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MOXIFLOXACIN HYDROCHLORIDE 400 mg/250mL Injection, Solution, 250 mL — NDC 67457-0323-25 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

MOXIFLOXACIN HYDROCHLORIDE 400 mg/250mL Injection, Solution, 250 mL — NDC 67457-323-25 (Billing 67457-0323-25)

by Mylan Institutional LLC · 1 BAG in 1 CARTON / 250 mL in 1 BAG

This is a package of 250 mL of MOXIFLOXACIN HYDROCHLORIDE 400 mg/250mL Injection, Solution from Mylan Institutional LLC, marketed since Oct 2017 and currently FDA-listed. It is this product's only package size.

NDC 67457-0323-25
🏷️ FDA NDC (as labeled) 67457-323-25 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 →

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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 67457-323-25 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
67457 labeler · 323 product · 25 package
Package marketed since
Oct 3, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
250 mL per package
Barcode (UPC-A, from the NDC)
3 6745732325 1
Medicaid fills, this package
241 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 67457-323-25
Product NDC 67457-323
11-digit billing NDC 67457032325
NCPDP billing unit ML — per mL (volume)
RxCUI 351156
UNII C53598599T
Application # ANDA205833
SPL Set ID c6fa4129-2f92-4179-ac5d-bb7b4a538789
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 2017-10-03
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance MOXIFLOXACIN HYDROCHLORIDE

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

GPI-14 05000037122020
GPI class Moxifloxacin HCl in NaCl
GCN Seq No 049742
GCN 15382
HICL code 025388
Ingredient (HICL) Moxifloxacin-Sod.chloride(Iso)
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 MOXIFLOXACIN 400 MG/250 ML BAG
FDB brand name Moxifloxacin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 049742
  • GCN: 15382
  • GPI-14 (Medi-Span): 05000037122020
  • HICL (First Databank): 025388
  • AHFS class code: 08:12.18.00
  • RxCUI (RxNorm): 351156
Why two NDCs? The FDA registers this code as 67457-323-25 — 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 → 67457-0323-25. 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 MOXIFLOXACIN 400 MG/250 ML BAG Ingredient Moxifloxacin-Sod.chloride(Iso)
📗 Our plain-language guide HelloPharmacist
  • It is an antibiotic for certain bacterial infections. As tablets or an IV, it treats pneumonia, skin infections, abdominal infections, sinus infections, bronchitis flare-ups and pl...
  • Take them once a day, with or without food. Keep them at least 4 hours before or 8 hours after antacids, iron, or multivitamins, because those can block absorption. Finish the cour...
  • How should I take my moxifloxacin tablets?
  • Nausea, diarrhea, headache and dizziness are the most common. Those are usually manageable. Call your doctor if you have severe or watery diarrhea, or any symptoms that worry you.
📖 Read our full Moxifloxacin guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
11
Nutrient depletion considerations

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

🧪 Full Moxifloxacin 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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $0.2157 $53.93 / 250 ml
Medicare drug plans payPart D · Q2 2026 $0.1600 $40.00 / 250 ml
Medicare Part B allowsASP · J2280 $8.744 / J2280 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)67457-323-25
11-digit billing NDC67457-0323-25
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ2280
DescriptorINJECTION, MOXIFLOXACIN, 100 MG
Billing units / pkg0.02 units
How the units are derivedThis package is 250 ML; the HCPCS unit is 100 MG, so one package = 0.02 billing units.
Medicare Part B spend (2026 (Q1))$20,708 · 2,225 claims · $9.31 per claim (all NDCs under J2280)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
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
67457-0323-25 You're viewing this Main listing 1 BAG in 1 CARTON / 250 mL in 1 BAG 2017-10-03 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Moxifloxacin 400 mg/250mL 63323-0850-74 Fresenius 250 ml — — FDA listed —
Moxifloxacin 400 mg/250mL 66298-8507-04 Hp 250 ml — — FDA listed —
Moxifloxacin Hydrochloride 400 mg/250mLthis 67457-0323-25 Mylan 250 ml — — 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

🏛️
2017
On the market since
Oct 2017
📍
2026
Currently FDA-listed
9 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.

🧪 Avoiding an ingredient? See Moxifloxacin inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 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 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.
  • 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.
  • 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.

Manufacturer & labeler

LabelerMylan Institutional LLC
Application holderMYLAN LABORATORIES LTD
FDA applicationANDA205833 (ANDA)
Labeler code67457
First marketedOct 2017
Product typeHuman Prescription Drug
Portfolio167 products on file

More NDCs from Mylan Institutional LLC labeler code 67457

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 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 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 moxifloxacin, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together [see Warnings and Precautions (5.1) ] , including: o Tendinitis and tendon rupture [see Warnings and Precautions (5.2) ] o Peripheral neuropathy [see Warnings and Precautions (5.3) ] o Central nervous system effects [see Warnings and Precautions (5.4) ] Discontinue moxifloxacin immediately and avoid the use of fluoroquinolones, including moxifloxacin, in patients who experience any of these serious adverse reactions [see Warnings and Precautions (5.1) ]. • Fluoroquinolones, including moxifloxacin, may exacerbate muscle weakness in patients with myasthenia gravis.

Avoid moxifloxacin in patients with known history of myasthenia gravis [see Warnings and Precautions (5.5) ]. • Because fluoroquinolones, including moxifloxacin, have been associated with serious adverse reactions [see Warnings and Precautions (5.1-5.14) ] , reserve moxifloxacin for use in patients who have no alternative treatment options for the following indications: o Acute bacterial sinusitis [see Indications and Usage (1.6) ] o Acute bacterial exacerbation of chronic bronchitis [see Indications and Usage (1.7) ] 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 moxifloxacin, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together ( 5.1 ) including: o Tendinitis and tendon rupture ( 5.2 ) o Peripheral Neuropathy ( 5.3 ) o Central nervous system effects ( 5.4 ) Discontinue moxifloxacin immediately and avoid the use of fluoroquinolones, including moxifloxacin, in patients who experience any of these serious adverse reactions ( 5.1 ) • Fluoroquinolones, including moxifloxacin, may exacerbate muscle weakness in patients with myasthenia gravis.

Avoid moxifloxacin in patients with known history of myasthenia gravis ( 5.5 ). • Because fluoroquinolones, including moxifloxacin, have been associated with serious adverse reactions ( 5.1 - 5.14 ), reserve moxifloxacin for use in patients who have no alternative treatment options for the following indications: o Acute bacterial sinusitis ( 1.6 ) o Acute bacterial exacerbation of chronic bronchitis ( 1.7 )

🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE Moxifloxacin is a fluoroquinolone antibacterial indicated for treating infections in adults 18 years of age and older caused by designated susceptible bacteria, in the conditions listed below: • Community Acquired Pneumonia ( 1.1 ) • Skin and Skin Structure Infections: Uncomplicated ( 1.2 ) and Complicated ( 1.3 ) • Complicated Intra-Abdominal Infections ( 1.4 ) • Plague ( 1.5 ) • Acute Bacterial Sinusitis ( 1.6 ) • Acute Bacterial Exacerbation of Chronic Bronchitis ( 1.7 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of moxifloxacin and other antibacterial drugs.

Moxifloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. ( 1.8 )

1.1Community Acquired Pneumonia Moxifloxacin hydrochloride in sodium chloride injection is indicated in adult patients for the treatment of Community Acquired Pneumonia caused by susceptible isolates of Streptococcus pneumoniae (including multi-drug resistant Streptococcus pneumoniae [MDRSP]) , Haemophilus influenzae, Moraxella catarrhalis, methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Clinical Studies (14.3) ] . MDRSP isolates are isolates resistant to two or more of the following antibacterial drugs: penicillin (minimum inhibitory concentrations [MIC] ≥ 2 mcg/mL), 2 nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole.

