FDA-filed SPL labeling · retrieved through openFDA

Amikacin Injection

Amikacin injection is an aminoglycoside antibiotic given by injection to treat serious bacterial infections caused by susceptible gram-negative bacteria, including septicemia, respiratory infections, meningitis, urinary tract infections, and more.

Brand names AmikinArikayce
Drug class Aminoglycoside Antibacterial
Rx Form 1 Routes Intramuscular; Intravenous · Intramuscular, Intravenous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 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 7 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 →

At a glance
Linked label effectiveJul 27, 2026
Clinical labels in scope 7
AvailabilityRx
Earliest approval/marketing year 1981
FDA-listed product records 25
Boxed warningYes
How we combine label and product data →
No current FDA shortage listed · checked Sep 21, 2026
Other forms & routes:
Amikacin Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Amikacin injection is a powerful antibiotic reserved for serious gram-negative bacterial infections — septicemia, meningitis, respiratory infections, urinary tract infections, and more — when other antibiotics won't work. It requires close medical supervision because it carries real risks of permanent hearing loss and kidney damage, especially with prolonged use or in people with kidney problems. Always follow your care team's dosing and monitoring instructions exactly, and report any changes in hearing, dizziness, or urination right away.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert

Amikacin can cause permanent hearing loss and serious kidney damage — these are the most important risks to know. Hearing damage (ototoxicity) often starts at high frequencies you may not notice right away, and it can become permanent even after the drug is stopped. Watch for ringing in the ears, dizziness, or any change in hearing. Kidney damage (nephrotoxicity) is more likely in people who already have kidney problems, receive high doses, or take the drug for a long time. Kidney and hearing function must be monitored closely throughout treatment.

Amikacin can also cause neuromuscular blockade — a dangerous muscle paralysis that can stop breathing — especially when used with anesthetics or certain muscle-relaxing drugs. People with certain rare genetic variants (in the MT-RNR1 gene) face an even higher risk of permanent hearing loss, even at normal drug levels. Avoid combining amikacin with other drugs that are toxic to the kidneys or hearing (such as vancomycin, cisplatin, or furosemide), as this greatly increases risk. Safety beyond 14 days of treatment has not been established.

Read the full warning on DailyMed →

📖 Amikacin Injection: Patient Information Guide

A plain-language walkthrough of Amikacin Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Amikacin sulfate injection is a short-term antibiotic treatment for serious bacterial infections caused by susceptible bacteria. It is used across a wide range of infection types:

  • Bacterial septicemia (blood infection), including neonatal (newborn) sepsis
  • Serious respiratory tract infections
  • Bone and joint infections
  • Central nervous system infections, including meningitis (infection of the membranes around the brain and spinal cord)
  • Skin and soft tissue infections
  • Intra-abdominal infections, including peritonitis (infection of the abdominal lining)
  • Burn infections and serious postoperative infections, including post-vascular surgery
  • Serious complicated or recurrent urinary tract infections caused by susceptible gram-negative bacteria
  • Infections caused by bacteria resistant to gentamicin or tobramycin, such as Pseudomonas aeruginosa and Serratia marcescens
  • Certain staphylococcal infections, especially in patients allergic to other antibiotics or when both gram-positive and gram-negative bacteria may be involved
⚙️How it works

Amikacin is an aminoglycoside antibiotic. It works by binding tightly to the prokaryotic ribosome — the machinery inside bacterial cells that builds proteins. Without the ability to make proteins, bacteria cannot survive or multiply, so amikacin kills them directly. It is effective against a broad range of gram-negative bacteria and some gram-positive bacteria, particularly staphylococci.

One key advantage of amikacin is that it resists breakdown by many of the enzymes bacteria use to inactivate other aminoglycosides like gentamicin and tobramycin. This makes it useful when infections don't respond to those drugs. Amikacin also works synergistically with beta-lactam antibiotics (like penicillins) against many gram-negative organisms, meaning the two drugs together are more effective than either alone.

💊How it's taken

Amikacin sulfate injection is given only by injection — either into a muscle (intramuscular) or slowly into a vein (intravenous). Dosing is carefully calculated based on your body weight and kidney function, and is typically given two to three times per day. Intravenous doses are infused over 30 to 60 minutes for adults; infants receive their dose over 1 to 2 hours.

