Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987)
Henry Schein, Inc.
INTRAVENOUS
PRESCRIPTION DRUG
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. Lidocaine hydrochloride is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type. Lidocaine hydrochloride should not be used in patients with Stokes-Adams syndrome, Wolff-Parkinson-White syndrome or with severe degrees of sinoatrial, atrioventricular or intraventricular block in the absence of an artificial pacemaker. Although specific studies have not been conducted, lidocaine HCl has been used clinically without evidence of abuse of this drug or of psychological or physical dependence as a result of its use.
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.] 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
Abbreviated New Drug Application
LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION HENRY SCHEIN, INC. ---------- LIDOCAINE HCL 1% 10 MG/ML INJECTION, USP 5 ML PREFILLED SYRINGE 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. CLINICAL PHARMACOLOGY Mechanism of Action an Les hele dokumentet