Levofloxacin 250 mg Tablet, 14-count — NDC 62135-655-14 (Billing 62135-0655-14)
This is a package of 14 tablets of Levofloxacin 250 mg Tablet from Chartwell RX, LLC, marketed since Mar 2012 and currently FDA-listed; retail pharmacies pay about $0.1086 per tablet (NADAC). It is this product's only package size.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 029927
- GCN: 47073
- GPI-14 (Medi-Span): 05000034000320
- HICL (First Databank): 012384
- AHFS class code: 08:12.18.00
- RxCUI (RxNorm): 199884
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Fluoroquinolone Antibacterial class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Levofloxacin is used to treat certain infections caused by bacteria. Levofloxacin is also used to prevent anthrax (a serious infection that may be spread on purpose as part of a bioterror attack) in people who may have been exposed to anthrax germs in the air, and to treat and prevent plague (a serious infection that may be spread on purpose as part of a bioterror attack.) Levofloxacin is in a class of antibiotics called fluoroquinolones. It works by killing bacteria that cause infections. Antibiotics such as levofloxacin will not work for colds, flu, or other viral infections. Using antibiot...
Read the full MedlinePlus article ↗- It treats bacterial infections such as pneumonia, skin, urinary tract, prostate and sinus infections, and is used after anthrax exposure and for plague. The eye drops treat bacteri...
- Tablets and oral solution are taken by mouth, usually once a day. Take it exactly as prescribed and finish the course. Keep it at least 2 hours apart from antacids, magnesium and s...
- Nausea, headache, diarrhea, trouble sleeping, constipation and dizziness are the most common. Most are manageable, but let me know if they bother you.
- Stop and call right away for tendon pain or swelling, tingling or numbness, new anxiety, confusion or mood changes, rash or swelling, severe diarrhea, or yellow skin or eyes. These...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Levofloxacin — tap one for details:
Levofloxacin may be associated with lower levels of 11 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.109 | $1.52 / 14 tablets |
| 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 | $5.51 / 14 tablets |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 2, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 62135-0655-14 You're viewing this Main listing | 14 TABLET in 1 BOTTLE | 2024-01-19 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Levofloxacin 250 mg 00904-6351-61 | Major | 1 tablet | $0.109 | AB | Availability likely | — |
| Levofloxacin 250 mg 33342-0531-08 | Macleods | 50 tablets | $0.109 | AB | Availability likely | — |
| Levofloxacin 250 mgthis 62135-0655-14 | Chartwell | 14 tablets | $0.109 | AB | Availability likely | — |
| Levofloxacin 250 mg 31722-0721-31 | Camber | 10 tablets | — | AB | FDA listed | — |
| Levofloxacin 250 mg 50090-3245-02 | A-S | 7 tablets | — | AB | FDA listed | — |
| Levofloxacin 250 mg 51407-0428-50 | Golden | 50 tablets | — | AB | FDA listed | — |
| Levofloxacin 250 mg 51655-0947-53 | Northwind | 10 tablets | — | AB | FDA listed | — |
| Levofloxacin 250 mg 55111-0279-01 | Dr. | 100 tablets | — | AB | FDA listed | — |
| levofloxacin 250 mg 65841-0691-01 | Zydus | 100 tablets | — | AB | FDA listed | — |
| Levofloxacin 250 mg 65862-0536-10 | Aurobindo | 10 tablets | — | — | FDA listed | — |
| levofloxacin 250 mg 67046-1078-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| levofloxacin 250 mg 67296-2242-03 | Redpharm | 5 tablets | — | AB | FDA listed | — |
| Levofloxacin 250 mg 68071-3093-02 | NuCare | 20 tablets | — | AB | FDA listed | — |
| Levofloxacin 250 mg 70518-0719-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Levofloxacin 250 mg 71205-0058-21 | Proficient | 21 tablets | — | AB | FDA listed | — |
| Levofloxacin 250 mg 71335-0794-01 | Bryant | 10 tablets | — | AB | FDA listed | — |
| levofloxacin 250 mg 72578-0098-01 | Viona | 100 tablets | — | AB | FDA listed | — |
| Levofloxacin 250 mg 76420-0815-00 | Asclemed | 1000 tablets | — | AB | FDA listed | — |
| Levofloxacin 250 mg 68180-0240-01 | Lupin | 100 tablets | — | — | Discontinued | — |
| Levofloxacin 250 mg 85534-0096-00 | HAWAII | 5 tablets | — | AB | FDA listed | — |
| levofloxacin 250 mg 71335-3173-01 | Bryant | 10 tablets | — | AB | FDA listed | — |
| Levofloxacin 250 mg 67296-1104-05 | Redpharm | 5 tablets | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
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?