1.2Uncomplicated Skin and Skin Structure Infections Moxifloxacin hydrochloride in sodium chloride injection is indicated in adult patients for the treatment of Uncomplicated Skin and Skin Structure Infections caused by susceptible isolates of methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes [see Clinical Studies (14.4) ].

1.3Complicated Skin and Skin Structure Infections Moxifloxacin hydrochloride in sodium chloride injection is indicated in adult patients for the treatment of Complicated Skin and Skin Structure Infections caused by susceptible isolates of methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae [see Clinical Studies (14.5) ].

1.4Complicated Intra-Abdominal Infections Moxifloxacin hydrochloride in sodium chloride injection is indicated in adult patients for the treatment of Complicated Intra-Abdominal Infections (cIAI) including polymicrobial infections such as abscess caused by susceptible isolates of Escherichia coli, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, Enterococcus faecalis, Proteus mirabilis, Clostridium perfringens, Bacteroides thetaiotaomicron, or Peptostreptococcus species [see Clinical Studies (14.6) ] .

1.5Plague Moxifloxacin hydrochloride in sodium chloride injection is indicated in adult patients for the treatment of plague, including pneumonic and septicemic plague, due to susceptible isolates of Yersinia pestis and prophylaxis of plague in adult patients. Efficacy studies of moxifloxacin could not be conducted in humans with plague for feasibility reasons. Therefore, this indication is based on an efficacy study conducted in animals only [see Clinical Studies (14.7) ] .

1.6Acute Bacterial Sinusitis Moxifloxacin hydrochloride in sodium chloride injection is indicated in adult patients for the treatment of acute bacterial sinusitis (ABS) caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae , or Moraxella catarrhalis [see Clinical Studies (14.1) ] . Because fluoroquinolones, including moxifloxacin, have been associated with serious adverse reactions [see Warnings and Precautions (5.1-5.14) ] and for some patients ABS is self-limiting, reserve moxifloxacin for treatment of ABS in patients who have no alternative treatment options.

1.7Acute Bacterial Exacerbation of Chronic Bronchitis Moxifloxacin hydrochloride in sodium chlor… [Excerpted — this section continues on DailyMed.]

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Type of Infection Dose Every 24 hours Duration (days) Community Acquired Pneumonia ( 1.1 ) 400 mg 7-14 Uncomplicated Skin and Skin Structure Infections (SSSI) ( 1.2 ) 400 mg 7 Complicated SSSI ( 1.3 ) 400 mg 7-21 Complicated Intra-Abdominal Infections ( 1.4 ) 400 mg 5-14 Plague ( 1.5 ) 400 mg 10-14 Acute Bacterial Sinusitis ( 1.6 ) 400 mg 10 Acute Bacterial Exacerbation of Chronic Bronchitis ( 1.7 ) 400 mg 5 • No dosage adjustment in patients with renal or hepatic impairment. ( 8.6 , 8.7 ) • Moxifloxacin Hydrochloride in Sodium Chloride Injection: Slow intravenous infusion over 60 minutes.

Avoid rapid or bolus intravenous injection. ( 2.2 ) • Do not mix with other medications in intravenous bag or in an intravenous line. ( 2.3 )

2.1Dosage in Adult Patients The dose of moxifloxacin is 400 mg (orally or as an intravenous infusion) once every 24 hours. The duration of therapy depends on the type of infection as described in Table 1. Table 1: Dosage and Duration of Therapy in Adult Patients Type of Infection Due to the designated pathogens [see Indications and Usage (1) ].

Dose Every 24 hours Duration Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician (days) Community Acquired Pneumonia ( 1.1 ) 400 mg 7-14 Uncomplicated Skin and Skin Structure Infections (SSSI) ( 1.2 ) 400 mg 7 Complicated SSSI ( 1.3 ) 400 mg 7-21 Complicated Intra-Abdominal Infections ( 1.4 ) 400 mg 5-14 Plague ( 1.5 ) Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis . 400 mg 10-14 Acute Bacterial Sinusitis (ABS) ( 1.6 ) 400 mg 10 Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) ( 1.7 ) 400 mg 5 Conversion of Intravenous to Oral Dosing in Adults Intravenous formulation is indicated when it offers a route of administration advantageous to the patient (for example, patient cannot tolerate an oral dosage form).

When switching from intravenous to oral formulation, no dosage adjustment is necessary. Patients whose therapy is started with moxifloxacin hydrochloride in sodium chloride injection may be switched to moxifloxacin tablets when clinically indicated at the discretion of the physician.

2.2Important Administration Instructions Moxifloxacin Hydrochloride in Sodium Chloride Injection Administer by intravenous infusion only. It is not intended for intra-arterial, intramuscular, intrathecal, intraperitoneal, or subcutaneous administration. Administer by intravenous infusion over a period of 60 minutes by direct infusion or through a Y-type intravenous infusion set which may already be in place.

Avoid rapid or bolus intravenous infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer moxifloxacin hydrochloride in sodium chloride injection if particulate matter and/or discoloration is observed.

Discard any unused portion because the premix flexible containers are for single-dose only.

2.3Drug and Diluent Compatibilities Because only limited data are available on the compatibility of moxifloxacin intravenous injection with other intravenous substances, additives or other medications should not be added to moxifloxacin hydrochloride in sodium chloride injection or infused simultaneously through the same intravenous line. If the same intravenous line or a Y-type line is used for sequential infusion of other drugs, or if the “piggyback” method of administration is used, the line should be flushed before and after infusion of moxifloxacin hydrochloride in sodium chloride injection with an infusion solution compatible with moxifloxacin hydrochloride in sodium chloride injection as well as with other drug(s) administered via this common line.

Compatible Intravenous Solutions : Moxifloxacin hydrochloride in sodium chloride injection is compatible with the following intravenous solutions at ratios from 1:1… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 57 words ▾

3 DOSAGE FORMS AND STRENGTHS • Injection: 400 mg moxifloxacin in 0.8% sodium chloride solution in a 250 mL single-dose flexible bag ( 3.2 )

3.2Moxifloxacin Hydrochloride in Sodium Chloride Injection Ready-to-use single-dose 250 mL flexible bags containing 400 mg moxifloxacin in 0.8% sodium chloride aqueous solution. The appearance of the intravenous solution is clear yellow.

⛔ Contraindications 42 words ▾

4 CONTRAINDICATIONS Moxifloxacin is contraindicated in persons with a history of hypersensitivity to moxifloxacin or any member of the quinolone class of antibacterials [see Warnings and Precautions (5.8) ] . Known hypersensitivity to moxifloxacin or other quinolones ( 4 , 5.8 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Prolongation of the QT interval and isolated cases of torsade de pointes has been reported. Avoid use in patients with known prolongation, proarrhythmic conditions such as clinically significant bradycardia or acute myocardial ischemia, hypokalemia, hypomagnesemia, and with drugs that prolong the QT interval. ( 5.6 , 7.5 , 8.5 ) • Hypersensitivity and other serious reactions: Serious and sometimes fatal reactions, including anaphylactic reactions, may occur after first or subsequent doses of moxifloxacin.

Discontinue moxifloxacin at first sign of skin rash, jaundice or any other sign of hypersensitivity. ( 5.7 , 5.8 ) • Clostridioides difficile -Associated Diarrhea: Evaluate if diarrhea occurs. ( 5.10 )

5.1Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects Fluoroquinolones, including moxifloxacin, 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 moxifloxacin. 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 moxifloxacin immediately at the first signs or symptoms of any serious adverse reaction.

