Home › NDC Lookup › Ingredients › Levofloxacin › 63323-0355-50
Levofloxacin 5 mg/mL Injection — NDC 63323-0355-50 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Levofloxacin 5 mg/mL Injection — NDC 63323-355-50 (Billing 63323-0355-50)

by Fresenius Kabi USA, LLC · 1 BAG in 1 POUCH / 50 mL in 1 BAG

This is a package of Levofloxacin 5 mg/mL Injection from Fresenius Kabi USA, LLC, marketed since Jun 2013 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 63323-0355-50
🏷️ FDA NDC (as labeled) 63323-355-50 billing pads the product segment with a zero
This package
Contains50 mL in 1 bag Pack sizes3 compare ↓
Also priced by: Part D plans $0.0540/unit — full pricing hub ↓
Main listing for product 63323-355 · Also comes in: 150 mL 63323-355-60 100 mL 63323-355-65
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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

NDC database record

One package, one record: these facts belong to NDC 63323-355-50 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
63323 labeler · 355 product · 50 package
Package marketed since
Jun 20, 2013
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6332335550 0
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63323-355-50
Product NDC 63323-355
11-digit billing NDC 63323035550
NCPDP billing unit ML — per mL (volume)
RxCUI 1665497, 1665507, 1665515
UNII 6GNT3Y5LMF
Application # ANDA200674
SPL Set ID eb30fafa-bbb9-458f-89df-ae610fa6aa96
Established class (EPC) Fluoroquinolone Antibacterial
Chemical class Fluoroquinolones
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-06-20
Route INTRAVENOUS
Dosage form INJECTION
Substance LEVOFLOXACIN
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 05000034112024
GPI class levoFLOXacin in D5W
GCN Seq No 029925
GCN 47072
HICL code 012383
Ingredient (HICL) Levofloxacin In Dextrose 5 %
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1Q
Therapeutic class — specific (HIC3) Quinolone Antibiotics
AHFS code 08:12.18.00
AHFS class Quinolone Antibiotics
FDB label name LEVOFLOXACIN 250 MG/50 ML-D5W
FDB brand name Levofloxacin-D5W
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 029925
  • GCN: 47072
  • GPI-14 (Medi-Span): 05000034112024
  • HICL (First Databank): 012383
  • AHFS class code: 08:12.18.00
  • RxCUI (RxNorm): 1665497
Why two NDCs? The FDA registers this code as 63323-355-50 — a 5-3-2 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 product segment → 63323-0355-50. 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 Fluoroquinolone Antibacterial class.

Pharmacologic class Fluoroquinolone Antibacterial
Drug family (ATC) Fluoroquinolones, Fluoroquinolones
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.

Clinical

Label name LEVOFLOXACIN 250 MG/50 ML-D5W Ingredient Levofloxacin In Dextrose 5 %
📖 What it is MedlinePlus · NLM

Levofloxacin injection is used to treat infections caused by bacteria. Levofloxacin injection is also used to prevent anthrax (a serious infection that may be spread on purpose as part of a bioterror attack) in people who may have been exposed to anthrax germs in the air and treat and prevent plague (a serious infection that may be spread on purpose as part of a bioterror attack.) Levofloxacin injection is in a class of antibiotics called fluoroquinolones. It works by killing bacteria that cause infections. Antibiotics such as levofloxacin injection will not work for colds, flu, or other viral...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats serious bacterial infections in adults, such as pneumonia, skin infections, urinary and kidney infections, and prostatitis. It is also used after anthrax exposure and for...
  • What is levofloxacin injection used for?
  • A nurse or clinician gives it as a slow drip into a vein, usually once a day over 60 to 90 minutes. It is never pushed quickly, since that can drop your blood pressure. Drink enoug...
  • Nausea, headache, diarrhea, trouble sleeping, constipation and dizziness are the most common. These are usually manageable, but tell your care team if they bother you.
📖 Read our full Levofloxacin Injection guide →
11
Nutrient depletion considerations

Levofloxacin may be associated with lower levels of 11 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Levofloxacin nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.

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 eachPer 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 $0.0540 $0.05 / 1 bag
Medicare Part B allowsASP · J1956 $1.909 / J1956 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)63323-355-50
11-digit billing NDC63323-0355-50
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ1956
DescriptorInjection, levofloxacin, 250 mg
Billing units / pkg24 units
How the units are derivedThis package is 50; the HCPCS unit is 250 MG, so one package = 24 billing units.
Medicare Part B spend (2026 (Q1))$2,908 · 524 claims · $5.55 per claim (all NDCs under J1956)
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
63323-0355-50 You're viewing this Main listing 1 BAG in 1 POUCH / 50 mL in 1 BAG 2013-06-20 — Active
63323-0355-60 63323-355-60 1 BAG in 1 POUCH / 150 mL in 1 BAG 2013-06-20 — Active
63323-0355-65 63323-355-65 1 BAG in 1 POUCH / 100 mL in 1 BAG 2013-06-20 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bag in 1 pouch / 50 ml in 1 bag.
What NDC number is used to bill for this package of Levofloxacin 5 mg/mL Injection?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Levofloxacin 5 mg/mLthis 63323-0355-50 Fresenius 1 pouch — AP FDA listed —
Levofloxacin 5 mg/mL 44567-0435-24 WG 24 pouches — AP FDA listed —
Levofloxacin 5 mg/mL 44567-0437-24 WG 24 pouches — AP FDA listed —
Levofloxacin 5 mg/mL 25021-0132-81 Sagent 24 pouches — AP FDA listed —
Levofloxacin 5 mg/mL 44567-0436-24 WG 24 pouches — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2013
On the market since
Jun 2013
📍
2026
Currently FDA-listed
13 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

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.

  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.

2 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.

Manufacturer & labeler

LabelerFresenius Kabi USA, LLC
Application holderFRESENIUS KABI USA LLC
FDA applicationANDA200674 (ANDA)
Labeler code63323
First marketedJun 2013
Product typeHuman Prescription Drug
Portfolio554 products on file

More NDCs from Fresenius Kabi USA, LLC labeler code 63323

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 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 💬 Medication Guide 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~2 min read ▾

WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS Fluoroquinolones, including Levofloxacin in 5% Dextrose Injection, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together [see Warnings and Precautions ( 5.1 )] , including: Tendinitis and tendon rupture [see Warnings and Precautions ( 5.2 )] Peripheral neuropathy [see Warnings and Precautions ( 5.3 )] Central nervous system effects [see Warnings and Precautions ( 5.4 )] Discontinue Levofloxacin in 5% Dextrose Injection immediately and avoid the use of fluoroquinolones, including Levofloxacin in 5% Dextrose Injection, in patients who experience any of these serious adverse reactions [see Warnings and Precautions ( 5.1 )] Fluoroquinolones, including Levofloxacin in 5% Dextrose Injection, may exacerbate muscle weakness in patients with myasthenia gravis.

Avoid Levofloxacin in 5% Dextrose Injection in patients with a known history of myasthenia gravis [see Warnings and Precautions ( 5.5 )] Because fluoroquinolones, including Levofloxacin in 5% Dextrose Injection, have been associated with serious adverse reactions [see Warnings and Precautions ( 5.1 - 5.15 )] , reserve Levofloxacin in 5% Dextrose Injection for use in patients who have no alternative treatment options for the following indications: Uncomplicated urinary tract infection [see Indications and Usage ( 1.12 )] Acute bacterial exacerbation of chronic bronchitis [see Indications and Usage ( 1.13 )] Acute bacterial sinusitis [see Indications and Usage ( 1.14 )] WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS See full prescribing information for complete boxed warning.

Fluoroquinolones, including Levofloxacin in 5% Dextrose Injection, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together ( 5.1 ), including: Tendinitis and tendon rupture ( 5.2 ) Peripheral neuropathy ( 5.3 ) Central nervous system effects ( 5.4 ) Discontinue Levofloxacin in 5% Dextrose Injection immediately and avoid the use of fluoroquinolones, including Levofloxacin in 5% Dextrose Injection, in patients who experience any of these serious adverse reactions ( 5.1 ) Fluoroquinolones, including Levofloxacin in 5% Dextrose Injection, may exacerbate muscle weakness in patients with myasthenia gravis.

