Cefoxitin

Warning

Cefoxitin is contraindicated in patients with hypersensitivity to cefoxitin or other cephalosporins. Increased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics.

Contraindications

• Hypersensitivity to cefoxitin or other cephalosporins

Adverse Reactions

• Local reactions, including thrombophlebitis and pain
• Allergic reactions, including rash, urticaria, and anaphylaxis
• Gastrointestinal reactions, including diarrhea and pseudomembranous colitis
• Hematologic reactions, including eosinophilia and leukopenia
• Renal reactions, including elevated serum creatinine and renal failure

General Guidance

Dose adjustments are recommended for patients with reduced renal function, with the following guidelines: mild impairment (creatinine clearance 50 to 30 mL/min), moderate impairment (creatinine clearance 29 to 10 mL/min), severe impairment (creatinine clearance 9 to 5 mL/min), and essentially no function (creatinine clearance <5 mL/min).

Pregnancy

• Reproduction studies performed in rats and mice at parenteral doses of approximately one to seven and one-half times the maximum recommended human dose did not reveal teratogenic or fetal toxic effects
• However, there are no adequate and well-controlled studies in pregnant women, and the drug should be used during pregnancy only if clearly needed

Nursing Mothers

• Cefoxitin is excreted in human milk in low concentrations
• Caution should be exercised when Cefoxitin for Injection is administered to a nursing woman

Pediatric Use

• Safety and efficacy in pediatric patients from birth to 3 months of age have not yet been established
• In pediatric patients 3 months of age and older, higher doses of Cefoxitin for Injection have been associated with an increased incidence of eosinophilia and elevated SGOT

Geriatric Use

• Of the 1,775 subjects who received cefoxitin in clinical studies, 424 (24%) were 65 and over, while 124 (7%) were 75 and over
• No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out
• This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function