FDA-filed SPL labeling · retrieved through openFDA

Imipenem, Cilastatin, and Relebactam Injection

A combination antibiotic given by IV infusion, used to treat serious bacterial infections including hospital-acquired pneumonia, complicated urinary tract infections, and complicated abdominal infections caused by hard-to-treat gram-negative bacteria.

Brand name Recarbrio
Drug classes Penem Antibacterial
Rx Form 1 Route 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 1 clinical label set 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 effectiveDec 9, 2025
AvailabilityRx
Earliest approval/marketing year 2020
FDA-listed product records 4
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 15, 2026
Imipenem, Cilastatin, and Relebactam Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Recarbrio is a powerful IV antibiotic combination reserved for serious, hard-to-treat bacterial infections — particularly in hospital settings. Because two of its three indications are approved based on limited data and are reserved for patients with no good alternatives, it's typically used when other antibiotics have failed or aren't an option. Kidney function, seizure history, and current medications (especially anti-seizure drugs) are key things your care team will review before and during treatment.

📖 Imipenem, Cilastatin, and Relebactam Injection: Patient Information Guide

A plain-language walkthrough of Imipenem, Cilastatin, and Relebactam 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

Recarbrio is a combination IV antibiotic approved for serious gram-negative bacterial infections in adults and children weighing at least 2 kg. It covers the following conditions:

  • Hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) — lung infections that develop in the hospital or while on a breathing machine
  • Complicated urinary tract infections (cUTI), including pyelonephritis — Recarbrio is approved for this use only in patients who have limited or no other treatment options
  • Complicated intra-abdominal infections (cIAI) — serious infections inside the abdominal cavity — Recarbrio is approved here only for patients with limited or no other treatment options
  • Recarbrio is not recommended in premature infants under 37 weeks corrected age, or in children weighing less than 30 kg who have kidney problems
⚙️How it works

Recarbrio works through three ingredients acting together. Imipenem kills bacteria by interfering with the construction of their cell walls — bacteria that can't build proper cell walls die. Cilastatin blocks an enzyme in the kidneys that would otherwise break imipenem down, ensuring enough antibiotic reaches the urinary tract. Relebactam is a beta-lactamase inhibitor: it disables the enzymes that certain resistant bacteria use to neutralize imipenem, allowing imipenem to work against bacteria that would otherwise survive it.

This combination is specifically designed to tackle gram-negative bacteria — including strains like Pseudomonas aeruginosa and Klebsiella pneumoniae — that are often resistant to other antibiotics.

💊How it's taken

Recarbrio is given only as an intravenous (IV) infusion in a hospital or clinical setting — it is not available as a pill or home injection. For most adults with normal kidney function, it is infused over 30 minutes, four times a day (every 6 hours). Pediatric dosing depends on the child's weight and age; very young infants receive it every 8 hours over a 60-minute infusion, while older or heavier children follow schedules closer to the adult regimen. Treatment typically lasts 4 to 14 days.

  • Patients with reduced kidney function need lower doses — your care team calculates this based on kidney function tests
  • Patients on hemodialysis receive their dose after each dialysis session
  • Follow your prescriber's instructions exactly; do not adjust doses on your own
🤒Side effects — in detail

Like all antibiotics, Recarbrio can cause side effects. The most commonly reported ones include:

  • Diarrhea, nausea, or vomiting
  • Headache
  • Elevated liver enzyme levels (seen on blood tests, usually without symptoms)
  • Anemia (low red blood cell count)
  • Low potassium or sodium levels in the blood
  • Rash
  • Constipation
  • Pain, redness, or swelling at the IV infusion site

Seek medical attention immediately for signs of a severe allergic reaction (difficulty breathing, facial swelling, or sudden drop in blood pressure), new seizures or muscle jerking, or severe or persistent diarrhea — these could signal serious complications that need prompt treatment.

