LIDOPEN SUMMARY
Lidocaine Hydrochloride Injection, intramuscular for Cardiac Arrhythmias, is a non-pyrogenic, sterile solution prepared from lidocaine hydrochloride, USP and Water for Injection.
Lidocaine hydrochloride is indicated in the management of cardiac arrhythmias, particularly those of ventricular origin, such as occur with acute myocardial infarction.
The selection of the intramuscular route of administration (single dose) is justified in the following circumstances:
- By a physician in whose opinion the potential benefits outweigh the possible risks even when ECG equipment is not available to verify the arrhythmia.
- By, or under the supervision of, a physician, including mobile coronary care units, when facilities for intravenous administration are not readily available, or under circumstances where maintaining continuous intravenous therapy is difficult or impossible.
- For use in the pre-hospital phase of suspected acute myocardial infarction by a patient who has transmitted his electrocardiogram with a CardioBeeper®, whose electrocardiogram demonstrates the presence of a ventricular arrhythmia and who is instructed by qualified medical personnel to self-administer the LidoPen® Auto-Injector.
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