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Ordering
NDC number |
80735-820-96 |
Package/configuration |
Single-use, 10-mL, flip-top vial (10 vials in carton) |
Plazomicin content |
500 mg in 10-mL vial (50 mg/mL) |
How supplied |
Single-use 10-mL vials. Each vial contains plazomicin sulfate equivalent to 500 mg plazomicin freebase at a concentration of 50 mg/mL plazomicin in Water for Injection |
Storage |
Refrigerate ZEMDRI vials at 2°C to 8°C (36°F to 46°F) |
Dimensions |
Carton: 6.125″ (length) × 2.375″ (height) × 2.594″ (depth) |
NDC, National Drug Code.
Specialty distributor |
Customer service: ordering |
ASD Healthcare |
800-746-6273 |
Cardinal Health Specialty Distribution/ |
855-855-0708 |
McKesson Plasma and Biologics LLC |
877-625-2566 |
FFF Enterprises |
800-843-7477 |
Reference: 1. ZEMDRI® (plazomicin) injection Prescribing Information. Cipla USA, Inc.
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