FDA-filed SPL labeling · retrieved through openFDA

Colistimethate Injection

Colistimethate injection is an antibiotic used to treat serious bacterial infections caused by certain gram-negative bacteria, including Pseudomonas aeruginosa, E. coli, Klebsiella pneumoniae, and Enterobacter aerogenes.

Brand names Coly-Mycin MColy-Mycin
Drug classes ⓘ Polymyxin-class 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 6 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 effectiveJun 8, 2026
Clinical labels in scope ⓘ6
AvailabilityRx
Earliest approval/marketing year ⓘ1970
FDA-listed product records ⓘ18
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 25, 2026
Other forms & routes:
⭐ Colistimethate Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Colistimethate injection is a powerful antibiotic reserved for serious gram-negative bacterial infections, including those caused by Pseudomonas aeruginosa. It requires careful monitoring of kidney function and neurological symptoms throughout treatment. Follow your healthcare team's dosing instructions closely, and report any changes in urination, breathing, or neurological symptoms right away.

📖 Colistimethate Injection: Patient Information Guide

A plain-language walkthrough of Colistimethate 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▾

Colistimethate for Injection is an antibiotic used to treat serious bacterial infections caused by certain gram-negative bacteria. It is available as Coly-Mycin, given by intramuscular or intravenous injection.

  • Infections caused by Pseudomonas aeruginosa — this is a primary indication
  • Infections caused by Escherichia coli (E. coli)
  • Infections caused by Klebsiella pneumoniae
  • Infections caused by Enterobacter aerogenes
  • Serious infections strongly suspected to be caused by gram-negative bacteria (used to start treatment while awaiting lab confirmation)
  • Not for infections caused by Proteus or Neisseria
⚙️How it works▾

Colistimethate sodium acts like a surface detergent that punches through the outer membrane of certain bacteria. Once it disrupts that protective barrier, the bacteria can no longer keep their internal environment stable — and they die. This makes it a bactericidal antibiotic, meaning it kills bacteria rather than just slowing their growth.

It is active against aerobic gram-negative bacteria specifically — a group that includes some of the most difficult-to-treat hospital-acquired infections. To protect the long-term effectiveness of this antibiotic, it should only be used when there is good reason to believe the infection is caused by a susceptible organism.

💊How it's taken▾

Coly-Mycin is given by injection — either into a vein (IV) or a muscle (IM) — by a healthcare professional. It is usually administered in divided doses, spread out two to four times per day, depending on the severity of the infection and the patient's kidney function.

  • Dosing is weight-based and individualized — your prescriber determines your schedule
  • In patients with kidney impairment, the dose and frequency are reduced to prevent toxicity
  • In obese patients, dosing is based on ideal body weight, not actual body weight
🤒Side effects — in detail▾

Like all medications, colistimethate can cause side effects. The most commonly reported ones include:

  • Tingling or numbness in the hands, feet, or tongue
  • Dizziness or vertigo
  • Slurred speech
  • Generalized itching, hives, or rash
  • Nausea or gastrointestinal upset
  • Fever
  • Decreased urine output or changes in kidney labs (elevated BUN and creatinine)

More serious reactions — including difficulty breathing, signs of kidney failure, severe diarrhea, dangerous electrolyte imbalances, or allergic reactions — require immediate medical attention.

⚠️Warnings & precautions▾
  • Kidney damage (nephrotoxicity): This is dose-related and usually reversible after stopping the drug, but it requires close monitoring — especially in patients with pre-existing kidney disease.
  • Respiratory arrest: Stopping breathing has been reported after intramuscular injection, particularly in patients with reduced kidney function. Emergency support must be available.
  • Neurological effects: Tingling, dizziness, and slurred speech can occur. Do not drive or operate machinery during treatment.
  • Electrolyte abnormalities: IV use has been linked to low potassium, calcium, and magnesium (a condition called Pseudo-Bartter syndrome). Electrolytes should be monitored during treatment.
  • C. difficile-associated diarrhea (CDAD): Severe or bloody diarrhea during or up to two months after treatment may signal a dangerous gut infection requiring separate treatment.
  • Overdose risk: Too much can cause neuromuscular blockade, respiratory paralysis, and acute kidney failure.
🔀What it interacts with▾

Colistimethate can interact with several other drugs, increasing the risk of serious side effects. Key interactions include:

  • Aminoglycoside antibiotics (e.g., gentamicin, tobramycin) and polymyxins — can add to nerve and muscle transmission problems; use together only with extreme caution
  • Curariform muscle relaxants (e.g., tubocurarine, succinylcholine, gallamine, decamethonium) — significantly intensify neuromuscular blockade (muscle paralysis risk); use with extreme caution
  • Ether and sodium citrate — also enhance neuromuscular blockade; use with extreme caution
  • Sodium cephalothin — increases the risk of kidney damage; this combination should be avoided

