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Piperacillin and Tazobactam and Sodium Chloride 375 mg/50mL; 3 g/50mL Injection, Solution — NDC 00264-3448-11 package photo

Piperacillin and Tazobactam and Sodium Chloride 375 mg/50mL; 3 g/50mL Injection, Solution

by B. Braun Medical Inc. · 24 CONTAINER in 1 CASE (0264-3448-11) / 50 mL in 1 CONTAINER
NDC 00264-3448-11
🏷️ FDA NDC (as labeled) 0264-3448-11 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 0264-3448-11
Product NDC 0264-3448
11-digit billing NDC 00264344811
NCPDP billing unit EA — each (per item)
RxCUI 1659131, 1659137, 1659149
UNII M98T69Q7HP, UXA545ABTT
Application # NDA206056
SPL Set ID a63ca653-27d4-45fe-a744-77e0efe45220
Established class (EPC) Penicillin-class Antibacterial; beta Lactamase Inhibitor
Mechanism of action beta Lactamase Inhibitors
Chemical class Penicillins
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-09-30
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance TAZOBACTAM SODIUM; PIPERACILLIN SODIUM
GPI-14 01990002732120
GCN Seq No 087568
GCN 57536
HICL code 008738
Ingredient (HICL) Piperacillin Sodium/Tazobactam
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1A
Therapeutic class — specific (HIC3) Penicillin Antibiotics
AHFS code 08:12.16.16
AHFS class Extended-Spectrum Penicillins
FDB label name PIPERACILLIN-TAZO 3.375 G DPLX
FDB brand name Piperacillin-Tazobactam
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 0264-3448-11 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00264-3448-11. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the beta Lactamase Inhibitor class.

Pharmacologic class beta Lactamase Inhibitor
Drug family (ATC) Beta-lactamase inhibitors
How it works beta Lactamase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerB. Braun Medical Inc.
Application holderB BRAUN MEDICAL INC
FDA applicationNDA206056 (NDA)
Labeler code00264
First marketedSep 2025
Product typeHuman Prescription Drug
Portfolio94 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name PIPERACILLIN-TAZO 3.375 G DPLX Ingredient Piperacillin Sodium/Tazobactam
📖 What it is MedlinePlus · NLM

Piperacillin and tazobactam injection is used to treat certain infections caused by bacteria. Piperacillin is in a class of medications called penicillin antibiotics. It works by killing bacteria that cause infection. Tazobactam is in a class called beta-lactamase inhibitor. It works by preventing bacteria from destroying piperacillin. Antibiotics such as piperacillin and tazobactam injection will not work for colds, flu, or other viral infections. Taking or using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • This medication only comes as an intravenous (IV) injection, so it has to be given directly into your vein by a healthcare professional. That's actually a good thing in this case —...
  • Why am I getting this antibiotic through an IV instead of a pill?
  • For most infections, treatment typically lasts 7 to 10 days. If you have hospital-acquired pneumonia, it may be up to 14 days. Your doctor will decide the right length based on how...
  • How long will I need to be on this antibiotic?
📖 Read our full Piperacillin / Sodium Chloride / Tazobactam guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 0.75 mg / 50 mL UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • 150 mg / 50 mL UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • 150 mg / 50 mL UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $7.37 $8,844.00 / 1200 ml
Medicare Part B allowsASP · J2543 $1.218 / J2543 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🧾 Billing & reimbursement

FDA NDC (as labeled)0264-3448-11
11-digit billing NDC00264-3448-11
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ2543
DescriptorInjection, piperacillin sodium/tazobactam sodium, 1 gram/0.125 grams (1.125 grams)
Billing units / pkg72 units
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Piperacillin and Tazobactam 3 g/15mL; .375 g/15mL 00409-3385-13 Hospira, 10 vials $3.493 AP Discontinued —
Piperacillin and Tazobactam 3 g/15mL; .375 g/15mL 00781-3113-95 Sandoz 10 vials $3.493 AP Availability likely —
Piperacillin and Tazobactam 3 g/1; .375 g 44567-0802-10 WG 10 vials $3.493 AP Availability likely —
Piperacillin and Tazobactam 3 g/1; .375 g 55150-0120-30 Eugia 10 vials $3.493 AP Availability likely —
Piperacillin and Tazobactam 3 g/15mL; .375 g/15mL 60505-6157-04 Apotex 10 vials $3.493 AP Availability likely —
Piperacillin and Tazobactam 3 g/15mL; .375 g/15mL 63323-0983-21 Fresenius 10 vials $3.493 AP Availability likely —
Piperacillin and Tazobactam 3 g/15mL; .375 g/15mL 65219-0436-20 Fresenius 10 vials $3.493 AP Availability likely —
Piperacillin and Tazobactam 3 g/15mL; .375 g/15mL 68001-0507-82 BluePoint 10 vials $3.493 AP Availability likely —
piperacillin and tazobactam 3 g/15mL; .375 g/15mL 72485-0403-10 Armas 10 vials $3.493 AP Availability likely —
Piperacillin and Tazobactam 3 g/15mL; .375 g/15mL 72572-0573-10 Civica, 10 vials $3.493 AP Availability likely —
Piperacillin And Tazobactam 3 g/15mL; .375 g/15mL 81284-0152-10 Provepharm 10 vials $3.493 AP Availability likely —
Zosyn in Galaxy Containers 375 mg/50mL; 3 g/50mL 00206-8861-02 Wyeth 50 ml — — Discontinued —
Piperacillin and Tazobactam and Sodium Chloride 375 mg/50mL; 3 g/50mLthis 00264-3448-11 B. 50 ml — — FDA listed —
Zosyn 3 g/50mL; .375 g/50mL 00338-9636-24 Baxter 50 ml — — FDA listed —
Piperacillin and Tazobactam 3 g/15mL; .375 g/15mL 00781-9213-95 Sandoz 10 vials — AP Discontinued —
Piperacillin and Tazobactam 3 g/15mL; .375 g/15mL 35369-0503-02 Shandong 10 vials — AP FDA listed —
Piperacillin and Tazobactam 3 g/15mL; .375 g/15mL 63323-0300-30 Fresenius 10 vials — AP FDA listed —
piperacillin and tazobactam 3 g/15mL; .375 g/15mL 72572-0414-10 Civica, 10 vials — AP FDA listed —
piperacillin and tazobactam 3 g/15mL; .375 g/15mL 83270-0302-10 ONESOURCE 10 vials — AP FDA listed —
Piperacillin and Tazobactam 3 g/15mL; .375 g/15mL 83634-0105-30 Avenacy, 10 vials — AP FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2025
On the market since
Sep 2025
📍
2026
Currently FDA-listed
1 year listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00264-3448-11 You're viewing this 24 CONTAINER in 1 CASE (0264-3448-11) / 50 mL in 1 CONTAINER 2025-09-30 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 0264-3448-11, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00264-3448-11, written without dashes as 00264344811. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00264-3448-11, the first segment (00264) is the labeler code FDA assigned to B. Braun Medical Inc.; the middle segment (3448) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (11) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by B. Braun Medical Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
B. Braun Medical Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J2543 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE Piperacillin and Tazobactam for Injection and Sodium Chloride Injection, is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: Intra-abdominal infections in adult and pediatric patients 2 months of age and older ( 1.1 ) Nosocomial pneumonia in adult and pediatric patients 2 months of age and older ( 1.2 ) Skin and skin structure infections in adults ( 1.3 ) Female pelvic infections in adults ( 1.4 ) Community-acquired pneumonia in adults ( 1.5 ) Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of Piperacillin and Tazobactam for Injection and Sodium Chloride Injection and other antibacterial drugs, Piperacillin and Tazobactam for Injection and Sodium Chloride Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

