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Levofloxacin 500 mg Tablet, Film Coated, 10-count — NDC 71205-0002-10 package photo

Levofloxacin 500 mg Tablet, Film Coated, 10-count

by Proficient Rx LP · 10 TABLET, FILM COATED in 1 BOTTLE (71205-002-10)
NDC 71205-0002-10
🏷️ FDA NDC (as labeled) 71205-002-10 billing pads the product segment with a zero
This package
Contains10-count Pack sizes7 compare ↓
Also priced by: Part D plans $0.3933/unit — full pricing hub ↓
Also comes in: 3 tablets 71205-0002-03 5 tablets 71205-0002-05 7 tablets 71205-0002-07 12 tablets 71205-0002-12 14 tablets 71205-0002-14 21 tablets 71205-0002-21
Rx only Generic On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 71205-002-10
Product NDC 71205-002
11-digit billing NDC 71205000210
NCPDP billing unit EA — each (per item)
RxCUI 199885
UNII 6GNT3Y5LMF
UPC 0371205002077
Application # ANDA202801
SPL Set ID 64141d0d-0347-470f-a427-9925a2eb357e
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 2015-01-09
Route ORAL
Dosage form TABLET, FILM COATED
Substance LEVOFLOXACIN
GPI-14 05000034000330
GPI class levoFLOXacin
GCN Seq No 029928
GCN 47074
HICL code 012384
Ingredient (HICL) Levofloxacin
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 500 MG TABLET
FDB brand name Levofloxacin
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 71205-002-10 — 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 → 71205-0002-10. 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.

🏭 Manufacturer & labeler

LabelerProficient Rx LP
Application holderHETERO LABS LTD UNIT V
FDA applicationANDA202801 (ANDA)
Labeler code71205
First marketedJan 2015
Product typeHuman Prescription Drug
Portfolio1,723 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name LEVOFLOXACIN 500 MG TABLET Ingredient Levofloxacin
📗 Our plain-language guide HelloPharmacist
  • Levofloxacin only works against bacterial infections. It won't help with viral infections like colds, flu, or COVID-19. Your doctor prescribed it because you have a specific bacter...
  • What is levofloxacin actually treating — is it for any kind of infection?
  • It's smart to be informed — levofloxacin does carry a black box warning, the FDA's most serious alert. The main concerns are tendon damage (especially in the heel/Achilles tendon),...
  • I heard this antibiotic has some serious risks. Should I be worried?
📖 Read our full Levofloxacin 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.

🧪 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 M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

