WARNINGS
EVERY EFFORT SHOULD BE MADE TO AVOID POSSIBLE INADVERTENT INTRAVASCULAR ADMINISTRATION THROUGH APPROPRIATE SELECTION OF INJECTION SITE SUCH AS THIGH OR DELTOID. DO NOT INJECT INTO BUTTOCK. Monitoring with an electrocardiograph is recommended when lidocaine hydrochloride is administered by the intramuscular route. In emergency situations when a ventricular rhythm disorder is suspected and electrocardiographic equipment is not available, a single dose may be administered when the physician in attendance has determined that the potential benefits outweigh the possible risks. If possible, emergency resuscitative equipment and drugs should be immediately available to manage potential adverse reactions involving the cardiovascular, respiratory, or central nervous system.
Occasional acceleration of ventricular rate may occur when lidocaine hydrochloride is administered to patients with atrial fibrillation.
PRECAUTIONS
General:
Caution should be employed in the repeated use of lidocaine hydrochloride in patients with severe liver or renal disease because accumulation may occur and lead to toxic phenomena since lidocaine hydrochloride is metabolized mainly in the liver and excreted by the kidneys. This drug should also be used with caution in patients with hypovolemia and shock and all forms of heart block.
Half-life and clearance of lidocaine are reduced, when administered to patients on propranolol. A recent study indicates that half-life was prolonged from 65 to 101 minutes and clearance was reduced from 18.0 to 10.7 mL/min/kg after single administration of lidocaine. The clearance of lidocaine was further reduced during continuous infusion. These factors should be considered when the LidoPen® Auto-Injector is prescribed and during use of lidocaine in patients on propranolol. See CONTRAINDICATIONS and WARNINGS.
Information for Patient:
A separate booklet containing patient information and instructions for self-administration is provided. The full text of the booklet is reprinted in DETAILED INSTRUCTIONS section.
Under no circumstances should the LidoPen® Auto-Injector be used without specific instructions to do so by qualified medical personnel.
Unless absolutely necessary, do not attempt to operate a motor vehicle after use.
Drug Interactions:
Caution should be exercised in administration to patient with known or suspected digitalis toxicity accompanied by atrioventricular block. See CONTRAINDICATIONS.
Many potent anesthetic drugs, neuromuscular blocking agents and possible amide local anesthetics may serve as triggering agents for the fulminant hypermetabolic process termed malignant hyperthermia.
Drug/Laboratory Test Interactions:
The intramuscular use of lidocaine hydrochloride may result in an increase in creatine phosphokinase levels. Thus, the use of the enzyme determination without isoenzyme separation, as a diagnostic test for the presence of acute myocardial infarction, may be compromised by the use of intramuscular lidocaine hydrochloride.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Studies of lidocaine in animals to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not been conducted.
Usage in Pregnancy:
Pregnancy Category B: Reproduction studies have been performed in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus due to lidocaine.
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.
Pediatric Use:
Intramuscular lidocaine hydrochloride should not be used in children under 50 kg (110 lbs).
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