국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
CEFUROXIME SODIUM (UNII: R8A7M9MY61) (CEFUROXIME - UNII:O1R9FJ93ED)
Hospira, Inc.
INTRAVENOUS
PRESCRIPTION DRUG
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefuroxime for injection 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 susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefuroxime for injection is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: Clinical microbiological studies in skin and skin-structure infections frequently reveal the growth of susceptible strains of both aerobic and anaerobic organisms. Cefuroxime for injection has been used successfully in these mixed infections in which several organisms have been isolated. In certai
Cefuroxime for injection in the dry state should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] and protected from light. Cefuroxime for injection is a dry, white to off-white powder supplied as follows: NDC 0409-0803-01 7.5 grams* per Pharmacy Bulk Package Bottle (Box of 10 Bottles) *Equivalent to cefuroxime.
CEFUROXIME- CEFUROXIME INJECTION, POWDER, FOR SOLUTION HOSPIRA, INC. ---------- CEFUROXIME FOR INJECTION, USP PRESCRIBING INFORMATION PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION RX ONLY To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefuroxime for injection, USP and other antibacterial drugs, cefuroxime for injection, USP 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 molecular formula is C H N NaO S, representing a molecular weight of 446.4. Cefuroxime for injection, USP contains approximately 54.2 mg (2.4 mEq) of sodium per gram of cefuroxime activity. Cefuroxime for injection, USP in sterile crystalline form is supplied in Pharmacy Bulk Package equivalent to 7.5 g of cefuroxime as cefuroxime sodium. Solutions of cefuroxime for injection, USP 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 parentral 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. FURTHER DILUTION IS REQUIRED BEFORE USE. CLINICAL PHARMACOLOGY After intramuscular (IM) injection of a 750 mg dose of cefuroxime to normal volunteers, the mean peak serum concentration was 27 mcg/mL. The peak occurred at approximately 45 minutes (range, 15 to 60 16 15 4 8 minutes). Following IV 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 mo 전체 문서 읽기