  • Treatment usually lasts 7 to 10 days; safety beyond 14 days has not been established
  • Patients with kidney problems need a reduced dose or longer time between doses — your care team will adjust this
  • Amikacin must never be mixed in the same IV line with other medications
  • Always follow your prescriber's exact instructions, and attend all scheduled blood and kidney tests
🤒Side effects — in detail

Like all aminoglycosides, amikacin carries a risk of serious side effects — primarily involving hearing and kidney function. Other reported side effects include:

  • High-frequency hearing loss (may occur before you notice it)
  • Ringing, roaring in the ears, or dizziness/vertigo
  • Kidney changes: reduced urine output, elevated creatinine, protein in urine
  • Numbness, tingling, or tremor
  • Nausea and vomiting
  • Skin rash or drug fever
  • Low magnesium levels in the blood (hypomagnesemia)
  • Anemia or low blood pressure (reported rarely)

Hearing loss from amikacin can be permanent and may worsen even after the drug is stopped — report any changes in hearing, ringing, or balance to your care team immediately. Kidney changes are usually reversible when the drug is stopped, but serious kidney failure has been reported.

⚠️Warnings & precautions
  • Permanent hearing loss: Amikacin can permanently damage the nerves responsible for hearing and balance. High-frequency hearing loss often starts silently. Warning signs include ringing in the ears, dizziness, or muffled hearing — report these immediately.
  • Kidney damage: Amikacin can harm the kidneys, especially in people with pre-existing kidney problems, the elderly, or those who are dehydrated. Kidney function must be monitored throughout treatment.
  • Neuromuscular blockade: Amikacin can cause sudden muscle paralysis and breathing failure, particularly in patients receiving anesthetics or muscle-relaxing drugs. Emergency respiratory support may be needed.
  • Genetic risk for hearing loss: People with certain mitochondrial DNA variants (especially MT-RNR1 m.1555A>G) can develop permanent hearing loss even at normal amikacin blood levels. Tell your doctor if there is a family history of aminoglycoside-related hearing loss.
  • Pregnancy: Aminoglycosides can cause permanent deafness in an unborn baby. Amikacin should only be used during pregnancy if absolutely necessary.
  • C. difficile colitis: Like all antibiotics, amikacin can trigger a serious gut infection (C. difficile) causing severe diarrhea that may require separate treatment.
  • Sulfite allergy: This injection contains sodium metabisulfite, which can cause serious allergic reactions in sulfite-sensitive patients, particularly those with asthma.
🔀What it interacts with

Amikacin interacts with several drugs that can increase toxicity risk or affect how the body handles the antibiotic:

  • Other aminoglycosides (e.g., gentamicin, tobramycin, kanamycin) — combined use greatly raises the risk of hearing and kidney damage
  • Nephrotoxic drugs (e.g., amphotericin B, vancomycin, cisplatin, colistin, polymyxin B, cephaloridine, paromomycin, bacitracin, viomycin) — increase risk of serious kidney damage
  • Potent diuretics (furosemide, ethacrynic acid) — can cause hearing damage on their own and amplify amikacin toxicity by altering drug levels in the blood and tissues
  • Neuromuscular blocking agents (e.g., succinylcholine, tubocurarine, decamethonium) — combined use can cause dangerous muscle paralysis and breathing failure
  • Anesthetics — may worsen the risk of neuromuscular blockade when given alongside amikacin
  • Citrate-anticoagulated blood transfusions — large transfusions may increase neuromuscular blockade risk

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Tell your doctor if you have any history of kidney disease or reduced kidney function — amikacin dosing must be adjusted and kidneys must be monitored closely
  • Tell your doctor if you or a family member has experienced hearing loss related to aminoglycoside use, or if you have a known mitochondrial DNA variant (MT-RNR1) — you may be at much higher risk for permanent hearing loss
  • Tell your doctor if you are pregnant or planning to become pregnant — aminoglycosides can cause irreversible deafness in an unborn baby
  • Tell your doctor about all other medications you take, especially other antibiotics, diuretics, or anesthetics
  • Tell your doctor if you have asthma or a known sulfite sensitivity — this injection contains sodium metabisulfite
  • Tell your doctor if you are allergic to amikacin or any other aminoglycoside antibiotic (cross-sensitivity is possible)
  • Older adults are at higher risk for hearing and kidney toxicity and need careful monitoring
  • Patients who are dehydrated are at increased risk of toxicity — stay well hydrated unless told otherwise by your care team
  • Newborns require special dosing calculated by weight and age — inform the care team of all relevant details
🚑If you take too much

Too much amikacin can cause serious hearing damage, kidney failure, and muscle paralysis. If an overdose is suspected, medical staff can remove amikacin from the body using peritoneal dialysis or hemodialysis (blood filtering procedures). In newborns, an exchange transfusion may also be considered. Seek emergency medical care immediately.

