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Dosing
Dosing recommendations for patients with cUTIa
Dosage regimen in adults with CrCl ≥90 mL/min
Dosage regimen in adults with CrCl <90 mL/min
Note: CrCl estimated by the Cockcroft-Gault formula using TBW. For patients with TBW greater than IBW by ≥25%, use IBW.
CrCl, creatinine clearance; cUTI, complicated urinary tract infection; IBW, ideal body weight; IV, intravenous; TBW, total body weight.
aIncluding pyelonephritis.
bCalculate dosage using TBW. For patients with TBW greater than IBW by ≥25%, use adjusted body weight based on the equation: Adjusted body weight = IBW + 0.4 x [TBW - IBW].
cAn appropriate oral therapy may be considered after 4 to 7 days of ZEMDRI therapy to complete a total duration of 7 to 10 days (IV + oral). The maximum duration of ZEMDRI for cUTI is 7 days.
CrCl, creatinine clearance; cUTI, complicated urinary tract infection; TDM, therapeutic drug management.
die, from every 24 hours to every 36 hours or from every 48 hours to every 72 hours.
A guide to dosing, preparing, and administering ZEMDRI, including instructions for therapeutic drug management.
LEARN MORETDM, therapeutic drug management.
Reference: 1. ZEMDRI [prescribing information]; 2020.
ZEMDRI® (plazomicin) injection 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.
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.
BOXED WARNINGS: NEPHROTOXICITY, OTOTOXICITY, NEUROMUSCULAR BLOCKADE AND FETAL HARM
ZEMDRI is contraindicated in patients with known hypersensitivity to any aminoglycoside.
Nephrotoxicity
Ototoxicity
Neuromuscular Blockade
Fetal Harm
Hypersensitivity Reactions
Clostridium difficile-Associated Diarrhea
Development of Drug-Resistant Bacteria
The most common adverse reactions (≥1% of patients treated with ZEMDRI) are decreased renal function, diarrhea, hypertension, headache, nausea, vomiting and hypotension.
Please see the full Prescribing Information, including BOXED WARNINGS, for additional Important Safety Information.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Cipla Therapeutics, a division of Cipla USA, Inc., at (866) 604-3268 or drugsafety@cipla.com
ZEMDRI (plazomicin) 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.
To reduce the development of drug-resistant bacteria and maintain 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 microorganisms.
BOXED WARNINGS: NEPHROTOXICITY, OTOTOXICITY, NEUROMUSCULAR BLOCKADE AND FETAL HARM