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

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer 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 $0.3933 $3.93 / 10 tablets
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Levofloxacin 500 mg 00904-6352-61 Major 1 tablet $0.134 AB Availability likely —
Levofloxacin 500 mg 33342-0532-08 Macleods 50 tablets $0.134 AB Availability likely —
Levofloxacin 500 mg 62135-0656-50 Chartwell 50 tablets $0.134 AB Availability likely —
Levofloxacin 500 mg 31722-0722-31 Camber 10 tablets — AB FDA listed —
Levofloxacin 500 mg 43063-0457-02 PD-Rx 2 tablets — AB FDA listed —
Levofloxacin 500 mg 50090-3311-00 A-S 7 tablets — AB FDA listed —
Levofloxacin 500 mg 50090-3314-00 A-S 10 tablets — AB FDA listed —
Levofloxacin 500 mg 51407-0429-50 Golden 50 tablets — AB FDA listed —
Levofloxacin 500 mg 51655-0666-07 Northwind 7 tablets — AB FDA listed —
Levofloxacin 500 mg 55111-0280-01 Dr. 100 tablets — AB FDA listed —
Levofloxacin 500 mg 55154-5897-00 Cardinal 1 tablet — AB FDA listed —
Levofloxacin 500 mg 61919-0426-07 DIRECT 7 tablets — AB FDA listed —
levofloxacin 500 mg 65841-0692-01 Zydus 100 tablets — AB FDA listed —
Levofloxacin 500 mg 65862-0537-10 Aurobindo 10 tablets — — FDA listed —
Levofloxacin 500 mg 67296-0743-05 Redpharm 5 tablets — AB FDA listed —
levofloxacin 500 mg 67296-2126-01 Redpharm 10 tablets — AB FDA listed —
Levofloxacin 500 mg 68071-3511-05 NuCare 50 tablets — AB FDA listed —
Levofloxacin 500 mg 68071-4512-01 NuCare 1 tablet — AB FDA listed —
Levofloxacin 500 mg 68071-4738-01 NuCare 10 tablets — AB FDA listed —
Levofloxacin 500 mg 68788-6938-01 Preferred 10 tablets — AB FDA listed —
levofloxacin 500 mg 68788-8772-01 Preferred 10 tablets — AB FDA listed —
Levofloxacin 500 mg 70518-0453-00 REMEDYREPACK 7 tablets — AB Discontinued —
Levofloxacin 500 mg 70518-0587-00 REMEDYREPACK 30 tablets — AB FDA listed —
Levofloxacin 500 mg 70518-3712-00 REMEDYREPACK 10 tablets — AB FDA listed —
levofloxacin 500 mg 70518-4568-00 REMEDYREPACK 30 tablets — AB FDA listed —
Levofloxacin 500 mgthis 71205-0002-10 Proficient 10 tablets — AB FDA listed —
Levofloxacin 500 mg 71335-0434-00 Bryant 90 tablets — AB Discontinued —
levofloxacin 500 mg 71335-2276-00 Bryant 90 tablets — AB FDA listed —
levofloxacin 500 mg 72578-0099-01 Viona 100 tablets — AB FDA listed —
Levofloxacin 500 mg 72789-0085-50 PD-Rx 50 tablets — AB FDA listed —
Levofloxacin 500 mg 72789-0367-07 PD-Rx 7 tablets — AB FDA listed —
Levofloxacin 500 mg 76420-0816-00 Asclemed 1000 tablets — AB FDA listed —
Levofloxacin 500 mg 80425-0007-01 ADVANCED 14 tablets — AB FDA listed —
Levofloxacin 500 mg 80425-0008-01 Advanced 14 tablets — AB FDA listed —
Levofloxacin 500 mg 83939-0020-01 VERITYRX, 1 tablet — AB FDA listed —
Levofloxacin 500 mg 68180-0241-01 Lupin 100 tablets — — Discontinued —
Levofloxacin 500 mg 85534-0097-00 HAWAII 5 tablets — AB FDA listed —
levofloxacin 500 mg 67046-1358-03 Coupler 30 tablets — AB 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

🏛️
2015
On the market since
Jan 2015
📍
2026
Currently FDA-listed
11 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.

📊 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.

🔬 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 Levofloxacin — the ingredient across all brands.

Top reported reactions

Dyspnoea3,048
Pneumonia2,963
Nausea2,908
Pyrexia2,805
Fatigue2,757
Acute Kidney Injury2,631
Diarrhoea2,553

Age at onset

Neonate42
Infant93
Child187
Adolescent154
Adult5,526
Elderly4,080

Reporter sex

0 reports
Male · 49%
Female · 51%
Unknown · 0%

Serious outcomes

Hospitalization27,957
Death8,137
Life-threatening4,896
Disabling3,107
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 5,017 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
71205-0002-03 3 TABLET, FILM COATED in 1 BOTTLE (71205-002-03) 2020-10-22 Active
71205-0002-05 5 TABLET, FILM COATED in 1 BOTTLE (71205-002-05) 2018-04-02 Active
71205-0002-07 7 TABLET, FILM COATED in 1 BOTTLE (71205-002-07) 2018-04-02 Active
71205-0002-10 You're viewing this 10 TABLET, FILM COATED in 1 BOTTLE (71205-002-10) 2018-04-02 Active
71205-0002-12 12 TABLET, FILM COATED in 1 BOTTLE (71205-002-12) 2019-04-01 Active
71205-0002-14 14 TABLET, FILM COATED in 1 BOTTLE (71205-002-14) 2018-04-02 Active
71205-0002-21 21 TABLET, FILM COATED in 1 BOTTLE (71205-002-21) 2018-04-02 Active

You're viewing one of 7 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71205-0002-10?
NDC 71205-0002-10 is a 10-count package — 10 tablet, film coated in 1 bottle.
What is the difference between NDC 71205-0002-10 and NDC 71205-0002-03?
Both are Levofloxacin 500 mg Tablet, Film Coated — the drug itself is identical. NDC 71205-0002-10 is the 10-count package, while NDC 71205-0002-03 is the 3 tablets package.
What NDC number is used to bill for this package of Levofloxacin 500 mg Tablet, Film Coated?
Bill NDC 71205-0002-10 — the 11-digit billing format is 71205000210. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 71205-002-10, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 71205-0002-10, written without dashes as 71205000210. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 71205-0002-10, the first segment (71205) is the labeler code FDA assigned to Proficient Rx LP; the middle segment (0002) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Proficient Rx LP. 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 6 other package presentations of this same product, including 3 tablets (71205-0002-03), 5 tablets (71205-0002-05), 7 tablets (71205-0002-07). 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?
Proficient Rx LP 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.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 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
🚨 Boxed Warning ~1 min read ▾

WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVISWARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS WARNING : SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS • Fluoroquinolones , including levofloxacin, 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 levofloxacin immediately and avoid the use of fluoroquinolones, including levofloxacin, in patients who experience any of these serious adverse reactions [ see Warnings and Precautions ( 5.1 ) ] • Fluoroquinolones , including levofloxacin, may exacerbate muscle weakness in patients with myasthenia gravis.

Avoid levofloxacin in patients with a known history of myasthenia gravis [ see Warnings and Precautions ( 5.5 ) ]. • Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions [ see Warnings and Precautions ( 5.1 to 5.14 ) ], reserve levofloxacin for use in patients who have no alternative treatment options for the following indications: o Uncomplicated urinary tract infection [ see Indications and Usage ( 1.12 ) ] o Acute bacterial exacerbation of chronic bronchitis [ see Indications and Usage ( 1.13 ) ] o Acute bacterial sinusitis [ see Indications and Usage ( 1.14 ) ].

🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS & USAGE Levofloxacin tablets are 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 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 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 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 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 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 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 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 is indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis . The effectiveness of levofloxacin is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. Levofloxacin has not been tested in humans for the post-exposure prevention of inhalation anthrax.

The safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients f…

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE & 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 7-14 Community Acquired Pneumonia ( 1.2 ) 500 mg 7-14 Community Acquired Pneumonia ( 1.3 ) 750 mg 5 Complicated Skin and Skin Structure Infections (SSSI) ( 1.6 ) 750 mg 7-14 Uncomplicated SSSI ( 1.7 ) 500 mg 7-10 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 10-14 • Adjust dose for creatinine clearance < 50 mL/min ( 2.3 , 8.6 , 12.3 )

2.1Dosage in Adult Patients with Normal Renal Function The usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally 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 7-14 Community Acquired Pneumonia ‡ 500 mg 7-14 Community Acquired Pneumonia § 750 mg 5 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7-14 Uncomplicated SSSI 500 mg 7-10 Chronic Bacterial Prostatitis 500 mg 28 Inhalation 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 á 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 10-14 * 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]), Haemophilusinfluenzae, 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, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli . Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B.anthracis .

This indication is based on a surrogate endpoint. Levofloxacin plasm…

💊 Dosage Forms and Strengths 97 words ▾

3 DOSAGE FORMS & STRENGTHS • Levofloxacin tablets, USP 250 mg are pink colored, capsule shaped, biconvex, film coated tablets debossed with '25on' one side and 'I' on the other side. • Levofloxacin tablets, USP 500 mg are orange colored, capsule shaped, biconvex, film coated tablets debossed with '26' on one side and 'I' on the other side. • Levofloxacin tablets, USP 750 mg are white colored, capsule shaped, biconvex, film coated tablets debossed with '18'on one side and 'I' on the other side. Formulation ( 3 ) Strength Tablets 250 mg, 500 mg, and 750 mg

⛔ Contraindications 36 words ▾

4 CONTRAINDICATIONS Levofloxacin is contraindicated in persons with known hypersensitivity to levofloxacin, or other quinolone antibacterials [see Warnings and Precautions ( 5.3 )] . Known hypersensitivity to levofloxacin 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, hepatoxicity has been reported. Discontinue immediately if signs and symptoms of hepatitis occur ( 5.8 ) • Clostridium difficile -associated colitis: evaluate if diarrhea occurs ( 5.9 ) • Prolongation of the QT interval and isolated cases of torsade de pointes have been reported.

Avoid use in patients with known prolongation, those with hypokalemia, and with other drugs that prolong the QT interval ( 5.10 , 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, 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. 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 immediately at the first signs or symptoms of any serious adverse reaction.