⚠️Warnings & precautions
  • Severe allergic reactions: Life-threatening anaphylaxis has occurred with beta-lactam antibiotics. Tell your care team about any prior antibiotic allergies before starting Recarbrio. Treatment must be stopped immediately if a serious reaction occurs.
  • Seizures and nervous system effects: Seizures, confusion, and involuntary muscle twitching have been reported — most commonly in patients with brain conditions or significant kidney problems. Existing anti-seizure medications should be continued during treatment.
  • Valproic acid interaction and seizure risk: Recarbrio can dramatically lower blood levels of valproic acid (Depakote) or divalproex sodium, potentially triggering breakthrough seizures in people using those drugs for seizure control. These combinations should be avoided when possible.
  • C. difficile-associated diarrhea: Like most antibiotics, Recarbrio can disrupt gut bacteria and allow Clostridioides difficile (C. diff) to overgrow, causing severe diarrhea or dangerous colitis. This can happen weeks after finishing the antibiotic.
  • Antibiotic resistance: Recarbrio should only be used for proven or strongly suspected bacterial infections to preserve its effectiveness and reduce the development of resistant bacteria.
🔀What it interacts with

Recarbrio has two important drug interactions to know about:

  • Valproic acid / divalproex sodium (Depakote): Recarbrio can significantly reduce blood levels of these anti-seizure medications, raising the risk of breakthrough seizures. These should not be used together unless there is no alternative antibiotic — in which case close monitoring is essential.
  • Ganciclovir (antiviral): Combining ganciclovir with imipenem/cilastatin (components of Recarbrio) has been linked to generalized seizures. This combination should be avoided unless the benefits clearly outweigh the risks.

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
  • Allergy history: Tell your doctor if you've ever had a serious allergic reaction to a carbapenem, penicillin, cephalosporin, or any other beta-lactam antibiotic.
  • Seizure history or brain conditions: Patients with prior seizures, brain lesions, or structural brain issues face a higher risk of seizure-related side effects.
  • Kidney disease: Doses must be adjusted based on kidney function. Recarbrio should not be given to patients with very low kidney function unless they are receiving hemodialysis within 48 hours.
  • Pregnancy: Animal studies showed potential risks to the fetus. There are no adequate human studies. Discuss the risks and benefits with your doctor if you are pregnant.
  • Breastfeeding: It is not known whether imipenem, cilastatin, or relebactam pass into human breast milk. Discuss this with your doctor before breastfeeding.
  • Premature infants: Recarbrio is not recommended for infants younger than 37 weeks corrected gestational age.
  • Children under 30 kg with kidney problems: There is not enough data to dose Recarbrio safely in this group; it is not recommended.
  • Older adults: Kidney function naturally declines with age, which may require dose adjustments. Your care team will monitor kidney function during treatment.
🚑If you take too much

If too much Recarbrio is given, treatment should be stopped and supportive care started right away. Imipenem, cilastatin, and relebactam can all be removed from the body by hemodialysis (a kidney-filtering procedure), which may be used to help clear the drug if needed. There is no specific antidote, and management focuses on treating symptoms as they arise.

📡Pharmacodynamics — effects in the body

For imipenem, the antibiotic's effectiveness depends on how long its concentration stays above the level needed to inhibit bacterial growth throughout each dosing interval. For relebactam, effectiveness is tied to the total amount of drug the body is exposed to over 24 hours relative to the bacterial inhibitory concentration. At doses nearly 5 times the recommended amount, relebactam does not meaningfully affect heart rhythm (QTc interval), which is reassuring from a cardiac safety standpoint.

🔬Pharmacokinetics — how your body processes it

Recarbrio is given intravenously and distributes throughout the body; imipenem and relebactam both reach the fluid lining the lungs at roughly 54–55% of their unbound blood concentrations, which supports their use in pneumonia. All three components — imipenem, cilastatin, and relebactam — are eliminated primarily by the kidneys, with short half-lives of about 1 to 1.2 hours. Because the kidneys do most of the work clearing these drugs, reduced kidney function leads to higher drug exposure and requires dose adjustments. Relebactam is minimally broken down in the body; more than 90% exits unchanged in the urine. Hemodialysis effectively removes all three components from the bloodstream.