🔬Pharmacokinetics — how your body processes it

After an intramuscular injection, amikacin is absorbed rapidly, with peak blood levels typically reached within 1 hour. After intravenous infusion over 30 minutes, peak blood levels occur at the end of the infusion. The drug's serum half-life is slightly over 2 hours in people with normal kidney function, meaning the body clears roughly half the drug every 2 hours.

Amikacin is eliminated almost entirely unchanged through the kidneys (by glomerular filtration), with about 91–98% of an intramuscular dose excreted in the urine within 24 hours. It distributes well into many body tissues including bone, lung, heart, and gallbladder, and penetrates into spinal fluid when the meninges are inflamed. In people with impaired kidney function, the drug is cleared much more slowly, significantly prolonging its half-life and increasing the risk of toxicity — which is why dose adjustments are essential in those patients. Amikacin crosses the placenta and reaches the fetus.

📦How to store it

Store at 20° to 25°C (68° to 77°F).

📄 Written from Amikacin 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 →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Amikacin Injection — the kind of thing our pharmacy team would talk through with you at the counter.

Why am I getting amikacin instead of a regular oral antibiotic?
Amikacin is reserved for serious, hard-to-treat bacterial infections — the kind that either don't respond to standard antibiotics or are caused by bacteria that are resistant to other drugs. It has to be given by injection because it isn't absorbed effectively when taken by mouth. Your doctor chose it because it's the right tool for the specific bacteria causing your infection.
How will I know if amikacin is affecting my hearing?
This is really important to stay on top of. The tricky thing is that hearing damage from amikacin often starts at high frequencies that you can't notice in everyday conversations. Signs to watch for include ringing or roaring in your ears, a feeling of fullness in your ears, dizziness, or any new trouble hearing. Tell your care team right away if any of these happen — catching it early can make a difference. If you're on a longer course, you may also get a hearing test (audiogram) during treatment.
What should I watch for with my kidneys while on this medication?
Your care team will monitor your kidney function with blood and urine tests throughout treatment. On your end, let them know immediately if you notice you're urinating much less than usual, or if your urine looks foamy or discolored. Staying well hydrated during treatment is also important — ask your nurse or doctor how much fluid is right for you. Any signs of kidney trouble mean the dose may need to be adjusted or the drug stopped.
Is it safe to take amikacin if I'm pregnant?
This is a serious concern. Aminoglycosides like amikacin can cross the placenta and reach the baby, and there are reports of permanent hearing loss in babies born to mothers who received similar drugs during pregnancy. If you are pregnant or think you might be, tell your doctor right away. Amikacin would only be used if the infection is severe enough that the benefit clearly outweighs this risk — and that's a conversation to have openly with your care team.
Are there any drugs I should avoid while receiving amikacin?
Yes — a few combinations are particularly risky. Water pills (diuretics) like furosemide can increase your risk of hearing damage when used with amikacin. Other antibiotics that are hard on the kidneys — like vancomycin, amphotericin B, or colistin — also raise the risk of kidney damage when combined. And if you're going into surgery, make sure your anesthesia team knows you're on amikacin, because some anesthetic and muscle-relaxing drugs can interact dangerously. Always tell every member of your care team exactly what medications you're on.
How long will I need to be on amikacin, and what happens after?
Most courses of amikacin last 7 to 10 days, and it's generally not used for longer than 14 days because the safety of longer treatment hasn't been well established. Your doctor will watch how your infection responds — if there's no clear improvement within 3 to 5 days, they'll reassess the plan. Once your treatment is finished, your kidney function and hearing will likely be rechecked to make sure everything is recovering well.
Is Amikacin Injection available over the counter?
Amikacin Injection is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Amikacin Injection first available?
Amikacin Injection has been available in the United States since at least 1981, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Amikacin Injection?
Amikacin Injection is supplied by 7 manufacturers listed in the FDA NDC Directory, including Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., Hikma Pharmaceuticals USA Inc., Fresenius Kabi USA, LLC.