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

5.2Tendinopathy and Tendon Rupture Fluoroquinolones, including levofloxacin, 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 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 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 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 patients who have a history of tendon disorders or tendon rupture [ see Adverse Reactions ( 6.3 ); Patient Counseling Information ( Error! Hyperlink reference not valid. ) ].

5.3Peripheral Neuropathy Fluoroquinolones, including levofloxacin, 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 levofloxacin. Symptoms may occur soon after initiation of levofloxacin and may be irreversible in some patients [ see W…

🤒 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 Hetero Labs Limited at 866-495-1995 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 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 ( 5.9 ) ] • Prolongation of the QT Interval [ see Warnings and Precautions ( 5.10 ) ] • Musculoskeletal Disorders in Pediatric Patients [ see Warnings and Precautions ( 5.11 ) ] • 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 ) ] Crystalluria and cylindruria have been reported with quinolones, including levofloxacin.

Therefore, adequate hydration of patients receiving levofloxacin 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 7537 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 for a wide variety of infectious diseases [see Indications and Usage ( 1 )] . Patients received levofloxacin 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 doses of 750 mg once daily, 250 mg once daily, and 500 mg once or twice daily. Discontinuation of levofloxacin 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-treated patients and less common adverse reactions, occurring in 0.1 to <1% of levofloxacin-treated patients, are shown in Table 4 and Table 5, respectively. The most common adverse drug reactions (≥3%) are nausea, headache, diarrhea, insomnia, constipation, and dizziness.

Table 4:Common (≥1%) Adverse Reactions Reported in Clinical Trials with Levofloxacin System/Organ Class Adverse Reaction % (N=7537) Infections and Infestation…

🔄 Drug Interactions ~2 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 formulation is taken within 2 hours of these products. ( 2.4 , 7.1 ) Warfarin Effect may be enhanced. Monitor prothrombin time, INR, watch for bleeding ( 7.2 ) Antidiabetic agents Carefully monitor blood glucose ( 5.12 , 7.3 )

7.1Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins Levofloxacin Tablets While the chelation by divalent cations is less marked than with other fluoroquinolones, concurrent administration of levofloxacin tablets with antacids containing magnesium, or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc may interfere with the gastrointestinal absorption of levofloxacin, resulting in systemic levels considerably lower than desired. Tablets with antacids containing magnesium, aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine may substantially interfere with the gastrointestinal absorption of levofloxacin, resulting in systemic levels considerably lower than desired.

These agents should be taken at least two hours before or two hours after oral levofloxacin administration.

7.2Warfarin No significant effect of levofloxacin 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 postmarketing experience in patients that levofloxacin enhances the effects of warfarin.

Elevations of the prothrombin time in the setting of concurrent warfarin and levofloxacin 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 is administered concomitantly with warfarin. Patients should also be monitored for evidence of bleeding [see Adverse Reactions ( 6.3 ); Patient Counseling Information ( Error!

Hyperlink reference not valid. )] .

7.3Antidiabetic Agents Disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concomitantly with fluoroquinolones and an antidiabetic agent. Therefore, careful monitoring of blood glucose is recommended when these agents are co-administered [see Warnings and Precautions ( 5.12 ); Adverse Reactions ( 6.2 ), Patient Counseling Information ( Error! Hyperlink reference not valid. )] .

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

7.5Theophylline No significant effect of levofloxacin 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 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 on the peak plasma concentrations, AUC, and other disposition parameters for cyclosporine was detected…

👥 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 ( 5.5 , 8.5 , Error! Hyperlink reference not valid. ).

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. ( 5.10 , 8.5 , Error!

Hyperlink reference not valid. ). 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 ( 5.11 , 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 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, it can be presumed that levofloxacin will be excreted in human milk. Because of the potential for serious adverse reactions from levofloxacin 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 ( 5.11 ) and Animal Toxicologyand/or Pharmacology ( 13.2 )] . 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 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, 1534 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/k…

🤰 Pregnancy 159 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 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 ( 5.11 ) and Animal Toxicologyand/or Pharmacology ( 13.2 )] . 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 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, 1534 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 (1340 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 = 1340 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 1199 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-treated children and most were treated with analgesics. The median time to resolution was 7 days for levofloxacin-treated children and 9 for non-fluoroquinolone-treated children (approximately 80% resolved within 2 months in both groups). No child had a severe or serious disorder and all musculoskeletal disorders resolved without sequelae.

