Country: United States
Language: English
Source: NLM (National Library of Medicine)
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)
Hospira, 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. For direct intravenous injection: Single-dose: 0409-1323-05 Ansyr® Plastic Syringe 2% (20 mg/mL) 5 mL 100 0409-9137-05 Ansyr® Plastic Syringe 1% (10 mg/mL) 5 mL 50 0409-4903-34 LifeShield® Abboject® Syringe with Male Luer Lock Adapter (20-Gauge protected needle)** 2% (20 mg/mL) 5 mL 100 0409-4904-34 LifeShield® Abboject® Syringe with Male Luer Lock Adapter (20-Gauge protected needle)** 1% (10 mg/mL) 5 mL 50 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.
Abbreviated New Drug Application
LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION HOSPIRA, INC. ---------- LIDOCAINE HYDROCHLORIDE INJECTION, USP _AQUEOUS SOLUTIONS FOR_ _ACUTE MANAGEMENT OF_ _VENTRICULAR ARRHYTHMIAS_ ANSYR PLASTIC SYRINGE LIFESHIELD ABBOJECT SYRINGE ABBOJECT SYRINGE Rx only DESCRIPTION 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: VOLUME (TOTAL LIDOCAINE HCL) LIDOCAINE HYDROCHLORIDE (MG/ML) PH For Direct Intravenous Injection: 5 mL (100 mg) 20 5.0 to 7.0 Single-dose: 5 mL (50 mg) 10 5.0 to 7.0 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 C H N O • HCl • H O. The molecular weight is 288.82. It has the following structural formula: ® ® ® ® 14 22 2 2 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 AND ELECTROPHYSIOLOGY: Studies of the effects of therapeutic concentrations of lidocaine on the electrophysiological properties of mammalian Purkinje fibers have shown that lidocaine atte Read the complete document