البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987), DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)
B. Braun Medical Inc.
LIDOCAINE HYDROCHLORIDE ANHYDROUS
LIDOCAINE HYDROCHLORIDE ANHYDROUS 0.8 g in 100 mL
INTRAVENOUS
PRESCRIPTION DRUG
Lidocaine hydrochloride administered intravenously is specifically indicated in the acute management of (1) ventricular arrhythmias occurring during cardiac manipulations, such as cardiac surgery and (2) life-threatening arrhythmias which are ventricular in origin, such as occur during acute myocardial infarction. Lidocaine hydrochloride is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type. Lidocaine should not be used in patients with Stokes-Adams syndrome, Wolff-Parkinson-White syndrome, or with severe degrees of sinoatrial, atrioventricular, or intraventricular block. Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.
Lidocaine Hydrochloride and 5% Dextrose Injection USP is supplied sterile and nonpyrogenic in Full Fill 500 mL and 250 mL EXCEL® Containers packaged 24 per case. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product. Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.
New Drug Application
LIDOCAINE HYDROCHLORIDE AND DEXTROSE- LIDOCAINE HYDROCHLORIDE ANHYDROUS AND DEXTROSE MONOHYDRATE INJECTION, SOLUTION B. BRAUN MEDICAL INC. ---------- LIDOCAINE HYDROCHLORIDE AND 5% DEXTROSE INJECTION USP DO NOT ADMIX WITH OTHER DRUGS. DESCRIPTION Lidocaine Hydrochloride and 5% Dextrose Injection USP is a sterile, nonpyrogenic solution prepared from lidocaine hydrochloride and dextrose in water for injection. Lidocaine hydrochloride is designated chemically as 2-(Diethylamino)-2',6'-acetoxylidide monohydrochloride. The solution serves as a cardiac antiarrhythmic agent intended for intravenous use. COMPOSITION - EACH 100 ML CONTAINS: SOLUTION LIDOCAINE HYDROCHLORIDE ANHYDROUS USP HYDROUS DEXTROSE USP PH CALCULATED OSMOLARITY MOSMOL/LITER 0.4% Lidocaine HCl and 5% Dextrose Injection USP 0.4 g 5 g 4.4 (3.0– 7.0) 280 0.8% Lidocaine HCl and 5% Dextrose Injection USP 0.8 g 5 g 4.2 (3.0– 7.0) 305 Water for Injection USP qs The formulas of the active ingredients are: Lidocaine Hydrochloride Anhydrous USP (M.W. 270.80) Hydrous Dextrose USP (M.W. 198.17) Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. The closure system has two ports; the one for the administration set has a tamper evident plastic protector. Refer to the Directions for Use of the container. CLINICAL PHARMACOLOGY Lidocaine hydrochloride exerts an antiarrhythmic effect by increasing the electric stimulation threshold of the ventricle during diastole. In usual therapeutic doses, lidocaine hydrochloride produc اقرأ الوثيقة كاملة