Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
CEFOXITIN SODIUM (UNII: Q68050H03T) (CEFOXITIN - UNII:6OEV9DX57Y)
Apotex Corporation
INTRAVENOUS
PRESCRIPTION DRUG
Many infections caused by aerobic and anaerobic gram-negative bacteria resistant to some cephalosporins respond to cefoxitin. Similarly, many infections caused by aerobic and anaerobic bacteria resistant to some penicillin antibiotics (ampicillin, carbenicillin, penicillin G) respond to treatment with cefoxitin. Many infections caused by mixtures of susceptible aerobic and anaerobic bacteria respond to treatment with cefoxitin. Cefoxitin for injection is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. (1) Lower respiratory tract infections , including pneumonia and lung abscess, caused by Streptococcus pneumoniae , other streptococci (excluding enterococci, e.g., Enterococcus faecalis [formerly Streptococcus faecalis ]), Staphylococcus aureus (including penicillinase-producing strains), Escherichia coli, Klebsiella species, Haemophilus influenzae, and Bacteroides species. (2) Urinary tract infections caused by
Sterile cefoxitin for injection is a dry white to off-white powder supplied in vials containing cefoxitin sodium as follows: Each Pharmacy Bulk Package contains cefoxitin sodium equivalent to 10 grams cefoxitin Also available as vials containing cefoxitin sodium equivalent to 1 gram or 2 grams cefoxitin. Cefoxitin for injection in the dry state should be stored between 2 to 25°C (36 to 77°F). Avoid exposure to temperatures above 50°C. The dry material as well as solutions tend to darken, depending on storage conditions; product potency, however, is not adversely affected.
Abbreviated New Drug Application
CEFOXITIN- CEFOXITIN INJECTION, POWDER, FOR SOLUTION APOTEX CORPORATION ---------- CEFOXITIN FOR INJECTION, USP PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION RX ONLY To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefoxitin for injection and other antibacterial drugs, cefoxitin for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Cefoxitin for injection is a semi-synthetic, broad-spectrum cepha antibiotic sealed under nitrogen for intravenous administration. It is derived from cephamycin C, which is produced by _Streptomyces_ _lactamdurans._ Its chemical name is sodium (6R,7S)-3-hydroxymethyl)-7-methoxy-8-oxo-7-2-(2- thienyl)acetamido]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate carbamate (ester). The molecular formula is C H N NaO S , and the structural formula is: Cefoxitin for injection contains approximately 53.8 mg (2.3 milliequivalents) of sodium per gram of cefoxitin activity. Solutions of cefoxitin for injection range from colorless to light amber in color. The pH of freshly constituted solutions usually ranges from 4.2 to 7. Each Pharmacy Bulk Package is supplied as a dry powder in vials containing sterile cefoxitin sodium, equivalent to 10 g cefoxitin and is intended for intravenous infusion only. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion. FURTHER DILUTION IS REQUIRED BEFORE USE. Each conventional vial contains sterile cefoxitin sodium, USP eqivalent to 10 g cefoxitin. CLINICAL PHARMACOLOGY CLINICAL PHARMACOLOGY Following an intravenous dose of 1 gram, serum concentrations were 110 mcg/mL at 5 minutes, declining to less than 1 mcg/mL at 4 hours. The half-life after an intravenous dose is 41 to 59 minutes. Approximately 85 percent of cefoxitin is excreted uncha Կարդացեք ամբողջական փաստաթուղթը