Vomiting and diarrhea were the most frequently reported adverse events, occurring in similar frequency in the levofloxacin-treated and non-fluoroquinolone-treated children. In addition to the events reported in pediatric patients in clinical trials, events reported in adults during clinical trials or post-marketing experience [see Adverse Reactions ( 6) ] may also be expected to occur in pedi…

🧓 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. 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 to elderly patients especially those on corticosteroids. Patients should be informed of this potential side effect and advised to discontinue levofloxacin 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.

The majority of fatal hepatotoxicity reports occurred in patients 65 years of age or older and most were not associated with hypersensitivity. Levofloxacin should be discontinued immediately if the patient develops signs and symptoms of hepatitis [see Warnings and Precautions ( 5.8 )] . Elderly patients may be more susceptible to drug-associated effects on the QT interval.

Therefore, precaution should be taken when using levofloxacin 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 torsade de pointes (e.g., known QT prolongation, uncorrected hypokalemia) [see Warnings and Precautions ( 5.10 )] . 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 85 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 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: ataxia, ptosis, decreased locomotor activity, dyspnea, prostration, tremors, and convulsions. Doses in excess of 1500 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 ± 2 091 ± 29 500 mg oral single dose tablet, patients with renal insufficiency: CLCR 50-80 mL/min 7.5 ± 1.8 1.5 ± 0.5 95.6 ± 11.8 88 ± 10 ND 9.1 ± 0.9 57 ± 8 CLCR 20-49 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 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-…

🧬 Mechanism of Action 21 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 87 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1Levofloxacin Tablets, USP •Levofloxacin Tablets USP, 500 mg are orange colored, capsule shaped, biconvex, film coated tablets debossed with '26' on one side and 'I' on the other side. They are supplied in Bottles of 03 tablets NDC-71205-002-03 Bottles of 05 tablets NDC-71205-002-05 Bottles of 07 tablets NDC-71205-002-07 Bottles of 10 tablets NDC-71205-002-10 Bottles of 12 tablets NDC-71205-002-12 Bottles of 14 tablets NDC-71205-002-14 Bottles of 21 tablets NDC-71205-002-21 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📋 Description ~1 min read ▾

11 DESCRIPTION Levofloxacin, USP is a synthetic broad-spectrum antibacterial agent for oral 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.

Figure 1: The Chemical Structure of Levofloxacin, USP The molecular formula is C 18 H 20 FN 3 O 4 •1/2 H 2 O and the molecular weight is 370.38. Levofloxacin, USP is a light yellowish-white to yellow-white crystals 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, USP is essentially constant (approximately 100 mg/mL). Levofloxacin, USP 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, USP 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 Form Levofloxacin Tablets, USP are available as film-coated tablets and contain the following inactive ingredients: • 250 mg: croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. • 500 mg: croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. • 750 mg: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide.

Levofloxacin tablets, USP meets USP Dissolution Test 2. levofloxacinfigure1

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-Approved Medication Guide ( Error! Hyperlink reference not valid. )

17.1Serious Adverse Reactions Advise patients to stop taking levofloxacin 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 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 and may occur together in the same patient.

Inform patients to stop taking levofloxacin 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 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 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 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.

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. • Diarrhea: Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more…

💬 Medication Guide ~3 min read ▾

Medication Guide MEDICATION GUIDE Levofloxacin (LEE-voe-FLOX-a-sin) Tablets Read this Medication Guide before you start taking levofloxacin 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? Levofloxacin, 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, you should stop taking levofloxacin immediately 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.

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 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. • Tendon problems can happen in people who do not have the above risk factors when they take levofloxacin. • 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 levofloxacin 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. Tendon ruptures can happen within hours or days of taking levofloxacin and have happened up to several months after people have finished taking their fluoroquinolone. • Stop taking levofloxacin 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 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. Stop taking levofloxacin 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.

Tell your healthcare provider if you have a history of seizures before you start taking levofloxacin. CNS side effects may happen as soon as after taking the first dose of levofloxacin. Stop taking levofloxacin 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 • trouble sleeping • hear voices, see things, or sense things that are not there (hallucinations) • nightmares • feel restless • feel lightheaded or dizzy • tremors • feel more suspicious (paranoia) • feel anxious or nervous • suicidal thoughts or acts • confusion • headaches that will not go away, with or without blurred vision • depression 4.

Worsening of myasthenia gravis (a problem that causes muscle weakness). Fluoroquinolones like levofloxacin may cause…

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