( 1.6 )

1.1Intra-abdominal Infections Piperacillin and Tazobactam for Injection and Sodium Chloride Injection is indicated in adults and pediatric patients (2 months of age and older) for the treatment of appendicitis (complicated by rupture or abscess) and peritonitis caused by beta-lactamase producing isolates of Escherichia coli or the following members of the Bacteroides fragilis group: B. fragilis, B. ovatus, B. thetaiotaomicron, or B. vulgatus .

1.2Nosocomial Pneumonia Piperacillin and Tazobactam for Injection and Sodium Chloride Injection is indicated in adults and pediatric patients (2 months of age and older) for the treatment of nosocomial pneumonia (moderate to severe) caused by beta-lactamase producing isolates of Staphylococcus aureus and by piperacillin and tazobactam-susceptible Acinetobacter baumannii, Haemophilus influenzae, Klebsiella pneumoniae, and Pseudomonas aeruginosa (Nosocomial pneumonia caused by P. aeruginosa should be treated in combination with an aminoglycoside) [see Dosage and Administration (2) ].

1.3Skin and Skin Structure Infections Piperacillin and Tazobactam for Injection and Sodium Chloride Injection is indicated in adults for the treatment of uncomplicated and complicated skin and skin structure infections, including cellulitis, cutaneous abscesses and ischemic/diabetic foot infections caused by beta-lactamase producing isolates of Staphylococcus aureus .

1.4Female Pelvic Infections Piperacillin and Tazobactam for Injection and Sodium Chloride Injection is indicated in adults for the treatment of postpartum endometritis or pelvic inflammatory disease caused by beta-lactamase producing isolates of Escherichia coli .

1.5Community-acquired Pneumonia Piperacillin and Tazobactam for Injection and Sodium Chloride Injection is indicated in adults for the treatment of community-acquired pneumonia (moderate severity only) caused by beta-lactamase producing isolates of Haemophilus influenzae .

1.6Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of Piperacillin and Tazobactam for Injection and Sodium Chloride Injection and other antibacterial drugs, Piperacillin and Tazobactam for Injection and Sodium Chloride Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.

In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION If a dose of Piperacillin and Tazobactam for Injection and Sodium Chloride injection is required that is not equal to 2.25 g, 3.375 g, or 4.5 g, this product is not recommended for use and an alternative formulation of piperacillin and tazobactam for injection should be considered ( 2.1 ). Adult Patients With Indications Other Than Nosocomial Pneumonia; The usual daily dosage of Piperacillin and Tazobactam for Injection and Sodium Chloride Injection, for intravenous use for adults is 3.375 g every 6 ( six ) hours.

( 2.2 ) Adult Patients with Nosocomial Pneumonia: Initial presumptive treatment of patients with nosocomial pneumonia should start with Piperacillin and Tazobactam for Injection and Sodium Chloride Injection, for intravenous use at a dosage of 4.5 g every 6 ( six ) hours plus an aminoglycoside. (2.3 ) Adult Patients with Renal Impairment: Dosage in patients with renal impairment (creatinine clearance ≤40 mL/min) and dialysis patients should be reduced, based on the degree of renal impairment. ( 2.4 ) Pediatric Patients by Indication and Age: See Table below ( 2.5 ) Recommended Dosage of Piperacillin and Tazobactam for Injection and Sodium Chloride Injection for Pediatric Patients 2 months of Age and Older, Weighing up to 40 Kg and With Normal Renal Function Age Appendicitis and /or Peritonitis Nosocomial Pneumonia 2 months to 9 months 90 mg/kg (80 mg piperacillin and 10 mg tazobactam) every 8 ( eight ) hours 90 mg/kg (80 mg piperacillin and 10 mg tazobactam) every 6 ( six ) hours Older than 9 months 112.5 mg/kg (100 mg piperacillin and 12.5 mg tazobactam) every 8 ( eight) hours 112.5 mg/kg (100 mg piperacillin and 12.5 mg tazobactam) every 6 ( six) hours Administer Piperacillin and Tazobactam for Injection and Sodium Chloride Injection by intravenous infusion over 30 minutes to both adult and pediatric patients 2 months of age and older.