In addition, avoid the use of fluoroquinolones, including moxifloxacin, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.

5.2Tendinitis and Tendon Rupture Fluoroquinolones, including moxifloxacin, 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 tendons. Tendinitis or tendon rupture can occur within hours or days of starting moxifloxacin or as long as several months after completion of therapy.

Tendinitis and tendon rupture can occur bilaterally. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in patients over 60 years of age, in patients 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 also occurred in patients taking fluoroquinolones who do not have the above risk factors. Discontinue moxifloxacin 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 fluoroquinolones, including moxifloxacin, in patients who have a history of tendon disorders or who have experienced tendinitis or tendon rupture [see Adverse Reactions (6.2 )] .

5.3Peripheral Neuropathy Fluoroquinolones, including moxifloxacin, 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 and weakness have been reported in patients receiving fluoroquinolones including moxifloxacin. Symptoms may occur soon after initiation of moxifloxacin and may be irreversible in some patients [see Warnings and Precautions (5.1) and A… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious and otherwise important adverse reactions are discussed in greater detail in the warnings and precautions section of the label: • Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects [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) ] • QT Prolongation [see Warnings and Precautions (5.6) ] • Other Serious and Sometimes Fatal Adverse Reactions [see Warnings and Precautions (5.7) ] • Hypersensitivity Reactions [see Warnings and Precautions (5.8) ] • Risk of Aortic Aneurysm and Dissection [see Warnings and Precautions (5.9) ] • Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions (5.10) ] • Blood Glucose Disturbances [see Warnings and Precautions (5.12) ] • Photosensitivity/Phototoxicity [see Warnings and Precautions (5.13) ] • Development of Drug Resistant Bacteria [see Warnings and Precautions (5.14) ] Most common reactions (3% or greater) were nausea, diarrhea, headache, and dizziness.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) 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 data described below reflect exposure to moxifloxacin in 14981 patients in 71 active controlled Phase II-IV clinical trials in different indications [see Indications and Usage (1) ] . The population studied had a mean age of 50 years (approximately 73% of the population was less than 65 years of age), 50% were male, 63% were Caucasian, 12% were Asian and 9% were Black.

Patients received moxifloxacin 400 mg once daily oral, intravenous, or sequentially (intravenous followed by oral). Treatment duration was usually 6 to 10 days, and the mean number of days on therapy was 9 days. Discontinuation of moxifloxacin due to adverse reactions occurred in 5% of patients overall, 4% of patients treated with 400 mg PO, 4% with 400 mg intravenous and 8% with sequential therapy 400 mg oral/intravenous.

The most common adverse reactions (> 0.3%) leading to discontinuation with the 400 mg oral doses were nausea, diarrhea, dizziness, and vomiting. The most common adverse reaction leading to discontinuation with the 400 mg intravenous dose was rash. The most common adverse reactions leading to discontinuation with the 400 mg intravenous/oral sequential dose were diarrhea, pyrexia.

Adverse reactions occurring in 1% of moxifloxacin-treated patients and less common adverse reactions, occurring in 0.1 to 1% of moxifloxacin-treated patients, are shown in Table 2 and Table 3, respectively. The most common adverse drug reactions (3%) are nausea, diarrhea, headache, and dizziness. Table 2: Common (1% or more) Adverse Reactions Reported in Active-Controlled Clinical Trials with Moxifloxacin System Organ Class Adverse Reactions % (N = 14,981) Blood and Lymphatic System Disorders Anemia 1 Gastrointestinal Disorders Nausea 7 Diarrhea 6 Vomiting 2 Constipation 2 Abdominal pain 2 Dyspepsia 1 General Disorders and Administration Site Conditions Pyrexia 1 Investigations Alanine aminotransferase increased 1 Metabolism and Nutritional Disorder Hypokalemia 1 Nervous System Disorders Headache 4 Dizziness 3 Psychiatric Disorders Insomnia 2 Table 3: Less Common (0.1 to less than 1%) Adverse Reactions Reported in Active-Controlled Clinical Trials with Moxifloxacin (N = 14,981) System Organ Class Adverse Reactions Blood a… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Interacting Drug Interaction Multivalent cation-containing products including: antacids, sucralfate, multivitamins Decreased moxifloxacin absorption. Take moxifloxacin tablet at least 4 hours before or 8 hours after these products. ( 7.1 , 12.3 ) Warfarin Anticoagulant effect enhanced.

Monitor prothrombin time/INR, and bleeding. ( 6 , 7.2 , 12.3 ) Class IA and Class III antiarrhythmics: Proarrhythmic effect may be enhanced. Avoid concomitant use.

( 5.6 , 7.5 ) Antidiabetic agents Carefully monitor blood glucose. (5.12 , 7.3 )

7.1Antacids, Sucralfate, Multivitamins and Other Products Containing Multivalent Cations Fluoroquinolones, including moxifloxacin, form chelates with alkaline earth and transition metal cations. Oral administration of moxifloxacin with antacids containing aluminum or magnesium, with sucralfate, with metal cations such as iron, or with multivitamins containing iron or zinc, or with formulations containing divalent and trivalent cations such as didanosine buffered tablets for oral suspension or the pediatric powder for oral solution, may substantially interfere with the absorption of moxifloxacin, resulting in systemic concentrations considerably lower than desired.

Therefore, moxifloxacin should be taken at least 4 hours before or 8 hours after these agents [see Clinical Pharmacology (12.3) ] .

7.2Warfarin Fluoroquinolones, including moxifloxacin, have been reported to enhance the anticoagulant effects of warfarin or its derivatives in the patient population. In addition, infectious disease and its accompanying inflammatory process, age, and general status of the patient are risk factors for increased anticoagulant activity. Therefore the prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests should be closely monitored if moxifloxacin is administered concomitantly with warfarin or its derivatives [see Adverse Reactions (6.2) and Clinical Pharmacology (12.3) ] .

7.3Antidiabetic Agents Disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concomitantly with fluoroquinolones, including moxifloxacin, and an antidiabetic agent. Therefore, careful monitoring of blood glucose is recommended when these agents are co-administered. If a hypoglycemic reaction occurs, moxifloxacin should be discontinued and appropriate therapy should be initiated immediately [see Warnings and Precautions (5.12) and Adverse Reactions (6.1) ] .

7.4Nonsteroidal Anti-Inflammatory Drugs The concomitant administration of a nonsteroidal anti-inflammatory drug (NSAID) with a fluoroquinolone, including moxifloxacin, may increase the risks of CNS stimulation and convulsions [see Warnings and Precautions (5.4) ].

7.5Drugs that Prolong QT There is limited information available on the potential for a pharmacodynamic interaction in humans between moxifloxacin and other drugs that prolong the QTc interval of the electrocardiogram. Sotalol, a Class III antiarrhythmic, has been shown to further increase the QTc interval when combined with high doses of intravenous moxifloxacin in dogs. Therefore, moxifloxacin should be avoided with Class IA and Class III antiarrhythmics [see Warnings and Precautions (5.6) and Nonclinical Toxicology (13.2) ] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Pregnancy: Based on animal data may cause fetal harm. ( 8.1 ) • Geriatrics: Increased risk for severe tendon disorders further increased by concomitant corticosteroid therapy and increased risk of prolongation of the QT interval. ( 5.1 , 5.6 , 8.5 )

8.1Pregnancy Risk Summary There are no available human data establishing a drug associated risk with the use of moxifloxacin. Based on animal studies with moxifloxacin, moxifloxacin may cause fetal harm. Moxifloxacin did not cause fetal malformations when administered to pregnant rats (IV and oral), rabbits (IV), and monkeys (oral) at exposures that were 0.24-2.5 times of those at the human clinical dose (400 mg/day moxifloxacin).

