BLACK BOX WARNING
- nephrotoxicity
- ototoxicity
- neuromuscular blockade
- fetal harm
plazomicin
Brand: Zemdri
⚠ BBW TDM Required Prototype: gentamicin
Drug Class: aminoglycoside antibiotic
Drug Family: antibiotic
Subclass: next-generation aminoglycoside (resistant to most aminoglycoside-modifying enzymes)
Organ Systems: infectious-disease
Mechanism of Action
Semi-synthetic aminoglycoside derived from sisomicin with substitutions that protect against the six most common aminoglycoside-modifying enzymes (AMEs); retains activity against CRE and many organisms resistant to all other aminoglycosides.
30S ribosomal subunit
Indications
- complicated urinary tract infections (cUTI) and acute pyelonephritis due to Enterobacteriaceae including CRE
Contraindications
- aminoglycoside hypersensitivity
- pregnancy
Adverse Effects
Common
- decreased renal function
- diarrhea
- headache
- hypertension
Serious
- nephrotoxicity
- ototoxicity
- neuromuscular blockade
Pharmacokinetics (ADME)
| Absorption | IV only |
| Distribution | extracellular distribution; low protein binding |
| Metabolism | not metabolized |
| Excretion | renal (unchanged) |
| Half-life | 3.5 hours |
| Onset | immediate (IV) |
| Peak | end of infusion |
| Duration | 24 hours (once-daily dosing) |
| Protein Binding | <20% |
| Vd | low-moderate |
Drug Interactions
| Drug / Agent | Mechanism | Severity |
|---|---|---|
| loop diuretics | additive ototoxicity | major |
| nephrotoxic agents | additive nephrotoxicity | major |
Nursing Considerations
- Administer IV over 30 minutes once daily; use pharmacokinetic/pharmacodynamic principles for dose optimization in renal impairment.
- Monitor serum creatinine, BUN, and urine output throughout therapy; dose adjustment required if renal function changes.
- Assess for audiological symptoms (tinnitus, hearing loss) and vestibular symptoms (dizziness, vertigo) and report immediately.
- Reserved for CRE cUTI when other options are limited; confirm susceptibility before use.
Clinical Pearls
- Plazomicin's chemical modifications confer resistance to acetyl-, adenyl-, and phosphoryl-transferases that inactivate gentamicin and tobramycin, making it active against most AME-producing CRE.
- It is FDA-approved only for cUTI, limiting its use; combination regimens with colistin or meropenem are being studied for systemic CRE infections.
Safety Profile
Pregnancy use-with-caution
Lactation avoid
Renal Adjustment Required
Hepatic Adjustment Not required
TDM Required
Guideline Update pending
Concordance Terms
Cross-referenced clinical concepts — click any term to see all content where it appears.