( 2.2 , 2.3 , 2.4 , 2.5 ) Piperacillin and Tazobactam for Injection and Sodium Chloride Injection and aminoglycosides should be reconstituted and administered separately. Co-administration via Y-site can be done under certain conditions. ( 2.7 ) See the full prescribing information for the preparation and administration instructions for Piperacillin and Tazobactam for Injection and Sodium Chloride Injection single-dose DUPLEX ® Container.

2.1Important Administration Instructions If a dose of Piperacillin and Tazobactam for Injection and Sodium Chloride Injection is required that does not equal 2.25 g, 3.375 g, or 4.5 g, this product is not recommended for use and an alternative formulation of piperacillin and tazobactam for injection should be considered.

2.2Recommended Dosage in Adult Patients With Indications Other Than Nosocomial Pneumonia The usual total daily dosage of Piperacillin and Tazobactam for Injection and Sodium Chloride Injection for adult patients with indications other than nosocomial pneumonia is 3.375 g every 6 ( six ) hours, to be administered by intravenous infusion over 30 minutes. The usual duration of Piperacillin and Tazobactam for Injection and Sodium Chloride Injection treatment is from 7 to 10 days.

2.3Recommended Dosage in Adult Patients With Nosocomial Pneumonia Initial presumptive treatment of adult patients with nosocomial pneumonia should start with Piperacillin and Tazobactam for Injection and Sodium Chloride Injection at a dosage of 4.5 g every 6 ( six ) hours plus an aminoglycoside, administered by intravenous infusion over 30 minutes. The recommended duration of Piperacillin and Tazobactam for Injection and Sodium Chloride Injection treatment for nosocomial pneumonia is 7 to 14 days. Treatment with the aminoglycoside should be continued in patients from whom P. aeruginosa is isolated.

2.4Recommended Dosage in Adult Patients With Renal Impairment In adult patients with renal impairment (creatinine clearance ≤ 40 mL/min) and dialysis patients (hemodialysis and CAPD), the intravenous dose of Piperacillin and Tazobactam…

💊 Dosage Forms and Strengths 192 words ▾

3 DOSAGE FORMS AND STRENGTHS Piperacillin and Tazobactam for Injection USP and Sodium Chloride Injection USP is supplied as a white to off-white powder and a clear, colorless solution in a single-dose DUPLEX ® Container consisting of: 2.25 g Piperacillin and Tazobactam for Injection USP (2 g of piperacillin and 0.25 g of tazobactam) and 50 mL of 0.45% Sodium Chloride Injection USP. 3.375 g Piperacillin and Tazobactam for Injection USP (3 g of piperacillin and 0.375 g of tazobactam) and 50 mL of 0.3% Sodium Chloride Injection USP.

4.5g Piperacillin and Tazobactam for Injection USP (4 g of piperacillin and 0.5 g of tazobactam) and 100 mL of 0.45% Sodium Chloride Injection USP. Piperacillin and Tazobactam for Injection and Sodium Chloride Injection in a single-dose DUPLEX ® Container consisting of: 2.25 g Piperacillin and Tazobactam for Injection USP and 50 mL of 0.45% Sodium Chloride Injection USP ( 3 ) 3.375 g Piperacillin and Tazobactam for Injection USP and 50 mL of 0.3% Sodium Chloride Injection USP ( 3 ) 4.5 g Piperacillin and Tazobactam for Injection USP and 100 mL of 0.45% Sodium Chloride Injection USP ( 3 )

⛔ Contraindications 49 words ▾

4 CONTRAINDICATIONS Piperacillin and Tazobactam for Injection and Sodium Chloride Injection is contraindicated in patients with a history of allergic reactions to any of the penicillins, cephalosporins, or betalactamase inhibitors. Patients with a history of allergic reactions to any of the penicillins, cephalosporins, or beta-lactamase inhibitors. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Serious hypersensitivity reactions (anaphylactic/anaphylactoid) reactions have been reported in patients receiving piperacillin and tazobactam. Discontinue Piperacillin and Tazobactam for Injection and Sodium Chloride Injection if a reaction occurs. ( 5.1 ) Piperacillin and tazobactam may cause severe cutaneous adverse reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis.

Discontinue Piperacillin and Tazobactam for Injection and Sodium Chloride Injection for progressive rashes. ( 5.2 ) Hemophagocytic lymphohistiocytosis (HLH) has been reported with the use of piperacillin and tazobactam. If HLH is suspected, discontinue Piperacillin and Tazobactam for Injection and Sodium Chloride Injection immediately.

( 5.3 ) Rhabdomyolysis: If signs or symptoms of rhabdomyolysis are observed, discontinue Piperacillin and Tazobactam for Injection and Sodium Chloride Injection and initiate appropriate therapy. ( 5.4 ) Hematological effects (including bleeding, leukopenia and neutropenia) have occurred. Monitor hematologic tests during prolonged therapy.

( 5.5 ) As with other penicillins, piperacillin and tazobactam may cause neuromuscular excitability or seizures. Patients receiving higher doses, especially in the presence of renal impairment may be at greater risk. Closely monitor patients with renal impairment or seizure disorders for signs and symptoms of neuromuscular excitability or seizures.

( 5.6 ) Nephrotoxicity in critically ill patients has been observed; the use of piperacillin and tazobactam was found to be an independent risk factor for renal failure and was associated with delayed recovery of renal function as compared to other beta-lactam antibacterial drugs in a randomized, multicenter, controlled trial in critically ill patients. Based on this study, alternative treatment options should be considered in the critically ill population. If alternative treatment options are inadequate or unavailable, monitor renal function during treatment with Piperacillin and Tazobactam for Injection and Sodium Chloride Injection.