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
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.
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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.
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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.
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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.
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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.
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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.
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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.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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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.
8 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
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Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🚨 Boxed Warning ▾
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: Tendinitis and tendon rupture [see Warnings and Precautions (5.2) ] Peripheral neuropathy [see Warnings and Precautions (5.3) ] Central nervous system effects [see Warnings and Precautions (5.4) ] Discontinue levofloxacin 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 - 5.15 )], reserve levofloxacin for use in patients who have no alternative treatment options for the following indications: Uncomplicated urinary tract infection [see Indications and Usage (1.12) ] Acute bacterial exacerbation of chronic bronchitis [see Indications and Usage (1.13) ] Acute bacterial sinusitis [see Indications and Usage (1.14) ].
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS See full prescribing information for complete boxed warning. Fluoroquinolones, including levofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together ( 5.1 ), including: Tendinitis and tendon rupture ( 5.2 ) Peripheral neuropathy ( 5.3 ) Central nervous system effects ( 5.4 ) Discontinue levofloxacin immediately and avoid the use of fluoroquinolones, including levofloxacin, in patients who experience any of these serious adverse reactions ( 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 ( 5.1 - 5.15 ), reserve levofloxacin for use in patients who have no alternative treatment options for the following indications: Uncomplicated urinary tract infection ( 1.12 ) Acute bacterial exacerbation of chronic bronchitis ( 1.13 ) Acute bacterial sinusitis ( 1.14 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Levofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated ( 1 , 12.4 ). Pneumonia: Nosocomial ( 1.1 ) and Community Acquired ( 1.2 , 1.3 ) Skin and Skin Structure Infections (SSSI): Complicated ( 1.4 ) and Uncomplicated ( 1.5 ) Chronic bacterial prostatitis ( 1.6 ) Inhalational Anthrax, Post-Exposure in adult and pediatric patients ( 1.7 ) Plague in adult and pediatric patients ( 1.8 ) Urinary Tract Infections (UTI): 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 ) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria ( 1.15 ).
1.1Nosocomial Pneumonia Levofloxacin is indicated in adult patients 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 in adult patients 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 in adult patients 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 in adult patients 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 in adult patients 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 in adult patients 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 in adults and pediatric patients, 6 months of age and older [see Dosage and Administration (2… [Excerpted — this section continues on DailyMed.]
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Administer levofloxacin tablets to pediatric patients weighing 30 kg and greater only ( 2.1 , 2.2 ). Levofloxacin tablets cannot be administered to pediatric patients who weigh less than 30 kg because of the limitations of the available strengths. Alternative formulations of levofloxacin may be considered for pediatric patients who weigh less than 30 kg ( 2.2 ).
Dosage in Adult and Pediatric Patients with Creatinine Clearance greater than or equal to 50 mL/minute ( 2.1 . 2.2 ) Type of Infection Dose Every 24 hours Duration (days) Nosocomial Pneumonia ( 1.1 ) 750 mg 7 to 14 Community Acquired Pneumonia ( 1.2 ) 500 mg 7 to 14 Community Acquired Pneumonia ( 1.3 ) 750 mg 5 Complicated SSSI ( 1.4 ) 750 mg 7 to 14 Uncomplicated SSSI ( 1.5 ) 500 mg 7 to 10 Chronic Bacterial Prostatitis ( 1.6 ) 500 mg 28 Inhalational Anthrax (Post-Exposure) ( 1.7 ) Adults and Pediatric Patients 50 kg or greater Pediatric Patients 30 kg to less than 50 kg ( 2.2 ) 500 mg 250 mg every 12 hours 60 60 Plague ( 1.8 ) Adults and Pediatric Patients 50 kg or greater Pediatric Patients 30 kg to less than 50 kg ( 2.2 ) 500 mg 250 mg every 12 hours 10 to 14 10 to 14 Complicated UTI ( 1.9 ) or Acute Pyelonephritis ( 1.11 ) 750 mg 5 Complicated UTI ( 1.10 ) or Acute Pyelonephritis ( 1.11 ) 250 mg 10 Uncomplicated UTI ( 1.12 ) 250 mg 3 Acute Bacterial Exacerbation of Chronic Bronchitis ( 1.13 ) 500 mg 7 Acute Bacterial Sinusitis ( 1.14 ) 750 mg 5 500 mg 10 to 14 Adjust dose for creatinine clearance less than 50 mL/minute ( 2.3 , 8.6 , 12.3 )
2.1Dosage of Levofloxacin Tablets in Adult Patients with Creatinine Clearance ≥50 mL/minute 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/minute. For patients with creatinine clearance less than 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3) ] .
