Plazomicin

Pronunciation: Pronunciation not provided in available sources; consult local product literature..

Generic name: plazomicin
Brand names: Zemdri
Drug class: Aminoglycoside antibiotic
Form: Single-dose vial containing 500 mg/10 mL (50 mg/mL) concentrate for solution for infusion after dilution
Route: Intravenous infusion
Legal status: Prescription-only medicine

Availability and supply rules vary by country

Trade names by country: United States

What plazomicin is and how it works

Plazomicin is an aminoglycoside antibiotic used to treat adults with complicated urinary tract infections, including pyelonephritis, when limited or no alternative treatment options exist. The medicine works by killing susceptible bacteria. In the United States, the product has been discontinued and is no longer available; where it remains authorised, local prescribing information must be followed. (1) (2)

Plazomicin is administered by intravenous infusion in a healthcare setting. Treatment requires careful monitoring of kidney function, hearing, and other potential serious side effects. It is not for viral infections or mild infections. Your doctor will confirm that the infection is caused by susceptible bacteria and that the benefit outweighs the risks.

Mechanism of action: how plazomicin works

Plazomicin is an aminoglycoside antibiotic. (1)

What plazomicin is used for

Complicated urinary tract infections (including pyelonephritis)

Plazomicin is indicated for the treatment of complicated urinary tract infections, including pyelonephritis, in adults. It is reserved for patients who have limited or no alternative treatment options, and should only be used when the infection is proven or strongly suspected to be caused by susceptible organisms. (1)

Before taking plazomicin

Do not take / not appropriate for

Do not receive plazomicin if you have a known hypersensitivity to plazomicin or another aminoglycoside antibiotic. Tell the clinician managing your treatment about every previous medicine allergy or reaction. (all products) (1)
Do not use plazomicin for a viral infection, a mild infection, or an infection that is not known to involve bacteria that are susceptible to plazomicin. It is reserved for serious infections when alternatives are inadequate. (all indications) (1)
Pregnant women should not receive plazomicin unless the treating specialist has decided that the potential benefit justifies the possible fetal harm. (all indications) (1)

Tell your clinician about

Any history of allergy to aminoglycoside antibiotics (such as gentamicin, tobramycin, amikacin) or other medicines.
Kidney problems, hearing loss, tinnitus, balance disorders, or neuromuscular disease.
Pregnancy, plans for pregnancy, or breastfeeding.
A complete list of all prescription and over-the-counter medicines, supplements, and any recent or planned vaccines.
Any current or previous medical conditions, especially those affecting nerves or muscles.

(1)

How to take plazomicin

Plazomicin is given as an intravenous infusion, usually over 30 minutes, by a healthcare professional in a hospital or clinic setting.
The dose, infusion schedule, and total duration of treatment are determined by the prescriber based on your body weight, kidney function, and the infection being treated. For adults with normal kidney function, a common regimen is 15 mg per kg body weight once daily for 4 to 7 days.
Your kidney function will be checked before the first dose and daily during treatment. Additional dose adjustments may be made based on these tests.
Do not skip doses or stop the treatment earlier than the full prescribed course unless your doctor tells you to because you are experiencing a serious side effect.
Plazomicin is not intended for self-administration; do not attempt to use it at home.

(1) (2)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2)

Missed dose

If you miss a scheduled dose session, contact your healthcare provider immediately to reschedule. Do not adjust the next dose or try to make up for the missed infusion on your own.

Overdose

Plazomicin is administered in a controlled clinical setting. If an overdose is suspected, the healthcare team will provide supportive care and monitoring. Contact the hospital or poison control centre if you have any concerns. (1)

Side effects

The most common side effects include kidney function changes, digestive disturbances, and blood pressure changes. Serious side effects can affect the kidneys, hearing, nerves, and muscles. Many of these are monitored regularly in hospital.

Changes in kidney function

What to notice: Decreased urine output, swelling in legs or ankles, fatigue, or confusion. These are monitored by blood tests.

What to do: Inform your treatment team immediately if you notice any of these symptoms. Do not wait for the next scheduled test. (1)

Diarrhoea, nausea, vomiting, headache, hypertension, or hypotension

What to notice: Symptoms may be mild or moderate.

What to do: Tell the healthcare team if symptoms are bothersome or persistent. (1)

Possible hearing or balance problems (ototoxicity)

What to notice: Ringing in the ears, hearing loss, a feeling of fullness in the ears, dizziness, or vertigo.

What to do: Report any such symptoms immediately to your doctor, even after treatment ends, as these effects can be irreversible. (1)

Kidney problems (nephrotoxicity)

What to notice: Noticeably less urine, swelling, unusual tiredness, shortness of breath.

What to do: Promptly notify the medical team; they will review kidney function tests and may adjust treatment. (1)

Hearing or balance disorders (ototoxicity)

What to notice: New ringing, hearing loss, or dizziness.

What to do: Tell your doctor promptly; hearing damage may be permanent. (1)

Muscle weakness or breathing difficulty (neuromuscular blockade)

What to notice: Muscle weakness, difficulty moving, or trouble breathing.

What to do: Seek immediate emergency medical attention; this is a medical emergency. (1)

Severe allergic reaction (anaphylaxis)

What to notice: Rash, itching, hives, swelling of face/tongue/throat, difficulty breathing, wheezing, severe dizziness, fast heartbeat.