📦How to store it

Store RECARBRIO vials at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (between 59°F to 86°F) .

📄 Written from Imipenem, Cilastatin, and Relebactam 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 →

33

Supplements & herbs that interact with Imipenem, Cilastatin, and Relebactam Injection

33 supplements and herbal products have documented interactions with Imipenem, Cilastatin, and Relebactam 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 · 32
  • Minor · 1
Every supplement checked against Imipenem, Cilastatin, and Relebactam Injection — ranked by severity The full interaction hub: 32 moderate · 1 minor · every one linked to its full report. Check Imipenem, Cilastatin, and Relebactam 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

Imipenem, Cilastatin, and Relebactam 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 Imipenem, Cilastatin, and Relebactam 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 Imipenem, Cilastatin, and Relebactam Injection — the kind of thing our pharmacy team would talk through with you at the counter.

Why am I getting this antibiotic instead of one in a pill form?
Recarbrio only comes as an IV infusion — there's no pill version. It's designed for serious infections that need high, reliable drug levels fast, and it works against some very tough bacteria that other oral antibiotics can't handle. Your care team chose it because your infection either requires this level of treatment or didn't respond to other options.
How long will I need to be on this antibiotic?
Most courses run between 4 and 14 days, depending on the type of infection, how serious it is, and how well you're responding to treatment. Your doctor will reassess as you go and decide the right length for you. It's important to finish the full course even if you start feeling better.
I take Depakote (valproic acid) for seizures. Is that a problem?
Yes — this is an important one to flag. Recarbrio can significantly lower the level of valproic acid in your blood, which could trigger a breakthrough seizure even if your epilepsy has been well controlled. Your doctor needs to know about this right away so they can either choose a different antibiotic or closely monitor your valproic acid levels and seizure control.
What side effects should I actually watch out for while I'm receiving this?
The most common ones are diarrhea, nausea, headache, and some changes in lab values like liver enzymes or potassium levels — your team will monitor those with blood tests. The ones to act on immediately are signs of a severe allergic reaction (like swelling, trouble breathing, or feeling faint), any seizure or sudden confusion, and severe or persistent diarrhea, which can sometimes be a serious C. diff bowel infection even after you finish the antibiotic.
I have kidney problems — does that affect how this antibiotic is given?
Absolutely, and your care team will already account for this. Since all three components of Recarbrio are cleared mainly by the kidneys, reduced kidney function means the drug stays in your body longer. The dose is lowered based on how well your kidneys are working. If you're on hemodialysis, you'll receive the dose right after each dialysis session, since dialysis removes the drug from your bloodstream.
Is this antibiotic safe during pregnancy?
There isn't enough human data to say for certain. Animal studies did show some potential risks — including fetal abnormalities in some species — so it's something your doctor takes seriously. That said, if you have a life-threatening infection, treating it is critical for both you and your baby. Your doctor will weigh the risks and benefits carefully and make the decision with you.
Is Imipenem, Cilastatin, and Relebactam Injection available over the counter?
Imipenem, Cilastatin, and Relebactam 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 Imipenem, Cilastatin, and Relebactam Injection first available?
Imipenem, Cilastatin, and Relebactam Injection has been available in the United States since at least 2020, based on FDA approval history (Drugs@FDA) and product marketing records.

💬 Answers drafted from Imipenem, Cilastatin, and Relebactam 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 Imipenem, Cilastatin, and Relebactam Injection comes

