Cefoxitin

CEFOXITIN

Manufacturer: Sagent Pharmaceuticals

Score: 141.0

Quick Summary

Cefoxitin is a broad-spectrum cephalosporin antibiotic used to treat various infections, including lower respiratory tract infections, urinary tract infections, intra-abdominal infections, and skin and skin structure infections. It is contraindicated in patients with hypersensitivity to cefoxitin or other cephalosporins. The usual adult dosage range is 1 gram to 2 grams every 6 to 8 hours, with dose adjustments recommended for patients with reduced renal function. Cefoxitin is excreted in human milk and should be used with caution in nursing mothers. Pediatric use is approved for patients 3 months of age and older, while geriatric patients may require dose adjustments due to decreased renal function.

Key Clinical Findings and Indications

Treatment of lower respiratory tract infections, including pneumonia and lung abscess
Treatment of urinary tract infections, including uncomplicated and complicated infections
Treatment of intra-abdominal infections, including peritonitis and intra-abdominal abscess
Treatment of skin and skin structure infections, including uncomplicated and complicated infections
Prophylaxis of infection in patients undergoing uncontaminated gastrointestinal surgery, vaginal hysterectomy, abdominal hysterectomy, or cesarean section

Important Safety Information

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

Dosing Recommendations

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).

Lower respiratory tract infections

Adult Dose

1 gram to 2 grams every 6 to 8 hours

Pediatric Dose

80 to 160 mg/kg of body weight per day divided into four to six equal doses

Urinary tract infections

Adult Dose

1 gram to 2 grams every 6 to 8 hours

Pediatric Dose

80 to 160 mg/kg of body weight per day divided into four to six equal doses

Intra-abdominal infections

Adult Dose

1 gram to 2 grams every 6 to 8 hours

Pediatric Dose

80 to 160 mg/kg of body weight per day divided into four to six equal doses

Special Population Considerations

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