However, when moxifloxacin was administered to rats and rabbits during pregnancy and throughout lactation (rats only) at doses associated with maternal toxicity, decreased neonatal body weights, increased incidence of skeletal variations (rib and vertebra combined), and increased fetal loss were observed (see Data). Advise pregnant women of the potential risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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 Animal reproductive and development studies were done in rats, rabbits and cynomolgus macaques.

Moxifloxacin did not cause fetal malformations when administered to pregnant rats during organogenesis (gestation days 6 to 17) at oral doses as high as 500 mg/kg/day or 0.24 times the maximum recommended human dose based on systemic exposure (AUC), but decreased fetal body weights and slightly delayed fetal skeletal development were observed. Intravenous administration of 80 mg/kg/day (approximately 2 times the maximum recommended human dose based on body surface area) to pregnant rats resulted in maternal toxicity and a marginal effect on fetal and placental weights and the appearance of the placenta (Gestation days 6 to 17).

Fetal malformations were not observed at intravenous doses as high as 80 mg/kg/day (approximately 2 times the maximum recommended human dose based on body surface area) in litters of pregnant rats that received moxifloxacin during organogenesis (Gestation days 6 to 17). Intravenous administration of 20 mg/kg/day (approximately equal to the maximum recommended human oral dose based upon systemic exposure) to pregnant rabbits during organogenesis (gestation days 6 to 20) resulted in decreased fetal body weights and delayed fetal skeletal ossification.

When rib and vertebral malformations were combined, there was an increased fetal and litter incidence of these effects in rabbits. Signs of maternal toxicity in rabbits at this dose included mortality, abortions, marked reduction of food consumption, decreased water intake, body weight loss and hypoactivity. Fetal malformations were not observed when pregnant cynomolgus macaques were given oral doses as high as 100 mg/kg/day (2.5 times the maximum recommended human dose based upon systemic exposure) during organogenesis (gestation days 20 to 50).

An increased incidence of smaller fetuses was observed at 100 mg/kg/day in macaques. In a pre- and postnatal development study conducted in rats given oral doses from Gestation day 6, throughout gestation and rearing to Postpartum day 21, effects observed at 500 mg/kg/day (0.24 times the maximum recommended human dose based on systemic exposure (AUC)) included slight increases in duration of pregnancy and prenatal loss, reduced pup birth weight and decreased neonatal survival. Treatment-related maternal mortality occurred during gestation at 500 mg/kg/day in this study.

8.2Lactation Risk Summary It is not known if moxifloxacin is present in human milk. Based on… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary There are no available human data establishing a drug associated risk with the use of moxifloxacin. Based on animal studies with moxifloxacin, moxifloxacin may cause fetal harm. Moxifloxacin did not cause fetal malformations when administered to pregnant rats (IV and oral), rabbits (IV), and monkeys (oral) at exposures that were 0.24-2.5 times of those at the human clinical dose (400 mg/day moxifloxacin).

However, when moxifloxacin was administered to rats and rabbits during pregnancy and throughout lactation (rats only) at doses associated with maternal toxicity, decreased neonatal body weights, increased incidence of skeletal variations (rib and vertebra combined), and increased fetal loss were observed (see Data). Advise pregnant women of the potential risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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 Animal reproductive and development studies were done in rats, rabbits and cynomolgus macaques.

Moxifloxacin did not cause fetal malformations when administered to pregnant rats during organogenesis (gestation days 6 to 17) at oral doses as high as 500 mg/kg/day or 0.24 times the maximum recommended human dose based on systemic exposure (AUC), but decreased fetal body weights and slightly delayed fetal skeletal development were observed. Intravenous administration of 80 mg/kg/day (approximately 2 times the maximum recommended human dose based on body surface area) to pregnant rats resulted in maternal toxicity and a marginal effect on fetal and placental weights and the appearance of the placenta (Gestation days 6 to 17).

Fetal malformations were not observed at intravenous doses as high as 80 mg/kg/day (approximately 2 times the maximum recommended human dose based on body surface area) in litters of pregnant rats that received moxifloxacin during organogenesis (Gestation days 6 to 17). Intravenous administration of 20 mg/kg/day (approximately equal to the maximum recommended human oral dose based upon systemic exposure) to pregnant rabbits during organogenesis (gestation days 6 to 20) resulted in decreased fetal body weights and delayed fetal skeletal ossification.

When rib and vertebral malformations were combined, there was an increased fetal and litter incidence of these effects in rabbits. Signs of maternal toxicity in rabbits at this dose included mortality, abortions, marked reduction of food consumption, decreased water intake, body weight loss and hypoactivity. Fetal malformations were not observed when pregnant cynomolgus macaques were given oral doses as high as 100 mg/kg/day (2.5 times the maximum recommended human dose based upon systemic exposure) during organogenesis (gestation days 20 to 50).

An increased incidence of smaller fetuses was observed at 100 mg/kg/day in macaques. In a pre- and postnatal development study conducted in rats given oral doses from Gestation day 6, throughout gestation and rearing to Postpartum day 21, effects observed at 500 mg/kg/day (0.24 times the maximum recommended human dose based on systemic exposure (AUC)) included slight increases in duration of pregnancy and prenatal loss, reduced pup birth weight and decreased neonatal survival. Treatment-related maternal mortality occurred during gestation at 500 mg/kg/day in this study.

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use Effectiveness in pediatric patients and adolescents less than 18 years of age has not been established. Moxifloxacin causes arthropathy in juvenile animals. Limited information on the safety of moxifloxacin in 301 pediatric patients is available from the cIAI trial [see Boxed Warning , Warnings and Precautions (5.11) and Nonclinical Toxicology (13.2) ].

Active Controlled Trial in Complicated Intra-Abdominal Infection (cIAI) The safety and efficacy of moxifloxacin in pediatric patients for the treatment of cIAI has not been demonstrated. Pediatric patients 3 months to < 18 years of age (mean age of 12 ± 4 years) were enrolled in a single randomized, double-blind, active controlled trial in cIAI including appendicitis with perforation, abscesses and peritonitis. Pediatric patients were randomized (2:1) to receive either moxifloxacin or comparator.

This study enrolled 451 patients who received study medication, 301 treated with moxifloxacin, and 150 with comparator. Of the 301 pediatric patients treated with moxifloxacin, 15 were below the age of 6 years and 286 were between the ages of 6 to < 18 years. Patients received sequential intravenous/oral moxifloxacin or comparator (intravenous ertapenem followed by oral amoxicillin/clavulanate) for 5 to 14 days (mean duration was 9 days with a range of 1 to 24 days).

The overall adverse reaction profile in pediatric patients was comparable to that of adult patients. The most frequently occurring adverse reactions in pediatric patients treated with moxifloxacin were QT prolongation 9.3% (28/301), vomiting, 6.6% (20/301) diarrhea 3.7% (11/301), arthralgia 3.0% (9/301), and phlebitis 2.7% (8/301) (see Table 5). Discontinuation of study drug due to an adverse reaction was reported in 5.3% (16/301) of moxifloxacin-treated patients versus 1.3% (2/150) of comparator-treated patients.

The adverse reaction profile of moxifloxacin or comparator was similar across all age groups studied. Musculoskeletal adverse reactions were monitored and followed up to 5 years after the end of study treatment. The rates of musculoskeletal adverse reactions were 4.3% (13/301) in the moxifloxacin-treated group versus 3.3% (5/150) in the comparator-treated group.

