and thereby reduce lidocaine clearance. The concomitant use of these two agents may cause an increased incidence of adverse reactions, including central nervous system adverse reactions such as seizure.

Lidocaine and tocainide are pharmacodynamically similar.

5. Carcinogenesis, Mutagenesis, Impairment of Fertility:

Long term studies in animals to evaluate the carcinogenic and mutagenic potential or the effect on fertility of lidocaine HCl have not been conducted.

6. Pregnancy:

Teratogenic Effects: Reproduction studies have been performed in rats at doses up to 6.6 times the maximum human doses and have revealed no significant findings. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

7. Labor and Delivery:

The effects of lidocaine HCl on the mother and the fetus, when used in the management of cardiac arrhythmias during labor and delivery are not known. Lidocaine readily crosses the placental barrier.

8. Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when lidocaine is administered to a nursing woman.

9. Pediatric Use:

Controlled clinical studies have not been conducted in the pediatric population to establish safety and efficacy in this population (see DOSAGE AND ADMINISTRATION).

ADVERSE REACTIONS

Adverse experiences following the administration of lidocaine are similar in nature to those observed with other amide local anesthetic agents. Adverse experiences may result from high plasma levels caused by excessive dosage 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. The adverse experiences under Central Nervous System and Cardiovascular System are listed, in general, in a progression from mild to severe.

  1. Central Nervous System: CNS reactions are excitatory and/or depressant and may be characterized by light-headedness, 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 reactions 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.

  2. Cardiovascular System: Cardiovascular reactions are usually depressant in nature and are characterized by bradycardia, hypotension and cardiovascular collapse, which may lead to cardiac arrest.

  3. Allergic reactions as a result of sensitivity to lidocaine are extremely rare and, if they occur, should be managed by conventional means.

  4. Neurologic: There have been reported cases of permanent injury to extraocular muscles requiring surgical repair following retrobulbar administration.

DRUG ABUSE AND DEPENDENCE

Although specific studies have not been conducted, lidocaine HCl has been used clinically without evidence of abuse of this drug or of psychological or physical dependence as a result of its use.

OVERDOSAGE

Overdosage of lidocaine HCl usually results in signs of central nervous system or cardiovascular toxicity (see ADVERSE REACTIONS).

Should convulsions or signs of respiratory depression and arrest develop, the patency of the airway and adequacy of ventilation must be assured immediately. Should convulsions persist despite ventilatory therapy with oxygen, small increments of anticonvulsive agents may be given intravenously. Examples of such agents include a benzodiazepine (e.g., diazepam), an ultrashort-acting barbiturate (e.g., thiopental or thiamylal) or a short-acting barbiturate (e.g., pentobarbital or secobarbital). If the patient is under general anesthesia, a short-acting muscle relaxant (e.g., succinylcholine) may be administered.

Should circulatory depression occur, vasopressors may be used. Should cardiac arrest occur, standard CPR procedures should be instituted.

Dialysis is of negligible value in the treatment of acute overdosage from lidocaine HCl.

DOSAGE AND ADMINISTRATION

Adults:

Single Direct Intravenous Injection (bolus): ONLY THE 5 mL, 50 MG or 100 MG DOSAGE SIZES should be used for direct intravenous injection. The usual dose is 50 to 100 mg of lidocaine hydrochloride (0.70 to 1.4 mg/kg; 0.32 to 0.63 mg/lb) administered intravenously under ECG monitoring. This dose may be administered at the rate of approximately 25 to 50 mg/min (0.35 to 0.70 mg/kg/min; 0.16 to 0.32 mg/lb/min). Sufficient time should be allowed to enable a slow circulation to carry the drug to the site of action. If the initial injection of 50 to 100 mg does not produce a desired response, a second dose may be injected after five minutes. NO MORE THAN 200 TO 300 MG OF LIDOCAINE HYDROCHLORIDE SHOULD BE ADMINISTERED DURING A ONE HOUR PERIOD.

Continuous Intravenous Infusion: Following bolus administration, intravenous infusions of lidocaine hydrochloride may be initiated at the rate of 1 to 4 mg/min of lidocaine hydrochloride (0.014 to 0.057 mg/kg/min; 0.006 to 0.026 mg/lb/min). The rate of intravenous infusions should be reassessed as soon as the patient’s basic cardiac rhythm appears to be stable or at the earliest signs of toxicity. It should rarely be necessary to continue intravenous infusions of lidocaine for prolonged periods.

When administering lidocaine hydrochloride (or any potent medication) by continuous intravenous infusion, it is advisable to use a precision volume control I.V. set.

Pediatric: Controlled clinical studies in the pediatric population to establish dosing schedules have not been conducted. The American Heart Association’s Standards and Guidelines recommends a bolus dose of 1 mg/kg, and an infusion rate of between 20-50 mcg/kg/min for prolonged therapy. When drug clearance is reduced, as in patients with shock, congestive heart failure or cardiac arrest, the infusion rate should not exceed 20 mcg/kg/min.

NOTE: Regarding Prolonged Infusions: There are data that indicate the half-life may be 3 hours or longer following infusions of greater than 24 hours in duration. Do not use if solution is discolored or cloudy.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

To prevent needle-stick injuries, needles should not be recapped, purposely bent or broken by hand.

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