Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
CEFUROXIME SODIUM (UNII: R8A7M9MY61) (CEFUROXIME - UNII:O1R9FJ93ED)
Samson Medical Technologies, L.L.C.
CEFUROXIME SODIUM
CEFUROXIME SODIUM 75 g
PRESCRIPTION DRUG
Abbreviated New Drug Application
CEFUROXIME SODIUM- CEFUROXIME SODIUM INJECTION, POWDER, FOR SOLUTION SAMSON MEDICAL TECHNOLOGIES, L.L.C. ---------- CEFUROXIME FOR INJECTION, USP PHARMACY BULK PACKAGE - NOT FOR DIRECT INFUSION To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefuroxime and other antibacterial drugs, Cefuroxime for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Cefuroxime is a semisynthetic, broad-spectrum, cephalosporin antibiotic for parenteral administration. It is the sodium salt of (6R,7R)-3-carbamoyloxymethyl-7-[Z-2-methoxyimino-2- (fur-2- yl)acetamido]ceph-3-em-4-carboxylate, and it has the following chemical structure: The empirical formula is C H N NaO S, representing a molecular weight of 446.4. Cefuroxime for Injection contains approximately 54.2 mg (2.4 mEq) of sodium per gram of cefuroxime activity. Cefuroxime for Injection in sterile crystalline form is supplied in Pharmacy Bulk Packages equivalent to 75 g or 225 g of cefuroxime as cefuroxime sodium. Solutions of cefuroxime range in color from light yellow to amber, depending on the concentration and diluent used. The pH of freshly constituted solutions usually ranges from 6 to 8.5. A Pharmacy Bulk Package is a container of a sterile preparation for intravenous use that contains many single doses. The contents are intended for use in a pharmacy admixture service and are restricted to the preparation of admixtures for intravenous infusion. BEFORE ADMINISTRATION, THIS PHARMACY BULK PACKAGE REQUIRES RECONSTITUTION TO A CONCENTRATION OF 95 MG/ML OR 100 MG/ML AND TRANSFER INTO STERILE SYRINGES. CLINICAL PHARMACOLOGY Following intravenous doses of 750 mg and 1.5 g, serum concentrations were approximately 50 and 100 mcg/mL, respectively, at 15 minutes. Therapeutic serum concentrations of approximately 2 mcg/mL or more were maintained for 5.3 hours and 8 hours or more, respectively. There was no evidence of accumulation of cefuroxime in the serum f Olvassa el a teljes dokumentumot