Avoid Levofloxacin in 5% Dextrose Injection in patients with a known history of myasthenia gravis [see Warnings and Precautions ( 5.5 )] Because fluoroquinolones, including Levofloxacin in 5% Dextrose Injection, have been associated with serious adverse reactions ( 5.1 - 5.15 ), reserve Levofloxacin in 5% Dextrose Injection for use in patients who have no alternative treatment options for the following indications: Uncomplicated urinary tract infection ( 1.12 ) Acute bacterial exacerbation of chronic bronchitis ( 1.13 ) Acute bacterial sinusitis( 1.14 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Levofloxacin in 5% Dextrose Injection and other antibacterial drugs, Levofloxacin in 5% Dextrose Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.( 1.15 )

🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE Levofloxacin in 5% Dextrose Injection is indicated for the treatment of adults (≥ 18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Levofloxacin in 5% Dextrose Injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form). Levofloxacin in 5% Dextrose Injection is a fluoroquinolone antibacterial indicated in adults (≥ 18 years of age) with infections caused by designated, susceptible bacteria ( 1 , 12.4 ). • Pneumonia: Nosocomial ( 1.1 ) and Community-Acquired ( 1.2 , 1.3 ) • Skin and Skin Structure Infections: Complicated ( 1.4 ) and Uncomplicated ( 1.5 ) • Chronic Bacterial Prostatitis ( 1.6 ) • Inhalational Anthrax, Post-Exposure ( 1.7 ) • Plague ( 1.8 ) • Urinary Tract Infections: Complicated ( 1.9 , 1.10 ) and Uncomplicated ( 1.12 ) • Acute Pyelonephritis ( 1.11 ) • Acute Bacterial Exacerbation of Chronic Bronchitis ( 1.13 ) • Acute Bacterial Sinusitis ( 1.14 )

1.1Nosocomial Pneumonia Levofloxacin in 5% Dextrose Injection is indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae . Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see Clinical Studies ( 14.1 )].

1.2Community-Acquired Pneumonia: 7 to 14 day Treatment Regimen Levofloxacin in 5% Dextrose Injection is indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Dosage and Administration ( 2.1 ) and Clinical Studies ( 14.2 )] .

MDRSP isolates are isolates resistant to two or more of the following antibacterials: penicillin (MIC ≥ 2 mcg/mL), 2 nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole.

1.3Community-Acquired Pneumonia: 5-day Treatment Regimen Levofloxacin in 5% Dextrose Injection is indicated for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Dosage and Administration ( 2.1 ) and Clinical Studies ( 14.3 )].

1.4Complicated Skin and Skin Structure Infections Levofloxacin in 5% Dextrose Injection is indicated for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus mirabilis [see Clinical Studies ( 14.5 )].

1.5Uncomplicated Skin and Skin Structure Infections Levofloxacin in 5% Dextrose Injection is indicated for the treatment of uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible Staphylococcus aureus , or Streptococcus pyogenes .

1.6Chronic Bacterial Prostatitis Levofloxacin in 5% Dextrose Injection is indicated for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or methicillin-susceptible Staphylococcus epidermidis [see Clinical Studies ( 14.6 )].

1.7Inhalational Anthrax (Post-Exposure) Levofloxacin in 5% Dextrose Injection is indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of diseas… [Excerpted — this section continues on DailyMed.]

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Dosage in patients with normal renal function ( 2.1 ) Type of Infection Dose Every 24 hours Duration (days) Nosocomial Pneumonia ( 1.1 ) 750 mg 7 to 14 Community-Acquired Pneumonia ( 1.2 ) 500 mg 7 to 14 Community-Acquired Pneumonia ( 1.3 ) 750 mg 5 Complicated Skin and Skin Structure Infections (SSSI) ( 1.6 ) 750 mg 7 to 14 Uncomplicated SSSI ( 1.7 ) 500 mg 7 to 10 Chronic Bacterial Prostatitis ( 1.8 ) 500 mg 28 Inhalational Anthrax (Post-Exposure) ( 1.13 ) Adults and Pediatric Patients > 50 kg Pediatric Patients < 50 kg and ≥ 6 months of age 500 mg 8 mg/kg BID (not to exceed 250 mg/dose) 60 60 Plague ( 1.14 ) Adults and Pediatric Patients > 50 kg Pediatric Patients < 50 kg and ≥ 6 months of age 500 mg 8 mg/kg BID (not to exceed 250 mg/dose) 10 to 14 10 to 14 Complicated Urinary Tract Infection ( 1.9 ) or Acute Pyelonephritis ( 1.11 ) 750 mg 5 Complicated Urinary Tract Infection ( 1.10 ) or Acute Pyelonephritis ( 1.11 ) 250 mg 10 Uncomplicated Urinary Tract Infection ( 1.12 ) 250 mg 3 Acute Bacterial Exacerbation of Chronic Bronchitis ( 1.5 ) 500 mg 7 Acute Bacterial Sinusitis (1.4 ) 750 mg 5 500 mg 10 to 14 Adjust dose for creatinine clearance < 50 mL/min ( 2.3 , 8.6 , 12.3 ) IV Injection, Premix: Slow IV infusion only, over 60 or 90 minutes depending on dose.

Avoid rapid or bolus IV ( 2.5 ) Do not mix with other medications in IV line ( 2.6 )

2.1Dosage in Adult Patients with Normal Renal Function The usual dose of Levofloxacin in 5% Dextrose Injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours, as indicated by infection and described in Table 1. These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration ( 2.3 )] .

Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) Type of Infection * Dosed Every 24 hours Duration (days) † Nosocomial Pneumonia 750 mg 7 to 14 Community-Acquired Pneumonia ‡ 500 mg 7 to 14 Community-Acquired Pneumonia § 750 mg 5 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7 to 14 Uncomplicated SSSI 500 mg 7 to 10 Chronic Bacterial Prostatitis 500 mg 28 Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg Þ,ß Pediatric patients < 50 kg and ≥ 6 months of age Þ,ß 500 mg see Table 2 below ( 2.2 ) 60 ß 60 ß Plague, adult and pediatric patients > 50 kg à Pediatric patients < 50 kg and ≥ 6 months of age 500 mg see Table 2 below ( 2.2 ) 10 to 14 10 to 14 Complicated Urinary Tract Infection (cUTI)or Acute Pyelonephritis (AP) ¶ 750 mg 5 Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) # 250 mg 10 Uncomplicated Urinary Tract Infection 250 mg 3 Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) 500 mg 7 Acute Bacterial Sinusitis (ABS) 750 mg 5 500 mg 10 to 14 * Due to the designated pathogens [see Indications and Usage ( 1 )] . † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage ( 1.2 )] . § Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage ( 1.3 )] . ¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli , including cases with concurrent bacteremia. # This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcu… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 80 words ▾

3 DOSAGE FORMS AND STRENGTHS Levofloxacin in 5% dextrose injection is supplied in single-use flexible containers for intravenous infusion, and is clear yellow to clear greenish-yellow in appearance. • 250 mg, in flexible container, 50 mL fill • 500 mg, in flexible container, 100 mL fill • 750 mg, in flexible container, 150 mL fill Formulation ( 3 ) Strength Injection: premix single-use flexible containers 250 mg in 50 mL 500 mg in 100 mL 750 mg in 150 mL

⛔ Contraindications 42 words ▾

4 CONTRAINDICATIONS Levofloxacin in 5% Dextrose Injection is contraindicated in persons with known hypersensitivity to levofloxacin, or other quinolone antibacterials [see Warnings and Precautions (5.3) ]. Known hypersensitivity to Levofloxacin in 5% Dextrose Injection or other quinolones ( 4 , 5.7 ).

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Anaphylactic reactions and allergic skin reactions, serious, occasionally fatal, may occur after first dose ( 4 , 5.7 ) • Hematologic (including agranulocytosis, thrombocytopenia), and renal toxicities may occur after multiple doses ( 5.6 ) • Hepatotoxicity: Severe, and sometimes fatal, hepatotoxicity has been reported. Discontinue immediately if signs and symptoms of hepatitis occur ( 5.8 ) • Clostridium difficile -associated colitis: evaluate if diarrhea occurs ( 5.10 ) • Prolongation of the QT interval and isolated cases of torsades de pointes have been reported.

Avoid use in patients with known prolongation, those with hypokalemia, and with other drugs that prolong the QT interval ( 5.11 , 8.5 )

5.1Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects Fluoroquinolones, including Levofloxacin in 5% Dextrose Injection, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion).

These reactions can occur within hours to weeks after starting Levofloxacin in 5% Dextrose Injection. Patients of any age or without pre-existing risk factors have experienced these adverse reactions [see Warnings and Precautions ( 5.2 , 5.3 , 5.4 )] . Discontinue Levofloxacin in 5% Dextrose Injection immediately at the first signs or symptoms of any serious adverse reaction.

In addition, avoid the use of fluoroquinolones, including Levofloxacin in 5% Dextrose Injection, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.

