Detailed Product Description

INDICATION

It is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below:

Lower infections, including , caused by S. pneumoniae, H. influenzae, spp., S. aureus (penicillinase- and non-penicillinase-producing), (beta)-hemolytic streptococci, and P. mirabilis

infections caused by , Proteus spp. (both indole-negative and indole-positive), Enterobacter spp., Klebsiella spp., group D streptococci (Note: Most enterococci, eg, E. faecalis, are resistant), and S. epidermidis

caused by E. coli and Enterobacter spp.

caused by E. coli, S. aureus (penicillinase- and non-penicillinase-producing), S. pneumoniae, S. pyogenes (group A (beta)-hemolytic streptococci), H. influenzae, and Klebsiella spp.

and skin structure infections caused by S. aureus (penicillinase- and non-penicillinase-producing), S. pyogenes (group A (beta)-hemolytic streptococci), H. influenzae, E. coli, Enterobacter spp., and P. mirabilis

and infections caused by S. aureus (penicillinase- and non-penicillinase-producing)

Clinical microbiologic studies in nongonococcal in females, lower respiratory infections, and skin infections frequently reveal the growth of susceptible strains of both and organisms. It has been used successfully in those infections in which several organisms have been isolated. Most strains of B. fragilis are resistant ; however, infections caused by susceptible strains have been treated successfully.

Specimens for bacteriologic cultures should be obtained in order to and identify causative organisms and to determine their susceptibilities to cefaIte. may be instituted before results of susceptibility studies are known; however, once these results become available, the treatment should be adjusted accordingly.

In certain cases of confirmed or suspected or or in patients with other serious infections in which the causative organism has not been identified, It may be used concomitantly with an aminoglycoside ( see ). The recommended doses of both antibiotics may be given, depending on the severity of the and the patient's . The function of the patient should be carefully monitored, especially if higher dosages of the antibiotics are to be administered.

Antibiotic therapy of (beta)-hemolytic streptococcal infections should continue for at least 10 days.

Preventive Therapy The administration of It preoperatively, intraoperatively, and postoperatively may reduce the of certain infections in patients undergoing surgical procedures that are classified as contaminated or potentially contaminated (eg, , cesarean section, , or in high-risk patients such as those with , obstructive , or common-bile-duct stones).

In major surgery in which the risk of postoperative infection is low but serious ( surgery, neurosurgery, or arthroplasty), It may be effective in preventing such infections.

If signs of infection occur, specimens for should be obtained for identification of the causative organism so that appropriate antibiotic therapy may be instituted.

DOSAGE AND ADMINISTRATION

Dosage Adults: The usual dosage for cefaIte is 500 mg to 1 g every 4 to 8 hours.

In infections of skin structures and in uncomplicated pneumonia, a dosage of 500 mg every 6 hours is adequate.

In uncomplicated tract infections, a dosage of 500 mg every 8 hours is sufficient. In more serious urinary tract infections, a dosage of 1 g every 8 hours may be needed.

In severe infections, 1-g doses may be given at 4 to 6-hour intervals.

In life-threatening infections or infections due to less susceptible organisms, doses up to 2 g every 4 hours (ie, 12 g/day) may be needed.

Infants and Children: Administration of 50 to 100 mg/kg/ day in equally divided doses every 4 to 8 hours has been effective for most infections susceptible to It. This may be increased to a total daily dose of 150 mg/kg (not to exceed the maximum adult dose) for severe infections. ( See recommendations regarding this age group in and .)

Note: As with antibiotic therapy in general, administration of It should be continued for a minimum of 48 to 72 hours after the patient becomes or after evidence of eradication has been obtained; a minimum of 10 days of treatment is recommended in infections caused by group A (beta)-hemolytic streptococci in order to guard against the risk of or glomerulonephritis; frequent bacteriologic and clinical appraisal is necessary during therapy of and may be required for several months after therapy has been completed; persistent infections may require treatment for several weeks; and doses smaller than those indicated above should not be used.

For use of It, the following dosages are recommended:

Adults 1 or 2 g intravenously or intramuscularly ¹ / ₂ to 1 hour prior to the surgical followed by 1 or 2 g every 6 hours for 24 to 48 hours.

Patients (3 months of age and older) 50 to 100 mg/kg/day in equally divided doses by the routes and schedule designated above.

Note: In patients undergoing prosthetic arthroplasty, administration is recommended for as long as 72 hours.

In patients undergoing cesarean section, the initial dose may be administered just prior to surgery or immediately after the cord has been clamped.

Modes of Administration It may be given intravenously or by deep injection into a large mass (such as the gluteus or part of the ) to minimize .

Intramuscular Administration Each g of It should be diluted with 3 mL of 1 of the following diluents: Sterile Water for Injection, Water for Injection, 0.9% Injection, or Bacteriostatic Sodium Chloride Injection. Shake well until dissolved.

Administration The intravenous route may be preferable for patients with bacterial septicemia, localized abscesses (such as intra-abdominal ), peritonitis, or other severe or life-threatening infections when they may be poor risks because of lowered . In those with normal renal function, the intravenous dosage for such infections is 3 to 12 g of It daily. In conditions such as bacterial septicemia, 6 to 12 g/day may be given initially by the intravenous route for several days, and dosage may then be gradually reduced according to clinical response and findings.

If combination therapy with It and an aminoglycoside is indicated, each of these antibiotics should be administered in different sites. Do not mix an aminoglycoside with It in the same intravenous fluid container.