国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987)
Cardinal Health
INFILTRATION
PRESCRIPTION DRUG
Lidocaine Hydrochloride Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.
Lidocaine Hydrochloride Injection, USP is supplied as follows: Unit of Sale Concentration Each Overbagged with 1 Single-Dose Glass Teartop Vial per bag 1% 300 mg/30 mL (10 mg/mL) NDC 55154-0147-8 Overbagged with 5 Single-Dose Glass Teartop Vials per bag 1% 300 mg/30 mL (10 mg/mL) NDC 55154-0147-5 Overbagged with 1 Plastic Fliptop Vial per bag 1% 500 mg/50 mL (10 mg/mL) NDC 55154-2371-8 Overbagged with 1 Multi-Dose Fliptop Vial per bag 2% 1000 mg/50 mL (20 mg/mL) NDC 55154-2373-8 Single-dose products are preservative-free. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Lidocaine Hydrochloride Injection, USP solutions packaged in ampuls and glass teartop vials may be autoclaved one time only. Autoclave at 15 pounds pressure, 121°C (250°F) for 15 minutes. DO NOT AUTOCLAVE PRODUCT IN PLASTIC VIALS. Revised: 1/2015 EN-3679 Hospira, Inc., Lake Forest, IL 60045 USA Repackaged By: Cardinal Health Zanesville, OH 43701 LA66001116 LA66400317 LA66030617 L32342670714
Abbreviated New Drug Application
LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION CARDINAL HEALTH ---------- LIDOCAINE Rx only HYDROCHLORIDE INJECTION, USP AQUEOUS SOLUTIONS FOR INFILTRATION AND NERVE BLOCK AMPUL PLASTIC MULTIPLE-DOSE FLIPTOP VIAL GLASS TEARTOP VIAL _DESCRIPTION_ Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride in water for injection for parenteral administration in various concentrations with characteristics as follows: CONCENTRATION 0.5% 1% 1.5% 2% mg/mL lidocaine HCl (anhyd.) 5 10 15 20 mg/mL sodium chloride 8 7 6.5 6 Multiple-dose vials contain 0.1% of methylparaben added as preservative. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The pH is 6.5 (5.0 to 7.0). See _HOW_ _SUPPLIED_ section for various sizes and strengths. Lidocaine is a local anesthetic of the amide type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethylamino)-N-(2,6-dimethylphenyl)- acetamide monohydrochloride monohydrate, a white powder freely soluble in water. 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. _CLINICAL PHARMACOLOGY_ MECHANISM OF ACTION: Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. HEMODYNAMICS: Excessive blood levels may cause changes in cardiac output, total peripheral resistance, and mean arterial pressure. With central neural blockade these changes may be attributable to block of autonomic fibers, a direct depressant effect of the local anesthetic agent on various components of the cardiovascular system and/or the b 完全なドキュメントを読む