Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)
Medical Purchasing Solutions, LLC
LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Lidocaine hydrochloride administered intravenously, 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 hydrochloride has been used clinically without evidence of abuse of this drug or of physiological or physical dependence as a result of its use.
Lidocaine Hydrochloride Injection, USP For Direct Intravenous Injection I n unit-use packages containing a Luer-Jet ™ Luer-Lock Prefilled Syringe. Ten cartons per package. Concentration Stock No. NDC No. Size 2% 3390 76329-3390-1 5 mL (100 mg) Syringe Assembly Directions: USE ASEPTIC TECHNIQUE Do not assemble until ready to use. *CAUTION: IMPROPER ENGAGING MAY CAUSE GLASS BREAKAGE AND SUBSEQUENT INJURY. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature]. INTERNATIONAL MEDICATION SYSTEMS, LIMITED REV. 8-11 So. El Monte , CA 91733, U.S.A. An Amphastar Pharmaceuticals Company
Abbreviated New Drug Application
LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE INJECTION MEDICAL PURCHASING SOLUTIONS, LLC ---------- 6933900B LIDOCAINE HYDROCHLORIDE INJECTION, USP {FOR VENTRICULAR ARRYTHMIAS} RX ONLY DESCRIPTION Lidocaine Hydrochloride Injection USP, is a sterile, aqueous solution of lidocaine, an antiarrhythmic agent, prepared with the aid of hydrochloric acid. It is intended for intravenous administration by either direct injection or continuous infusion. Lidocaine hydrochloride is designated 2-(Diethylamino)-2’, 6’-acetoxylidide monohydrochloride and isrepresented by the following structural formula: *pH of the above solution adjusted with sodium hydroxide and/or hydrochloric acid to finished product pH limits between 5 and 7. The medication and fluid pathway of these disposable syringes are sterile and nonpyrogenic in the original, unopened package with component caps in place. These dosage forms do not contain preservatives; once the unit is assembled and used, any remaining portion of the solution must be discarded with the entire unit. CLINICAL PHARMACOLOGY MECHANISMS 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 attenuates phase 4 diastolic depolarization, decreases automaticity and causes a decrease or no change in excitability and membrane responsiveness. Action potential duration and effective refractory period of Purkinje fibers are decreased, while the ratio of effective refractory period to action potential duration is increased. Action potential duration and effective refractory period of ventricular muscle are also decreased. Effective refractory period of the AV node may increase, decrease or remain unchanged, and atrial effective refractory period is unchanged. Lidocaine raises the ventricular fibrillation threshold. No significant interactions between lidocaine and the autonomic nervous system have been described and consequently lidocaine has little or no Прочитать полный документ