Drug Catalog - Product Detail
LIDOCAINE HCI IV SOL 20MG/ML 5ML X 10
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00409-1323-05 | HOSPIRA | 5 | 100MG/5ML | NA |
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Description
Description AQUEOUS SOLUTIONS FOR ACUTE MANAGEMENT OF VENTRICULAR ARRHYTHMIAS Ansyr® Plastic Syringe LifeShield® Abboject® Syringe Rx only 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: 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. Formula1.jpg Image1.jpg
How Supplied
How Supplied Lidocaine Hydrochloride Injection, USP is supplied as follows: **Abboject® Unit of Use Syringe with Male Luer Lock Adapter and protected needle. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature.] Product repackaged by: Henry Schein, Inc., Bastian, VA 24314 From Original Manufacturer/Distributor's NDC and Unit of Sale To Henry Schein Repackaged Product NDC and Unit of Sale Total Strength/Total Volume (Concentration) per unit NDC 0409-1323-05 5 mL Ansyr® Plastic Syringe 10 in a Carton NDC 0404-9894-05 1 5 mL Ansyr® Plastic Syringe in a bag (Syringe bears NDC 0409-1323-15) 2% (20 mg/mL) 100 mg Total NDC 0409-9137-05 5 mL Ansyr® Plastic Syringe NDC 0404-9889-05 1 5 mL Ansyr® Plastic Syringe in a bag (Syringe bears NDC 0409-9137-11) 1% (10 mg/mL) 50 mg Total NDC 0409-4903-34 LifeShield® Abboject® Syringe with Male Luer Lock Adapter NDC 0404-9892-05 1 5 mL Lifeshield® Abboject® Syringe with Male Luer Lock Adapter in a bag (Syringe bears 0409-4903-11) 2% (20 mg/mL) 100 mg Total NDC 0409-4904-34 LifeShield® Abboject® Syringe with Male Luer Lock Adapter NDC 0404-9890-05 1 5 mL Lifeshield® Abboject® Syringe with Male Luer Lock Adapter in a bag (Syringe bears NDC 0409-4904-11) 1% (10 mg/mL) 50 mg Total Distributed by: Hospira, Inc., Lake Forest, IL 60045 USA Abboject® is a trademark of the Abbott group of companies. LIFESHIELD® is the trademark of ICU Medical, Inc. and is used under license. LAB-1021-3.0 Revised: 04/2018 Image2.jpg
Indications & Usage
Indications and Usage Lidocaine hydrochloride injection administered intravenously or intramuscularly, is specifically indicated in the acute management of ventricular arrhythmias such as those occurring in relation to acute myocardial infarction, or during cardiac manipulation, such as cardiac surgery.
Dosage and Administration
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: RegardingProlongedInfusions: 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.