1 INDICATIONS AND USAGE Cefoxitin for Injection and Dextrose Injection is a cephalosporin antibacterial indicated for the treatment of the following infections caused by susceptible isolates of the designated bacteria ( 1 ): Lower respiratory tract infections ( 1.1 ); Urinary tract infections ( 1.2 ); Intra-abdominal infections ( 1.3 ); Gynecological infections ( 1.4 ); Septicemia ( 1.5 ); Bone and joint infections ( 1.6 ); Skin and skin structure infections ( 1.7 ); Prophylaxis ( 1.8 ).

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefoxitin for Injection and Dextrose Injection and other antibacterial drugs, Cefoxitin for Injection and Dextrose Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria ( 1.9 ).

1.1 Lower Respiratory Tract Infections Cefoxitin for Injection and Dextrose Injection is indicated for the treatment of 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.

1.2 Urinary Tract Infections Cefoxitin for Injection and Dextrose Injection is indicated for the treatment of urinary tract infections caused by Escherichia coli , Klebsiella species, Proteus mirabilis , Morganella morganii , Proteus vulgaris and Providencia species (including P.

rettgeri ).

1.3 Intra-abdominal Infections Cefoxitin for Injection and Dextrose Injection is indicated for the treatment of intra-abdominal infections , including peritonitis and intra-abdominal abscess, caused by Escherichia coli, Klebsiella species, Bacteroides species including Bacteroides fragilis , and Clostridium species.

1.4 Gynecological Infections Cefoxitin for Injection and Dextrose Injection is indicated for the treatment of gynecological infections , including endometritis, pelvic cellulitis, and pelvic inflammatory disease caused by Escherichia coli , Neisseria gonorrhoeae (including penicillinase-producing strains), Bacteroides species including B.

fragilis , Clostridium species, Peptococcus niger , Peptostreptococcus species, and Streptococcus agalactiae .

Cefoxitin has no activity against Chlamydia trachomatis .

Therefore, when cefoxitin is used in the treatment of patients with pelvic inflammatory disease and C.

trachomatis is one of the suspected pathogens, appropriate anti-chlamydial coverage should be added.

1.5 Septicemia Cefoxitin for Injection and Dextrose Injection is indicated for the treatment of Septicemia caused by Streptococcus pneumoniae , Staphylococcus aureus (including penicillinase-producing strains), Escherichia coli , Klebsiella species, and Bacteroides species including B.

fragilis .

1.6 Bone and Joint Infections Cefoxitin for Injection and Dextrose Injection is indicated for the treatment of bone and joint infections caused by Staphylococcus aureus (including penicillinase-producing strains).

1.7 Skin and Skin Structure Infections Cefoxitin for Injection and Dextrose Injection is indicated for the treatment of skin and skin structure infections caused by Staphylococcus aureus (including penicillinase-producing strains), Staphylococcus epidermidis , Streptococcus pyogenes and other streptococci (excluding enterococci, e.g., Enterococcus faecalis [formerly Streptococcus faecalis ]), Escherichia coli , Proteus mirabilis , Klebsiella species, Bacteroides species including B.

fragilis , Clostridium species, Peptococcus niger , and Peptostreptococcus species.

1.8 Prophylaxis Cefoxitin for Injection and Dextrose Injection is indicated for the prophylaxis of infection in patients undergoing uncontaminated gastrointestinal surgery, vaginal hysterectomy, abdominal hysterectomy, or cesarean section.

If there are signs of infection, specimens for culture should be obtained for identification of the causative organism so that appropriate treatment may be instituted.

1.9 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefoxitin for Injection and Dextrose Injection and other antibacterial drugs, Cefoxitin for Injection and Dextrose 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.

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of labeling: • Hypersensitivity Reactions to Cefoxitin or other Beta-lactam Antibacterial Drugs [see Warnings and Precautions (5.1)] • Use in Patients with Renal Impairment [see Dosage and Administration (2.3) , Use in Specific Populations (8.6)] • Clostridium difficile -associated Diarrhea [see Warnings and Precautions (5.2)] • Risk of Development of Drug-resistant Bacteria [see Warnings and Precautions (5.3)] • Drug/Laboratory Test Interactions [see Warnings and Precautions (5.4)] • Patients with a History of Gastrointestinal Disease [see Warnings and Precautions (5.5) ] • Patients with Overt or Known Subclinical Diabetes Mellitus or Carbohydrate Intolerance [see Warnings and Precautions (5.6) ] The most common adverse reactions have been local reactions following intravenous injection.

Local Reactions Thrombophlebitis has occurred with intravenous administration.

Skin and Subcutaneous Tissue Disorders Rash (including exfoliative dermatitis and toxic epidermal necrolysis), urticaria, flushing, pruritus, eosinophilia, fever, dyspnea, and other allergic reactions including anaphylaxis, interstitial nephritis and angioedema have been noted.

Cardiovascular Disorders Hypotension.

Gastrointestinal Disorders Diarrhea, including documented pseudomembranous colitis which can appear during or after antibiotic treatment.

Nausea and vomiting have been reported.

Nervous System Disorders Possible exacerbation of myasthenia gravis.

Blood and Lymphatic System Disorders Eosinophilia, leukopenia including granulocytopenia, neutropenia, anemia including hemolytic anemia, thrombocytopenia, and bone marrow depression.

A positive direct Coombs test may develop in some individuals, especially those with azotemia.

Hepatobiliary Disorders Reversible elevation in SGOT, SGPT, serum LDH, and serum alkaline phosphatase; and jaundice have been reported.

Renal and Urinary Disorders Elevations in serum creatinine and/or blood urea nitrogen levels have been observed.

Acute renal failure has been reported.

Most common adverse reactions: Local reactions.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact B.

Braun Medical Inc.

at 1-800-854-6851 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Cephalosporin-class Adverse Reactions In addition to the adverse reactions listed above which have been observed in patients treated with cefoxitin, the following adverse reactions and altered laboratory test results have been reported for cephalosporin class antibacterials: pruritus, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, vomiting, abdominal pain, colitis, superinfection, vaginitis including vaginal candidiasis, renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemorrhage, elevated bilirubin, pancytopenia, and neutropenia.

Several cephalosporins, including Cefoxitin for Injection and Dextrose Injection, have been implicated in triggering seizures, particularly in patients with renal impairment, when the dosage was not reduced [ see Dosage and Administration (2.3) and Overdosage (10 ) ] .

If seizures associated with drug therapy occur, the drug should be discontinued.

Anticonvulsant therapy can be given if clinically indicated.