5.2Tendinitis and Tendon Rupture Fluoroquinolones, including Levofloxacin in 5% Dextrose Injection have been associated with an increased risk of tendinitis and tendon rupture in all ages [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.2 )] . This adverse reaction most frequently involves the Achilles tendon and has also been reported with the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendon sites. Tendinitis or tendon rupture can occur within hours or days of starting Levofloxacin in 5% Dextrose Injection or as long as several months after completion of fluoroquinolone therapy.

Tendinitis and tendon rupture can occur bilaterally. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in patients usually over 60 years of age, in those taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Other factors, that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis.

Tendinitis and tendon rupture have been reported in patients taking fluoroquinolones who do not have the above risk factors. Discontinue Levofloxacin in 5% Dextrose Injection immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon. Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to contact their healthcare provider regarding changing to a non-quinolone antimicrobial drug.

Avoid Levofloxacin in 5% Dextrose Injection in patients who have a history of tendon disorders or tendon rupture [see Adverse Reactions ( 6.3 ) and Patient Counseling Information ( 17 )] .

5.3Peripheral Neuropathy Fluoroquinolones, including Levofloxacin in 5% Dextrose Injection, have been associated with an increased risk of peripheral neuropathy. Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias an… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most common reactions (≥ 3%) were nausea, headache, diarrhea, insomnia, constipation and dizziness ( 6.2 ). To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Serious and Otherwise Important Adverse Reactions The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling: • Disabling and Potentially Irreversible Serious Adverse Reactions [see Warnings and Precautions ( 5.1 )] • Tendinitis and Tendon Rupture [see Warnings and Precautions ( 5.2 )] • Peripheral Neuropathy [see Warnings and Precautions ( 5.3 )] • Central Nervous System Effects [see Warnings and Precautions ( 5.4 )] • Exacerbation of Myasthenia Gravis [see Warnings and Precautions ( 5.5 )] • Other Serious and Sometimes Fatal Adverse Reactions [see Warnings and Precautions ( 5.6 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.7 )] • Hepatotoxicity [see Warnings and Precautions ( 5.8 )] • Clostridium difficile -Associated Diarrhea [see Warnings and Precautions ( 5.10 )] • Prolongation of the QT Interval [see Warnings and Precautions ( 5.11 )] • Musculoskeletal Disorders in Pediatric Patients [see Warnings and Precautions ( 5.12 )] • Blood Glucose Disturbances [see Warnings and Precautions ( 5.13 )] • Photosensitivity/Phototoxicity [see Warnings and Precautions ( 5.14 )] • Development of Drug-Resistant Bacteria [see Warnings and Precautions ( 5.15 )] Hypotension has been associated with rapid or bolus intravenous infusion of Levofloxacin in 5% Dextrose Injection.

Levofloxacin in 5% Dextrose Injection should be infused slowly over 60 to 90 minutes, depending on dosage [see Dosage and Administration (2.5) ]. Crystalluria and cylindruria have been reported with quinolones, including Levofloxacin in 5% Dextrose Injection. Therefore, adequate hydration of patients receiving Levofloxacin in 5% Dextrose Injection should be maintained to prevent the formation of a highly concentrated urine [see Dosage and Administration (2.5) ].

6.2Clinical Trial 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 data described below reflect exposure to Levofloxacin in 5% Dextrose Injection in 7,537 patients in 29 pooled Phase 3 clinical trials. The population studied had a mean age of 50 years (approximately 74% of the population was < 65 years of age), 50% were male, 71% were Caucasian, 19% were Black.

Patients were treated with Levofloxacin in 5% Dextrose Injection for a wide variety of infectious diseases [see Indications and Usage (1) ] . Patients received Levofloxacin in 5% Dextrose Injection doses of 750 mg once daily, 250 mg once daily, or 500 mg once or twice daily. Treatment duration was usually 3 to 14 days, and the mean number of days on therapy was 10 days.

The overall incidence, type and distribution of adverse reactions was similar in patients receiving Levofloxacin in 5% Dextrose Injection doses of 750 mg once daily, 250 mg once daily, and 500 mg once or twice daily. Discontinuation of Levofloxacin in 5% Dextrose Injection due to adverse drug reactions occurred in 4.3% of patients overall, 3.8% of patients treated with the 250 mg and 500 mg doses and 5.4% of patients treated with the 750 mg dose. The most common adverse drug reactions leading to discontinuation with the 250 and 500 mg doses were gastrointestinal (1.4%), primarily nausea (0.6%); vomiting (0.4%); dizziness (0.3%); and headache (0.2%).

The most common adverse drug reactions leading to discontinuation with the 750 mg dose were gastrointestinal (1.2%), primarily nausea (0.6%), vomiting (0.5%); dizziness (0.3%); and headache (0.3%). Adverse reactions occurring in ≥ 1% of Levofloxacin in 5% De… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS Interacting Drug Interaction Multivalent cation-containing products including antacids, metal cations or didanosine Absorption of levofloxacin is decreased when the tablet or oral solution formulation is taken within 2 hours of these products. Do not co-administer the intravenous formulation in the same IV line with a multivalent cation, e.g., magnesium ( 2.4, 7.1 ) Warfarin Effect may be enhanced. Monitor prothrombin time, INR, watch for bleeding ( 7.2 ) Anti-diabetic agents Carefully monitor blood glucose ( 5.13 , 7.3 )

7.1Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins There are no data concerning an interaction of intravenous fluoroquinolones with oral antacids, sucralfate, multivitamins, didanosine, or metal cations. However, no fluoroquinolone should be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line [see Dosage and Administration (2.5) ].

7.2Warfarin No significant effect of Levofloxacin in 5% Dextrose Injection on the peak plasma concentrations, AUC, and other disposition parameters for R- and S- warfarin was detected in a clinical study involving healthy volunteers. Similarly, no apparent effect of warfarin on levofloxacin absorption and disposition was observed. However, there have been reports during the post-marketing experience in patients that Levofloxacin in 5% Dextrose Injection enhances the effects of warfarin.

Elevations of the prothrombin time in the setting of concurrent warfarin and Levofloxacin in 5% Dextrose Injection use have been associated with episodes of bleeding. Prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests should be closely monitored if Levofloxacin in 5% Dextrose Injection is administered concomitantly with warfarin. Patients should also be monitored for evidence of bleeding [see Adverse Reactions ( 6.3 ) and Patient Counseling Information ( 17 )].

7.3Anti-diabetic Agents Disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concomitantly with fluoroquinolones and an anti-diabetic agent. Therefore, careful monitoring of blood glucose is recommended when these agents are co-administered [see Warnings and Precautions ( 5.13 ), Adverse Reactions (6.2) and Patient Counseling Information ( 17 )].

7.4Non-Steroidal Anti-Inflammatory Drugs The concomitant administration of a non-steroidal anti-inflammatory drug with a fluoroquinolone, including Levofloxacin in 5% Dextrose Injection, may increase the risk of CNS stimulation and convulsive seizures [see Warnings and Precautions (5.4) ].

7.5Theophylline No significant effect of Levofloxacin in 5% Dextrose Injection on the plasma concentrations, AUC, and other disposition parameters for theophylline was detected in a clinical study involving healthy volunteers. Similarly, no apparent effect of theophylline on levofloxacin absorption and disposition was observed. However, concomitant administration of other fluoroquinolones with theophylline has resulted in prolonged elimination half-life, elevated serum theophylline levels, and a subsequent increase in the risk of theophylline-related adverse reactions in the patient population.

Therefore, theophylline levels should be closely monitored and appropriate dosage adjustments made when Levofloxacin in 5% Dextrose Injection is co-administered. Adverse reactions, including seizures, may occur with or without an elevation in serum theophylline levels [see Warnings and Precautions (5.4) ].

7.6Cyclosporine No significant effect of Levofloxacin in 5% Dextrose Injection on the peak plasma concentrations, AUC, and other disposition parameters for cyclosporine was detected in a clinical study involving healthy volunteers. However, elevated serum levels of cyclosporine have been reported in the patient population when co-administered with some other fluoroquinolones. Levofloxacin C max and k e were sli… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Geriatrics: Severe hepatotoxicity has been reported. The majority of reports describe patients 65 years of age or older ( 5.8 , 8.5 , 17 ). May have increased risk of tendinopathy (including rupture), especially with concomitant corticosteroid use ( 5.2 , 8.5 , 17 ).

May be more susceptible to prolongation of the QT interval ( 5.11 , 8.5 , 17 ). • Pediatrics: Musculoskeletal disorders (arthralgia, arthritis, tendinopathy, and gait abnormality) seen in more levofloxacin-treated patients than in comparator. Shown to cause arthropathy and osteochondrosis in juvenile animals ( 5.12 , 8.4 , 13.2 ). Safety in pediatric patients treated for more than 14 days has not been studied.

