Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987), EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)
US MedSource, LLC
INFILTRATION
PRESCRIPTION DRUG
Lidocaine Hydrochloride and Epinephrine Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection, 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 and Epinephrine Injection, USP is supplied in single-dose and multiple-dose containers as shown below: NDC No. Container Size Drug Concentration Lidocaine HCl Epinephrine Single-dose 0409-3181-01 Fliptop Vial 30 mL 1.5% 1:200,000 0409-3183-01 Fliptop Vial 20 mL 2% 1:200,000 Epidural Test Dose (single-dose) 0409-1209-01 Ampul 5 mL 1.5% 1:200,000 0409-1209-05 Ampul 5 mL 1.5% 1:200,000 0409-1209-65 Ampul 5 mL 1.5% 1:200,000 Multiple-dose 0409-3177-01 Fliptop Vial 50 mL 0.5% 1:200,000 0409-3178-01 Fliptop Vial 20 mL 1% 1:100,000 0409-3178-02 Fliptop Vial 30 mL 1% 1:100,000 0409-3178-03 Fliptop Vial 50 mL 1% 1:100,000 0409-3182-01 Fliptop Vial 20 mL 2% 1:100,000 0409-3182-02 Fliptop Vial 30 mL 2% 1:100,000 0409-3182-03 Fliptop Vial 50 mL 2% 1:100,000 Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from light. Revised: March, 2010 Printed in USA EN-2440 Hospira, Inc., Lake Forest, IL 60045 USA
Abbreviated New Drug Application
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE- LIDOCAINE HYDROCHLORIDE ANHYDROUS AND EPINEPHRINE INJECTION, SOLUTION US MEDSOURCE, LLC ---------- LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, USP For Infiltration and Nerve Block. AMPUL FLIPTOP VIAL MULTIPLE-DOSE FLIPTOP VIAL PROTECT FROM LIGHT. Rx only DESCRIPTION Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows: CONCENTRATION LIDOCAINE HCLEPINEPHRINE LIDOCAINE HCL (ANHYD.) MG/ML EPINEPHRINE MCG/ML SODIUM CHLORIDE MG/ML 0.5% 1:200,000 5 5 8 1% 1:200,000 10 5 7 1.5% 1:200,000 15 5 6.5 2% 1:200,000 20 5 6 1% 1:100,000 10 10 7 2% 1:100,000 20 10 6 Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, and 3179 are carbon dioxide gassed and Lists 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See _HOW SUPPLIED_ section for various sizes and strengths. Multiple-dose vials contain methylparaben 1 mg/mL added as preservative. Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2’,6’-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula: Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula: 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 Pročitajte cijeli dokument