FDA-filed SPL labeling · retrieved through openFDA

Cefotetan Injection

Cefotetan is a cephalosporin antibiotic injection used to treat serious bacterial infections of the urinary tract, lower respiratory tract, skin, gynecologic system, abdomen, and bones, and to prevent infections around certain surgeries.

Drug class ⓘ Cephalosporin 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 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 →

At a glance
Linked label effectiveApr 8, 2024
Clinical labels in scope ⓘ3
AvailabilityRx
Earliest approval/marketing year ⓘ1985
FDA-listed product records ⓘ10
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 24, 2026
⭐ Cefotetan Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Cefotetan injection (Cefotan) is a broad-spectrum antibiotic used in hospital and clinical settings to treat or prevent serious bacterial infections. It carries important risks — including a rare but potentially fatal destruction of red blood cells and serious allergic reactions — so close monitoring during and after treatment is essential. Always inform your care team about any allergy history, kidney problems, or new symptoms like unusual fatigue or diarrhea.

📖 Cefotetan Injection: Patient Information Guide

A plain-language walkthrough of Cefotetan 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▾

Cefotetan injection (brand: Cefotan) is a broad-spectrum antibiotic used to treat or prevent a range of serious bacterial infections. It is given only in clinical settings by injection.

  • Urinary tract infections — caused by susceptible bacteria including E. coli, Klebsiella, and Proteus species
  • Lower respiratory tract infections — including pneumonia caused by organisms such as Streptococcus pneumoniae, Haemophilus influenzae, and Klebsiella
  • Skin and skin structure infections — caused by susceptible staph and strep species, as well as certain anaerobic bacteria
  • Gynecologic infections — including those caused by Neisseria gonorrhoeae, Bacteroides fragilis, and various streptococci; note that cefotetan has no activity against Chlamydia trachomatis, so additional coverage must be added if that organism is suspected
  • Intra-abdominal infections — caused by susceptible gram-negative and anaerobic bacteria
  • Bone and joint infections — caused by methicillin-susceptible Staphylococcus aureus
  • Surgical infection prevention (prophylaxis) — Cefotan is used before surgeries such as cesarean section, hysterectomy, transurethral surgery, and biliary or gastrointestinal procedures to reduce the risk of postoperative infection
⚙️How it works▾

Cefotetan is a bactericidal antibiotic — meaning it kills bacteria rather than just slowing their growth. It works by blocking the enzymes bacteria need to build and repair their outer cell walls. Without an intact wall, bacteria fall apart and die. Cefotetan is also active in the presence of some beta-lactamases, which are enzymes certain bacteria use to destroy antibiotics like penicillin.

Resistance to cefotetan can develop when bacteria produce beta-lactamases that break it down, change the proteins it targets (penicillin-binding proteins), or reduce the drug's ability to get inside the bacterial cell.

💊How it's taken▾

Cefotan is given only by injection — either into a vein (intravenously) or into a muscle (intramuscularly). The intravenous route is preferred for severe or life-threatening infections. Dosing frequency depends on the type and severity of the infection and is typically every 12 to 24 hours.

  • For surgical prevention, a single intravenous dose is given 30–60 minutes before the procedure (or immediately after umbilical cord clamping for cesarean sections)
  • People with kidney disease require a reduced dosing schedule — their prescriber will adjust timing based on kidney function
  • For patients on dialysis, special dosing guidance applies — follow the prescriber's instructions carefully
🤒Side effects — in detail▾

Most people tolerate cefotetan well, but some side effects can occur:

  • Diarrhea or nausea
  • Skin rash or itching
  • Elevated liver enzymes (shown on blood tests)
  • Pain, redness, or irritation at the injection site
  • Fever
  • Changes in blood cell counts (seen on lab work)

More serious reactions — including severe allergic reactions, hemolytic anemia (destruction of red blood cells), serious intestinal infection (C. difficile colitis), and bleeding problems — require immediate medical attention. Seek care right away if you notice difficulty breathing, unusual fatigue, pale skin, or severe or bloody diarrhea.