What to do: Call emergency services and use any prescribed emergency medicine if available. Do not delay. (1)

Serious warnings

Anaphylaxis — emergency

Symptoms: Difficulty breathing, swelling of the face or throat, hives, severe dizziness, fast heartbeat.

Action: Use emergency treatment immediately as directed by your healthcare provider and seek emergency medical care. (1)

Nephrotoxicity — high_risk

Symptoms: Markedly reduced urine output, swelling in the legs, confusion, or unusual tiredness.

Action: Notify your healthcare team immediately. Kidney function tests will guide any necessary changes to treatment. (1)

Ototoxicity — high_risk

Symptoms: Ringing in the ears, hearing loss, dizziness, or vertigo.

Action: Report symptoms promptly to the prescribing doctor; damage may be irreversible. Do not delay. (1)

Neuromuscular blockade — emergency

Symptoms: Muscle weakness or difficulty breathing.

Action: Seek emergency medical help immediately; this can affect breathing muscles and requires urgent intervention. (1)

Fetal harm — high_risk

Symptoms: Pregnancy or missed period.

Action: Do not use during pregnancy unless the specialist confirms the benefit outweighs the risk. Inform your doctor immediately if pregnancy occurs. (1)

Interactions

Medicine or test	Effect	Action
Other medicines that may affect kidneys, hearing, or nerves	Aminoglycosides can have additive toxic effects with nephrotoxic, ototoxic, or neuromuscular blocking agents. The prescriber will manage the risk.	Provide a complete list of all medicines, including over‑the‑counter products and supplements. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy and breastfeeding

Plazomicin can cause fetal harm when administered to a pregnant woman. It should not be used during pregnancy unless the potential benefit justifies the potential risk. It is not known whether plazomicin is excreted in human milk; breastfeeding is not recommended during treatment. Discuss contraception and pregnancy planning with your doctor. (1)

Children and adolescents

Safety and effectiveness in patients under 18 years have not been established. Plazomicin is not approved for use in children. (1)

Patients with kidney impairment

The dose must be adjusted based on kidney function, measured by creatinine clearance. Patients with impaired kidney function are at higher risk of kidney toxicity and may require therapeutic drug monitoring of plazomicin levels to guide dose adjustments. Close monitoring is essential. (1)

Monitoring

Before starting

Confirm the infection is complicated UTI with susceptibility to plazomicin and that alternative treatment options are limited.
Assess baseline kidney function (serum creatinine, estimated creatinine clearance).
Obtain pregnancy test in women of childbearing potential.
Review patient history for allergies to aminoglycosides, hearing or balance disorders, neuromuscular diseases, and all concomitant medicines.
Ensure the setting is appropriate for intravenous infusion and emergency management of anaphylaxis.

During treatment

Monitor kidney function daily and adjust dose as needed.
Perform therapeutic drug monitoring of plazomicin levels in patients with renal impairment.
Observe for signs of ototoxicity (hearing loss, tinnitus, vertigo) and neuromuscular blockade.
Monitor for hypersensitivity reactions and C. difficile‑associated diarrhoea.
Reassess the need for continued treatment daily; duration generally 4‑7 days.

(1)

Storage

Storage and preparation requirements depend on the supplied product and setting. Follow the current manufacturer's label and the instructions from the healthcare team or supplying pharmacy; do not improvise preparation or storage conditions.

Professional information

For clinician use only. This summary is based on the US FDA prescribing information and MedlinePlus patient monograph. Plazomicin has been discontinued in the United States; availability elsewhere is unconfirmed. Always refer to the current local product label and national treatment guidelines.

All regions (US label reference)

Indication: Complicated urinary tract infection, including pyelonephritis, in adults

Dose summary: Adults with creatinine clearance (CrCl) ≥ 90 mL/min: 15 mg/kg every 24 hours by intravenous infusion over 30 minutes for 4 to 7 days. For CrCl 60–<90 mL/min: 10 mg/kg every 24 hours; CrCl 30–<60 mL/min: 7.5 mg/kg every 24 hours; CrCl 15–<30 mL/min: 10 mg/kg every 48 hours. End‑stage renal disease on haemodialysis: 7.5 mg/kg after haemodialysis on dialysis days. Therapeutic drug monitoring is recommended for patients with CrCl < 90 mL/min and those with changing renal function.

Renal context: Dose adjustment is required; monitoring of renal function and plazomicin concentrations is advised. (1)

Mechanism of action

Hepatic guidance

No hepatic dose adjustment is described in the US label.

Overdose note

Standard supportive measures; consult a poison centre. (1)

Frequently asked questions

Is plazomicin still available in the United States?

No. The manufacturer discontinued plazomicin in the US. It is no longer on the market there. If you need treatment for a complicated UTI, your doctor will consider other antibiotic options. (2)

What should I do if I develop ringing in the ears or hearing loss during treatment?

Contact your healthcare team immediately. Hearing changes can be irreversible and may require stopping the medicine (under medical supervision) or adjusting the dose. (1)

Can plazomicin be used during pregnancy?

It is not recommended. Plazomicin can cause harm to the unborn baby. If you are pregnant or become pregnant, tell your doctor right away. (1)

Why is kidney function monitored so closely?

Plazomicin can damage the kidneys. Daily blood tests help the doctor adjust the dose to keep you safe while effectively treating the infection. (1)

What is the mechanism of action of plazomicin?