Claims for Patent: 10,376,496

Summary for Patent: 10,376,496

Title:	Treating infections with ceftolozane/tazobactam in subjects having impaired renal function
Abstract:	Disclosed are methods of administering cephalosporin/tazobactam to human patients with end stage renal disease undergoing hemodialysis and suffering from a complicated intra-abdominal infection or a complicated urinary tract infection.
Inventor(s):	Krishna; Gopal (Stow, MA), Chandorkar; Gurudatt (Waltham, MA), Hershberger; Elham (Lexington, MA), Miller; Benjamin (Cambridge, MA), Xiao; Alan (Lexington, MA)
Assignee:	Merck, Sharp & Dohme Corp. (Rahway, NJ)
Application Number:	14/481,496
Patent Claims:	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.