⚠️Warnings & precautions▾
  • Hemolytic anemia: Cefotetan carries a higher risk than most other cephalosporins of causing an immune reaction that destroys red blood cells. This can be fatal. Symptoms — like unusual tiredness, pale skin, or fast heartbeat — can appear up to 2–3 weeks after the last dose. Monitoring blood counts during treatment is important.
  • Severe allergic reactions: Serious, life-threatening hypersensitivity reactions can occur. Anyone with a cephalosporin or penicillin allergy is at increased risk. Emergency treatment may be needed.
  • C. difficile colitis: Like most antibiotics, cefotetan can disrupt gut bacteria and allow C. difficile to overgrow, causing diarrhea that ranges from mild to life-threatening colitis. This can happen during treatment or up to two months afterward.
  • Bleeding risk: Cefotetan can reduce prothrombin activity (a key part of blood clotting), raising bleeding risk — especially in elderly patients, those with kidney or liver problems, cancer, or poor nutrition.
  • Kidney function: Cefotetan alone can raise creatinine levels. If used with aminoglycoside antibiotics, the risk of kidney damage increases further and kidney function must be closely monitored.
  • Seizures: Like other cephalosporins, cefotetan has been linked to seizures, mainly in patients with kidney impairment who receive too high a dose.
🔀What it interacts with▾

Cefotetan has a key interaction to be aware of:

  • Aminoglycoside antibiotics (e.g., gentamicin, tobramycin, amikacin): Using these together with cefotetan increases the risk of kidney damage (nephrotoxicity). Kidney function must be monitored carefully. Importantly, cefotetan and aminoglycosides must never be mixed in the same IV bag or syringe — they must always be given as separate injections.

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 a cephalosporin antibiotic — cefotetan cannot be used in those patients
  • Tell your doctor if you have a penicillin allergy — cross-reactions are possible in up to 10% of people with penicillin sensitivity
  • Tell your doctor if you have ever developed hemolytic anemia from a cephalosporin — this is a contraindication to cefotetan use
  • Tell your doctor if you have kidney disease — dose timing must be adjusted based on how well your kidneys are working
  • Tell your doctor if you are on dialysis — a special dosing schedule is required
  • Tell your doctor if you have liver problems, poor nutrition, cancer, or are elderly — these factors raise the risk of bleeding related to reduced clotting activity
  • Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding
  • Tell your doctor about all other medications you take, especially other antibiotics
🚑If you take too much▾

There is limited information on what happens if too much cefotetan is given. If an overdose occurs, treatment focuses on managing symptoms. Because cefotetan can be removed from the body by hemodialysis (a kidney-filtering procedure), dialysis may be considered — especially if kidney function is already impaired.

📡Pharmacodynamics — effects in the body▾

Cefotetan is a bactericidal antibiotic, meaning it kills bacteria by preventing them from forming intact cell walls. It achieves high and prolonged concentrations in the urine after dosing, which is particularly useful for treating urinary tract infections. It distributes broadly into many body tissues and fluids, including the skin, muscle, reproductive organs, bile, and peritoneal fluid, allowing it to reach the sites of most infections it is approved to treat.

🔬Pharmacokinetics — how your body processes it▾

Cefotetan reaches high levels in the blood quickly after either intravenous or intramuscular injection and is about 88% bound to plasma proteins. Its half-life — the time it takes for the body to clear half the drug — is roughly 3 to 4.6 hours in people with normal kidney function, but this can extend to about 10 hours in those with moderate kidney impairment. The drug is not significantly broken down by the body; between 51% and 81% of a dose is eliminated unchanged in the urine within 24 hours, which is why dose adjustments are necessary in kidney disease.

📦How to store it▾

stored at 20°C to 25° C (68° to 77° F) and should be protected from light.

📄 Written from Cefotetan 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 →

43

Supplements & herbs that interact with Cefotetan Injection

43 supplements and herbal products have documented interactions with Cefotetan 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
  • Major · 2
  • Moderate · 39
  • Minor · 2
Every supplement checked against Cefotetan Injection — ranked by severity The full interaction hub: 2 major · 39 moderate · 2 minor · every one linked to its full report. Check Cefotetan 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

Cefotetan 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 Cefotetan 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 Cefotetan Injection — the kind of thing our pharmacy team would talk through with you at the counter.