( 5.7 ) High Sodium Load and Electrolyte Effects: Piperacillin and Tazobactam for Injection and Sodium Chloride Injection contains a total of 220 mg, 256 mg, 440 mg of sodium per 2.25 g, 3.375 g, and 4.5 g product, respectively. Consider an alternative formulation of piperacillin-tazobactam in patients requiring restricted sodium intake. Periodic electrolyte determinations should be performed in patients with low potassium reserves.

( 5.8 ) Clostridioides difficile -Associated Diarrhea: Evaluate patients if diarrhea occurs. ( 5.9 )

5.1Hypersensitivity Adverse Reactions Serious and occasionally fatal hypersensitivity (anaphylactic/anaphylactoid) reactions (including shock) have been reported in patients receiving therapy with piperacillin and tazobactam. These reactions are more likely to occur in individuals with a history of penicillin, cephalosporin, or carbapenem hypersensitivity or a history of sensitivity to multiple allergens. Before initiating therapy with Piperacillin and Tazobactam for Injection and Sodium Chloride Injection, careful inquiry should be made concerning previous hypersensitivity reactions.

If an allergic reaction occurs, Piperacillin and Tazobactam for Injection and Sodium Chloride Injection should be discontinued and appropriate therapy instituted.

5.2Severe Cutaneous Adverse Reactions Piperacillin and tazobactam may cause severe cutaneous adverse reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis. If patients develop a skin rash they should be monitored closely and Piperacillin and Tazobactam for Injection and Sodium Chloride Injection discontinued if lesions progress.

5.3 Hemophagocytic Lymphohistiocytosis Cases of hemopha…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Adverse Reactions [see Warnings and Precautions (5.1) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.2) ] Hemophagocytic Lymphohistiocytosis [see Warnings and Precautions (5.3) ] Rhabdomyolysis [see Warnings and Precautions (5.4) ] Hematologic Adverse Reactions [see Warnings and Precautions (5.5) ] Central Nervous System Adverse Reactions [see Warnings and Precautions (5.6) ] Nephrotoxicity in Critically Ill Patients [see Warnings and Precautions (5.7) ] High Sodium Load and Electrolyte Effects [see Warnings and Precautions (5.8) ] Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions (5.9) ] The most common adverse reactions (incidence >5%) are diarrhea, constipation, nausea, headache, and insomnia.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact B. Braun Medical Inc. at 1-833-425-1464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Piperacillin and Tazobactam for Injection and Sodium Chloride Injection has been established from adequate and well-controlled studies of piperacillin and tazobactam. Below is a display of the adverse reactions of piperacillin and tazobactam in these adequate and well controlled studies.

Clinical Trials in Adult Patients During the initial clinical investigations, 2621 patients worldwide were treated with piperacillin and tazobactam in phase 3 trials. In the key North American monotherapy clinical trials (n=830 patients), 90% of the adverse events reported were mild to moderate in severity and transient in nature. However, in 3.2% of the patients treated worldwide, piperacillin and tazobactam was discontinued because of adverse events primarily involving the skin (1.3%), including rash and pruritus; the gastrointestinal system (0.9%), including diarrhea, nausea, and vomiting; and allergic reactions (0.5%).

Table 4: Adverse Reactions from Piperacillin and Tazobactam Monotherapy Clinical Trials System Organ Class Adverse Reaction Gastrointestinal disorders Diarrhea (11.3%) Constipation (7.7%) Nausea (6.9%) Vomiting (3.3%) Dyspepsia (3.3%) Abdominal pain (1.3%) General disorders and administration site conditions Fever (2.4%) Injection site reaction (≤1%) Rigors (≤1%) Immune system disorders Anaphylaxis (≤1%) Infections and infestations Candidiasis (1.6%) Pseudomembranous colitis (≤1%) Metabolism and nutrition disorders Hypoglycemia (≤1%) Musculoskeletal and connective tissue disorders Myalgia (≤1%) Arthralgia (≤1%) Nervous system disorders Headache (7.7%) Psychiatric disorders Insomnia (6.6%) Skin and subcutaneous tissue disorders Rash (4.2%, including maculopapular, bullous, and urticarial) Pruritus (3.1%) Purpura (≤1%) Vascular disorders Phlebitis (1.3%) Thrombophlebitis (≤1%) Hypotension (≤1%) Flushing (≤1%) Respiratory, thoracic and mediastinal disorders Epistaxis (≤1%) Nosocomial Pneumonia Trials Two trials of nosocomial lower respiratory tract infections were conducted.

In one study, 222 patients were treated with piperacillin and tazobactam in a dosing regimen of 4.5 g every 6 hours in combination with an aminoglycoside and 215 patients were treated with imipenem/cilastatin (500 mg/500 mg every 6 hours) in combination with an aminoglycoside. In this trial, treatment-emergent adverse events were reported by 402 patients, 204 (91.9%) in the piperacillin and tazobactam group and 198 (92.1%) in the imipenem/cilastatin group. Twenty-five (11.0%) patients in the piperacillin and tazobactam group and 14 (6.5%) in the imipenem/cilastatin group (p > 0.05) discontinued treatment due to an adverse event.

The second t…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Piperacillin and Tazobactam for Injection and Sodium Chloride Injection administration can significantly reduce tobramycin concentrations in hemodialysis patients. Monitor tobramycin concentrations in these patients. ( 7.1 ) Probenecid prolongs the half-lives of piperacillin and tazobactam and should not be co-administered with Piperacillin and Tazobactam for Injection and Sodium Chloride Injection unless the benefit outweighs the risk.

( 7.2 ) Co-administration of Piperacillin and Tazobactam for Injection and Sodium Chloride Injection with vancomycin may increase the incidence of acute kidney injury. Monitor kidney function in patients receiving Piperacillin and Tazobactam for Injection and Sodium Chloride Injection and vancomycin. ( 7.3 ) Monitor coagulation parameters in patients receiving Piperacillin and Tazobactam for Injection and Sodium Chloride Injection and heparin or oral anticoagulants.