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 ever had an allergic reaction to colistimethate sodium or any component of the injection
  • Tell your doctor if you have kidney disease — dosing must be adjusted and kidney function monitored closely
  • Disclose all other medications, especially antibiotics and muscle relaxants, to avoid dangerous interactions
  • Do not drive, operate machinery, or do tasks requiring full alertness during treatment — neurological side effects like dizziness and tingling can impair your ability to do so safely
  • This medication is used in both adults and children, including premature infants — dosing is individualized by weight and kidney function
🚑If you take too much▾

Taking too much colistimethate can cause neuromuscular blockade — meaning the muscles, including breathing muscles, may stop working properly. This can lead to confusion, loss of coordination, slurred speech, and in severe cases, respiratory arrest and death. It can also cause acute kidney failure, seen as reduced urine output and rising creatinine levels.

If an overdose is suspected, the drug should be stopped immediately and supportive medical care provided. Whether dialysis can remove colistimethate from the body in an overdose situation is not known.

📡Pharmacodynamics — effects in the body▾

Colistimethate sodium disrupts the cell membrane of susceptible gram-negative bacteria, causing the membrane to break down and the bacteria to die. It has demonstrated bactericidal activity — meaning it kills bacteria outright — against organisms including Pseudomonas aeruginosa, E. coli, Klebsiella pneumoniae, and Enterobacter aerogenes. This activity has been confirmed both in laboratory testing and in clinical infections.

🔬Pharmacokinetics — how your body processes it▾

After a single dose given either intravenously (IV) or intramuscularly (IM), colistimethate reaches its peak concentration in the blood quickly — IV gives a higher peak at 10 minutes than IM. The drug is then cleared from the bloodstream with a half-life of about 2 to 3 hours in both adults and children, including premature infants. It is excreted through the urine, where it achieves high concentrations for several hours after dosing.

📦How to store it▾

Store unreconstituted product between 20° to 25°C (68° to 77°F). Store reconstituted solution in refrigerator 2° to 8°C (36° to 46°F) or between 20° to 25°C (68° to 77°F) and use within 7 days.

📄 Written from Colistimethate 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 →

27

Supplements & herbs that interact with Colistimethate Injection

27 supplements and herbal products have documented interactions with Colistimethate Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Moderate · 26
  • Minor · 1
Every supplement checked against Colistimethate Injection — ranked by severity The full interaction hub: 26 moderate · 1 minor · every one linked to its full report. Check Colistimethate Injection against your exact supplements

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.

7

Nutrient depletion considerations

Colistimethate Injection has been associated with lower levels of 7 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.

Evidence & significance mix
  • Higher significance · 6
  • Moderate · 1
See the full Colistimethate Injection nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

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

What kind of infections does this medication treat? ▾
Colistimethate injection is used for serious bacterial infections caused by certain gram-negative bacteria — especially Pseudomonas aeruginosa, which can be a tough bug to treat. It's also effective against E. coli, Klebsiella pneumoniae, and Enterobacter aerogenes. It's not used for every type of infection, so your doctor will confirm it's the right choice based on your lab results.
How will I receive this medication — will I get it at home or in the hospital? ▾
Colistimethate is given by injection — either into a vein (IV) or into a muscle (IM). It's typically administered by a healthcare professional, most often in a hospital or clinical setting. Your care team will prepare and give each dose, and they'll monitor you during treatment.
What side effects should I actually watch out for? ▾
The most common ones are tingling or numbness in your hands, feet, or tongue, along with dizziness and sometimes slurred speech — these are nerve-related effects. You should also watch your urine output; if you're urinating much less than usual, let your team know right away, as this can signal kidney stress. If you have trouble breathing at any point, that's an emergency — get help immediately.
Is it safe to drive while I'm being treated with this drug? ▾
It's best to avoid driving or operating heavy machinery while you're on colistimethate. Dizziness, tingling, and slurred speech can occur and could affect your reaction time and coordination. Once your treatment is done and those effects have cleared, you should be fine — but check with your doctor first.
I've heard antibiotics can cause diarrhea — is that something to worry about here? ▾
Yes, it's worth paying attention to. Like most antibiotics, colistimethate can disrupt the normal bacteria in your gut, which sometimes leads to a C. difficile infection — a type of gut infection that causes severe diarrhea. If you develop persistent, watery, or bloody diarrhea during or even up to two months after treatment, contact your doctor right away. This kind of infection needs its own specific treatment.
My kidneys aren't 100% — is this medication safe for me? ▾
Colistimethate can be used in people with kidney disease, but your dose will need to be carefully adjusted — and your kidney function will be watched closely throughout treatment. The drug is cleared through the kidneys, so reduced kidney function means it can build up and cause more side effects, including further kidney stress. Your prescriber will tailor your dose specifically to your kidney function, so be sure they have an up-to-date picture of your kidney health before starting.
Is Colistimethate Injection available over the counter? ▾
Colistimethate 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 Colistimethate Injection first available? ▾
Colistimethate Injection has been available in the United States since at least 1970, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Colistimethate Injection? ▾
Colistimethate Injection is supplied by 11 manufacturers listed in the FDA NDC Directory, including Xellia Pharmaceuticals USA LLC, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., Par Pharmaceutical, Inc..