Imipenem, Cilastatin, and Relebactam 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 vein
Brands Recarbrio
How this form is used
What it may be used for
  • Recarbrio is used to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in adults and children weighing at least 2 kg
  • Recarbrio is used to treat complicated urinary tract infections (cUTI), including pyelonephritis, in adults and children weighing at least 2 kg who have limited or no other treatment options
  • Recarbrio is used to treat complicated intra-abdominal infections (cIAI) in adults and children weighing at least 2 kg who have limited or no other treatment options
Important instructions
  • Recarbrio is given as an intravenous (IV) infusion by a healthcare provider — it cannot be taken by mouth
  • Recarbrio is typically infused over 30 minutes every 6 hours in adults and in children weighing 30 kg or more with normal kidney function; smaller pediatric patients receive a 60-minute infusion
  • Recarbrio must be prepared from a dry powder vial, dissolved and diluted into an IV bag before infusion — preparation is done by pharmacy or clinical staff
  • Recarbrio dose is reduced in patients with impaired kidney function and must not be used in patients with very low kidney function unless they are on hemodialysis
Available strengths 2 strengths
4 FDA-listed product records

📊 Imipenem, Cilastatin, and Relebactam Injection across the U.S. market

How Imipenem, Cilastatin, and Relebactam 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
1
Manufacturers
1
Brand names
4
FDA-listed product records
2020
First marketed

📈 How widely Imipenem, Cilastatin, and Relebactam Injection is used

A general measure of how commonly Imipenem, Cilastatin, and Relebactam 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 Imipenem, Cilastatin, and Relebactam 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.

96
Medicaid prescriptions filled (Q1–Q4 2025)
$1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Imipenem, Cilastatin, and Relebactam Injection prescribed? Of the 1,594 medications we measure, Imipenem, Cilastatin, and Relebactam Injection ranks #1,508 by Medicaid prescriptions — more than 5% of them.

Where Imipenem, Cilastatin, and Relebactam Injection ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Imipenem, Cilastatin, and Relebactam 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.

cilastatin 500 MG / imipenem 500 MG / relebactam 250 MG Injection

96 Medicaid prescriptions (Q1–Q4 2025) 100% of Imipenem, Cilastatin, and Relebactam Injection prescriptions shown $1M gross reimbursement (before rebates) ≈ $10,482 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2184142

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 Imipenem, Cilastatin, and Relebactam 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 1 of 2 listed Imipenem, Cilastatin, and Relebactam Injection NDCs with Medicaid activity.

🔍 Compare Imipenem, Cilastatin, and Relebactam Injection products

A representative set of FDA-listed product records for Imipenem, Cilastatin, and Relebactam 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
IMIPENEM ANHYDROUS 500 mg/100 mL; CILASTATIN 500 mg/100 mL; RELEBACTAM ANHYDROUS 250 mg/100 mL Intravenous Merck Sharp & Dohme LLC NDA View NDC →
IMIPENEM ANHYDROUS 500 mg/100 mL; CILASTATIN 500 mg/100 mL; RELEBACTAM ANHYDROUS 250 mg/100 mL Merck Sharp & Dohme LLC DRUG FOR FURTHER PROCESSING View NDC →
500; 500; 250 mg/100 mL; mg/100 mL; mg/100 mL Intravenous Merck Sharp & Dohme LLC × 2 listings NDA View NDC →

Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Imipenem, Cilastatin, and Relebactam Injection NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.

Multiple ingredients (MIN) Imipenem, Cilastatin, and Relebactam Injection RxCUI 2184141 1 dose form · 1 strength

Look up RxCUI 2184141 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

Recarbrio

🏭 Manufacturers & labelers

Merck Sharp & Dohme LLC 4

RxNorm drug class

Imipenem, Cilastatin, and Relebactam Injection belongs to the beta Lactamase Inhibitor class.

Pharmacologic class beta Lactamase Inhibitor
Drug family (ATC) Carbapenems
How it works beta Lactamase Inhibitors

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 Dec 9, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Imipenem, Cilastatin, and Relebactam 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 Imipenem, Cilastatin, and Relebactam Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
4
Distinct labelers/manufacturers represented
1
Linked representative label
Merck Sharp & Dohme LLC
Linked label effective
Dec 9, 2025
Composite sections available
22
Linked SPL Set ID
be32f468-738b-40df-a425-591e12f65159
Linked SPL Document ID
11f74255-d000-4759-a561-136a5f13f667
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 1 FDA-filed SPL label set 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. Merck Sharp & Dohme LLC 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.