Plazomicin Injection
Plazomicin Injection (Zemdri) is an intravenous aminoglycoside antibiotic used to treat complicated urinary tract infections, including kidney infection (pyelonephritis), in adults who have few or no other treatment options.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 3 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Zemdri can cause kidney damage, permanent hearing and balance problems, muscle weakness (neuromuscular blockade), and harm to an unborn baby.
- Kidney risk is higher if you already have kidney problems, are older, or take other kidney-harming medicines. Kidney function is checked before and every day during treatment.
- Hearing loss, ringing in the ears or vertigo may be irreversible and may not appear until after treatment ends. Risk is higher with a family history of hearing loss, kidney problems, or higher or longer dosing than recommended.
- Muscle weakness is a concern especially if you have myasthenia gravis or get muscle-blocking drugs.
- It can cause fetal harm if used in pregnancy.
📖 Plazomicin Injection: Patient Information Guide
A plain-language walkthrough of Plazomicin Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
What Plazomicin Injection is used for
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Plazomicin Injection treats a specific type of bacterial infection.
- Zemdri (IV) treats complicated urinary tract infections (cUTI), including pyelonephritis, in adults 18 and older.
- It is for infections caused by susceptible E. coli, Klebsiella pneumoniae, Proteus mirabilis and Enterobacter cloacae.
- It is reserved for people with limited or no alternative treatment options.
How Plazomicin Injection works
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Plazomicin is an aminoglycoside antibacterial drug. It acts against certain bacteria that cause urinary tract infections.
Its effect is best linked to how much drug exposure is achieved relative to the amount needed to stop the bacteria from growing.
How Plazomicin Injection is taken (dosage)
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Zemdri is given by IV infusion over about 30 minutes, generally once every 24 hours, by a healthcare professional. Treatment usually lasts 4 to 7 days, and the maximum is 7 days. A pill antibiotic may be considered afterward to complete the course.
- People with reduced kidney function may get different amounts or less frequent dosing.
- Blood levels of the drug may be checked in people with reduced kidney function.
- Kidney function is checked before and daily during treatment.
Plazomicin Injection side effects in detail
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The most common side effects seen in studies were:
- Decreased kidney function
- Diarrhea
- High blood pressure
- Headache
- Nausea and vomiting
- Low blood pressure
Seek help for hearing changes, vertigo, muscle weakness, allergic reactions, or severe diarrhea.
Plazomicin Injection warnings and precautions
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- Kidney damage: Higher risk with kidney problems, older age and other kidney-harming drugs. Most creatinine rises were reversible in studies.
- Hearing and balance damage: May be permanent and may appear after treatment ends. Rare genetic variants (MT-RNR1) raise risk even with normal drug levels.
- Muscle weakness: Can worsen in people with myasthenia gravis or those given muscle-blocking drugs.
- Fetal harm: Aminoglycosides can harm an unborn baby.
- Allergy: Serious and sometimes fatal allergic reactions can occur. Stop the drug if one happens.
- C. difficile diarrhea: Can occur during or even months after antibiotic treatment.
- Resistance: Use only for proven or strongly suspected bacterial infection.
Plazomicin Injection interactions: what it interacts with
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A few medicine combinations need extra care.
- Other kidney-harming (nephrotoxic) medicines: raise the risk of kidney damage.
- Neuromuscular blocking agents: can delay recovery of muscle function.
- Other drugs in the same IV line: compatibility has not been established, so they should not be mixed or infused together.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
Before taking Plazomicin Injection
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- Do not use if you are allergic to any aminoglycoside.
- Kidney problems: dose changes and monitoring are needed. There is not enough information to recommend dosing if clearance is below 15 mL/min or on dialysis.
- Family history of hearing loss or a known mitochondrial variant: your doctor weighs the risks.
- Myasthenia gravis or other neuromuscular disorders: higher risk of weakness.
- Pregnancy: can cause fetal harm. Tell your doctor if pregnant or planning pregnancy.
- Breastfeeding: there are no human data, so benefits and risks are weighed.
- Under 18: safety and effectiveness have not been established.
- Older adults: more likely to have kidney effects and need monitoring.