Table 1: Dosage of Levofloxacin Tablets in Adult Patients with Creatinine Clearance greater than or equal to 50 mL/minute Type of Infection* Dosed Every 24 hours Duration (days) † Nosocomial Pneumonia 750 mg 7 to 14 Community Acquired Pneumonia ‡ 500 mg ‡ 7 to 14 ‡ Community Acquired Pneumonia § 750 mg § 5 § Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7 to 14 Uncomplicated SSSI 500 mg 7 to 10 Chronic Bacterial Prostatitis 500 mg 28 Inhalational Anthrax (Post-Exposure), adult and pediatric patients weighing 50 kg Þ,ß or greater Pediatric patients weighing 30 kg to less than 50 kg Þ,ß 500 mg see Table 2 below (2.2) 60 ß 60 ß Plague, adult and pediatric patients weighing 50 kg à or greater Pediatric patients weighing 30 kg to less than 50 kg 500 mg see Table 2 below (2.2) 10 to 14 10 to 14 Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) ¶ 750 mg 5 Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) # 250 mg # 10 # Uncomplicated Urinary Tract Infection 250 mg 3 Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) 500 mg 7 Acute Bacterial Sinusitis (ABS) 750 mg 5 500 mg 10 to 14 * Due to the designated pathogens [see Indications and Usage (1) ] . † Sequential therapy (intravenous levofloxacin to oral levofloxacin tablets) may be instituted at the discretion of the healthcare provider. ‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2) ] . § Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3) ] . ¶ This regimen is indicated f… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS TABLETS, Film-coated 250 mg White to off white, Oval shaped, standard convex coated tablets with " CE " debossed on one side and " 150 " on the other side 500 mg White to off white, Oval shaped, standard convex coated tablets with " CE " debossed on one side and " 151 " on the other side 750 mg White to off white, Oval shaped, standard convex coated tablets with " CE " debossed on one side and " 152 " on the other side Tablets: 250 mg, 500 mg, and 750 mg ( 3 )
⛔ Contraindications ▾
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 ▾
5 WARNINGS AND PRECAUTIONS Anaphylactic reactions and allergic skin reactions, serious, occasionally fatal, may occur after first dose ( 4 , 5.7 ) Hematologic (including agranulocytosis, thrombocytopenia), and renal toxicities may occur after multiple doses ( 5.6 ) Hepatotoxicity: Severe, and sometimes fatal, hepatotoxicity has been reported. Discontinue immediately if signs and symptoms of hepatitis occur ( 5.8 ) Clostridium difficile -associated colitis: evaluate if diarrhea occurs ( 5.10 ) Prolongation of the QT interval and isolated cases of 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 ( 5.11 , 8.5 )
5.1Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects Fluoroquinolones, including levofloxacin, 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.
5.2Tendinitis 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 tablets 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) and Patient Counseling Information (17) ].
