To reduce the development of drug-resistant bacteria and maintain the effectiveness of MEFOXIN1and other antibacterial drugs, MEFOXIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
DESCRIPTION
Cefoxitin sodium is a semi-synthetic, broad-spectrum cepha antibiotic for intravenous administration. It is derived from cephamycinC, 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 empirical formula is C16H16N3NaO7S2, and the molecular weight is 449.44. The structural formula is:
Cefoxitin sodium contains approximately 53.8mg (2.3 milliequivalents) of sodium per gram of cefoxitin activity.
Premixed Intravenous Solution MEFOXIN (Cefoxitin Injection) is supplied as a sterile, nonpyrogenic, frozen iso-osmotic solution of cefoxitin sodium. Each 50 mL contains cefoxitin sodium equivalent to either 1 gram or 2 grams cefoxitin. Dextrose hydrous USP has been added to the above dosages to adjust osmolality (approximately 2 grams and 1.1 grams to 1 gram and 2 gram dosages, respectively). The pH is adjusted with sodium bicarbonate and may have been adjusted with hydrochloric acid. The pH is approximately 6.5. After thawing, the solution is intended for intravenous use only. Solutions of MEFOXIN range from colorless to light amber.
The plastic container is fabricated from a specially designed multilayer plastic (PL 2040). Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability and safety of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.
CLINICAL PHARMACOLOGY
Clinical Pharmacology
Following an intravenous dose of 1gram of cefoxitin, serum concent