Risk-benefit appropriate only for the treatment of inhalational anthrax (post-exposure) ( 1.7 , 2.2 , 8.4 , 14.9 ) and plague ( 1.8 , 2.2 , 8.4 , 14.10 ).

8.1Pregnancy Pregnancy Category C. Levofloxacin was not teratogenic in rats at oral doses as high as 810 mg/kg/day which corresponds to 9.4 times the highest recommended human dose based upon relative body surface area, or at intravenous doses as high as 160 mg/kg/day corresponding to 1.9 times the highest recommended human dose based upon relative body surface area. The oral dose of 810 mg/kg/day to rats caused decreased fetal body weight and increased fetal mortality.

No teratogenicity was observed when rabbits were dosed orally as high as 50 mg/kg/day which corresponds to 1.1 times the highest recommended human dose based upon relative body surface area, or when dosed intravenously as high as 25 mg/kg/day, corresponding to 0.5 times the highest recommended human dose based upon relative body surface area. There are, however, no adequate and well-controlled studies in pregnant women. Levofloxacin in 5% Dextrose Injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

8.3Nursing Mothers Based on data on other fluoroquinolones and very limited data on Levofloxacin in 5% Dextrose Injection, it can be presumed that levofloxacin will be excreted in human milk. Because of the potential for serious adverse reactions from Levofloxacin in 5% Dextrose Injection in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

8.4Pediatric Use Quinolones, including levofloxacin, cause arthropathy and osteochondrosis in juvenile animals of several species [see Warnings and Precautions ( 5.12 ) and Animal Toxicology and/or Pharmacology ( 13.2 )]. Pharmacokinetics following intravenous administration The pharmacokinetics of levofloxacin following a single intravenous dose were investigated in pediatric patients ranging in age from six months to 16 years. Pediatric patients cleared levofloxacin faster than adult patients resulting in lower plasma exposures than adults for a given mg/kg dose [see Clinical Pharmacology (12.3) and Clinical Studies (14.9) ].

Inhalational Anthrax (Post-Exposure) Levofloxacin is indicated in pediatric patients 6 months of age and older, for inhalational anthrax (post-exposure). The risk-benefit assessment indicates that administration of levofloxacin to pediatric patients is appropriate. The safety of levofloxacin in pediatric patients treated for more than 14 days has not been studied [see Indications and Usage ( 1.7 ), Dosage and Administration ( 2.2 ) and Clinical Studies ( 14.9 )] .

Plague Levofloxacin is indicated in pediatric patients, 6 months of age and older, for treatment of plague, including pneumonic and septicemic plague due to Yersinia pestis ( Y. pestis ) and prophylaxis for plague. Efficacy studies of Levofloxacin in 5% Dextrose Injection could not be conducted in humans with pneumonic plague for ethical and feasibility reasons. Therefore, approval of this indication was based on an efficacy study conducted in animals.

The risk-benefit assessment indicates that administration of levofl… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy 163 words ▾

8.1Pregnancy Pregnancy Category C. Levofloxacin was not teratogenic in rats at oral doses as high as 810 mg/kg/day which corresponds to 9.4 times the highest recommended human dose based upon relative body surface area, or at intravenous doses as high as 160 mg/kg/day corresponding to 1.9 times the highest recommended human dose based upon relative body surface area. The oral dose of 810 mg/kg/day to rats caused decreased fetal body weight and increased fetal mortality.

No teratogenicity was observed when rabbits were dosed orally as high as 50 mg/kg/day which corresponds to 1.1 times the highest recommended human dose based upon relative body surface area, or when dosed intravenously as high as 25 mg/kg/day, corresponding to 0.5 times the highest recommended human dose based upon relative body surface area. There are, however, no adequate and well-controlled studies in pregnant women. Levofloxacin in 5% Dextrose Injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use Quinolones, including levofloxacin, cause arthropathy and osteochondrosis in juvenile animals of several species [see Warnings and Precautions ( 5.12 ) and Animal Toxicology and/or Pharmacology ( 13.2 )]. Pharmacokinetics following intravenous administration The pharmacokinetics of levofloxacin following a single intravenous dose were investigated in pediatric patients ranging in age from six months to 16 years. Pediatric patients cleared levofloxacin faster than adult patients resulting in lower plasma exposures than adults for a given mg/kg dose [see Clinical Pharmacology (12.3) and Clinical Studies (14.9) ].

Inhalational Anthrax (Post-Exposure) Levofloxacin is indicated in pediatric patients 6 months of age and older, for inhalational anthrax (post-exposure). The risk-benefit assessment indicates that administration of levofloxacin to pediatric patients is appropriate. The safety of levofloxacin in pediatric patients treated for more than 14 days has not been studied [see Indications and Usage ( 1.7 ), Dosage and Administration ( 2.2 ) and Clinical Studies ( 14.9 )] .

Plague Levofloxacin is indicated in pediatric patients, 6 months of age and older, for treatment of plague, including pneumonic and septicemic plague due to Yersinia pestis ( Y. pestis ) and prophylaxis for plague. Efficacy studies of Levofloxacin in 5% Dextrose Injection could not be conducted in humans with pneumonic plague for ethical and feasibility reasons. Therefore, approval of this indication was based on an efficacy study conducted in animals.

The risk-benefit assessment indicates that administration of levofloxacin to pediatric patients is appropriate [see Indications and Usage ( 1.8 ), Dosage and Administration ( 2.2 ) and Clinical Studies ( 14.10 )]. Safety and effectiveness in pediatric patients below the age of six months have not been established. Adverse Events In clinical trials, 1,534 children (6 months to 16 years of age) were treated with oral and intravenous levofloxacin.

Children 6 months to 5 years of age received levofloxacin 10 mg/kg twice a day and children greater than 5 years of age received 10 mg/kg once a day (maximum 500 mg per day) for approximately 10 days. A subset of children in the clinical trials (1,340 levofloxacin-treated and 893 non-fluoroquinolone-treated) enrolled in a prospective, long-term surveillance study to assess the incidence of protocol-defined musculoskeletal disorders (arthralgia, arthritis, tendinopathy, gait abnormality) during 60 days and 1 year following the first dose of the study drug.

Children treated with levofloxacin had a significantly higher incidence of musculoskeletal disorders when compared to the non-fluoroquinolone-treated children as illustrated in Table 7. Table 7: Incidence of Musculoskeletal Disorders in Pediatric Clinical Trial Follow-up Period Levofloxacin N = 1,340 Non-Fluoroquinolone* N = 893 p-value † 60 days 28 (2.1%) 8 (0.9%) p = 0.038 1 year ‡ 46 (3.4%) 16 (1.8%) p = 0.025 * Non-Fluoroquinolone: ceftriaxone, amoxicillin/clavulanate, clarithromycin † 2-sided Fisher’s Exact Test ‡ There were 1,199 levofloxacin-treated and 804 non-fluoroquinolone-treated children who had a one-year evaluation visit.

However, the incidence of musculoskeletal disorders was calculated using all reported events during the specified period for all children enrolled regardless of whether they completed the 1-year evaluation visit. Arthralgia was the most frequently occurring musculoskeletal disorder in both treatment groups. Most of the musculoskeletal disorders in both groups involved multiple weight-bearing joints.

Disorders were moderate in 8/46 (17%) children and mild in 35/46 (76%) Levofloxacin in 5% Dextrose Injection-treated children and most were treated with analgesics. The median time to resolution was 7 days for Levofloxacin in 5% Dextrose Injection-treated children and 9 for non-fluoroquinolone-treated children (approximately 80% resolved within 2 months in both groups). No ch… [Excerpted — this section continues on DailyMed.]

🧓 Geriatric Use ~2 min read ▾

8.5Geriatric Use Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as Levofloxacin in 5% Dextrose Injection. This risk is further increased in patients receiving concomitant corticosteroid therapy. Tendinitis or tendon rupture can involve the Achilles, hand, shoulder, or other tendon sites and can occur during or after completion of therapy; cases occurring up to several months after fluoroquinolone treatment have been reported.

Caution should be used when prescribing Levofloxacin in 5% Dextrose Injection to elderly patients especially those on corticosteroids. Patients should be informed of this potential side effect and advised to discontinue Levofloxacin in 5% Dextrose Injection and contact their healthcare provider if any symptoms of tendinitis or tendon rupture occur [see Boxed Warning; Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.3 )] . In Phase 3 clinical trials, 1,945 levofloxacin-treated patients (26%) were ≥ 65 years of age.

