Drug updated on 5/17/2024
Dosage Form | Injection (intravenous; 500 mg/ 10mL [50 mg/mL] in a single-dose vial containing plazomicin sulfate equivalent to 500 mg plazomicin free base) |
Drug Class | Aminoglycoside antibacterials |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of patients 18 years of age or older with complicated urinary tract infections (cUTI) including pyelonephritis.
Latest News
![loading GIF](/img/news-loading.gif)
Summary
- Plazomicin (Zemdri) is indicated for the treatment of patients 18 years or older with complicated urinary tract infections (cUTI), including pyelonephritis.
- The information was derived from a single study, which was a randomized controlled trial comparing plazomicin to meropenem in treating cUTIs.
- In terms of effectiveness, at day 5, clinical cure and microbiologic eradication were slightly lower in the plazomicin group compared to the meropenem group. However, by the test-of-cure visit time point, plazomicin showed superior results in composite cure rates and higher microbiologic eradication rates among resistant Enterobacteriaceae.
- There is an increased risk of nephrotoxicity with Zemdri as demonstrated by elevated serum creatinine levels compared to those treated with meropenem.
- While specific subgroup data are not detailed within this study beyond adults aged 18 years or older suffering from cUTIs caused by multidrug-resistant Enterobacteriaceae; it suggests that Zemdri may be suitable for these individuals.
- Despite its potential nephrotoxicity risks, Plazomicin represents a valuable option particularly where multidrug-resistant pathogens are involved but requires careful consideration depending on individual patient risk factors and susceptibilities.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Zemdri (plazomicin) Prescribing Information. | 2020 | Cipla USA, Inc., Warren, NJ |
Randomized Controlled Trials
Document Title | Sex Distribution | Year | Source |
---|---|---|---|
Once-daily plazomicin for complicated urinary tract infections. | 388Subjects F: 53% M: 47% | 2019 | New England Journal of Medicine |
Sex Distribution:
F:53%
M:47%
388Subjects
Year:
2019
Source:New England Journal of Medicine