Country: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)
Hospira, Inc.
LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg in 1 mL
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 HCl 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: NDC 0409-4278-01 Tray of 25 Glass Single-dose Teartop Vials 0.5% 250 mg/50 mL (5 mg/mL) NDC 0409-4713-62 Case of 800 Glass Single-dose Ampuls 1% 20 mg/2 mL (10 mg/mL) NDC 0409-4713-65 Case of 800 Glass Single-dose Ampuls 1% 50 mg/5 mL (10 mg/mL) NDC 0409-4279-02 Tray of 25 Glass Single-dose Teartop Vials 1% 300 mg/30 mL (10 mg/mL) NDC 0409-4776-01 Carton of 25 Glass Single-dose Ampuls 1.5% 300 mg/20 mL (15 mg/mL) NDC 0409-4282-02 Carton of 25 Glass Single-dose Ampuls 2% 200 mg/10 mL (20 mg/mL) NDC 0409-4713-02 Bundle of 5 Clamcells containing 5 Single-dose Ampuls per Clamcell 1% 50 mg/5 mL (10 mg/mL) NDC 0409-4713-32 Bundle of 5 Cartons containing 10 Single-dose Ampuls per Carton 1% 20 mg/2 mL (10 mg/mL) NDC 0409-4282-01 Bundle of 5 Clamcells containing 5 Single-dose Ampuls per Clamcell 2% 40 mg/2 mL (20 mg/mL) NDC 0409-4275-01 Tray of 25 Plastic Multiple-dose Fliptop Vials 0.5% 250 mg/50 mL (5 mg/mL) NDC 0409-4276-01 Tray of 25 Plastic Multiple-dose Fliptop Vials 1% 200 mg/20 mL (10 mg/mL) NDC 0409-4276-02 Tray of 25 Plastic Multiple-dose Fliptop Vials 1% 500 mg/50 mL (10 mg/mL) NDC 0409-4277-01 Tray of 25 Plastic Multiple-dose Fliptop Vials 2% 400 mg/20 mL (20 mg/mL) NDC 0409-4277-02 Tray of 25 Plastic Multiple-dose Fliptop Vials 2% 1000 mg/50 mL (20 mg/mL) For single-dose vials and ampuls: Discard unused portion. 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.
Abbreviated New Drug Application
LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION HOSPIRA, INC. ---------- LIDOCAINE HYDROCHLORIDE INJECTION, USP AQUEOUS SOLUTIONS FOR INFILTRATION AND NERVE BLOCK AMPUL PLASTIC MULTIPLE-DOSE FLIPTOP VIAL GLASS TEARTOP VIAL RX ONLY 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 HCl 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 beta- adrenergic re সম্পূর্ণ নথি পড়ুন