Zemdri (plazomicin sulfate)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Plazomicin sulfate is a semisynthetic aminoglycoside antibiotic derived from sisomicin.
Plazomicin sulfate is a semisynthetic aminoglycoside antibacterial derived from sisomicin. Plazomicin has an expanded spectrum of activity compared with other commercially available aminoglycosides because it contains certain structural modifications (e.g., N-1-hydroxyaminobutyric acid and 6'-hydroxyethyl substituents) that result in activity against many bacteria that possess aminoglycoside-modifying enzymes that inactivate most other aminoglycosides.
Plazomicin exhibits concentration-dependent bactericidal activity against susceptible bacteria. Like other aminoglycosides, the antibacterial activity of plazomicin is due to binding of the drug to 16S rRNA of the bacterial 30S ribosomal subunit, resulting in inhibition of bacterial protein synthesis.
Following multiple doses of plazomicin (15 mg/kg IV once every 24 hours) in healthy adults with normal renal function, there is no appreciable accumulation of the drug and steady-state trough plasma concentrations are attained after the second dose. Peak and trough plasma concentrations of plazomicin increase proportionally over IV doses ranging from 4-15 mg/kg. Plazomicin is approximately 20% bound to plasma proteins; in vitro, protein binding is concentration independent over concentrations ranging from 5-100 mcg/mL.
Plazomicin does not appear to be metabolized and is primarily eliminated by the kidneys. Following a single 15-mg/kg IV dose of plazomicin in healthy adults, 97.5% of the dose is eliminated in urine as unchanged drug. The mean half-life of plazomicin in healthy adults with normal renal function is 3.5 hours; a half-life of 4-5 hours has been reported in patients with complicated urinary tract infections and blood stream infections.
USES: This medication is used to treat a variety of bacterial infections. Plazomicin belongs to a class of drugs known as aminoglycoside antibiotics. It works by stopping the growth of bacteria.
Generic name: plazomicin sulfate
Pronunciation: (PLA-zoe-MYE-sin)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Zemdri
Indications
The following indications are listed for Zemdri:
- Complicated E. Coli Uti
- Complicated Proteus Uti
- Enterobacter Complicated Uti
- Klebsiella Complicated Uti
Also known as: Complicated Urinary Tract Infection Due To Aerobacter, Complicated Urinary Tract Infection Due To Enterobacter, Complicated Urinary Tract Infection Due To Escherichia Coli, Complicated Urinary Tract Infection Due To Klebsiella, Complicated Urinary Tract Proteus Species Infection, Complicated Uti Due To E. Coli, Complicated Uti Due To Enterobacter Species, Complicated Uti Due To Klebsiella Species, Complicated Uti Due To Proteus Species.
Dosing
Plazomicin is commercially available as plazomicin sulfate; dosage is expressed in terms of plazomicin.
Dosage of plazomicin should be calculated using total body weight. If total body weight exceeds ideal body weight by 25% or more, adjusted body weight should be used to calculate dosage.
Plazomicin sulfate is administered by IV infusion.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*Known hypersensitivity to any aminoglycoside.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
Adverse effects reported in 1% or more of patients receiving plazomicin include decreased renal function, diarrhea, hypertension, headache, nausea, vomiting, and hypotension.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
Safety and efficacy of plazomicin have not been established in patients younger than 18 years of age.
Aminoglycosides, including plazomicin, can cause fetal harm when administered to pregnant women.
Data are not available regarding use of plazomicin in pregnant women to inform a drug-associated risk of adverse developmental outcomes. Pregnant women should be advised of the potential risk to a fetus.
In animal studies, no plazomicin-related visceral or skeletal malformations were observed in pregnant rats or rabbits receiving plazomicin at doses that resulted in maternal exposures 0.8- or 2.5-fold higher, respectively, than human exposures at the recommended dosage; auditory function was not measured in the offspring of these animals.
Plazomicin is distributed into milk in rats. It is not known if the drug is distributed into human milk, affects the breast-fed infant, or affects milk production.
The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for plazomicin and any potential adverse effects on the breast-fed infant from the drug or the underlying maternal condition.
Dosage should be selected with caution because of age-related decreases in renal function, and plasma concentrations of plazomicin should be monitored as appropriate.
In phase 2 and 3 clinical studies evaluating plazomicin, 40% of patients were 65 years of age and older; 17.2% of patients were 75 years of age and older. In patients 65 years of age or older in the phase 3 study (Trial 1), adverse effects were reported in 27 or 18.9% of those receiving plazomicin or meropenem, respectively; in those younger than 65 years of age, adverse effects were reported in 13.3 or 24.1%, respectively. The rate of adverse renal effects in patients 65 years and older was 6.6 or 2.8% in those receiving plazomicin or meropenem, respectively; in those younger than 65 years of age, such adverse effects were reported in 1.2 or 0%, respectively.
Clinically relevant age-related differences in plazomicin exposures have not been observed. Although trough plasma concentrations of plazomicin reported in geriatric patients 65-90 years of age were higher than those reported in younger adults, these increased trough plasma concentrations were mainly attributed to age-related changes in renal function.
Since the risk of adverse effects may be greater in patients with renal impairment and geriatric patients are more likely to have decreased renal function, plazomicin dosage should be selected carefully in geriatric patients and renal function should be monitored. Dosage adjustments in geriatric patients should take into account renal function and plazomicin plasma concentrations as appropriate.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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