ZEMDRI Dosage & Rx Info | Uses, Side Effects

Zemdri Generic Name & Formulations

Legal Class

General Description

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

Pharmacological Class

Aminoglycoside.

How Supplied

Single-dose vials—10

Manufacturer

Cipla USA Inc.

Generic Availability

Mechanism of Action

Plazomicin is an aminoglycoside that acts by binding to bacterial 30S ribosomal subunit, thereby inhibiting protein synthesis. Plazomicin has concentration-dependent bactericidal activity as measured by time kill studies.

Zemdri Indications

Indications

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

Zemdri Dosage and Administration

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.

Zemdri Contraindications

Not Applicable

Zemdri Boxed Warnings

Boxed Warning

Nephrotoxicity. Ototoxicity. Neuromuscular blockade. Fetal harm.

Zemdri Warnings/Precautions

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 for ototoxicity (eg, family history of hearing loss, renal impairment, taking higher doses and/or prolonged use, or with certain mitochondrial DNA variants); consider alternative therapies. 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.

Zemdri Pharmacokinetics

Elimination

Renal. Half-life: 3.5 hours.

Zemdri Interactions

Interactions

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

Zemdri Adverse Reactions

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.

Zemdri Clinical Trials

See Literature

Zemdri Note