Of these, 1,081 patients (14%) were between the ages of 65 and 74 and 864 patients (12%) were 75 years or older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. Severe, and sometimes fatal, cases of hepatotoxicity have been reported post-marketing in association with Levofloxacin in 5% Dextrose Injection.

The majority of fatal hepatotoxicity reports occurred in patients 65 years of age or older and most were not associated with hypersensitivity. Levofloxacin in 5% Dextrose Injection should be discontinued immediately if the patient develops signs and symptoms of hepatitis [see Warnings and Precautions ( 5.8 )] . Epidemiologic studies report an increased rate of aortic aneurysm and dissection within two months following use of fluoroquinolones, particularly in elderly patients [ see Warnings and Precautions ( 5.9 )].

Elderly patients may be more susceptible to drug-associated effects on the QT interval. Therefore, precaution should be taken when using Levofloxacin in 5% Dextrose Injection with concomitant drugs that can result in prolongation of the QT interval (e.g., Class IA or Class III antiarrhythmics) or in patients with risk factors for torsades de pointes (e.g., known QT prolongation, uncorrected hypokalemia) [see Warnings and Precautions ( 5.11 )] . The pharmacokinetic properties of levofloxacin in younger adults and elderly adults do not differ significantly when creatinine clearance is taken into consideration.

However, since the drug is known to be substantially excreted by the kidney, 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 Clinical Pharmacology ( 12.3 )] .

🆘 Overdosage 93 words ▾

10 OVERDOSAGE In the event of an acute overdosage, the stomach should be emptied. The patient should be observed and appropriate hydration maintained. Levofloxacin is not efficiently removed by hemodialysis or peritoneal dialysis.

Levofloxacin in 5% Dextrose Injection exhibits a low potential for acute toxicity. Mice, rats, dogs and monkeys exhibited the following clinical signs after receiving a single high dose of Levofloxacin in 5% Dextrose Injection: ataxia, ptosis, decreased locomotor activity, dyspnea, prostration, tremors, and convulsions. Doses in excess of 1,500 mg/kg orally and 250 mg/kg IV produced significant mortality in rodents.

🧬 Clinical Pharmacology ~4 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Levofloxacin is a member of the fluoroquinolone class of antibacterial agents [see Microbiology (12.4) ].

12.3Pharmacokinetics The mean ± SD pharmacokinetic parameters of levofloxacin determined under single and steady-state conditions following oral tablet, oral solution, or intravenous (IV) doses of levofloxacin are summarized in Table 8. Table 8: Mean ± SD Levofloxacin PK Parameters Regimen C max (mcg/mL) T max (h) AUC (mcg•h/mL) CL/F 1 (mL/min) Vd/F 2 (L) t 1/2 (h) CL R (mL/min) Single dose 250 mg oral tablet 3 2.8 ± 0.4 1.6 ± 1 27.2 ± 3.9 156 ± 20 ND 7.3 ± 0.9 142 ± 21 500 mg oral tablet 3 * 5.1 ± 0.8 1.3 ± 0.6 47.9 ± 6.8 178 ± 28 ND 6.3 ± 0.6 103 ± 30 500 mg oral solution 12 5.8 ± 1.8 0.8 ± 0.7 47.8 ± 10.8 183 ± 40 112 ± 37.2 7 ±

1.4ND 500 mg IV 3 6.2 ± 1 1 ± 0.1 48.3 ± 5.4 175 ± 20 90 ± 11 6.4 ± 0.7 112 ± 25 750 mg oral tablet 5 * 9.3 ± 1.6 1.6 ± 0.8 101 ± 20 129 ± 24 83 ± 17 7.5 ±

0.9ND 750 mg IV 5 11.5 ± 4 4 ND 110 ± 40 126 ± 39 75 ± 13 7.5 ±

1.6ND Multiple dose 500 mg every 24h oral tablet 3 5.7 ± 1.4 1.1 ± 0.4 47.5 ± 6.7 175 ± 25 102 ± 22 7.6 ± 1.6 116 ± 31 500 mg every 24h IV 3 6.4 ±

0.8ND 54.6 ± 11.1 158 ± 29 91 ± 12 7 ± 0.8 99 ± 28 500 mg or 250 mg every 24h IV, patients with bacterial infection 6 8.7 ± 4 7 ND 72.5 ± 51.2 7 154 ± 72 111 ± 58 ND ND 750 mg every 24h oral tablet 5 8.6 ± 1.9 1.4 ± 0.5 90.7 ± 17.6 143 ± 29 100 ± 16 8.8 ± 1.5 116 ± 28 750 mg every 24h IV 5 12.1 ± 4.1 4 ND 108 ± 34 126 ± 37 80 ± 27 7.9 ±

1.9ND 500 mg oral tablet single dose, effects of gender and age: Male 8 5.5 ± 1.1 1.2 ± 0.4 54.4 ± 18.9 166 ± 44 89 ± 13 7.5 ± 2.1 126 ± 38 Female 9 7 ± 1.6 1.7 ± 0.5 67.7 ± 24.2 136 ± 44 62 ± 16 6.1 ± 0.8 106 ± 40 Young 10 5.5 ± 1 1.5 ± 0.6 47.5 ± 9.8 182 ± 35 83 ± 18 6 ± 0.9 140 ± 33 Elderly 11 7 ± 1.6 1.4 ± 0.5 74.7 ± 23.3 121 ± 33 67 ± 19 7.6 ± 2 91 ± 29 500 mg oral single dose tablet, patients with renal insufficiency: CLCR 50 to 80 mL/min 7.5 ± 1.8 1.5 ± 0.5 95.6 ± 11.8 88 ± 10 ND 9.1 ± 0.9 57 ± 8 CLCR 20 to 49 mL/min 7.1 ± 3.1 2.1 ± 1.3 182.1 ± 62.6 51 ± 19 ND 27 ± 10 26 ± 13 CLCR < 20 mL/min 8.2 ± 2.6 1.1 ± 1 263.5 ± 72.5 33 ± 8 ND 35 ± 5 13 ± 3 Hemodialysis 5.7 ± 1 2.8 ±

2.2ND ND ND 76 ± 42 ND CAPD 6.9 ± 2.3 1.4 ±

1.1ND ND ND 51 ± 24 ND 1 clearance/bioavailability 2 volume of distribution/bioavailability 3 healthy males 18 to 53 years of age 4 60 min infusion for 250 mg and 500 mg doses, 90 min infusion for 750 mg dose 5 healthy male and female subjects 18 to 54 years of age 6 500 mg every 48h for patients with moderate renal impairment (CLCR 20 to 50 mL/min) and infections of the respiratory tract or skin 7 dose-normalized values (to 500 mg dose), estimated by population pharmacokinetic modeling 8 healthy males 22 to 75 years of age 9 healthy females 18 to 80 years of age 10 young healthy male and female subjects 18 to 36 years of age 11 healthy elderly male and female subjects 66 to 80 years of age 12 healthy males and females 19 to 55 years of age * Absolute bioavailability; F=0.99 ± 0.08 from a 500 mg tablet and F=0.99 ± 0.06 from a 750 mg tablet ND=not determined Absorption Levofloxacin is rapidly and essentially completely absorbed after oral administration.

Peak plasma concentrations are usually attained one to two hours after oral dosing. The absolute bioavailability of levofloxacin from a 500 mg tablet and a 750 mg tablet of levofloxacin are both approximately 99%, demonstrating complete oral absorption of levofloxacin. Following a single intravenous dose of Levofloxacin in 5% Dextrose Injection to healthy volunteers, the mean ± SD peak plasma concentration attained was 6.2 ± 1 mcg/mL after a 500 mg dose infused over 60 minutes and 11.5 ± 4 mcg/mL after a 750 mg dose infused over 90 minutes.

Levofloxacin Oral Solution and Tablet formulations are bioequivalent. Levofloxacin pharmacokinetics are linear and predictable after single and multiple oral or IV dosing regimens. Steady-state conditions are reached within 48 hours followin… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 19 words ▾

12.1Mechanism of Action Levofloxacin is a member of the fluoroquinolone class of antibacterial agents [see Microbiology (12.4) ].

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

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1Levofloxacin Injection Pre-Mixed Solution, Single-Use in Flexible Container Levofloxacin in 5% Dextrose Injection is supplied as a single-use, premixed solution in flexible containers. Each bag contains a dilute solution with the equivalent of 250, 500, or 750 mg of levofloxacin, respectively, in 5% Dextrose (D5W). Product No.

