Lidopen label

Lidopen

Lidopen Recall

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Side Effects & Adverse Reactions

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.

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

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Uses

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:

  1. By a physician in whose opinion the potential benefits outweigh the possible risks even when ECG equipment is not available to verify the arrhythmia.
  2. 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.
  3. 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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History

There is currently no drug history available for this drug.

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Other Information

Lidocaine hydrochloride: acetamide, 2-(diethylamino)-N-(2, 6-dimethylphenyl)-, monohydrochloride has the following structural formula:

Image from Drug Label Content

Lidocaine Hydrochloride Injection, intramuscular for Cardiac Arrhythmias, is a non-pyrogenic, sterile solution prepared from lidocaine hydrochloride, USP and Water for Injection. Lidocaine hydrochloride: C14H22N2O • HCI • H2O has a molecular weight of 288.82.

Each LidoPen® contains 300 mg lidocaine hydrochloride, 3 mg disodium edetate, 3 mg methylparaben, sodium hydroxide in sufficient quantity to adjust pH to 5.2 in 3.0 mL Water for Injection.

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Lidopen Manufacturers

  • Meridian Medical Technologies, Inc.
    Lidopen | Meridian Medical Technologies, Inc.
    No Recall

    Lidopen | Meridian Medical Technologies, Inc.

    Lidopen | Meridian Medical Technologies, Inc.

    A physician who prescribes this device for the patient, must take appropriate steps to insure that his patient understands the indications and use of this device including review with the patient, in detail, the patient package insert and operation of the Auto-Injector.

    Inject the contents of 1 LidoPen® Auto-Injector (300 mg lidocaine hydrochloride, 3 mL, 10% solution) intramuscularly into the anterolateral aspect of the thigh or deltoid region of the arm. See DETAILED INSTRUCTIONS below.

    As soon as possible, and when indicated, patients should be changed to an intravenous infusion of lidocaine hydrochloride or to an oral antiarrhythmic preparation for maintenance therapy. However, if necessary, an additional intramuscular injection may be made after an interval of 60-90 minutes. IT SHOULD BE MADE CLEAR TO THE PATIENT THAT THIS SECOND INJECTION SHOULD NOT BE MADE WITHOUT FURTHER INSTRUCTIONS BY QUALIFIED MEDICAL PERSONNEL.

    DETAILED INSTRUCTIONS

    NOTE: A separate booklet containing information regarding self-administration of the LidoPen®Auto-Injector by patients equipped with a CardioBeeper®will be made available to the patient.

    Introduction:

    As part of the early management of a heart attack, your physician has prescribed for you a drug — lidocaine hydrochloride contained in an automatic injector — The LidoPen® Auto-Injector.

    This drug has been shown to be valuable in the management of certain abnormal heart rhythms which sometimes accompany heart attacks. As with all other drugs, it is not without risk. UNDER NO CIRCUMSTANCES SHOULD IT BE USED WITHOUT SPECIFIC INSTRUCTIONS TO DO SO BY QUALIFIED MEDICAL PERSONNEL.

    Therefore, your physician has taken steps to provide you with a CardioBeeper® with which to transmit your heart rate and rhythm by conventional telephone.

    Be certain to review the information contained in this booklet and practice with the use of the CardioBeeper®.

    The LidoPen® Auto-Injector:

    The LidoPen® Auto-Injector is a disposable, prefilled automatic injection device containing 300 mg lidocaine hydrochloride.

    Keep the LidoPen® Auto-Injector with you at all times. It should not be kept in excessive heat or cold. You should note the expiration date on the LidoPen® Auto-Injector and make sure yours is replaced prior to that date. When to use the LidoPen® Auto-Injector:

    If you experience the signs and symptoms described to you by your physician as suggesting a possible heart attack, immediately telephone your physician, or center designated by your physician, and transmit your electrocardiogram by CardioBeeper®. You will then be instructed whether or not you are to use the LidoPen® Auto-Injector.

    Directions for Use:

    When as described above, you have been instructed to use the LidoPen® Auto-Injector, proceed as follows:

    Remove gray safety cap. Place black end on thickest part of thigh and press hard until injector functions. Hold firmly in place for ten seconds, then remove. Massage the area of injection for 10 seconds.

    UNLESS ABSOLUTELY NECESSARY, DO NOT ATTEMPT TO OPERATE A MOTOR VEHICLE AFTER USE OF THE LidoPen® Auto-Injector.

    Proceed as instructed by physician.

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