What infections does cefotetan treat? ▾
Cefotetan is a broad-spectrum antibiotic used to fight serious bacterial infections — including infections of the urinary tract, lungs, skin, female reproductive organs, abdomen, and bones. It's also given before certain surgeries like C-sections or hysterectomies to lower the risk of infection afterward. It only works against bacterial infections, not viral ones.
How will I receive this medication? ▾
You won't take cefotetan at home as a pill — it's given only by injection, either into a vein (IV) or into a muscle (IM). Your care team will administer it in a hospital or clinical setting. For treatment, it's usually given every 12 to 24 hours depending on your infection. For surgery prevention, you'll get a single dose before your procedure.
What side effects should I watch out for? ▾
The most common side effects are diarrhea, nausea, skin rash, and some irritation at the injection site. However, there are two serious ones to know about: first, cefotetan can sometimes trigger a reaction where your body destroys its own red blood cells — this can happen up to 2 to 3 weeks after your last dose, so watch for unusual tiredness or pale skin even after you leave the hospital. Second, if you develop persistent or bloody diarrhea during or after treatment, contact your doctor right away, as this could be a serious gut infection called C. difficile colitis.
I'm allergic to penicillin — is cefotetan safe for me? ▾
This is an important conversation to have with your doctor. Cefotetan belongs to a related family of antibiotics called cephalosporins, and there is a chance — in up to about 1 in 10 people with a penicillin allergy — of a cross-reaction. Your doctor will weigh the risks and benefits and may take extra precautions or choose an alternative. Always mention your penicillin allergy before receiving this medication.
Do I need any special monitoring while receiving cefotetan? ▾
Yes — your care team will likely monitor your blood counts and kidney function during and potentially after treatment. This is especially important because cefotetan can raise the risk of a blood cell destruction problem (hemolytic anemia) and can affect kidney function, particularly if you're also receiving certain other antibiotics called aminoglycosides. If you have kidney disease, your dosing schedule will be adjusted to keep the medication at safe levels.
Can cefotetan affect my blood's ability to clot? ▾
It can, yes. Cefotetan can reduce prothrombin activity — which is part of how your blood clots normally. This raises the risk of bleeding, and the risk is higher in older adults, people with kidney or liver problems, those who are malnourished, or people with cancer. Your doctor may check your clotting time and may give you vitamin K if needed. Let your team know right away if you notice unusual bruising or bleeding.
Is Cefotetan Injection available over the counter? ▾
Cefotetan 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 Cefotetan Injection first available? ▾
Cefotetan Injection has been available in the United States since at least 1985, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Cefotetan Injection? ▾
Cefotetan Injection is supplied by 3 manufacturers listed in the FDA NDC Directory, including Fresenius Kabi USA, LLC, Hikma Pharmaceuticals USA Inc., PAI Holdings, LLC dba PAI Pharma.

💬 Answers drafted from Cefotetan 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 Cefotetan Injection comes

Cefotetan 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
  • Cefotan is used intravenously or intramuscularly to treat susceptible bacterial infections of the urinary tract, skin, lower respiratory tract, gynecologic system, abdomen, and bones
  • Cefotan is given intravenously before certain surgeries (such as cesarean section, hysterectomy, or gastrointestinal surgery) to prevent postoperative infection
  • Cefotan given intravenously is preferred for serious or life-threatening infections, bacteremia (bacteria in the blood), or in patients with weakened defenses
Important instructions
  • Cefotan for intravenous use is given either as a slow injection over 3–5 minutes or as a longer infusion through an IV line
  • Cefotan for intramuscular use is injected deep into a large muscle, such as the upper outer buttock
  • Cefotan must never be mixed in the same syringe or IV bag as aminoglycoside antibiotics — they must always be given separately
  • For surgical prevention, Cefotan is given as a single intravenous dose 30–60 minutes before the procedure; for cesarean section, it is given once the umbilical cord is clamped
Available strengths 4 strengths
10 FDA-listed product records ⓘ

📊 Cefotetan Injection across the U.S. market

How Cefotetan 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 ⓘ
3
Manufacturers
2
Brand names
10
FDA-listed product records ⓘ
1985
First marketed ⓘ
Fresenius Kabi USA, LLC40%
Hikma Pharmaceuticals USA Inc.40%
PAI Holdings, LLC dba PAI Pharma20%

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

📈 How widely Cefotetan Injection is used

A general measure of how commonly Cefotetan 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 Cefotetan 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.