NDC No. Strength Size 315550 63323-355-50 250 mg in 50 mL (5 mg per mL) 50 mL fill in a 100 mL flexible container. 315565 63323-355-65 500 mg in 100 mL (5 mg per mL) 100 mL fill in a 100 mL flexible container 315560 63323-355-60 750 mg in 150 mL (5 mg per mL) 150 mL fill in a 150 mL flexible container Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Avoid excessive heat and protect from freezing and light. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.

16.1Levofloxacin Injection Pre-Mixed Solution, Single-Use in Flexible Container Levofloxacin in 5% Dextrose Injection is supplied as a single-use, premixed solution in flexible containers. Each bag contains a dilute solution with the equivalent of 250, 500, or 750 mg of levofloxacin, respectively, in 5% Dextrose (D5W). Product No.

NDC No. Strength Size 315550 63323-355-50 250 mg in 50 mL (5 mg per mL) 50 mL fill in a 100 mL flexible container. 315565 63323-355-65 500 mg in 100 mL (5 mg per mL) 100 mL fill in a 100 mL flexible container 315560 63323-355-60 750 mg in 150 mL (5 mg per mL) 150 mL fill in a 150 mL flexible container Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Avoid excessive heat and protect from freezing and light. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.

📋 Description ~2 min read ▾

11 DESCRIPTION Levofloxacin in 5% dextrose injection is a synthetic broad-spectrum antibacterial agent for intravenous administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate.

Levofloxacin is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL).

Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9.

Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al +3 >Cu +2 >Zn +2 >Mg +2 >Ca +2 . Excipients and Description of Dosage Forms The appearance of levofloxacin in 5% dextrose injection may range from a clear yellow to a clear greenish-yellow solution.

This does not adversely affect product potency. Levofloxacin Injection Premix in Single-Use Flexible Containers is a sterile, preservative-free aqueous solution of levofloxacin with pH ranging from 3.8 to 5.8. This is a dilute, non-pyrogenic, nearly isotonic premixed solution that contains levofloxacin in 5% Dextrose (D5W).

Solutions of hydrochloric acid and sodium hydroxide may have been added to adjust the pH. The flexible container is fabricated from a specially formulated non-plasticized film containing polypropylene and thermoplastic elastomers ( free flex ® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly.

Solutions in contact with the flexible container can leach out certain of the container’s chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers. chemstruct

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Serious Adverse Reactions Advise patients to stop taking Levofloxacin in 5% Dextrose Injection if they experience an adverse reaction and to call their healthcare provider for advice on completing the full course of treatment with another antibacterial drug. Inform patients of the following serious adverse reactions that have been associated with Levofloxacin in 5% Dextrose Injection or other fluoroquinolone use: Disabling and Potentially Irreversible Serious Adverse Reactions That May Occur Together: Inform patients that disabling and potentially irreversible serious adverse reactions, including tendinitis and tendon rupture, peripheral neuropathies, and central nervous system effects, have been associated with use of Levofloxacin in 5% Dextrose Injection and may occur together in the same patient.

Inform patients to stop taking Levofloxacin in 5% Dextrose Injection immediately if they experience an adverse reaction and to call their healthcare provider. Tendinitis and Tendon Rupture: Instruct patients to contact their healthcare provider if they experience pain, swelling, or inflammation of a tendon, or weakness or inability to use one of their joints; rest and refrain from exercise; and discontinue Levofloxacin in 5% Dextrose Injection treatment. Symptoms may be irreversible.

The risk of severe tendon disorder with fluoroquinolones is higher in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Peripheral Neuropathies: Inform patients that peripheral neuropathies have been associated with levofloxacin use, symptoms may occur soon after initiation of therapy and may be irreversible. If symptoms of peripheral neuropathy including pain, burning, tingling, numbness and/or weakness develop, immediately discontinue Levofloxacin in 5% Dextrose Injection and tell them to contact their physician.

Central Nervous System Effects (for example, convulsions, dizziness, lightheadedness, increased intracranial pressure): Inform patients that convulsions have been reported in patients receiving fluoroquinolones, including levofloxacin. Instruct patients to notify their physician before taking this drug if they have a history of convulsions. Inform patients that they should know how they react to Levofloxacin in 5% Dextrose Injection before they operate an automobile or machinery or engage in other activities requiring mental alertness and coordination.

Instruct patients to notify their physician if persistent headache with or without blurred vision occurs. Exacerbation of Myasthenia Gravis: Instruct patients to inform their physician of any history of myasthenia gravis. Instruct patients to notify their physician if they experience any symptoms of muscle weakness, including respiratory difficulties.

Hypersensitivity Reactions: Inform patients that levofloxacin can cause hypersensitivity reactions, even following a single dose, and to discontinue the drug at the first sign of a skin rash, hives or other skin reactions, a rapid heartbeat, difficulty in swallowing or breathing, any swelling suggesting angioedema (for example, swelling of the lips, tongue, face, tightness of the throat, hoarseness), or other symptoms of an allergic reaction. Hepatotoxicity: Inform patients that severe hepatotoxicity (including acute hepatitis and fatal events) has been reported in patients taking Levofloxacin in 5% Dextrose Injection.

Instruct patients to inform their physician if they experience any signs or symptoms of liver injury including: loss of appetite, nausea, vomiting, fever, weakness, tiredness, right upper quadrant tenderness, itching, yellowing of the skin and eyes, light colored bowel movements or dark colored urine. Aortic aneurysm and dissection: Inform patients to seek emergency medical care if they experience sudden chest, stomach, or back… [Excerpted — this section continues on DailyMed.]

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Levofloxacin (LEE-voe-FLOX-a-sin) in 5% Dextrose Injection, for Intravenous Use Read this Medication Guide before you start taking Levofloxacin in 5% Dextrose Injection and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about Levofloxacin in 5% Dextrose Injection? Levofloxacin in 5% Dextrose Injection, a fluoroquinolone antibiotic, can cause serious side effects. Some of these serious side effects can happen at the same time and could result in death.

If you have any of the following serious side effects while you take Levofloxacin in 5% Dextrose Injection, you should stop taking Levofloxacin in 5% Dextrose Injection and get medical help right away. 1. Tendon rupture or swelling of the tendon (tendinitis). • Tendon problems can happen in people of all ages who take Levofloxacin in 5% Dextrose Injection.

Tendons are tough cords of tissue that connect muscles to bones. Some tendon problems include pain, swelling, tears, and swelling of tendons including the back of the ankle (Achilles), shoulder, hand, or other tendon sites. • The risk of getting tendon problems while you take Levofloxacin in 5% Dextrose Injection is higher if you: • are over 60 years of age • are taking steroids (corticosteroids) • have had a kidney, heart or lung transplant • Tendon problems can happen in people who do not have the above risk factors when they take Levofloxacin in 5% Dextrose Injection. • Other reasons that can increase your risk of tendon problems can include: • physical activity or exercise • kidney failure • tendon problems in the past, such as in people with rheumatoid arthritis (RA) • Stop taking Levofloxacin in 5% Dextrose Injection immediately and get medical help right away at the first sign of tendon pain, swelling, or inflammation.

Avoid exercise and using the affected area. The most common area of pain and swelling is the Achilles tendon at the back of your ankle. This can also happen with other tendons.

You may need a different antibiotic that is not a fluoroquinolone to treat your infection. • Tendon rupture can happen while you are taking or after you have finished taking Levofloxacin in 5% Dextrose Injection. Tendon ruptures can happen within hours or days of taking Levofloxacin in 5% Dextrose Injection and have happened up to several months after people have finished taking their fluoroquinolone. • Stop taking Levofloxacin in 5% Dextrose Injection immediately and get medical help right away if you get any of the following signs or symptoms of a tendon rupture: • hear or feel a snap or pop in a tendon area • bruising right after an injury in a tendon area • unable to move the affected area or bear weight 2.

Changes in sensation and possible nerve damage (Peripheral Neuropathy). Damage to the nerves in arms, hands, legs, or feet can happen in people who take fluoroquinolones, including Levofloxacin in 5% Dextrose Injection. Stop taking Levofloxacin in 5% Dextrose Injection immediately and talk to your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet: • pain • numbness • burning • weakness • tingling The nerve damage may be permanent.

3. Central Nervous System (CNS) effects. Seizures have been reported in people who take fluoroquinolone antibacterial medicines, including Levofloxacin in 5% Dextrose Injection.