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 Warnings and Precautions (5.1) and Adverse React… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 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) ] Risk of Aortic Aneurysm and Dissection [see Warnings and Precautions (5.9) ] Clostridium difficile -Associated Diarrhea [see Warnings and Precautions (5.10) ] Prolongation of the QT Interval [see Warnings and Precautions (5.11) ] Musculoskeletal Disorders in Pediatric Patients [see Warnings and Precautions (5.12) ] Blood Glucose Disturbances [see Warnings and Precautions (5.13) ] Photosensitivity/Phototoxicity [see Warnings and Precautions (5.14) ] Development of Drug Resistant Bacteria [see Warnings and Precautions (5.15) ] 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) ]. The most common reactions (≥3%) were nausea, headache, diarrhea, insomnia, constipation and dizziness ( 6.2 ). To report SUSPECTED ADVERSE REACTIONS, contact Chartwell RX, LLC. at 1-845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
6.1Clinical 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 3-14 days, and the mean number of days on therapy was 10 days.
Table 4: Common (≥1%) Adverse Reactions Reported in Clinical Trials with levofloxacin # System/Organ Class Adverse Reaction % (N=7537) Infections and Infestations moniliasis 1 Psychiatric Disorders insomnia* [see Warnings and Precautions (5.4) ] 4 Nervous System Disorders headache dizziness [see Warnings and Precautions (5.4) ] 6 3 Respiratory, Thoracic and Mediastinal Disorders dyspnea [see Warnings and Precautions (5.7) ] 1 Gastrointestinal Disorders nausea diarrhea constipation abdominal pain vomiting dyspepsia 7 5 3 2 2 2 Skin and Subcutaneous Tissue Disorders rash [see Warnings and Precautions (5.7) ] pruritus 2 1 Reproductive System and Breast Disorders vaginitis 1 † General Disorders and Administration Site Conditions edema injection site reaction chest pain 1 1 1 * N=7274 † N=3758 (women) # pool of studies included IV and oral administration 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… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Interacting Drug Interaction Multivalent cation-containing products including antacids, metal cations or didanosine Absorption of levofloxacin is decreased when the tablets are taken within 2 hours of these products. ( 2.4 , 7.1 ) Warfarin Effect may be enhanced. Monitor prothrombin time, INR and watch for bleeding ( 7.2 ) Antidiabetic agents Carefully monitor blood glucose ( 5.13 , 7.3 )
7.1Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins 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 levofloxacinadministration.
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) and Patient Counseling Information (17) ].
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 (5.13) , Adverse Reactions (6.2) , and Patient Counseling Information (17) ].
7.4Non-Steroidal Anti-Inflammatory Drugs The concomitant administration of a non-steroidal anti-inflammatory drug with a fluoroquinolone, including levofloxacin, 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 in a clinical study involving healthy volunteers. However, elevated serum levels of cyclosporine have b… [Excerpted — this section continues on DailyMed.]
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Geriatrics : Severe hepatotoxicity has been reported. The majority of reports describe patients 65 years of age or older ( 5.8 , 8.5 , 17 ). May have increased risk of tendinopathy (including rupture), especially with concomitant corticosteroid use ( 5.2 , 8.5 , 17 ).
May be more susceptible to prolongation of the QT interval. ( 5.11 , 8.5 , 17 ). Pediatrics: Musculoskeletal disorders (arthralgia, arthritis, tendinopathy, and gait abnormality) seen in more levofloxacin-treated patients than in comparator.
Shown to cause arthropathy and osteochondrosis in juvenile animals ( 5.12 , 8.4 , 13.2 ). Safety in pediatric patients treated for more than 14 days has not been studied. Risk-benefit appropriate only for the treatment of inhalational anthrax (post-exposure) ( 1.7 , 2.2 , 8.4 , 14.9 ) and plague ( 1.8 , 2.2 , 8.4 , 14.10 ) Lactation: Breastfeeding is not recommended during treatment, but a lactating woman may pump and discard breastmilk during treatment and an additional 2 days after the last dose.
In patients treated for inhalational anthrax (post exposure), consider the risks and benefits of continuing breastfeeding.
8.1Pregnancy Risk Summary Published information from case reports, case control studies and observational studies on levofloxacin administered during pregnancy have not identified any drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of levofloxacin to pregnant rats and rabbits during organogenesis at doses up to 9.4 times and 1.1 times the maximum recommended human dose (MRHD), respectively, did not result in teratogenicity.
