Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
Bupivacaine Hydrochloride (UNII: 7TQO7W3VT8) (Bupivacaine - UNII:Y8335394RO), Epinephrine Bitartrate (UNII: 30Q7KI53AK) (Epinephrine - UNII:YKH834O4BH)
General Injectables & Vaccines, Inc
Bupivacaine Hydrochloride
BUPIVACAINE HYDROCHLORIDE ANHYDROUS 2.5 mg in 1 mL
INFILTRATION
PRESCRIPTION DRUG
Bupivacaine Hydrochloride is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia. (See WARNINGS .) Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of 0.75% concentration of Bupivacaine Hydrochloride in these patients. Bupivacaine Hydrochloride is not recommended for intravenous regional anesthesia (Bier Block). (See WARNINGS .) The routes of administration and indicated Bupivacaine Hydrochloride concentrations are: (See DOSAGE AND ADMINISTRATION for additional information.) Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of Bupivacaine Hydrochloride. Bupivacaine Hydrochloride is contraindicated in obstetrical paracervical block anesthesia. Its use in this technique ha
These solutions are not for spinal anesthesia. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Bupivacaine Hydrochloride ─ Solutions of Bupivacaine Hydrochloride that do not contain epinephrine may be autoclaved. Autoclave at 15-pound pressure, 121°C (250°F) for 15 minutes. Bupivacaine Hydrochloride with epinephrine 1:200,000 (as bitartrate) - Solutions of Bupivacaine Hydrochloride that contain epinephrine should not be autoclaved and should be protected from light. Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate. Revised: 3/2016 EN-4179 Hospira, Inc. Lake Forest, IL 60045 USA
Abbreviated New Drug Application
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE- BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION GENERAL INJECTABLES & VACCINES, INC ---------- 0.25% BUPIVACAINE HCL AND EPINEPHRINE 1:200,000 INJECTION, USP 30 ML SINGLE DOSE VIAL DESCRIPTION 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-a-[(methylamino)methyl] benzyl alcohol. It has the following structural formula: Bupivacaine Hydrochloride 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 Hydrochloride 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 Hydrochloride Injection, USP is available in sterile, isotonic solutions containing bupivacaine hydrochloride in water for injection with characteristics as follows: May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. (See HOW SUPPLIED section for pH information.) Multiple-dose vials contain methylparaben 1 mg/mL added as a preservative. Bupivacaine and Epinephrine Injection, USP is available in sterile, isotonic solutions containing bupivacaine hydrochloride and epinephrine 1:200,000 with characteristics as follows: Sodium metabisulfite 0.1 mg/mL added as antioxidant and edetate calcium disodium, anhydrous Olvassa el a teljes dokumentumot