Plazomicin Injection overdose: if you take too much
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If an overdose happens, Zemdri is stopped and supportive care is given. Kidney function is monitored closely and kept supported. Hemodialysis may help remove it from the blood, especially if kidney function is poor, though there is no clinical information on its use for overdose.
Pharmacodynamics: what Plazomicin Injection does in the body
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Plazomicin's effect against bacteria best matches the ratio of drug exposure to the minimum amount needed to stop bacterial growth. Kidney side effects were linked to higher trough (lowest) blood levels: in people with mild to moderate kidney impairment, 36% with trough levels of 3 mcg/mL or higher had nephrotoxicity compared with 5% below that level. At a dose 1.3 times the maximum recommended, it did not meaningfully affect the heart's QTc interval.
Pharmacokinetics: how your body processes Plazomicin Injection
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After an IV infusion, plazomicin levels rise in proportion to the dose and do not build up meaningfully with daily dosing in people with normal kidney function. About 20% is bound to blood proteins. It is not appreciably metabolized. It is cleared almost entirely by the kidneys, with about 97.5% recovered unchanged in urine, and a half-life of about 3.5 hours in healthy adults with normal kidney function. Reduced kidney function slows clearance.
How to store Plazomicin Injection
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Store ZEMDRI injection 500 mg/10 mL (50 mg/mL) refrigerated at 2°C to 8°C (36°F to 46°F).
📄 Written from Plazomicin Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Plazomicin Injection
35 supplements and herbal products have documented interactions with Plazomicin Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 2
- Moderate · 31
- Minor · 2
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Plazomicin Injection has been associated with lower levels of 8 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
- Higher significance · 6
- Moderate · 2
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
🩺 Plazomicin Injection: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Plazomicin Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What am I getting this medicine for?
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How will I get it, and for how long?
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Why do you keep checking my kidneys and drug levels?
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What side effects should I expect, and which ones should I report?
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Can I use this if I'm pregnant or breastfeeding?
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Do I need to tell you about my other medicines?
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Is Plazomicin Injection available over the counter?
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When was Plazomicin Injection first available?
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Who makes Plazomicin Injection?
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💬 Answers drafted from Plazomicin Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 More about Plazomicin Injection on HelloPharmacist
💊 Plazomicin Injection forms and strengths (how it comes)
Plazomicin Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Zemdri treats complicated urinary tract infections, including pyelonephritis, in adults 18 and older with limited or no alternative options.
- Zemdri is given as an IV infusion over about 30 minutes, generally once every 24 hours, with changes for reduced kidney function.
- Zemdri comes as a single-dose vial that is diluted before infusion.
- Zemdri should not be mixed with other drugs or infused through the same IV line as other medicines.
- Zemdri treatment is limited to a maximum of 7 days for cUTI.
📊 Plazomicin Injection on the U.S. market: products, makers and brands
How Plazomicin Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
🔍 Compare Plazomicin Injection products
A representative set of FDA-listed product records for Plazomicin Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 500 mg/10 mL | Intravenous | Achaogen, Inc. | NDA | View NDC → |
| 500 mg/10 mL | Intravenous | Cipla Therapeutics Inc. × 2 listings | NDA | View NDC → |
| 500 mg/10 mL | Intravenous | Cipla USA Inc. × 3 listings | NDA | View NDC → |
Showing 6 of 6 products — FDA National Drug Code Directory. See every product, package size and price: browse all 6 Plazomicin Injection NDCs →
📈 Plazomicin Injection side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Plazomicin Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Plazomicin Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ Plazomicin Injection FDA approval history
How Plazomicin Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Plazomicin Injection recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2049549 1 dose form · 1 strength
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Dose form (SCDF) Injection RxCUI 2049552In current FDA listingsClinical drug / strength (SCD) 10 ML plazomicin 50 MG/MLRxCUI 2049553
Look up RxCUI 2049549 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Plazomicin Injection supply and shortage status
Whether Plazomicin Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Plazomicin Injection brand names
🏭 Who makes Plazomicin Injection: manufacturers and labelers
Plazomicin Injection drug class (RxNorm)
Plazomicin Injection belongs to the Other aminoglycosides class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Sources for this Plazomicin Injection page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 3 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Cipla Therapeutics Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.