Tell your healthcare provider if you have a history of seizures before you start taking Levofloxacin in 5% Dextrose Injection. CNS side effects may happen as soon as after taking the first dose of Levofloxacin in 5% Dextrose Injection. Stop taking Levofloxacin in 5% Dextrose Injection immediately and talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior: • seizures • tro… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 73 words ▾

8.3Nursing Mothers Based on data on other fluoroquinolones and very limited data on Levofloxacin in 5% Dextrose Injection, it can be presumed that levofloxacin will be excreted in human milk. Because of the potential for serious adverse reactions from Levofloxacin in 5% Dextrose Injection in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

🧬 Pharmacokinetics ~4 min read ▾

12.3Pharmacokinetics The mean ± SD pharmacokinetic parameters of levofloxacin determined under single and steady-state conditions following oral tablet, oral solution, or intravenous (IV) doses of levofloxacin are summarized in Table 8. Table 8: Mean ± SD Levofloxacin PK Parameters Regimen C max (mcg/mL) T max (h) AUC (mcg•h/mL) CL/F 1 (mL/min) Vd/F 2 (L) t 1/2 (h) CL R (mL/min) Single dose 250 mg oral tablet 3 2.8 ± 0.4 1.6 ± 1 27.2 ± 3.9 156 ± 20 ND 7.3 ± 0.9 142 ± 21 500 mg oral tablet 3 * 5.1 ± 0.8 1.3 ± 0.6 47.9 ± 6.8 178 ± 28 ND 6.3 ± 0.6 103 ± 30 500 mg oral solution 12 5.8 ± 1.8 0.8 ± 0.7 47.8 ± 10.8 183 ± 40 112 ± 37.2 7 ±

1.4ND 500 mg IV 3 6.2 ± 1 1 ± 0.1 48.3 ± 5.4 175 ± 20 90 ± 11 6.4 ± 0.7 112 ± 25 750 mg oral tablet 5 * 9.3 ± 1.6 1.6 ± 0.8 101 ± 20 129 ± 24 83 ± 17 7.5 ±

0.9ND 750 mg IV 5 11.5 ± 4 4 ND 110 ± 40 126 ± 39 75 ± 13 7.5 ±

1.6ND Multiple dose 500 mg every 24h oral tablet 3 5.7 ± 1.4 1.1 ± 0.4 47.5 ± 6.7 175 ± 25 102 ± 22 7.6 ± 1.6 116 ± 31 500 mg every 24h IV 3 6.4 ±

0.8ND 54.6 ± 11.1 158 ± 29 91 ± 12 7 ± 0.8 99 ± 28 500 mg or 250 mg every 24h IV, patients with bacterial infection 6 8.7 ± 4 7 ND 72.5 ± 51.2 7 154 ± 72 111 ± 58 ND ND 750 mg every 24h oral tablet 5 8.6 ± 1.9 1.4 ± 0.5 90.7 ± 17.6 143 ± 29 100 ± 16 8.8 ± 1.5 116 ± 28 750 mg every 24h IV 5 12.1 ± 4.1 4 ND 108 ± 34 126 ± 37 80 ± 27 7.9 ±

1.9ND 500 mg oral tablet single dose, effects of gender and age: Male 8 5.5 ± 1.1 1.2 ± 0.4 54.4 ± 18.9 166 ± 44 89 ± 13 7.5 ± 2.1 126 ± 38 Female 9 7 ± 1.6 1.7 ± 0.5 67.7 ± 24.2 136 ± 44 62 ± 16 6.1 ± 0.8 106 ± 40 Young 10 5.5 ± 1 1.5 ± 0.6 47.5 ± 9.8 182 ± 35 83 ± 18 6 ± 0.9 140 ± 33 Elderly 11 7 ± 1.6 1.4 ± 0.5 74.7 ± 23.3 121 ± 33 67 ± 19 7.6 ± 2 91 ± 29 500 mg oral single dose tablet, patients with renal insufficiency: CLCR 50 to 80 mL/min 7.5 ± 1.8 1.5 ± 0.5 95.6 ± 11.8 88 ± 10 ND 9.1 ± 0.9 57 ± 8 CLCR 20 to 49 mL/min 7.1 ± 3.1 2.1 ± 1.3 182.1 ± 62.6 51 ± 19 ND 27 ± 10 26 ± 13 CLCR < 20 mL/min 8.2 ± 2.6 1.1 ± 1 263.5 ± 72.5 33 ± 8 ND 35 ± 5 13 ± 3 Hemodialysis 5.7 ± 1 2.8 ±

2.2ND ND ND 76 ± 42 ND CAPD 6.9 ± 2.3 1.4 ±

1.1ND ND ND 51 ± 24 ND 1 clearance/bioavailability 2 volume of distribution/bioavailability 3 healthy males 18 to 53 years of age 4 60 min infusion for 250 mg and 500 mg doses, 90 min infusion for 750 mg dose 5 healthy male and female subjects 18 to 54 years of age 6 500 mg every 48h for patients with moderate renal impairment (CLCR 20 to 50 mL/min) and infections of the respiratory tract or skin 7 dose-normalized values (to 500 mg dose), estimated by population pharmacokinetic modeling 8 healthy males 22 to 75 years of age 9 healthy females 18 to 80 years of age 10 young healthy male and female subjects 18 to 36 years of age 11 healthy elderly male and female subjects 66 to 80 years of age 12 healthy males and females 19 to 55 years of age * Absolute bioavailability; F=0.99 ± 0.08 from a 500 mg tablet and F=0.99 ± 0.06 from a 750 mg tablet ND=not determined Absorption Levofloxacin is rapidly and essentially completely absorbed after oral administration.

Peak plasma concentrations are usually attained one to two hours after oral dosing. The absolute bioavailability of levofloxacin from a 500 mg tablet and a 750 mg tablet of levofloxacin are both approximately 99%, demonstrating complete oral absorption of levofloxacin. Following a single intravenous dose of Levofloxacin in 5% Dextrose Injection to healthy volunteers, the mean ± SD peak plasma concentration attained was 6.2 ± 1 mcg/mL after a 500 mg dose infused over 60 minutes and 11.5 ± 4 mcg/mL after a 750 mg dose infused over 90 minutes.

Levofloxacin Oral Solution and Tablet formulations are bioequivalent. Levofloxacin pharmacokinetics are linear and predictable after single and multiple oral or IV dosing regimens. Steady-state conditions are reached within 48 hours following a 500 mg or 750 mg once-daily dosage regimen.

The mean ± SD peak and trough plasma concentrations attained following multiple once-daily oral dosage regim… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Nosocomial Pneumonia Adult patients with clinically and radiologically documented nosocomial pneumonia were enrolled in a multi-center, randomized, open-label study comparing intravenous levofloxacin (750 mg once daily) followed by oral levofloxacin (750 mg once daily) for a total of 7 to 15 days to intravenous imipenem/cilastatin (500 to 1,000 mg every 6 to 8 hours daily) followed by oral ciprofloxacin (750 mg every 12 hours daily) for a total of 7 to 15 days. Levofloxacin-treated patients received an average of 7 days of intravenous therapy (range: 1 to 16 days); comparator-treated patients received an average of 8 days of intravenous therapy (range: 1 to 19 days).

Overall, in the clinically and microbiologically evaluable population, adjunctive therapy was empirically initiated at study entry in 56 of 93 (60.2%) patients in the levofloxacin arm and 53 of 94 (56.4%) patients in the comparator arm. The average duration of adjunctive therapy was 7 days in the levofloxacin arm and 7 days in the comparator. In clinically and microbiologically evaluable patients with documented Pseudomonas aeruginosa infection, 15 of 17 (88.2%) received ceftazidime (N=11) or piperacillin/tazobactam (N=4) in the levofloxacin arm and 16 of 17 (94.1%) received an aminoglycoside in the comparator arm.

Overall, in clinically and microbiologically evaluable patients, vancomycin was added to the treatment regimen of 37 of 93 (39.8%) patients in the levofloxacin arm and 28 of 94 (29.8%) patients in the comparator arm for suspected methicillin-resistant S. aureus infection. Clinical success rates in clinically and microbiologically evaluable patients at the post-therapy visit (primary study endpoint assessed on day 3 to 15 after completing therapy) were 58.1% for levofloxacin and 60.6% for comparator. The 95% CI for the difference of response rates (levofloxacin minus comparator) was [-17.2, 12].

The microbiological eradication rates at the post-therapy visit were 66.7% for levofloxacin and 60.6% for comparator. The 95% CI for the difference of eradication rates (levofloxacin minus comparator) was [-8.3, 20.3]. Clinical success and bacteriological eradication rates by pathogen are detailed in Table 11.