Fetal toxicity was seen in the rat study, but was absent at doses up to 1.2 times the maximum recommended human dose (see Data) . 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 risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Levofloxacin was not teratogenic in an embryofetal development study in rats treated during organogenesis with oral doses as high as 810 mg/kg/day which corresponds to 9.4 times the MRHD (based upon doses normalized for total body surface area). The oral dose of 810 mg/kg/day (high dose) to rats caused decreased fetal body weight and increased fetal mortality that was not seen at the next lower dose (mid-dose, 90 mg/kg/day, equivalent to 1.2 times the MRHD (based upon doses normalized for total body surface area).
Maternal toxicity was limited to lower weight gain in the mid and high dose groups. No teratogenicity was observed in an embryofetal development study in rabbits dosed orally during organogenesis with doses as high as 50 mg/kg/day, which corresponds to 1.1 times the MRHD (based upon doses normalized for total body surface area). Maternal toxicity at that dose consisted of lower weight gain and decreased food consumption relative to controls and abortion in four of sixteen dams.
8.2Lactation Risk Summary Published literature reports that levofloxacin is present in human milk following intravenous and oral administration ( see Data ). There is no information regarding effects of levofloxacin on milk production or the breastfed infant. Because of the potential risks of serious adverse reactions, in breastfed infants, for most indications, a lactating woman may consider pumping and discarding breast milk during treatment with levofloxacin and an additional two days (five half-lives) after the last dose.
Alternatively, advise a lactating woman that breastfeeding is not recommended during treatment with levofloxacin and for an additional two days (five half-lives) after the last dose [ see Use in Specific Populations (8.4) and Clinical Pharmacology… [Excerpted — this section continues on DailyMed.]
🆘 Overdosage ▾
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 (approximately 10 or 19 times MRHD in mice and rats, respectively) and 250 mg/kg IV produced significant mortality (estimated to be greater than or equal to 50%) in rodents.
🧬 Clinical Pharmacology ▾
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 administration of the oral tablets, 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 ± 1.0 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 ± 30 750 mg oral tablet 4* 9.3 ± 1.6 1.6 ± 0.8 101 ± 20 129 ± 24 83 ± 17 7.5 ±
0.9ND 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 ± 31 750 mg every 24h oral tablet 4 8.6 ± 1.9 1.4 ± 0.5 90.7 ± 17.6 143 ± 29 100 ± 16 8.8 ± 1.5 116 ± 28 500 mg oral tablet single dose, effects of gender and age: Male 5 5.5 ± 1.1 1.2 ± 0.4 54.4 ± 18.9 166 ± 44 89 ± 13 7.5 ± 2.1 126 ± 38 Female 6 7.0 ± 1.6 1.7 ± 0.5 67.7 ± 24.2 136 ± 44 62 ± 16 6.1 ± 0.8 106 ± 40 Young 7 5.5 ± 1.0 1.5 ± 0.6 47.5 ± 9.8 182 ± 35 83 ± 18 6.0 ± 0.9 140 ± 33 Elderly 8 7.0 ± 1.6 1.4 ± 0.5 74.7 ± 23.3 121 ± 33 67 ± 19 7.6 ± 2.0 91 ± 29 500 mg oral single dose tablet, patients with renal impairment: 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 ± 1.0 263.5 ± 72.5 33 ± 8 ND 35 ± 5 13 ± 3 Hemodialysis 5.7 ± 1.0 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 18-53 years of age 4 healthy male and female subjects 18-54 years of age 5 healthy males 22-75 years of age 6 healthy females 18-80 years of age 7 young healthy male and female subjects 18-36 years of age 8 healthy elderly male and female subjects 66-80 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. Levofloxacin pharmacokinetics are linear and predictable after single and multiple oral or IV dosing regimens.
Steady-state conditions are reached within 48 hours following a 500 mg or 750 mg once-daily dosage regimen. The mean ± SD peak and trough plasma concentrations attained following multiple once-daily oral dosage regimens were approximately 5.7 ± 1.4 and 0.5 ± 0.2 mcg/mL after the 500 mg doses, and 8.6 ± 1.9 and 1.1 ± 0.4 mcg/mL after the 750 mg doses, respectively. The mean ± SD peak and trough plasma concentrations attained following multiple once-daily IV regimens were approximately 6.4 ± 0.8 and 0.6 ± 0.2 mcg/mL after the 500 mg doses, and 12.1 ± 4.1 and 1.3 ± 0.71 mcg/mL after the 750 mg doses, respectively.