( 7.4 ) Piperacillin and Tazobactam for Injection and Sodium Chloride Injection may prolong the neuromuscular blockade of vecuronium and other non-depolarizing neuromuscular blockers. Monitor for adverse reactions related to neuromuscular blockade. ( 7.5 )

7.1Aminoglycosides Piperacillin may inactivate aminoglycosides by converting them to microbiologically inert amides. In vivo inactivation : When aminoglycosides are administered in conjunction with piperacillin to patients with end-stage renal disease requiring hemodialysis, the concentrations of the aminoglycosides (especially tobramycin) may be significantly reduced and should be monitored. Sequential administration of piperacillin and tazobactam and tobramycin to patients with either normal renal function or mild to moderate renal impairment has been shown to modestly decrease serum concentrations of tobramycin but no dosage adjustment is considered necessary.

In vitro inactivation : Due to the in vitro inactivation of aminoglycosides by piperacillin, piperacillin and tazobactam and aminoglycosides are recommended for separate administration. Piperacillin and Tazobactam for Injection and Sodium Chloride Injection and aminoglycosides should be reconstituted, and administered separately when concomitant therapy with aminoglycosides is indicated. Piperacillin and Tazobactam for Injection and Sodium Chloride Injection, which contains EDTA, is compatible with amikacin and gentamicin for simultaneous Y-site infusion in certain diluents and at specific concentrations.

Piperacillin and Tazobactam for Injection and Sodium Chloride Injection is not compatible with tobramycin for simultaneous Y-site infusion [see Dosage and Administration (2.7) ].

7.2Probenecid Probenecid administered concomitantly with Piperacillin and Tazobactam for Injection and Sodium Chloride Injection prolongs the half-life of piperacillin by 21% and that of tazobactam by 71% because probenecid inhibits tubular renal secretion of both piperacillin and tazobactam. Probenecid should not be co-administered with Piperacillin and Tazobactam for Injection and Sodium Chloride Injection unless the benefit outweighs the risk.

7.3Vancomycin Studies have detected an increased incidence of acute kidney injury in patients concomitantly administered piperacillin and tazobactam and vancomycin as compared to vancomycin alone [see Warnings and Precautions (5.7) ]. Monitor kidney function in patients concomitantly administered with Piperacillin and Tazobactam for Injection and Sodium Chloride Injection and vancomycin. No pharmacokinetic interactions have been noted between piperacillin and tazobactam and vancomycin.

7.4Anticoagulants Coagulation parameters should be tested more frequently and monitored regularly during simultaneous administration of high doses of heparin, oral anticoagulants, or other drugs that may affect the blood coagulation system or the thrombocyte function [see Warnings and Precautions (5.5) ].

7.5Vecuronium Piperacillin when used concomitantly with vecuronium has been implicated in the…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Dosage in patients with renal impairment (creatinine clearance ≤40 mL/min) should be reduced based on the degree of renal impairment. ( 2.4 , 8.6 )

8.1Pregnancy Risk Summary Piperacillin and tazobactam cross the placenta in humans. However, there are insufficient data with piperacillin and/or tazobactam in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. No fetal structural abnormalities were observed in rats or mice when piperacillin and tazobactam was administered intravenously during organogenesis at doses 1 to 2 times and 2 to 3 times the human dose of piperacillin and tazobactam, respectively, based on body-surface area (mg/m 2 ).

However, fetotoxicity in the presence of maternal toxicity was observed in developmental toxicity and peri/postnatal studies conducted in rats (intraperitoneal administration prior to mating and throughout gestation or from gestation day 17 through lactation day 21) at doses less than the maximum recommended human daily dose based on body-surface area (mg/m 2 ) (see Data). The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data Animal Data In embryo-fetal development studies in mice and rats, pregnant animals received intravenous doses of piperacillin and tazobactam up to 3000/750 mg/kg/day during the period of organogenesis. There was no evidence of teratogenicity up to the highest dose evaluated, which is 1 to 2 times and 2 to 3 times the human dose of piperacillin and tazobactam, in mice and rats respectively, based on body-surface area (mg/m 2 ). Fetal body weights were reduced in rats at maternally toxic doses at or above 500/62.5 mg/kg/day, minimally representing 0.4 times the human dose of both piperacillin and tazobactam based on body-surface area (mg/m 2 ).

A fertility and general reproduction study in rats using intraperitoneal administration of tazobactam or the combination piperacillin and tazobactam prior to mating and through the end of gestation, reported a decrease in litter size in the presence of maternal toxicity at 640 mg/kg/day tazobactam (4 times the human dose of tazobactam based on body-surface area), and decreased litter size and an increase in fetuses with ossification delays and variations of ribs, concurrent with maternal toxicity at ≥640/160 mg/kg/day piperacillin and tazobactam (0.5 times and 1 times the human dose of piperacillin and tazobactam, respectively, based on body-surface area).

Peri/postnatal development in rats was impaired with reduced pup weights, increased stillbirths, and increased pup mortality concurrent with maternal toxicity after intraperitoneal administration of tazobactam alone at doses ≥320 mg/kg/day (2 times the human dose based on body surface area) or of the combination piperacillin and tazobactam at doses ≥640/160 mg/kg/day (0.5 times and 1 times the human dose of piperacillin and tazobactam, respectively, based on body-surface area) from gestation day 17 through lactation day 21.

8.2Lactation Risk Summary Piperacillin is excreted in human milk; tazobactam concentrations in human milk have not been studied. No information is available on the effects of piperacillin and tazobactam on the breast- fed child or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Piperacillin and Tazobactam for Injection and Sodium Chloride Injection and any potential adverse effects on the breast-fed child from Piperacillin and Tazobactam for Injection and Sodium Chloride Injection or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of Piperacillin and Tazobactam for Injection and Sodium Chloride Injection for intra-abdominal infections, and no…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Piperacillin and tazobactam cross the placenta in humans. However, there are insufficient data with piperacillin and/or tazobactam in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. No fetal structural abnormalities were observed in rats or mice when piperacillin and tazobactam was administered intravenously during organogenesis at doses 1 to 2 times and 2 to 3 times the human dose of piperacillin and tazobactam, respectively, based on body-surface area (mg/m 2 ).

