US 10,376,496 B2
Treating infections with ceftolozane/tazobactam in subjects having impaired renal function
Gopal Krishna, Stow, MA (US); Gurudatt Chandorkar, Waltham, MA (US); Elham Hershberger, Lexington, MA (US); Benjamin Miller, Cambridge, MA (US); and Alan Xiao, Lexington, MA (US)
Assigned to Merck, Sharp & Dohme Corp., Rahway, NJ (US)
Filed by MERCK SHARP & DOHME CORP., Rahway, NJ (US)
Filed on Sep. 9, 2014, as Appl. No. 14/481,496.
Claims priority of provisional application 61/875,358, filed on Sep. 9, 2013.
Claims priority of provisional application 61/883,579, filed on Sep. 27, 2013.
Claims priority of provisional application 61/984,299, filed on Apr. 25, 2014.
Claims priority of provisional application 61/988,085, filed on May 2, 2014.
Claims priority of provisional application 62/046,417, filed on Sep. 5, 2014.
Claims priority of provisional application 62/002,457, filed on May 23, 2014.
Prior Publication US 2016/0113910 A1, Apr. 28, 2016
Int. Cl. A61K 31/431 (2006.01); A61K 31/546 (2006.01); A61K 9/00 (2006.01); A61K 47/18 (2017.01); A61K 9/19 (2006.01); A61K 9/08 (2006.01); A61K 31/4164 (2006.01); A61M 1/14 (2006.01)
CPC A61K 31/431 (2013.01) [A61K 9/0019 (2013.01); A61K 9/08 (2013.01); A61K 9/19 (2013.01); A61K 31/4164 (2013.01); A61K 31/546 (2013.01); A61K 47/183 (2013.01); A61M 1/14 (2013.01); Y02A 50/473 (2018.01)] 14 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.