54
Medicaid prescriptions filled (Q1–Q4 2025)
$2,296 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Cefotetan Injection prescribed? Of the 1,597 medications we measure, Cefotetan Injection ranks #1,537 by Medicaid prescriptions — more than 4% of them.

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

Utilization by Cefotetan 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 2000 mg injection is the most-dispensed Cefotetan Injection product — about 78% of these Medicaid prescriptions.

cefotetan 2000 MG Injection Most dispensed

42 Medicaid prescriptions (Q1–Q4 2025) 78% of Cefotetan Injection prescriptions shown $1,843 gross reimbursement (before rebates) ≈ $44 per prescription (gross)

Summed across the 1 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1722921

cefotetan 1000 MG Injection

12 Medicaid prescriptions (Q1–Q4 2025) 22% of Cefotetan Injection prescriptions shown $454 gross reimbursement (before rebates) ≈ $38 per prescription (gross)

Summed across the 1 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1722919

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 Cefotetan 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 2 of 16 listed Cefotetan Injection NDCs with Medicaid activity.

🔍 Compare Cefotetan Injection products

A representative set of FDA-listed product records for Cefotetan 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
1 g/10 mL Intramuscular, Intravenous Fresenius Kabi USA, LLC ANDA View NDC →
1 g/10 mL Intramuscular; Intravenous Fresenius Kabi USA, LLC ANDA View NDC →
2 g/20 mL Intramuscular, Intravenous Fresenius Kabi USA, LLC ANDA View NDC →
2 g/20 mL Intramuscular; Intravenous Fresenius Kabi USA, LLC ANDA View NDC →
1 g Intramuscular, Intravenous Hikma Pharmaceuticals USA Inc. ANDA View NDC →
1 g Intramuscular; Intravenous Hikma Pharmaceuticals USA Inc. ANDA View NDC →
2 g Intramuscular, Intravenous Hikma Pharmaceuticals USA Inc. ANDA View NDC →
2 g Intramuscular; Intravenous Hikma Pharmaceuticals USA Inc. ANDA View NDC →
1 g/10 mL Intramuscular, Intravenous PAI Holdings, LLC dba PAI Pharma NDA View NDC →
2 g/20 mL Intramuscular, Intravenous PAI Holdings, LLC dba PAI Pharma NDA View NDC →

Showing 10 of 10 products — FDA National Drug Code Directory. See every product, package size and price: browse all 10 Cefotetan 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) Cefotetan Injection RxCUI 2187 2 dose forms · 3 strengths
  1. Dose form (SCDF) Injectable Solution RxCUI 376594 In current FDA listings
    Clinical drug / strength (SCD) 180 MG/ML RxCUI 1722916
  2. Dose form (SCDF) Injection RxCUI 1722918 In current FDA listings
    Clinical drug / strength (SCD) 1000 MG RxCUI 1722919 2000 MG RxCUI 1722921

Look up RxCUI 2187 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.

🏭 Manufacturers & labelers

Fresenius Kabi USA, LLC 4 Hikma Pharmaceuticals USA Inc. 4 PAI Holdings, LLC dba PAI Pharma 2

RxNorm drug class

Cefotetan Injection belongs to the Cephalosporin Antibacterial class.

Pharmacologic class Cephalosporin Antibacterial
Drug family (ATC) Second-generation cephalosporins

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 Apr 8, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Cefotetan 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 Cefotetan Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
3
NDC products indexed
10
Distinct labelers/manufacturers represented
3
Linked representative label ⓘ
PAI Holdings, LLC dba PAI Pharma
Linked label effective
Apr 8, 2024
Composite sections available
13
Linked SPL Set ID
f1510f5e-d001-44e0-accb-27cf79fd4f9a
Linked SPL Document ID
7e29cb53-c401-49b0-9b47-209601f7ec55
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 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. PAI Holdings, LLC dba PAI Pharma 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.