The majority of musculoskeletal adverse reactions were reported between 12 and 53 weeks after start of study treatment with complete resolution at the end of the study [see Warnings and Precautions (5.11) and Nonclinical Toxicology (13.2) ]. Table 5: Incidence (%) of Selected Adverse Reactions in ≥ 2.0% of Pediatric Patients Treated with Moxifloxacin in cIAI Clinical Trial System Organ Class Adverse Reactions Moxifloxacin N = 301 (%) Comparator N = 150 (%) Gastrointestinal disorders Abdominal pain 8 (2.7) 3 (2.0) Diarrhea 11 (3.7) 1 (0.7) Vomiting 20 (6.6) 12 (8.0) General disorders and administration site conditions Pyrexia 6 (2.0) 4 (2.7) Investigations Aspartate aminotransferase increased 2 (0.7) 3 (2.0) Electrocardiogram QT prolonged 28 (9.3) 4 (2.7) Musculoskeletal and connective tissue disorders Arthralgia 9 (3.0) 2 (1.3) Nervous system disorders Headache 6 (2.0) 2 (1.3) Vascular disorders Phlebitis 8 (2.7) 0 (0) Clinical response was assessed at the test-of-cure visit (28 to 42 days after end of treatment).

The clinical response rates observed in the modified intent to treat population were 83.9% (208/248) for moxifloxacin and 95.5% (127/133) for comparator; see Table 6. Table 6: Clinical Response Rates at 28-42 Days After End of Treatment in Pediatric Patients with cIAI Moxifloxacin n (%) Comparator n (%) Difference Difference in clinical cure rates (Moxifloxacin - Comparator) and 95% confidence intervals, presented as percentages, are based on stratified analysis by age group using Mantel-Haenszel methods. (95% CI) mITT Population The modified intent-to-treat (mITT) population is defined as all subjects who were treated with at least one dose of study medication and who have at least one pre-treatment causative organism from the… [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 moxifloxacin. 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 moxifloxacin to elderly patients especially those on corticosteroids. Patients should be informed of this potential side effect and advised to discontinue moxifloxacin and contact their healthcare provider if any symptoms of tendinitis or tendon rupture occur [see Boxed Warning and Warnings and Precautions (5.2) ] . 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) ] .

In controlled multiple-dose clinical trials, 23% of patients receiving oral moxifloxacin were greater than or equal to 65 years of age and 9% were greater than or equal to 75 years of age. The clinical trial data demonstrate that there is no difference in the safety and efficacy of oral moxifloxacin in patients aged 65 or older compared to younger adults. In trials of intravenous use, 42% of moxifloxacin patients were greater than or equal to 65 years of age, and 23% were greater than or equal to 75 years of age.

The clinical trial data demonstrate that the safety of intravenous moxifloxacin in patients aged 65 or older was similar to that of comparator-treated patients. In general, elderly patients may be more susceptible to drug-associated effects of the QT interval. Therefore, moxifloxacin should be avoided in patients taking drugs that can result in prolongation of the QT interval (for example, class IA or class III antiarrhythmics) or in patients with risk factors for torsade de pointes (for example, known QT prolongation, uncorrected hypokalemia) [see Warnings and Precautions (5.6) , Drug Interactions (7.5) and Clinical Pharmacology (12.3) ] .

🆘 Overdosage 98 words ▾

10 OVERDOSAGE Single oral overdoses up to 2.8 g were not associated with any serious adverse events. In the event of acute overdose, empty the stomach and maintain adequate hydration. Monitor ECG due to the possibility of QT interval prolongation.

Carefully observe the patient and give supportive treatment. The administration of activated charcoal as soon as possible after oral overdose may prevent excessive increase of systemic moxifloxacin exposure. About 3% and 9% of the dose of moxifloxacin, as well as about 2% and 4.5% of its glucuronide metabolite are removed by continuous ambulatory peritoneal dialysis and hemodialysis, respectively.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

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

12.2Pharmacodynamics Photosensitivity Potential A study of the skin response to ultraviolet (UVA and UVB) and visible radiation conducted in 32 healthy volunteers (8 per group) demonstrated that moxifloxacin does not show phototoxicity in comparison to placebo. The minimum erythematous dose (MED) was measured before and after treatment with moxifloxacin (200 mg or 400 mg once daily), lomefloxacin (400 mg once daily), or placebo. In this study, the MED measured for both doses of moxifloxacin were not significantly different from placebo, while lomefloxacin significantly lowered the MED [see Warnings and Precautions (5.13) ] .

12.3Pharmacokinetics Absorption Moxifloxacin, given as an oral tablet, is well absorbed from the gastrointestinal tract. The absolute bioavailability of moxifloxacin is approximately 90 percent. Co-administration with a high fat meal (that is, 500 calories from fat) does not affect the absorption of moxifloxacin.

Consumption of 1 cup of yogurt with moxifloxacin does not affect the rate or extent of the systemic absorption (that is, area under the plasma concentration time curve (AUC). Table 7: Mean (± SD) C max and AUC values following single and multiple doses of 400 mg moxifloxacin given orally C max (mg/L) AUC (mg·h/L) Half-life (hr) Single Dose Oral Healthy (n = 372) 3.1 ± 1 36.1 ± 9.1 11.5-15.6 Range of means from different studies Multiple Dose Oral Healthy young male/female (n = 15) 4.5 ± 0.5 48 ± 2.7 12.7 ±

1.9Healthy elderly male (n = 8) 3.8 ± 0.3 51.8 ±

6.7Healthy elderly female (n = 8) 4.6 ± 0.6 54.6 ±

6.7Healthy young male (n = 8) 3.6 ± 0.5 48.2 ± 9 Healthy young female (n = 9) 4.2 ± 0.5 49.3 ±

9.5Table 8: Mean (± SD) C max and AUC values following single and multiple doses of 400 mg moxifloxacin given by 1-hour intravenous infusion C max (mg/L) AUC (mg·h/L) Half-life (hour) Single Dose intravenous Healthy young male/female (n = 56) 3.9 ± 0.9 39.3 ± 8.6 8.2-15.4 Range of means from different studies Patients (n = 118) Male (n = 64) 4.4 ±

3.7Female (n = 54) 4.5 ± 2 < 65 years (n = 58) 4.6 ± 4.2 ≥ 65 years (n = 60) 4.3 ±

1.3Multiple Dose intravenous Healthy young male (n = 8) 4.2 ± 0.8 38 ± 4.7 14.8 ±

2.2Healthy elderly (n =12; 8 male, 4 female) 6.1 ± 1.3 48.2 ± 0.9 10.1 ±

1.6Patients Expected C max (concentration obtained around the time of the end of the infusion) (n = 107) Male (n = 58) 4.2 ±

2.6Female (n = 49) 4.6 ± 1.5 < 65 years (n = 52) 4.1 ± 1.4 ≥ 65 years (n = 55) 4.7 ±

2.7Plasma concentrations increase proportionately with dose up to the highest dose tested (1200 mg single oral dose). The mean (± SD) elimination half-life from plasma is 12 ± 1.3 hours; steady-state is achieved after at least three days with a 400 mg once daily regimen. Mean Steady-State Plasma Concentrations of Moxifloxacin Obtained With Once Daily Dosing of 400 mg Either Orally (n = 10) or by Intravenous Infusion (n = 12) Mean Steady-State Plasma Concentrations of Moxifloxacin Obtained With Once Daily Dosing of 400 mg Either Orally (n=10) or by Intravenous Infusion (n=12) Distribution Moxifloxacin is approximately 30-50% bound to serum proteins, independent of drug concentration.