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 ± 1.0 mcg/mL after a 500 mg dose infused over 60 minutes and 11.5 ± 4.0 mcg/mL after a 750 mg dose infused over 90 minutes. Oral administration of a 500 mg dose of levofloxacin tablet with food prolongs the time to peak concentration by approximately 1 hour and decreases the peak concentration by approximately 14% following tablet and approximately 25% following oral solution administration.
Therefore, levofloxacin tablets can be administered without regard to food. The plasma concentration profile of levofloxacin after IV administration is similar and compa… [Excerpted — this section continues on DailyMed.]
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Levofloxacin tablets, USP are supplied as 250, 500, and 750 mg oval-shaped, coated tablets. Levofloxacin tablets, USP are packaged in bottles and in unit-dose blister strips in the following configurations: 250 mg: White to off white, Oval shaped, standard convex Film-coated tablets with "CE" debossed on one side and "150" on the other side. 250 mg bottles of 14 Tablets (NDC 62135-655-14) 500 mg: White to off white, Oval shaped, standard convex Film-coated tablets with "CE" debossed on one side and "151" on the other side.
500 mg bottles of 50 Tablets (NDC 62135-656-50) 750 mg: White to off white, Oval shaped, standard convex Film-coated tablets with "CE" debossed on one side and "152" on the other side. 750 mg bottles of 14 Tablets (NDC 62135-657-14) and bottles of 20 Tablets (NDC 62135-657-20) Dispense in a well-closed container as defined in the USP. Use child-resistant closure (as required).
Store at 20ºC to 25ºC (68ºF to 77ºF) [See USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Levofloxacin tablets, USP is a synthetic 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 The empirical formula is C 18 H 20 FN 3 O 4 •½ H 2 O and the molecular weight is 370.38. Levofloxacin, USP is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine.
The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin, 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 .
Levofloxacin tablets, USP are available as film-coated tablets and contain the following inactive ingredients: 250 mg (as expressed in the anhydrous form): corn starch, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, and titanium dioxide . 500 mg (as expressed in the anhydrous form): corn starch, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, and titanium dioxide. 750 mg (as expressed in the anhydrous form): corn starch, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, and titanium dioxide.
Meets USP dissolution test 4. image description
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide) Serious Adverse Reactions Advise patients to stop taking levofloxacin 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. 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, patients can develop wa… [Excerpted — this section continues on DailyMed.]
💬 Medication Guide ▾
MEDICATION GUIDE LEVOFLOXACIN TABLETS, USP [LEE-voe-FLOX-a-sin] What is the most important information I should know about levofloxacin tablets? 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 tablets, you should stop taking levofloxacin tablets 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 tablets. 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 tablets is higher if you: are over 60 years of age are taking steroids (corticosteroids) have had a kidney, heart or lung transplant. Tendon problems can happen in people who do not have the above risk factors when they take levofloxacin tablets. Other reasons that can increase your risk of tendon problems can include: physical activity or exercise kidney failure tendon problems in the past, such as in people with rheumatoid arthritis (RA) Stop taking levofloxacin tablets 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 tablets. Tendon ruptures can happen within hours or days of taking levofloxacin tablets and have happened up to several months after people have finished taking their fluoroquinolone.
Stop taking levofloxacin tablets immediately and get medical help right away if you get any of the following signs or symptoms of a tendon rupture: hear or feel a snap or pop in a tendon area bruising right after an injury in a tendon area unable to move the affected area or bear weight The tendon problems may be permanent. 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 tablets. Stop taking levofloxacin tablets 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. Mental health problems and seizures have been reported in people who take fluoroquinolone antibacterial medicines, including levofloxacin. Tell your healthcare provider if you have a history of mental health problems, including depression, or have a history of seizures before you start taking levofloxacin tablets.
CNS side effects may happen as soon as after taking the first dose of levofloxacin tablets. Stop taking levofloxacin tablets 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 or agitated • 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 • memory problems • reduced awareness of surroundings • false or strange thoughts or beliefs (delusions) The CNS changes may be permanent.
