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1. Indications And Usage Zemdri Is An Aminoglycoside Antibacterial Indicated For The Treatment Of Patients 18 Years Of Age Or Older With Complicated Urinary Tract Infections (Cuti) Including Pyelonephritis. ( 1.1 ) As Only Limited Clinical Safety And Efficacy Data Are Available, Reserve Zemdri For Use In Patients Who Have Limited Or No Alternative Treatment Options. ( 1.1 ) To Reduce The Development Of Drug-Resistant Bacteria And Maintain Effectiveness Of Zemdri And Other Antibacterial Drugs, Zemdri Should Be Used Only To Treat Infections That Are Proven Or Strongly Suspected To Be Caused By Susceptible Microorganisms. ( 1.2 ) 1.1 Complicated Urinary Tract Infections (Cuti), Including Pyelonephritis Zemdri Is Indicated In Patients 18 Years Of Age Or Older For The Treatment Of Complicated Urinary Tract Infections (Cuti), Including Pyelonephritis Caused By The Following Susceptible Microorganism(S): Escherichia Coli, Klebsiella Pneumoniae, Proteus Mirabilis , And Enterobacter Cloacae . As Only Limited Clinical Safety And Efficacy Data For Zemdri Are Currently Available, Reserve Zemdri For Use In Cuti Patients Who Have Limited Or No Alternative Treatment Options [See Clinical Studies (14.1) ]. 1.2 Usage To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Zemdri And Other Antibacterial Drugs, Zemdri 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.
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