The volume of distribution of moxifloxacin ranges from 1.7 to

2.7L/kg. Moxifloxacin is widely distributed throughout the body, with tissue concentrations often exceeding plasma concentrations. Moxifloxacin has been detected in the saliva, nasal and bronchial secretions, mucosa of the sinuses, skin blister fluid, subcutaneous tissue, skeletal muscle, and abdominal tissues and fluids following oral or intravenous administration of 400 mg.

Moxifloxacin concentrations measured post-dose in various tissues and fluids following a 400 mg oral or intravenous dose are summarized in Table 9. The rates of elimination of moxifloxacin from tissues generally parallel the elimination from pla… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 48 words ▾

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

Mechanism of Action The bactericidal action of moxifloxacin results from inhibition of the topoisomerase II (DNA gyrase) and topoisomerase IV required for bacterial DNA replication, transcription, repair, and recombination.

📦 How Supplied / Storage and Handling 101 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.2Moxifloxacin Hydrochloride in Sodium Chloride Injection – Premix Bags Moxifloxacin hydrochloride in sodium chloride injection is available in ready-to-use 250 mL single-dose flexible bags containing moxifloxacin hydrochloride, USP (equivalent to 400 mg of moxifloxacin) in 0.8% sodium chloride aqueous solution. The flexible bag is not made with natural rubber latex. No further dilution of this preparation is necessary.

Discard unused portion. Package NDC Code 250 mL flexible container 67457-323-25 Store at 25°C (77°F); excursions permitted to 15ºC to 30°C (59ºF to 86°F). [See USP Controlled Room Temperature.] Do not refrigerate – product precipitates upon refrigeration.

📋 Description 198 words ▾

11 DESCRIPTION Moxifloxacin hydrochloride in sodium chloride injection is a synthetic antibacterial agent for intravenous administration. Moxifloxacin, a fluoroquinolone, is available as the monohydrochloride salt of 1-cyclopropyl-7-[(S,S)-2,8-diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3 quinoline carboxylic acid. It is a light yellow or yellow powder or crystals with a molecular weight of 437.89.

Its empirical formula is C 21 H 24 FN 3 O 4 · HCl and its chemical structure is as follows:

11.2Moxifloxacin Hydrochloride in Sodium Chloride Injection • Moxifloxacin hydrochloride in sodium chloride injection for intravenous use is available in ready-to-use single-dose 250 mL flexible bags as a sterile, preservative free, 0.8% sodium chloride aqueous solution of 400 mg moxifloxacin (equivalent to 436.34 mg moxifloxacin hydrochloride, USP) with pH ranging from 4.1 to 4.6. The flexible bag is not made with natural rubber latex. • The appearance of the intravenous solution is clear yellow. The color does not affect, nor is it indicative of, product stability. • The inactive ingredients are sodium chloride, USP, Water for Injection, USP, and may include hydrochloric acid and/or sodium hydroxide for pH adjustment. • Moxifloxacin hydrochloride in sodium chloride injection contains approximately 34.2 mEq (787 mg) of sodium in 250 mL.

Moxifloxacin hydrochloride chemical structure

💬 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 moxifloxacin 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 moxifloxacin 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 moxifloxacin and may occur together in the same patient.

Inform patients to stop taking moxifloxacin 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 moxifloxacin 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 moxifloxacin 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 moxifloxacin 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 moxifloxacin. 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 moxifloxacin 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 moxifloxacin 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 moxifloxacin.

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 pain. • Diarrhea: Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued.

Sometimes after starting treatment with antibiotics, patien… [Excerpted — this section continues on DailyMed.]

💬 Medication Guide ~3 min read ▾

Medication Guide Moxifloxacin Hydrochloride (moxʺ i floxʹ a sin hyeʺ droe klorʹ ide) in Sodium Chloride Injection, for intravenous use Read the Medication Guide that comes with moxifloxacin hydrochloride injection before you start taking it 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 moxifloxacin hydrochloride injection? Moxifloxacin hydrochloride injection is in a class of antibiotics called fluoroquinolones. Moxifloxacin hydrochloride injection can cause serious side effects that can happen at the same time and could result in death.

If you get any of the following serious side effects, you should stop taking moxifloxacin hydrochloride injection and get medical help right away. Talk with your healthcare provider about whether you should continue to take moxifloxacin hydrochloride injection. 1.

Tendon rupture or swelling of the tendon (tendinitis). • Tendon problems can happen in people of all ages who take moxifloxacin hydrochloride injection. Tendons are tough cords of tissue that connect muscles to bones. Symptoms of tendon problems may include: o Pain, swelling, tears and inflammation of tendons including the back of the ankle (Achilles), shoulder, hand, or other tendon sites. • The risk of getting tendon problems while you take moxifloxacin hydrochloride injection is higher if you: o Are over 60 years of age. o Are taking steroids (corticosteroids). o Have had a kidney, heart or lung transplant. o Tendon problems can happen in people who do not have the above risk factors when they take moxifloxacin hydrochloride injection. • Other reasons that can increase your risk of tendon problems can include: o Physical activity or exercise. o Kidney failure. o Tendon problems in the past, such as in people with rheumatoid arthritis (RA). • Stop taking moxifloxacin hydrochloride injection immediately and call your healthcare provider right away at the first sign of tendon pain, swelling or inflammation.

Stop taking moxifloxacin hydrochloride injection until tendinitis or tendon rupture has been ruled out by your healthcare provider. Avoid exercise and using the affected area. The most common area of pain and swelling is in the Achilles tendon at the back of your ankle.

This can also happen with other tendons. • Talk to your healthcare provider about the risk of tendon rupture with continued use of moxifloxacin hydrochloride injection. 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 stopped taking moxifloxacin hydrochloride injection. Tendon ruptures can happen within hours or days after taking moxifloxacin hydrochloride injection and have happened up to several months after people have stopped taking their fluoroquinolone. • Stop taking moxifloxacin hydrochloride injection immediately and get medical help right away if you get any of the following signs or symptoms of a tendon rupture: o Hear or feel a snap or pop in a tendon area. o Bruising right after an injury in a tendon area. o Unable to move the affected area or put weight on the area.

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 moxifloxacin hydrochloride injection.

Stop taking moxifloxacin hydrochloride 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 • burning • tingling • numbness • weakness Moxifloxacin hydrochloride injection may need to be stopped to prevent permanent nerve damage. 3. Central Nervous System (CNS) effects.

Seizures have been reported in people who take fluoroquinolone antibi… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption Moxifloxacin, given as an oral tablet, is well absorbed from the gastrointestinal tract. The absolute bioavailability of moxifloxacin is approximately 90 percent. Co-administration with a high fat meal (that is, 500 calories from fat) does not affect the absorption of moxifloxacin.

