Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
BUPIVACAINE HYDROCHLORIDE (UNII: 7TQO7W3VT8) (BUPIVACAINE - UNII:Y8335394RO)
SA3, LLC
BUPIVACAINE HYDROCHLORIDE
BUPIVACAINE HYDROCHLORIDE ANHYDROUS 5 mg in 1 mL
PRESCRIPTION DRUG
New Drug Application
BT- BUPIVACAINE HYDROCHLORIDE, TRIAMCINOLONE ACETONIDE, POVIDONE-IODINE AND ISOPROPYL ALCOHOL SA3, LLC ---------- BT INJECTION KIT BT INJECTION KIT PACKAGE INSERT Bupivacaine Hydrochloride Injection, USP Bupivacaine Hydochloride and Epineprine Injection, USP With Epineprine 1:200,000 (as bitartrate) Rx Only DES CRIPTION Bupivacaine hydrochloride is 2-Piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate, a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula: Epinephrine is (-)-3,4-Dihydroxy-α-[(methylamino)methyl] benzyl alcohol. It has the following structural formula: Bupivacaine is available in sterile isotonic solutions with and without epinephrine (as bitartrate) 1:200,000 for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. Solutions of Bupivacaine may be autoclaved if they do not contain epinephrine. Solutions are clear and colorless. Bupivacaine is related chemically and pharmacologically to the aminoacyl local anesthetics. It is a homologue of mepivacaine and is chemically related to lidocaine. All three of these anesthetics contain an amide linkage between the aromatic nucleus and the amino, or piperidine group. They differ in this respect from the procaine-type local anesthetics, which have an ester linkage. Bupivacaine — Sterile isotonic solutions containing sodium chloride. In multiple-dose vials, each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 4 and 6.5 with sodium hydroxide or hydrochloric acid. Bupivacaine_ with epinephrine 1:200,000_ (as bitartrate)—Sterile isotonic solutions containing sodium chloride. Each mL contains bupivacaine hydrochloride and 0.0091 mg epinephrine bitartrate, with 0.5 mg sodium metabisulfite, 0.001 mL monothioglycerol, and 2 mg ascorbic acid as antioxidants, 0.0017 mL 60% sodium lactate buffer, and Olvassa el a teljes dokumentumot