Drug Information for 2% Lidocaine HCl Injection, USP100 mg (20 mg/mL) Aqueous Solutions For Acute Management of Ventricular Arrhythmias (McKesson Packaging Services Business Unit of McKesson Corporation): DESCRIPTION

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  • Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of an antiarrhythmic agent administered intravenously by either direct injection or continuous infusion. It is available in various concentrations with the following characteristics:

    Lidocaine

    Volume

    Hydrochloride

    (Total Lidocaine HCl)

    (mg/mL)

    pH

    For Direct Intravenous Injection

    5 mL (100 mg)

    20

    6.0 (5.0 to 7.0)

    Single-dose

    5 mL (50 mg)

    10

    6.0 (5.0 to 7.0)

    For Preparation

    10 mL (1000 mg)

    100

    5.7 (5.0 to 7.0)

    of Intravenous

    Infusion Solutions*

    10 mL (2000 mg)

    200

    5.7 (5.0 to 7.0)

    *1000 mg and 2000 mg concentrations FOR DILUTION ONLY.

    Must not be administered without proper dilution prior to injection.

    May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. Injections containing 10 mg/mL (1%) contain sodium chloride 7 mg and injections containing 20 mg/mL (2%) lidocaine hydrochloride contain sodium chloride 6 mg to adjust tonicity. Single-dose solutions contain no preservative and unused portions must be discarded after use.

    Lidocaine Hydrochloride, USP is chemically designated 2-(Diethylamino)-2’,6’-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. The molecular formula is C14H22N2O• HCl •H2O. 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.

    The plastic syringe is molded from a specially formulated polypropylene. Water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration over the expected shelf life. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the syringe material.

  • Drug Information Provided by National Library of Medicine (NLM).
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