Consumption of 1 cup of yogurt with moxifloxacin does not affect the rate or extent of the systemic absorption (that is, area under the plasma concentration time curve (AUC). Table 7: Mean (± SD) C max and AUC values following single and multiple doses of 400 mg moxifloxacin given orally C max (mg/L) AUC (mg·h/L) Half-life (hr) Single Dose Oral Healthy (n = 372) 3.1 ± 1 36.1 ± 9.1 11.5-15.6 Range of means from different studies Multiple Dose Oral Healthy young male/female (n = 15) 4.5 ± 0.5 48 ± 2.7 12.7 ±

1.9Healthy elderly male (n = 8) 3.8 ± 0.3 51.8 ±

6.7Healthy elderly female (n = 8) 4.6 ± 0.6 54.6 ±

6.7Healthy young male (n = 8) 3.6 ± 0.5 48.2 ± 9 Healthy young female (n = 9) 4.2 ± 0.5 49.3 ±

9.5Table 8: Mean (± SD) C max and AUC values following single and multiple doses of 400 mg moxifloxacin given by 1-hour intravenous infusion C max (mg/L) AUC (mg·h/L) Half-life (hour) Single Dose intravenous Healthy young male/female (n = 56) 3.9 ± 0.9 39.3 ± 8.6 8.2-15.4 Range of means from different studies Patients (n = 118) Male (n = 64) 4.4 ±

3.7Female (n = 54) 4.5 ± 2 < 65 years (n = 58) 4.6 ± 4.2 ≥ 65 years (n = 60) 4.3 ±

1.3Multiple Dose intravenous Healthy young male (n = 8) 4.2 ± 0.8 38 ± 4.7 14.8 ±

2.2Healthy elderly (n =12; 8 male, 4 female) 6.1 ± 1.3 48.2 ± 0.9 10.1 ±

1.6Patients Expected C max (concentration obtained around the time of the end of the infusion) (n = 107) Male (n = 58) 4.2 ±

2.6Female (n = 49) 4.6 ± 1.5 < 65 years (n = 52) 4.1 ± 1.4 ≥ 65 years (n = 55) 4.7 ±

2.7Plasma concentrations increase proportionately with dose up to the highest dose tested (1200 mg single oral dose). The mean (± SD) elimination half-life from plasma is 12 ± 1.3 hours; steady-state is achieved after at least three days with a 400 mg once daily regimen. Mean Steady-State Plasma Concentrations of Moxifloxacin Obtained With Once Daily Dosing of 400 mg Either Orally (n = 10) or by Intravenous Infusion (n = 12) Mean Steady-State Plasma Concentrations of Moxifloxacin Obtained With Once Daily Dosing of 400 mg Either Orally (n=10) or by Intravenous Infusion (n=12) Distribution Moxifloxacin is approximately 30-50% bound to serum proteins, independent of drug concentration.

The volume of distribution of moxifloxacin ranges from 1.7 to

2.7L/kg. Moxifloxacin is widely distributed throughout the body, with tissue concentrations often exceeding plasma concentrations. Moxifloxacin has been detected in the saliva, nasal and bronchial secretions, mucosa of the sinuses, skin blister fluid, subcutaneous tissue, skeletal muscle, and abdominal tissues and fluids following oral or intravenous administration of 400 mg.

Moxifloxacin concentrations measured post-dose in various tissues and fluids following a 400 mg oral or intravenous dose are summarized in Table 9. The rates of elimination of moxifloxacin from tissues generally parallel the elimination from plasma. Table 9: Moxifloxacin Concentrations (mean ± SD) in Tissues and the Corresponding Plasma Concentrations After a Single 400 mg Oral or Intravenous Dose All moxifloxacin concentrations were measured 3 hours after a single 400 mg dose, except the abdominal tissue and exudate concentrations which were measured at 2 hours post-dose and the sinus concentrations which were measured 3 hours post-dose after 5 days of dosing.

Tissue or Fluid N Plasma Concentration (mcg/mL) Tissue or Fluid Concentration (mcg/mL or mcg/g) Tissue Plasma Ratio Respiratory Alveolar Macrophages 5 3.3 ± 0.7 61.8 ± 27.3 21.2 ± 10 Bronchial Mucosa 8 3.3 ± 0.7 5.5 ± 1.3 1.7 ±

0.3Epithelial Lining Fluid 5 3.3 ± 0.7 24.4 ± 14.7 8.7 ±

6.1Sinus Maxillary Sinus Mucosa 4 3.7 ±

1.1N = 5 7.6 ± 1.7 2 ±

0.3Anterior E… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 94 words ▾

12.2Pharmacodynamics Photosensitivity Potential A study of the skin response to ultraviolet (UVA and UVB) and visible radiation conducted in 32 healthy volunteers (8 per group) demonstrated that moxifloxacin does not show phototoxicity in comparison to placebo. The minimum erythematous dose (MED) was measured before and after treatment with moxifloxacin (200 mg or 400 mg once daily), lomefloxacin (400 mg once daily), or placebo. In this study, the MED measured for both doses of moxifloxacin were not significantly different from placebo, while lomefloxacin significantly lowered the MED [see Warnings and Precautions (5.13) ] .

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Acute Bacterial Sinusitis In a controlled double-blind study conducted in the US, moxifloxacin tablets (400 mg once daily for ten days) were compared with cefuroxime axetil (250 mg twice daily for ten days) for the treatment of acute bacterial sinusitis. The trial included 457 patients valid for the efficacy analysis. Clinical success (cure plus improvement) at the 7 to 21 day post-therapy test of cure visit was 90% for moxifloxacin and 89% for cefuroxime.

An additional non-comparative study was conducted to gather bacteriological data and to evaluate microbiological eradication in adult patients treated with moxifloxacin 400 mg once daily for seven days. All patients (n = 336) underwent antral puncture in this study. Clinical success rates and eradication/presumed eradication rates at the 21 to 37 day follow-up visit were 97% (29 out of 30) for Streptococcus pneumoniae , 83% (15 out of 18) for Moraxella catarrhalis , and 80% (24 out of 30) for Haemophilus influenzae .

14.2Acute Bacterial Exacerbation of Chronic Bronchitis Moxifloxacin tablets (400 mg once daily for five days) were evaluated for the treatment of acute bacterial exacerbation of chronic bronchitis in a randomized, double-blind, controlled clinical trial conducted in the US. This study compared moxifloxacin with clarithromycin (500 mg twice daily for 10 days) and enrolled 629 patients. Clinical success was assessed at 7-17 days post-therapy.

The clinical success for moxifloxacin was 89% (222/250) compared to 89% (224/251) for clarithromycin. Table 10: Clinical Success Rates at Follow-Up Visit for Clinically Evaluable Patients by Pathogen (Acute Bacterial Exacerbation of Chronic Bronchitis) PATHOGEN Moxifloxacin Clarithromycin Streptococcus pneumoniae 16/16 (100%) 20/23 (87%) Haemophilus influenzae 33/37 (89%) 36/41 (88%) Haemophilus parainfluenzae 16/16 (100%) 14/14 (100%) Moraxella catarrhalis 29/34 (85%) 24/24 (100%) Staphylococcus aureus 15/16 (94%) 6/8 (75%) Klebsiella pneumoniae 17/20 (85%) 10/11 (91%) The microbiological eradication rates (eradication plus presumed eradication) in moxifloxacin treated patients were Streptococcus pneumoniae 100%, Haemophilus influenzae 89%, Haemophilus parainfluenzae 100%, Moraxella catarrhalis 85%, Staphylococcus aureus 94%, and Klebsiella pneumoniae 85%.

14.3Community Acquired Pneumonia A randomized, double-blind, controlled clinical trial was conducted in the US to compare the efficacy of moxifloxacin tablets (400 mg once daily) to that of high-dose clarithromycin (500 mg twice daily) in the treatment of patients with clinically and radiologically documented community acquired pneumonia. This study enrolled 474 patients (382 of whom were valid for the efficacy analysis conducted at the 14-35 day follow-up visit). Clinical success for clinically evaluable patients was 95% (184/194) for moxifloxacin and 95% (178/188) for high dose clarithromycin.

A randomized, double-blind, controlled trial was conducted in the US and Canada to compare the efficacy of sequential intravenous/oral moxifloxacin 400 mg once a day for 7-14 days to an intravenous/oral fluoroquinolone control (trovafloxacin or levofloxacin) in the treatment of patients with clinically and radiologically documented community acquired pneumonia. This study enrolled 516 patients, 362 of whom were valid for the efficacy analysis conducted at the 7-30 day post-therapy visit. The clinical success rate was 86% (157/182) for moxifloxacin therapy and 89% (161/180) for the fluoroquinolone comparators.