4. Worsening of myast… [Excerpted — this section continues on DailyMed.]
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Nosocomial Pneumonia Adult patients with clinically and radiologically documented nosocomial pneumonia were enrolled in a multicenter, randomized, open-label study comparing intravenous levofloxacin (750 mg once daily) followed by oral levofloxacin (750 mg once daily) for a total of 7-15 days to intravenous imipenem/cilastatin (500-1000 mg every 6-8 hours daily) followed by oral ciprofloxacin (750 mg every 12 hours daily) for a total of 7-15 days. Levofloxacin-treated patients received an average of 7 days of intravenous therapy (range: 1-16 days); comparator-treated patients received an average of 8 days of intravenous therapy (range: 1-19 days).
Overall, in the clinically and microbiologically evaluable population, adjunctive therapy was empirically initiated at study entry in 56 of 93 (60.2%) patients in the levofloxacin arm and 53 of 94 (56.4%) patients in the comparator arm. The average duration of adjunctive therapy was 7 days in the levofloxacin arm and 7 days in the comparator. In clinically and microbiologically evaluable patients with documented Pseudomonas aeruginosa infection, 15 of 17 (88.2%) received ceftazidime (N=11) or piperacillin/tazobactam (N=4) in the levofloxacin arm and 16 of 17 (94.1%) received an aminoglycoside in the comparator arm.
Overall, in clinically and microbiologically evaluable patients, vancomycin was added to the treatment regimen of 37 of 93 (39.8%) patients in the levofloxacin arm and 28 of 94 (29.8%) patients in the comparator arm for suspected methicillin-resistant S. aureus infection. Clinical success rates in clinically and microbiologically evaluable patients at the post-therapy visit (primary study endpoint assessed on day 3-15 after completing therapy) were 58.1% for levofloxacin and 60.6% for comparator. The 95% CI for the difference of response rates (levofloxacin minus comparator) was [-17.2, 12.0].
The microbiological eradication rates at the posttherapy visit were 66.7% for levofloxacin and 60.6% for comparator. The 95% CI for the difference of eradication rates (levofloxacin minus comparator) was [-8.3, 20.3]. Clinical success and microbiological eradication rates by pathogen are detailed in Table 9.
Table 9: Clinical Success Rates and Bacteriological Eradication Rates (Nosocomial Pneumonia) Pathogen N Levofloxacin No. (%) of Patients Microbiologic/ Clinical Outcomes N Imipenem/Cilastatin No. (%) of Patients Microbiologic/ Clinical Outcomes MSSA * 21 14 (66.7)/13 (61.9) 19 13 (68.4)/15 (78.9) P. aeruginosa † 17 10 (58.8)/11 (64.7) 17 5 (29.4)/7 (41.2) S. marcescens 11 9 (81.8)/7 (63.6) 7 2 (28.6)/3 (42.9) E. coli 12 10 (83.3)/7 (58.3) 11 7 (63.6)/8 (72.7) K. pneumoniae ‡ 11 9 (81.8)/5 (45.5) 7 6 (85.7)/3 (42.9) H. influenzae 16 13 (81.3)/10 (62.5) 15 14 (93.3)/11 (73.3) S. pneumoniae 4 3 (75.0)/3 (75.0) 7 5 (71.4)/4 (57.1) * Methicillin-susceptible S. aureus † See above text for use of combination therapy ‡ The observed differences in rates for the clinical and microbiological outcomes may reflect other factors that were not accounted for in the study
14.2Community-Acquired Pneumonia: 7-14 day Treatment Regimen Adult inpatients and outpatients with a diagnosis of community-acquired bacterial pneumonia were evaluated in 2 pivotal clinical studies. In the first study, 590 patients were enrolled in a prospective, multi-center, unblinded randomized trial comparing levofloxacin 500 mg once daily orally or intravenously for 7 to 14 days to ceftriaxone 1 to 2 grams intravenously once or in equally divided doses twice daily followed by cefuroxime axetil 500 mg orally twice daily for a total of 7 to 14 days.
