II. Indications

  1. Complicated, drug-resistant Urinary Tract Infection (Enterobacteriaceae, ESBL, CRE)

III. Contraindications

  1. Pregnancy
  2. Not approved for use in children

IV. Mechanism

  1. See Aminoglycoside
  2. Bactericidal Aminoglycoside

V. Dosing

  1. Dosing Weight
    1. Based on Total Body Weight (TBW) and Ideal Body Weight (IBW)
    2. TBW< (IBW * 0.25)
      1. Use Total Body Weight for dosing
    3. TBW > (IBW * 0.25)
      1. Use Adjusted Body Weight = IBW + 0.4 * (TBW - IBW)
  2. Adults (eGFR >60 ml/min)
    1. Give 15 mg/kg IV infused over 30 minutes every 24 hours
    2. Plazomicin 500 mg vial (50 mg/ml) is diluted in NS or LR to total volume of 50 ml for infusion
      1. Diluted solution is stable at room Temperature for 24 hours after mixing
  3. Renal Dosing in Adults (eGFR <60 ml/min)
    1. eGFR 30 to 60 ml/min: Give 10 mg/kg IV over 30 minutes every 24 hours
    2. eGFR 15 to 30 ml/min: Give 10 mg/kg IV over 30 minutes every 48 hours
    3. Avoid in eGFR <15 ml/min or Hemodialysis

VI. Pharmacokinetics

  1. Eliminated unchanged in urine (>97%)
  2. Half Life: 3 to 4 hours (when Renal Function is normal)
  3. Obtain baseline and daily Serum Creatinine and eGFR and follow levels (and Urine Output) carefully if eGFR <90 ml/min
  4. Target trough plasma levels (within 30 min of second dose): <3 mcg/ml
    1. If trough >3 mcg/ml, increase dosing interval by 1.5x (e.g. increase every 24 hour dosing to every 36 hours)
    2. At time of release, plasma levels were only available from Mayo Medical Labs

VII. Adverse Effects

  1. See Aminoglycoside
  2. Aminoglycosides are associated with risk of Ototoxicity and nephrotoxicity (FDA black box warning)
    1. See Aminoglycoside for risk factors

VIII. Safety

  1. Unknown safety in Lactation
  2. Pregnancy Category X
    1. Congenital Deafness risk

X. References

  1. (2018) Presc Lett, Resource #340921, New Drug: Zemdri (Plazomycin)
  2. (2018) Med Lett Drugs Ther 60(1559): 180-81

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