💬 Answers drafted from Colistimethate 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 Colistimethate Injection comes

Colistimethate 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

By injection · Into a muscle · Into a vein
Brands Coly-Mycin
How this form is used
What it may be used for
  • Coly-Mycin is used to treat acute or chronic infections caused by susceptible gram-negative bacteria, including Pseudomonas aeruginosa, E. coli, Klebsiella pneumoniae, and Enterobacter aerogenes
  • Coly-Mycin may be used to start treatment in serious infections strongly suspected to be caused by gram-negative bacteria while awaiting lab results
Important instructions
  • Coly-Mycin is given by injection into a vein (intravenous) or into a muscle (intramuscular) — your healthcare team will administer it
  • Coly-Mycin is typically given in divided doses throughout the day; frequency is adjusted based on kidney function
  • Coly-Mycin vials must be reconstituted (mixed) with sterile water before use and should be inspected for particles or discoloration before administration
  • Coly-Mycin dosing in patients with kidney impairment must be reduced — your prescriber will determine the right schedule based on your kidney function
Available strengths 4 strengths
18 FDA-listed product records ⓘ

📊 Colistimethate Injection across the U.S. market

How Colistimethate 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 ⓘ
11
Manufacturers
4
Brand names
18
FDA-listed product records ⓘ
1970
First marketed ⓘ
Xellia Pharmaceuticals USA LLC28%
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.17%
Par Pharmaceutical, Inc.11%
Fresenius Kabi USA, LLC6%
Hikma Pharmaceuticals USA Inc.6%
Nexus Pharmaceuticals Inc6%
Other makers28%

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

📈 How widely Colistimethate Injection is used

A general measure of how commonly Colistimethate 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 Colistimethate 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.

894
Medicaid prescriptions filled (Q1–Q4 2025)
$1.4M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Colistimethate Injection prescribed? Of the 1,597 medications we measure, Colistimethate Injection ranks #1,298 by Medicaid prescriptions — more than 19% of them.

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

Utilization by Colistimethate 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.

Other Colistimethate Injection products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

894 Medicaid prescriptions (Q1–Q4 2025) 100% of Colistimethate Injection prescriptions shown $1.4M gross reimbursement (before rebates) ≈ $1,541 per prescription (gross)

Summed across the 5 of 32 listed NDC products with Medicaid activity.

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 Colistimethate 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 5 of 32 listed Colistimethate Injection NDCs with Medicaid activity.

🔍 Compare Colistimethate Injection products

A representative set of FDA-listed product records for Colistimethate 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 18 of 18 products — FDA National Drug Code Directory. See every product, package size and price: browse all 18 Colistimethate Injection NDCs →

🏷️ Sold under these brand names

Coly-Mycin M Coly-Mycin

🏭 Manufacturers & labelers

Xellia Pharmaceuticals USA LLC 5 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 3 Par Pharmaceutical, Inc. 2 Fresenius Kabi USA, LLC 1 Hikma Pharmaceuticals USA Inc. 1 Nexus Pharmaceuticals Inc 1 Par Health USA, LLC 1 Patheon Manufacturing Services LLC 1 X-GEN Pharmaceuticals, Inc. 1 Xellia Pharmaceuticals ApS 1 XGen Pharmaceuticals DJB, Inc. 1

RxNorm drug class

Colistimethate Injection belongs to the Polymyxin-class Antibacterial class.

Pharmacologic class Polymyxin-class Antibacterial
Drug family (ATC) Antibiotics, Polymyxins

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 Jun 8, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Colistimethate 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 Colistimethate Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
6
NDC products indexed
18
Distinct labelers/manufacturers represented
11
Linked representative label ⓘ
Par Pharmaceutical, Inc.
Linked label effective
Jun 8, 2026
Composite sections available
17
Linked SPL Set ID
6d6e13e2-dc33-4b7b-84d0-66146a57c552
Linked SPL Document ID
2a986c38-f75d-48e0-a567-a4b8d4644347
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 6 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. Par Pharmaceutical, 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.