An open-label ex-US study that enrolled 628 patients compared moxifloxacin to sequential intravenous/oral amoxicillin/clavulanate (1.2 gram intravenously every 8 hours/625 mg orally every 8 hours) with or without high-dose intravenous/oral clarithromycin (500 mg twice a day). The intravenous formulations of the comparators are not FDA approved. The clinical success rate at Day 5-7 for moxifloxacin therapy was 93% (241/258) and demonstrated superiorit… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long term studies in animals to determine the carcinogenic potential of moxifloxacin have not been performed. Moxifloxacin was not mutagenic in 4 bacterial strains (TA 98, TA 100, TA 1535, TA 1537) used in the Ames Salmonella reversion assay. As with other fluoroquinolones, the positive response observed with moxifloxacin in strain TA 102 using the same assay may be due to the inhibition of DNA gyrase.

Moxifloxacin was not mutagenic in the CHO/HGPRT mammalian cell gene mutation assay. An equivocal result was obtained in the same assay when v79 cells were used. Moxifloxacin was clastogenic in the v79 chromosome aberration assay, but it did not induce unscheduled DNA synthesis in cultured rat hepatocytes.

There was no evidence of genotoxicity in vivo in a micronucleus test or a dominant lethal test in mice. Moxifloxacin had no effect on fertility in male and female rats at oral doses as high as 500 mg/kg/day, approximately 12 times the maximum recommended human dose based on body surface area) or at intravenous doses as high as 45 mg/kg/day, approximately equal to the maximum recommended human dose based on body surface area). At 500 mg/kg orally there were slight effects on sperm morphology (head-tail separation) in male rats and on the estrous cycle in female rats.

13.2Animal Toxicology and/or Pharmacology Fluoroquinolones have been shown to cause arthropathy in immature animals. In studies in juvenile dogs oral doses of moxifloxacin 30 mg/kg/day or more (approximately 1.5 times the maximum recommended human dose based upon systemic exposure) for 28 days resulted in arthropathy. There was no evidence of arthropathy in mature monkeys and rats at oral doses up to 135 and 500 mg/kg/day, respectively.

Moxifloxacin at an oral dose of 300 mg/kg did not show an increase in acute toxicity or potential for CNS toxicity (for example, seizures) in mice when used in combination with NSAIDs such as diclofenac, ibuprofen, or fenbufen. Some fluoroquinolones have been reported to have proconvulsant activity that is exacerbated with concomitant use of NSAIDs. A QT-prolonging effect of moxifloxacin was found in dog studies, at plasma concentrations about five times the human therapeutic level.

The combined infusion of sotalol, a Class III antiarrhythmic agent, with moxifloxacin induced a higher degree of QTc prolongation in dogs than that induced by the same dose (30 mg/kg) of moxifloxacin alone. Electrophysiological in vitro studies suggested an inhibition of the rapid activating component of the delayed rectifier potassium current (I Kr ) as an underlying mechanism. No signs of local intolerability were observed in dogs when moxifloxacin was administered intravenously.

After intra-arterial injection, inflammatory changes involving the peri-arterial soft tissue were observed suggesting that intra-arterial administration of moxifloxacin should be avoided.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 216 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long term studies in animals to determine the carcinogenic potential of moxifloxacin have not been performed. Moxifloxacin was not mutagenic in 4 bacterial strains (TA 98, TA 100, TA 1535, TA 1537) used in the Ames Salmonella reversion assay. As with other fluoroquinolones, the positive response observed with moxifloxacin in strain TA 102 using the same assay may be due to the inhibition of DNA gyrase.

Moxifloxacin was not mutagenic in the CHO/HGPRT mammalian cell gene mutation assay. An equivocal result was obtained in the same assay when v79 cells were used. Moxifloxacin was clastogenic in the v79 chromosome aberration assay, but it did not induce unscheduled DNA synthesis in cultured rat hepatocytes.

There was no evidence of genotoxicity in vivo in a micronucleus test or a dominant lethal test in mice. Moxifloxacin had no effect on fertility in male and female rats at oral doses as high as 500 mg/kg/day, approximately 12 times the maximum recommended human dose based on body surface area) or at intravenous doses as high as 45 mg/kg/day, approximately equal to the maximum recommended human dose based on body surface area). At 500 mg/kg orally there were slight effects on sperm morphology (head-tail separation) in male rats and on the estrous cycle in female rats.

📄 Recent Major Changes 9 words ▾

Warnings and Precautions, Hypersensitivity Reactions ( 5.8 ) 7/2025

📄 Package Label / Principal Display Panel 215 words ▾

PRINCIPAL DISPLAY PANEL -250 mL NDC 67457-323-25 250 mL Moxifloxacin Hydrochloride in Sodium Chloride Injection 400 mg*/250 mL (1.6 mg/mL) in 0.8% Saline INFUSION OVER A PERIOD OF 60 MINUTES. Each 250 mL contains: 400 mg Moxioxacin (*equivalent to 436.34 mg Moxioxacin Hydrochloride, USP); Sodium Chloride 0.8% w/v; Hydrochloric Acid and/or Sodium Hydroxide may have been added to adjust pH; Water for Injection, USP. pH 4.1 to 4.6. Sterile, Single-dose flexible plastic container.

Discard any unused portion. Nonpyrogenic. Contains no preservative.

Usual Adult Dosage: See package insert. Use only if solution is clear and container is undamaged. Must not be used in series connections.

Do not admix with other drugs or additives. No further dilution of this preparation is necessary. Insert piercing pin from an appropriate transfer set (e.g. one that does not require excessive force, such as ISO compatible administration set) into port with a gentle twisting motion until pin is firmly seated.

DO NOT REFRIGERATE – PRODUCT PRECIPITATES UPON REFRIGERATION. NOT MADE WITH NATURAL RUBBER LATEX. Store at 25º C (77º F); excursions permitted to 15º to 30º C [59º to 86º F]. [See USP Controlled Room Temperature.] Manufactured in India for: Mylan Institutional LLC Morgantown, WV 26505 U.S.A.

Rx only Mylan Code No.: KR/DRUGS/KTK/28D/18/2016 50105075 Moxifloxacin Hydrochloride in Sodium Chloride Injection Label

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
241
Units reimbursed last 4 qtrs
24K
Gross reimbursed last 4 qtrs
$5.2K
Avg / prescription
$21.48
Avg / unit
$0.2157
Latest quarter Q1 2026
35Rx
Fee-for-service vs managed care ⓘ
22% FFS 78% MCO
Fee-for-service · 54 Rx Managed care · 187 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 9,000 units · 46.0 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 4,188 units · 98.9 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 6,313 units · 72.4 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: 4,500 units · 314 per 100k residents HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
46.0314
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Hawaii 314 /100k
2 Oregon 98.9 /100k
3 Virginia 72.4 /100k
4 New York 46.0 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Moxifloxacin hydrochloride — the ingredient across all brands.

Top reported reactions

Dyspnoea2,204
Asthma2,071
Drug Hypersensitivity2,056
Pneumonia1,997
Vomiting1,856
Pain1,737
Wheezing1,664

Age at onset

Neonate47
Infant19
Child71
Adolescent59
Adult2,591
Elderly2,094

Reporter sex

20,160 reports
Male · 42%
Female · 58%
Unknown · 0%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2,425 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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) ✓ Available
“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 Mylan Institutional LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Mylan Institutional 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 J2280 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.
← 67457-0317-25 · Mylan 67457-0339-50 · Mylan →
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.