Cefoxitin and Dextrose

CEFOXITIN AND DEXTROSE- cefoxitin sodium injection, solution
B. Braun Medical Inc.

1 INDICATIONS AND USAGE

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.

2 DOSAGE AND ADMINISTRATION

2.1 Dosage in Adults for Treatment

The usual adult dosage range is 1 gram to 2 grams every six to eight hours. Dosage should be determined by susceptibility of the causative organisms, severity of infection, and the condition of the patient (see Table 1 for dosage guidelines). Administer Cefoxitin for Injection and Dextrose Injection intravenously over approximately 30 minutes.

If C. trachomatis is a suspected pathogen, appropriate anti-chlamydial coverage should be added, because cefoxitin sodium has no activity against this organism [see Indications and Usage (1.4)].

Antibacterial therapy for group A beta-hemolytic streptococcal infections should be maintained for at least 10 days to guard against the risk of rheumatic fever or glomerulonephritis.

In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated.

Use this formulation of cefoxitin only in patients who require the entire 1 or 2 gram dose and not any fraction thereof.

* Including patients in whom bacteremia is absent or unlikely.
Table 1: Guidelines for Dosage of Cefoxitin for Injection
Type of Infection	Daily Dosage	Frequency and Route
Uncomplicated forms *of infections such as pneumonia, urinary tract infection, cutaneous infection	3-4 grams	1 gram every 6-8 hours IV
Moderately severe or severe infections	6-8 grams	1 gram every 4 hours or 2 grams every 6-8 hours IV
Infections commonly needing antibacterial drugs in higher dosage (e.g., gas gangrene)	12 grams	2 grams every 4 hours or 3 grams every 6 hours IV

2.2 Dosage in Adults for Prophylaxis

Effective prophylactic use depends on the time of administration. Cefoxitin for Injection and Dextrose Injection usually should be given one-half to one hour before the operation, which is sufficient time to achieve effective levels in the wound during the procedure. Prophylactic administration should usually be stopped within 24 hours since continuing administration of any antibacterial increases the possibility of adverse reactions but, in the majority of surgical procedures, does not reduce the incidence of subsequent infection.

For prophylactic use in uncontaminated gastrointestinal surgery, vaginal hysterectomy, or abdominal hysterectomy, the following doses are recommended:

• 2 grams administered intravenously just prior to surgery (approximately one-half to one hour
before the initial incision) followed by • 2 grams every 6 hours after the first dose for no more than 24 hours.

For patients undergoing cesarean section, either a single 2 gram dose administered intravenously as soon as the umbilical cord is clamped OR a 3-dose regimen consisting of 2 grams given intravenously as soon as the umbilical cord is clamped followed by 2 grams 4 and 8 hours after the initial dose is recommended [see Clinical Studies (14.1)].