However, fetotoxicity in the presence of maternal toxicity was observed in developmental toxicity and peri/postnatal studies conducted in rats (intraperitoneal administration prior to mating and throughout gestation or from gestation day 17 through lactation day 21) at doses less than the maximum recommended human daily dose based on body-surface area (mg/m 2 ) (see Data). The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data Animal Data In embryo-fetal development studies in mice and rats, pregnant animals received intravenous doses of piperacillin and tazobactam up to 3000/750 mg/kg/day during the period of organogenesis. There was no evidence of teratogenicity up to the highest dose evaluated, which is 1 to 2 times and 2 to 3 times the human dose of piperacillin and tazobactam, in mice and rats respectively, based on body-surface area (mg/m 2 ). Fetal body weights were reduced in rats at maternally toxic doses at or above 500/62.5 mg/kg/day, minimally representing 0.4 times the human dose of both piperacillin and tazobactam based on body-surface area (mg/m 2 ).

A fertility and general reproduction study in rats using intraperitoneal administration of tazobactam or the combination piperacillin and tazobactam prior to mating and through the end of gestation, reported a decrease in litter size in the presence of maternal toxicity at 640 mg/kg/day tazobactam (4 times the human dose of tazobactam based on body-surface area), and decreased litter size and an increase in fetuses with ossification delays and variations of ribs, concurrent with maternal toxicity at ≥640/160 mg/kg/day piperacillin and tazobactam (0.5 times and 1 times the human dose of piperacillin and tazobactam, respectively, based on body-surface area).

Peri/postnatal development in rats was impaired with reduced pup weights, increased stillbirths, and increased pup mortality concurrent with maternal toxicity after intraperitoneal administration of tazobactam alone at doses ≥320 mg/kg/day (2 times the human dose based on body surface area) or of the combination piperacillin and tazobactam at doses ≥640/160 mg/kg/day (0.5 times and 1 times the human dose of piperacillin and tazobactam, respectively, based on body-surface area) from gestation day 17 through lactation day 21.

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The safety and effectiveness of Piperacillin and Tazobactam for Injection and Sodium Chloride Injection for intra-abdominal infections, and nosocomial pneumonia have been established in pediatric patients 2 months of age and older. Use of Piperacillin and Tazobactam for Injection and Sodium Chloride Injection in pediatric patients 2 months of age and older with intra-abdominal infections including appendicitis and/or peritonitis is supported by evidence from well-controlled studies and pharmacokinetic studies in adults and in pediatric patients.

This includes a prospective, randomized, comparative, open-label clinical trial with 542 pediatric patients 2 to 12 years of age with intra-abdominal infections (including appendicitis (complicated by rupture or abscess) and/or peritonitis), in which 273 pediatric patients received piperacillin and tazobactam [see Adverse Reactions (6.1) and Clinical Pharmacology (12.3) ]. Use of Piperacillin and Tazobactam for Injection and Sodium Chloride Injection in pediatric patients 2 months of age and older with nosocomial pneumonia is supported by evidence from well-controlled studies in adults with nosocomial pneumonia, a simulation study performed with a population pharmacokinetic model, and a retrospective, cohort study of pediatric patients with nosocomial pneumonia in which 140 pediatric patients were treated with Piperacillin and Tazobactam for Injection and 267 patients treated with comparators (which included ticarcillinclavulanate, carbapenems, ceftazidime, cefepime, or ciprofloxacin) [see Adverse Reactions (6.1) and Clinical Pharmacology (12.3) ].

Because of the limitations of the available strengths and administration requirements (i.e., administration of fractional doses is not recommended) of Piperacillin and Tazobactam for Injection and Sodium Chloride Injection, and to avoid unintentional overdose, this product is not recommended for use if a dose of Piperacillin and Tazobactam for Injection and Sodium Chloride Injection, that does not equal 2.25 g, 3.375 g, or 4.5 g is required, and an alternative formulation of piperacillin and tazobactam for injection should be considered [see Dosage and Administration (2.5) ].

The safety and effectiveness of Piperacillin and Tazobactam for Injection and Sodium Chloride Injection have not been established in pediatric patients less than 2 months of age [see Clinical Pharmacology (12) and Dosage and Administration (2) ]. Dosage of Piperacillin and Tazobactam for Injection and Sodium Chloride Injection in pediatric patients with renal impairment has not been determined.

🧓 Geriatric Use 218 words ▾

8.5Geriatric Use Patients over 65 years are not at an increased risk of developing adverse effects solely because of age. However, dosage should be adjusted in the presence of renal impairment [see Dosage and Administration (2) ]. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Piperacillin and Tazobactam for Injection and Sodium Chloride Injection contains a total of 220 mg, 256 mg, 440 mg of sodium per 2.25 g, 3.375 g, and 4.5 g product, respectively. At the usual recommended doses, patients would receive between 1,320 and 1,760 mg/day of sodium. The geriatric population may respond with a blunted natriuresis to salt loading.

This may be clinically important with regard to such diseases as congestive heart failure [see Warnings and Precautions (5.8) ]. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Warnings and Precautions (5.7) ].

🆘 Overdosage 118 words ▾

10 OVERDOSAGE There have been postmarketing reports of overdose with piperacillin and tazobactam. The majority of those events experienced, including nausea, vomiting, and diarrhea, have also been reported with the usual recommended dosages. Patients may experience neuromuscular excitability or seizures if higher than recommended doses are given intravenously (particularly in the presence of renal failure) [see Warnings and Precautions (5.6) ].