Patients assigned to treatment with the control regimen were allowed to receive erythromycin (or doxycycline if intolerant of erythromycin) if an infection due to atypical pathogens was suspected or proven. Clinical and microbiologic evaluations were performed during treatment, 5 to 7 days posttherapy, and 3 to 4 weeks posttherapy. Clinical success (cure… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a lifetime bioassay in rats, levofloxacin exhibited no carcinogenic potential following daily dietary administration for 2 years; the highest dose (100 mg/kg/day) was 1.4 times the Maximum Recommended Human Dose (MRHD) (750 mg) after normalization for total body surface area. Levofloxacin did not shorten the time to tumor development of UV-induced skin tumors in hairless albino (Skh-1) mice at any levofloxacin dose level and was therefore not photo-carcinogenic under conditions of this study.
Dermal levofloxacin concentrations in the hairless mice ranged from 25 to 42 mcg/g at the highest levofloxacin dose level (300 mg/kg/day) used in the photo-carcinogenicity study. By comparison, dermal levofloxacin concentrations in human subjects receiving 750 mg of levofloxacin averaged approximately 11.8 mcg/g at C max . Levofloxacin was not mutagenic in the following assays: Ames bacterial mutation assay ( S. typhimurium and E. coli ), CHO/HGPRT forward mutation assay, mouse micronucleus test, mouse dominant lethal test, rat unscheduled DNA synthesis assay, and the mouse sister chromatid exchange assay.
It was positive in the in vitro chromosomal aberration (CHL cell line) and sister chromatid exchange (CHL/IU cell line) assays. Levofloxacin caused no impairment of fertility or reproductive performance in rats at oral doses as high as 360 mg/kg/day, corresponding to 4.2 times the MRHD and intravenous doses as high as 100 mg/kg/day, corresponding to 1.2 times the MRHD after normalization for total body surface area.
13.2Animal Toxicology and/or Pharmacology Levofloxacin and other quinolones have been shown to cause arthropathy in immature animals of most species tested [see Warnings and Precautions (5.12) ]. In immature dogs (4-5 months old), oral doses of 10 mg/kg/day for 7 days and intravenous doses of 4 mg/kg/day for 14 days of levofloxacin resulted in arthropathic lesions. Administration at oral doses of 300 mg/kg/day for 7 days and intravenous doses of 60 mg/kg/day for 4 weeks produced arthropathy in juvenile rats.
Three-month old beagle dogs dosed orally with levofloxacin at 40 mg/kg/day exhibited clinically severe arthrotoxicity resulting in the termination of dosing at Day 8 of a 14-day dosing routine (dosing was terminated in the low and mid-dose groups on Day 9 due to similar findings at the mid-dose). Slight musculoskeletal clinical effects, in the absence of gross pathological or histopathological effects, resulted from the lowest dose level of 2.5 mg/kg/day (approximately 0.2-fold the pediatric dose based upon AUC comparisons).
Synovitis and articular cartilage lesions were observed at the 10 and 40 mg/kg dose levels (approximately 0.7-fold and 2.4-fold the pediatric dose, respectively, based on AUC comparisons). Articular cartilage gross pathology and histopathology persisted to the end of the 18-week recovery period for those dogs from the 10 and 40 mg/kg/day dose levels. The low and mid-dose groups in that study were also evaluated by electron microscopy, revealing compound-related ultrastructural effects in articular cartilage chondrocytes at the end of treatment and at the end of recovery in both of those doses.
When tested in a mouse ear swelling bioassay, levofloxacin exhibited phototoxicity similar in magnitude to ofloxacin, but less phototoxicity than other quinolones. While crystalluria has been observed in some intravenous rat studies, urinary crystals are not formed in the bladder, being present only after micturition and are not associated with nephrotoxicity. In mice, the CNS stimulatory effect of quinolones is enhanced by concomitant administration of non-steroidal anti-inflammatory drugs.
In dogs, levofloxacin administered at 6 mg/kg or higher by rapid intravenous injection produced hypotensive effects. These effects were considered to be related to histamine release. In vitro and in vivo studies in animals indicate that… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
Levofloxacin Tablets, USP 250 mg - NDC 62135-655-14 - 14 Tablets - Bottle - Label Levofloxacin Tablets, USP 500 mg - NDC 62135-656-50 - 50 Tablets - Bottle - Label Levofloxacin Tablets, USP 750 mg - NDC 62135-657-14 - 14 Tablets - Bottle - Label Levofloxacin Tablets, USP 750 mg - NDC 62135-657-20 - 20 Tablets - Bottle - Label image description image description image description image description