Table 11: Clinical Success Rates and Bacteriological Eradication Rates (Nosocomial Pneumonia) Pathogen N Levofloxacin No. (%) of Patients Microbiologic/ Clinical Outcomes N Imipenem/Cilastatin No. (%) of Patients Microbiologic/ Clinical Outcomes MSSA * 21 14 (66.7)/13 (61.9) 19 13 (68.4)/15 (78.9) P. aeruginosa † 17 10 (58.8)/11 (64.7) 17 5 (29.4)/7 (41.2) S. marcescens 11 9 (81.8)/7 (63.6) 7 2 (28.6)/3 (42.9) E. coli 12 10 (83.3)/7 (58.3) 11 7 (63.6)/8 (72.7) K. pneumoniae ‡ 11 9 (81.8)/5 (45.5) 7 6 (85.7)/3 (42.9) H. influenzae 16 13 (81.3)/10 (62.5) 15 14 (93.3)/11 (73.3) S. pneumoniae 4 3 (75)/3 (75) 7 5 (71.4)/4 (57.1) * Methicillin-susceptible S. aureus † See above text for use of combination therapy ‡ The observed differences in rates for the clinical and microbiological outcomes may reflect other factors that were not accounted for in the study

14.2Community-Acquired Pneumonia: 7 to 14 day Treatment Regimen Adult inpatients and outpatients with a diagnosis of community-acquired bacterial pneumonia were evaluated in 2 pivotal clinical studies. In the first study, 590 patients were enrolled in a prospective, multi-center, unblinded randomized trial comparing levofloxacin 500 mg once daily orally or intravenously for 7 to 14 days to ceftriaxone 1 to 2 grams intravenously once or in equally divided doses twice daily followed by cefuroxime axetil 500 mg orally twice daily for a total of 7 to 14 days.

Patients assigned to treatment with the control regimen were allowed to receive erythromycin (or doxycycline if intolerant of erythromycin) if an infection due to atypical pathogens was suspected or proven. Clinical and microbiologic evaluations were performed during treatment, 5 to 7 days post-therapy, and 3 to 4 weeks post-therapy… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~3 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a lifetime bioassay in rats, levofloxacin exhibited no carcinogenic potential following daily dietary administration for 2 years; the highest dose (100 mg/kg/day ) was 1.4 times the highest recommended human dose (750 mg) based upon relative body surface area. Levofloxacin did not shorten the time to tumor development of UV-induced skin tumors in hairless albino (Skh-1) mice at any levofloxacin dose level and was therefore not photo-carcinogenic under conditions of this study.

Dermal levofloxacin concentrations in the hairless mice ranged from 25 to 42 mcg/g at the highest levofloxacin dose level (300 mg/kg/day) used in the photo-carcinogenicity study. By comparison, dermal levofloxacin concentrations in human subjects receiving 750 mg of levofloxacin averaged approximately 11.8 mcg/g at C max . Levofloxacin was not mutagenic in the following assays: Ames bacterial mutation assay ( S. typhimurium and E. coli) , CHO/HGPRT forward mutation assay, mouse micronucleus test, mouse dominant lethal test, rat unscheduled DNA synthesis assay, and the mouse sister chromatid exchange assay.

It was positive in the in vitro chromosomal aberration (CHL cell line) and sister chromatid exchange (CHL/IU cell line) assays. Levofloxacin caused no impairment of fertility or reproductive performance in rats at oral doses as high as 360 mg/kg/day, corresponding to 4.2 times the highest recommended human dose based upon relative body surface area and intravenous doses as high as 100 mg/kg/day, corresponding to 1.2 times the highest recommended human dose based upon relative body surface area.

13.2Animal Toxicology and/or Pharmacology Levofloxacin and other quinolones have been shown to cause arthropathy in immature animals of most species tested [see Warnings and Precautions (5.12) ]. In immature dogs (4 to 5 months old), oral doses of 10 mg/kg/day for 7 days and intravenous doses of 4 mg/kg/day for 14 days of levofloxacin resulted in arthropathic lesions. Administration at oral doses of 300 mg/kg/day for 7 days and intravenous doses of 60 mg/kg/day for 4 weeks produced arthropathy in juvenile rats.

Three-month old beagle dogs dosed orally with levofloxacin at 40 mg/kg/day exhibited clinically severe arthrotoxicity resulting in the termination of dosing at Day 8 of a 14-day dosing routine. Slight musculoskeletal clinical effects, in the absence of gross pathological or histopathological effects, resulted from the lowest dose level of 2.5 mg/kg/day (approximately 0.2-fold the pediatric dose based upon AUC comparisons). Synovitis and articular cartilage lesions were observed at the 10 and 40 mg/kg dose levels (approximately 0.7-fold and 2.4-fold the pediatric dose, respectively, based on AUC comparisons).

Articular cartilage gross pathology and histopathology persisted to the end of the 18-week recovery period for those dogs from the 10 and 40 mg/kg/day dose levels. When tested in a mouse ear swelling bioassay, levofloxacin exhibited phototoxicity similar in magnitude to ofloxacin, but less phototoxicity than other quinolones. While crystalluria has been observed in some intravenous rat studies, urinary crystals are not formed in the bladder, being present only after micturition and are not associated with nephrotoxicity.

In mice, the CNS stimulatory effect of quinolones is enhanced by concomitant administration of non-steroidal anti-inflammatory drugs. In dogs, levofloxacin administered at 6 mg/kg or higher by rapid intravenous injection produced hypotensive effects. These effects were considered to be related to histamine release.

In vitro and in vivo studies in animals indicate that levofloxacin is neither an enzyme inducer nor inhibitor in the human therapeutic plasma concentration range; therefore, no drug metabolizing enzyme-related interactions with other drugs or agents are anticipated.

13.2Animal Toxicology and/or Pharmacology Levofloxacin and other quino… [Excerpted — this section continues on DailyMed.]

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a lifetime bioassay in rats, levofloxacin exhibited no carcinogenic potential following daily dietary administration for 2 years; the highest dose (100 mg/kg/day ) was 1.4 times the highest recommended human dose (750 mg) based upon relative body surface area. Levofloxacin did not shorten the time to tumor development of UV-induced skin tumors in hairless albino (Skh-1) mice at any levofloxacin dose level and was therefore not photo-carcinogenic under conditions of this study.

Dermal levofloxacin concentrations in the hairless mice ranged from 25 to 42 mcg/g at the highest levofloxacin dose level (300 mg/kg/day) used in the photo-carcinogenicity study. By comparison, dermal levofloxacin concentrations in human subjects receiving 750 mg of levofloxacin averaged approximately 11.8 mcg/g at C max . Levofloxacin was not mutagenic in the following assays: Ames bacterial mutation assay ( S. typhimurium and E. coli) , CHO/HGPRT forward mutation assay, mouse micronucleus test, mouse dominant lethal test, rat unscheduled DNA synthesis assay, and the mouse sister chromatid exchange assay.

It was positive in the in vitro chromosomal aberration (CHL cell line) and sister chromatid exchange (CHL/IU cell line) assays. Levofloxacin caused no impairment of fertility or reproductive performance in rats at oral doses as high as 360 mg/kg/day, corresponding to 4.2 times the highest recommended human dose based upon relative body surface area and intravenous doses as high as 100 mg/kg/day, corresponding to 1.2 times the highest recommended human dose based upon relative body surface area.

📄 Recent Major Changes 18 words ▾

Boxed Warning 06/2016 Indications and Usage (1) 06/2016 Dosage and Administration (2) 06/2016 Warnings and Precautions (5) 06/2016

📄 Package Label / Principal Display Panel 75 words ▾

PACKAGE LABEL - PRINCIPAL DISPLAY - Levofloxacin 50 mL bag NDC 63323-355-50 315550 Levofloxacin in 5% Dextrose Injection 250 mg levofloxacin in 50 mL (5 mg/mL) For Intravenous Infusion Single Use Rx Only PACKAGE LABEL - PRINCIPAL DISPLAY - Levofloxacin 50 mL overwrap NDC 63323-355-50 315550 To Open Overwrap - Tear at Notch Levofloxacin in 5% Dextrose Injection 250 mg levofloxacin in 50 mL (5 mg/mL) For Intravenous Infusion Single Use Rx Only bag overwrap

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Levofloxacin — the program that covers self-administered drugs. 10 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Levofloxacin. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$4.19M
Claims incl. refills
615.6K
Beneficiaries
533.8K
Spend / beneficiary
$7.85
Spend / claim
$6.81
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 ✓ Available
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Fresenius Kabi USA, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 pouch (63323-0355-60), 1 pouch (63323-0355-65). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Fresenius Kabi USA, LLC 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 J1956 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.
← 63323-0351-20 · Fresenius 63323-0356-10 · Fresenius →
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.