Treatment should be supportive and symptomatic according to the patient's clinical presentation. Excessive serum concentrations of either piperacillin or tazobactam may be reduced by hemodialysis. Following a single 3.375 g dose of piperacillin and tazobactam, the percentage of the piperacillin and tazobactam dose removed by hemodialysis was approximately 31% and 39%, respectively [see Clinical Pharmacology (12) ].

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Piperacillin and Tazobactam for Injection and Sodium Chloride Injection is an antibacterial drug [see Microbiology (12.4) ].

12.2Pharmacodynamics The pharmacodynamic parameter for piperacillin and tazobactam that is most predictive of clinical and microbiological efficacy is time above MIC.

12.3Pharmacokinetics The mean and coefficients of variation (CV%) for the pharmacokinetic parameters of piperacillin and tazobactam after multiple intravenous doses are summarized in Table 6. C max : maximum observed concentration, AUC: Area under the curve, CL=clearance, CL R = Renal clearance V=volume of distribution, T 1/2 = elimination half-life Table 6: Mean (CV%) Piperacillin and Tazobactam PK Parameters Piperacillin Piperacillin and Tazobactam Dose Piperacillin and tazobactam were given in combination, infused over 30 minutes.

C max (mcg/mL) AUC Numbers in []parentheses are coefficients of variation [CV%]. (mcg∙h/mL) CL (mL/min) V (L) T 1/2 (h) CL R (mL/min) 2.25 g 134 131 [14] 257 17.4 0.79 -- 3.375 g 242 242 [10] 207 15.1 0.84 140 4.5 g 298 322 [16] 210 15.4 0.84 -- Tazobactam Piperacillin and Tazobactam Dose C max (mcg/mL) AUC (mcg∙h/mL) CL (mL/min) V (L) T 1/2 (h) CL R (mL/min) 2.25 g 15 16.0 [21] 258 17.0 0.77 -- 3.375 g 24 25.0 [8] 251 14.8 0.68 166 4.5 g 34 39.8 [15] 206 14.7 0.82 -- Peak plasma concentrations of piperacillin and tazobactam are attained immediately after completion of an intravenous infusion of Piperacillin and Tazobactam for Injection and Sodium Chloride Injection.

Piperacillin plasma concentrations, following a 30-minute infusion of Piperacillin and Tazobactam for Injection and Sodium Chloride Injection, were similar to those attained when equivalent doses of piperacillin were administered alone. Steady-state plasma concentrations of piperacillin and tazobactam were similar to those attained after the first dose due to the short half-lives of piperacillin and tazobactam. Distribution Both piperacillin and tazobactam are approximately 30% bound to plasma proteins.

The protein binding of either piperacillin or tazobactam is unaffected by the presence of the other compound. Protein binding of the tazobactam metabolite is negligible. Piperacillin and tazobactam are widely distributed into tissues and body fluids including intestinal mucosa, gallbladder, lung, female reproductive tissues (uterus, ovary, and fallopian tube), interstitial fluid, and bile.

Mean tissue concentrations are generally 50% to 100% of those in plasma. Distribution of piperacillin and tazobactam into cerebrospinal fluid is low in subjects with non-inflamed meninges, as with other penicillins (see Table 7). Table 7: Piperacillin and Tazobactam Concentrations in Selected Tissues and Fluids after Single 4 g/0.5 g 30-min Intravenous Infusion of Piperacillin and Tazobactam Tissue or Fluid N Each subject provided a single sample.

Sampling period Time from the start of the infusion (h) Mean PIP Concentration Range (mg/L) Tissue:Plasma Range Tazo Concentration Range (mg/L) Tazo Tissue:Plasma Range Skin 35 0.5 – 4.5 34.8 – 94.2 0.60 – 1.1 4.0 – 7.7 0.49 –

0.93Fatty Tissue 37 0.5 – 4.5 4.0 – 10.1 0.097 – 0.115 0.7 – 1.5 0.10 –

0.13Muscle 36 0.5 – 4.5 9.4 – 23.3 0.29 – 0.18 1.4 – 2.7 0.18 –

0.30Proximal Intestinal Mucosa 7 1.5 – 2.5 31.4 0.55 10.3

1.15Distal Intestinal Mucosa 7 1.5 – 2.5 31.2 0.59 14.5

2.1Appendix 22 0.5 – 2.5 26.5 – 64.1 0.43 – 0.53 9.1 – 18.6 0.80 –

1.35Elimination Metabolism Piperacillin is metabolized to a minor microbiologically active desethyl metabolite. Tazobactam is metabolized to a single metabolite that lacks pharmacological and antibacterial activities. Excretion Following single or multiple Piperacillin and Tazobactam for Injection and Sodium Chloride Injection doses to healthy subjects, the plasma half-life of piperacillin and of tazobactam ranged from 0.7 to 1.2 hours and was unaffected by dose or duration of infusion.

Both piperacillin and tazobactam are elimina…

🧬 Mechanism of Action 21 words ▾

12.1Mechanism of Action Piperacillin and Tazobactam for Injection and Sodium Chloride Injection is an antibacterial drug [see Microbiology (12.4) ].

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Piperacillin and Tazobactam for Injection USP and Sodium Chloride Injection USP is a white to off-white powder and a clear, colorless solution supplied in a single-dose DUPLEX ® Container (packaged 24 single-dose units per case) in the following strengths described in Table 8 below: Table 8: Strengths, Volume of Diluent, National Drug Code (NDC), Total Sodium for Piperacillin and Tazobactam for Injection and Sodium Chloride Injection Strength (piperacillin and tazobactam) Piperacillin Tazobactam Volume of Diluent NDC Total Sodium REF 2.25 g 2 g 0.25 g 50 mL of 0.45% Sodium Chloride 0264- 3446-11 9.6 mEq (220 mg) 3446-11 3.375 g 3 g 0.375 g 50 mL of 0.3% Sodium Chloride 0264- 3448-11 11.1 mEq (256 mg) 3448-11 4.5 g 4 g 0.5 g 100 mL of 0.45% Sodium Chloride 0264- 3450-22 19.1 mEq (440 mg) 3450-22 Prior to reconstitution, store Piperacillin and Tazobactam for Injection USP and Sodium Chloride Injection USP at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Do not remove the foil strip until ready to use to protect from light.

