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ZEMDRI
Bacterial infections
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Drug Name:

ZEMDRI Rx

Generic Name and Formulations:
Plazomicin sulfate 500mg/10mL; per vial; soln for IV infusion after dilution; preservative-free.

Company:
Achaogen, Inc.

Therapeutic Use:

RECENT UPDATES

Monograph added.

Indications for ZEMDRI:

Susceptible complicated urinary tract infections (cUTI), including pyelonephritis.

Adult:

Give by IV infusion over 30mins. ≥18yrs (CrCl ≥90mL/min): 15mg/kg every 24hrs for 4–7 days (an oral therapy may be considered after Zemdri to complete a total of 7–10 days [IV + oral]). Dose adjustments may be required based on renal function changes. Renal impairment (CrCl ≥60–<90mL/min): 15mg/kg every 24hrs; (CrCl ≥30–<60mL/min): 10mg/kg every 24hrs; (CrCl ≥15–<30mL/min): 10mg/kg every 48hrs; (CrCl <15mL/min or on renal replacement therapy, including hemodialysis): insufficient data.

Children:

<18yrs: not established.

Boxed Warning:

Nephrotoxicity. Ototoxicity. Neuromuscular blockade. Fetal harm.

Warnings/Precautions:

Assess CrCl in all patients prior to initiation, daily during therapy, and esp. in those at increased risk of nephrotoxicity (eg, renal impairment, elderly, concomitant potentially nephrotoxic drugs). Patients with CrCl ≥15–<90mL/min: monitor and maintain plasma trough level <3mcg/mL. Risk of ototoxicity (eg, family history of hearing loss, renal impairment, taking higher doses and/or prolonged use): consider benefit-risk of therapy. Underlying neuromuscular disorders (eg, myasthenia gravis) or concomitant neuromuscular blockers: monitor for adverse reactions. Discontinue if allergic reaction occurs. Renal impairment: monitor and adjust dose (see Adult). Elderly: monitor. Pregnancy: fetal harm can occur. Nursing mothers.

Pharmacological Class:

Aminoglycoside.

Interactions:

Increased risk of nephrotoxicity with concomitant nephrotoxic drugs. May potentiate neuromuscular blockade.

Adverse Reactions:

Decreased renal function, diarrhea, hypertension, headache, nausea, vomiting, hypotension; ototoxicity (eg, hearing loss, tinnitus, vertigo), neuromuscular blockade, hypersensitivity, possible C. difficile-associated diarrhea.

Generic Availability:

NO

How Supplied:

Single-dose vials—10

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