💬 Answers drafted from Amikacin 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 →

🧰 Keep exploring

💊 How Amikacin Injection comes

Amikacin 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

Into a muscle · Into a vein
How this form is used
What it may be used for
  • amikacin sulfate injection is used to treat serious infections caused by susceptible gram-negative bacteria, including septicemia, respiratory, bone, joint, skin, and abdominal infections
  • amikacin sulfate injection is used for bacterial meningitis and central nervous system infections
  • amikacin sulfate injection is used for serious complicated urinary tract infections caused by susceptible organisms
  • amikacin sulfate injection may be used in certain staphylococcal infections, including in patients allergic to other antibiotics
Important instructions
  • amikacin sulfate injection may be given intramuscularly (into a muscle) or intravenously (into a vein), as directed by your care team
  • amikacin sulfate injection given intravenously is infused slowly over 30 to 60 minutes for adults and older children; infants should receive their dose over 1 to 2 hours
  • amikacin sulfate injection must not be mixed in the same IV line with other drugs — it is always given separately
  • amikacin sulfate injection dosing is based on your body weight and kidney function; follow your prescriber's instructions exactly and attend all scheduled lab monitoring
Available strengths 3 strengths
25 FDA-listed product records

📊 Amikacin Injection across the U.S. market

How Amikacin 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.

1
Dose forms
7
Manufacturers
1
Brand names
25
FDA-listed product records
1981
First marketed
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.36%
Hikma Pharmaceuticals USA Inc.24%
Fresenius Kabi USA, LLC8%
Mullan Pharmaceutical Inc.8%
Qilu Pharmaceutical Co., Ltd.8%
Sagent Pharmaceuticals8%
Other makers8%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Amikacin Injection is used

A general measure of how commonly Amikacin Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Amikacin Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

2,869
Medicaid prescriptions filled (Q1–Q4 2025)
$123,551 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Amikacin Injection prescribed? Of the 1,596 medications we measure, Amikacin Injection ranks #1,134 by Medicaid prescriptions — more than 29% of them.

Where Amikacin Injection ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Amikacin Injection product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 4 mL / 250 mg/mL injection is the most-dispensed Amikacin Injection product — about 50% of these Medicaid prescriptions.

4 ML amikacin 250 MG/ML Injection Most dispensed

1,438 Medicaid prescriptions (Q1–Q4 2025) 50% of Amikacin Injection prescriptions shown $50,566 gross reimbursement (before rebates) ≈ $35 per prescription (gross)

Summed across the 5 of 15 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1723160

2 ML amikacin 250 MG/ML Injection

1,431 Medicaid prescriptions (Q1–Q4 2025) 50% of Amikacin Injection prescriptions shown $72,985 gross reimbursement (before rebates) ≈ $51 per prescription (gross)

Summed across the 4 of 15 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1723156

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Amikacin Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 9 of 30 listed Amikacin Injection NDCs with Medicaid activity.

🔍 Compare Amikacin Injection products

A representative set of FDA-listed product records for Amikacin 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.)

Showing 25 of 25 products — FDA National Drug Code Directory. See every product, package size and price: browse all 25 Amikacin Injection NDCs →

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.

Ingredient (IN) Amikacin Injection RxCUI 641 3 dose forms · 6 strengths
  1. Dose form (SCDF) Inhalation Suspension RxCUI 2285804 No current FDA listing
    Clinical drug / strength (SCD) liposomal 70.3 MG/ML RxCUI 2059184
  2. Dose form (SCDF) Injectable Solution RxCUI 370563 In current FDA listings
    Clinical drug / strength (SCD) sulfate 5 MG/ML RxCUI 905156 sulfate 50 MG/ML RxCUI 905148 250 MG/ML RxCUI 1598047

Look up RxCUI 641 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.

🏷️ Sold under these brand names

Amikin Arikayce

🏭 Manufacturers & labelers

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 9 Hikma Pharmaceuticals USA Inc. 6 Fresenius Kabi USA, LLC 2 Mullan Pharmaceutical Inc. 2 Qilu Pharmaceutical Co., Ltd. 2 Sagent Pharmaceuticals 2 Teva Parenteral Medicines, Inc. 2

RxNorm drug class

Amikacin Injection belongs to the Aminoglycoside Antibacterial class.

Pharmacologic class Aminoglycoside Antibacterial
Drug family (ATC) Other antibiotics for topical use, Other aminoglycosides, Antibiotics

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.

🔬 Where this comes from

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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jul 27, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Amikacin Injection.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Amikacin Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
7
NDC products indexed
25
Distinct labelers/manufacturers represented
7
Linked representative label
Sagent Pharmaceuticals
Linked label effective
Jul 27, 2026
Composite sections available
18
Linked SPL Set ID
f260ff2a-76a0-4672-9516-91c344b67890
Linked SPL Document ID
199988b6-2417-4072-803d-fa6acab5703f
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 7 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. Sagent Pharmaceuticals 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.