After removal of the foil strip, product must be used within 7 days, but not beyond the labeled expiration date. Protect from light after removal of foil strip. Storage conditions for reconstituted Piperacillin and Tazobactam for Injection are described in another section of labeling [see Dosage and Administration (2.5) ].

Do not freeze.

📋 Description ~2 min read ▾

11 DESCRIPTION Piperacillin and Tazobactam for Injection and Sodium Chloride Injection is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2 S ,5 R ,6 R )-6-[( R )-2-(4-ethyl-2,3-dioxo-1-piperazine-carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate.

The chemical formula is C 23 H 26 N 5 NaO 7 S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is: Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2 S, 3 S, 5 R )-3-methyl-7-oxo-3-(1 H -1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide.

The chemical formula is C 10 H 11 N 4 NaO 5 S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is: Piperacillin and Tazobactam for Injection and Sodium Chloride Injection is supplied as a sterile powder for injection and a sterile solution in a single-dose DUPLEX ® Container with a strength of 2.25 g, 3.375 g, or 4.5 g in the following presentations: 2.25 g: contains 2 grams of piperacillin (equivalent to 2.085 g of piperacillin sodium), 0.25 g of tazobactam (equivalent to 0.269 g of tazobactam sodium), 0.5 mg of edetate sodium dihydrate (EDTA), and 100 mg of sodium citrate dihydrate in the powder chamber.

The diluent chamber contains 225 mg of sodium chloride and 50 mL of water for injection. 3.375 g: contains 3 grams of piperacillin (equivalent to 3.127 g of piperacillin sodium) and 0.375 g of tazobactam (equivalent to 0.402 g of tazobactam sodium), 0.75 mg of EDTA, and 150 mg of sodium citrate dihydrate in the powder chamber. The diluent chamber contains 150 mg of sodium chloride and 50 mL of water for injection.

4.5g: contains 4 grams of piperacillin (equivalent to 4.170 g of piperacillin sodium), 0.5 g of tazobactam (equivalent to 0.538 g of tazobactam sodium), 1 mg of EDTA, and 200 mg of sodium citrate dihydrate. The diluent chamber contains 450 mg of sodium chloride and 100 mL of water for injection. Piperacillin and Tazobactam for Injection and Sodium Chloride Injection contains a total of 9.6 mEq (220 mg), 11.1 mEq (256 mg), and 19.1 mEq (440 mg) of sodium (Na+) per 2.25 g, 3.375 g, and 4.5 g product, respectively [see Warnings and Precautions (5.8) and Use in Specific Populations (8.5) ] .

The reconstituted solution has a pH between 5.0 and 7.0. The osmolality of the reconstituted solution of Piperacillin and Tazobactam for Injection and Sodium Chloride Injection is approximately 318 mOsmol/kg for the 2.25 g strength, approximately 348 mOsmol/kg for the 3.375 g strength, and approximately 318 mOsmol/kg for the 4.5 g strength. Piperacillin and Tazobactam for Injection and Sodium Chloride Injection Meets USP Monograph Organic Impurities Procedure 3.

The DUPLEX ® Container is a flexible dual chamber container. After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is hyperosmotic and is intended for single intravenous use. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene copolymer that contains no plasticizers.

Not made with natural rubber latex, PVC or Di(2-ethylhexyl)phthalate (DEHP). Chemical Structure illustration of piperacillin sodium Chemical structure illustration of tazobactam sodium

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Serious Hypersensitivity Reactions Advise patients, their families, or caregivers that serious hypersensitivity reactions, including serious allergic cutaneous reactions, could occur with use of Piperacillin and Tazobactam for Injection and Sodium Chloride Injection that require immediate treatment. Ask them about any previous hypersensitivity reactions to Piperacillin and Tazobactam for Injection and Sodium Chloride Injection, other beta-lactams (including cephalosporins), or other allergens [see Warnings and Precautions (5.2) ].

Hemophagocytic Lymphohistiocytosis Prior to initiation of treatment with Piperacillin and Tazobactam for Injection and Sodium Chloride Injection, inform patients that excessive immune activation may occur with Piperacillin and Tazobactam for Injection and Sodium Chloride Injection and that they should report signs or symptoms such as fever, rash, or lymphadenopathy to a healthcare provider immediately [see Warnings and Precautions (5.3) ]. High Sodium Load Piperacillin and Tazobactam for Injection and Sodium Chloride Injection contains a high sodium load.

Instruct patients to inform their healthcare provider if they develop symptoms of difficulty breathing, swelling, or increased weight [see Warnings and Precautions (5.8) ]. Diarrhea Advise patients, their families, or caregivers that diarrhea is a common problem caused by antibacterial drugs, including Piperacillin and Tazobactam for Injection and Sodium Chloride Injection, which usually ends when the drug is discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the drug.

If this occurs, patients should contact their physician as soon as possible [see Warnings and Precautions (5.9) ]. Antibacterial Resistance Patients should be counseled that antibacterial drugs including Piperacillin and Tazobactam for Injection and Sodium Chloride Injection should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).

When Piperacillin and Tazobactam for Injection and Sodium Chloride Injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Piperacillin and Tazobactam for Injection and Sodium Chloride Injection or other antibacterial drugs in the future.

Pregnancy and Lactation Patients should be counseled that Piperacillin and Tazobactam for Injection and Sodium Chloride Injection can cross the placenta in humans and is excreted in human milk [see Use in Specific Populations ( 8.1 , 8.2 )].

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.