Treating infections with ceftolozane/tazobactam in subjects having impaired renal function

1. A method of treating a complicated intra-abdominal infection or a complicated urinary tract infection in a human patient with end stage renal disease on hemodialysis, said method comprising administering to the patient a single loading dose comprising ceftolozane or a pharmaceutically acceptable salt thereof and tazobactam or a pharmaceutically acceptable salt thereof that provides 500 mg of ceftolozane active and 250 mg of tazobactam active, followed by administering to the patient maintenance doses comprising ceftolozane or a pharmaceutically acceptable salt thereof and tazobactam or a pharmaceutically acceptable salt thereof that provides 100 mg of ceftolozane active and 50 mg of tazobactam active, wherein the maintenance doses are delivered intravenously about every 8 hours, wherein the complicated intra-abdominal infection is caused by one or more microorganisms selected from the group consisting of: Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Escherichia coli CTX-M-14 extended spectrum beta-lactamase producing strains, Escherichia coli CTX-M-15 extended spectrum beta-lactamase producing strains, Klebsiella oxytoca, Klebsiella pneumonia, Klebsiella pneumoniae CTX-M-15 extended spectrum beta-lactamase producing strains, Proteus mirabilis, Pseudomonas aeruginosa, Bacteroides fragilis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus, Streptococcus anginosus, Streptococcus constellatus , and Streptococcus salivarius , and wherein the complicated urinary tract infection is caused by one or more microorganisms selected from the group consisting of: Escherichia coli, Escherichia coli levofloxacin resistant strains, Escherichia coli CTX-M-14 extended spectrum beta-lactamase producing strains, Escherichia coli CTX-M-15 extended spectrum beta-lactamase producing strains, Klebsiella pneumoniae, Klebsiella pneumonia levofloxacin restraint strains, Klebsiella pneumonia CTX-M-15 extended spectrum beta-lactamase producing strains, Proteus mirabilis and Pseudomonas aeruginosa.

2. The method of claim 1 , wherein the infection is a complicated intra-abdominal infection (cIAI).

3. The method of claim 1 , wherein the infection is a complicated urinary tract infection (cUTI).

4. The method of claim 1 , wherein each dose is administered in a 1-hour intravenous infusion.

5. The method of claim 2 , further comprising administering to the patient a therapeutically effective amount of metronidazole.

6. The method of claim 1 , wherein the ceftolozane active is provided as ceftolozane sulfate and the tazobactam active is provided as tazobactam sodium.

7. The method of claim 1 , wherein the first maintenance dose following completion of hemodialysis is administered to the patient within 3 hours following completion of hemodialysis.

8. The method of claim 1 , wherein the first maintenance dose following completion of hemodialysis is administered to the patient within 2 hours following completion of hemodialysis.

9. The method of claim 2 , wherein the ceftolozane active is provided as ceftolozane sulfate and the tazobactam active is provided as tazobactam sodium.

10. The method of claim 3 , wherein the ceftolozane active is provided as ceftolozane sulfate and the tazobactam active is provided as tazobactam sodium.

11. The method of claim 4 , wherein the ceftolozane active is provided as ceftolozane sulfate and the tazobactam active is provided as tazobactam sodium.

12. The method of claim 5 , wherein the ceftolozane active is provided as ceftolozane sulfate and the tazobactam active is provided as tazobactam sodium.

13. The method of claim 7 , wherein the ceftolozane active is provided as ceftolozane sulfate and the tazobactam active is provided as tazobactam sodium.

14. The method of claim 8 , wherein the ceftolozane active is provided as ceftolozane sulfate and the tazobactam active is provided as tazobactam sodium.