Levofloxacin 750 mg Tablet, Film Coated, 14-count
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Fluoroquinolone Antibacterial class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 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 ↗- 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?
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?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 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 R75537T0T4
Hypromellose 2910 is a plant-derived thickening agent made from cellulose. It serves as a binder that holds tablet ingredients together, a film-coating for pills, and a viscosity controller in liquids.
-
UNII 0WZ8WG20P6
Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
-
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 B697894SGQ
Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
-
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 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.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 each | Per 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 | $5.51 / 14 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Levofloxacin 750 mg 00904-6353-61 | Major | 1 tablet | $0.267 | AB | Availability likely | — |
| Levofloxacin 750 mg 31722-0723-20 | Camber | 20 tablets | $0.267 | AB | Availability likely | — |
| Levofloxacin 750 mg 62135-0657-14 | Chartwell | 14 tablets | $0.267 | AB | Availability likely | — |
| Levofloxacin 750 mg 33342-0533-11 | Macleods | 100 tablets | — | AB | FDA listed | — |
| Levofloxacin 750 mg 43063-0459-05 | PD-Rx | 5 tablets | — | AB | FDA listed | — |
| Levofloxacin 750 mg 50090-3214-00 | A-S | 5 tablets | — | AB | FDA listed | — |
| Levofloxacin 750 mg 51407-0430-20 | Golden | 20 tablets | — | AB | FDA listed | — |
| Levofloxacin 750 mg 51655-0327-07 | Northwind | 7 tablets | — | AB | FDA listed | — |
| Levofloxacin 750 mg 55111-0281-01 | Dr. | 100 tablets | — | AB | FDA listed | — |
| Levofloxacin 750 mg 55154-5898-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| Levofloxacin 750 mg 60760-0769-10 | ST. | 10 tablets | — | AB | FDA listed | — |
| Levofloxacin 750 mg 63187-0833-05 | Proficient | 5 tablets | — | AB | FDA listed | — |
| levofloxacin 750 mg 65841-0693-01 | Zydus | 100 tablets | — | AB | FDA listed | — |
| Levofloxacin 750 mg 65862-0538-05 | Aurobindo | 500 tablets | — | AB | FDA listed | — |
| levofloxacin 750 mg 67296-2187-05 | Redpharm | 5 tablets | — | AB | FDA listed | — |
| Levofloxacin 750 mg 68071-1860-02 | NuCare | 20 tablets | — | AB | FDA listed | — |
| Levofloxacin 750 mg 68071-2074-05 | NuCare | 5 tablets | — | AB | FDA listed | — |
| Levofloxacin 750 mg 68071-3218-01 | NuCare | 10 tablets | — | AB | FDA listed | — |
| Levofloxacin 750 mg 68788-8340-01 | Preferred | 10 tablets | — | AB | FDA listed | — |
| levofloxacin 750 mg 68788-8809-01 | Preferred | 10 tablets | — | AB | FDA listed | — |
| Levofloxacin 750 mg 70518-0932-00 | REMEDYREPACK | 7 tablets | — | AB | Discontinued | — |
| Levofloxacin 750 mg 70518-0968-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Levofloxacin 750 mg 71335-0593-01 | Bryant | 10 tablets | — | AB | Discontinued | — |
| levofloxacin 750 mg 71335-2265-01 | Bryant | 10 tablets | — | AB | FDA listed | — |
| Levofloxacin 750 mg 72189-0338-07 | DirectRx | 7 tablets | — | AB | FDA listed | — |
| levofloxacin 750 mg 72578-0100-01 | Viona | 100 tablets | — | AB | FDA listed | — |
| Levofloxacin 750 mg 72789-0248-05 | PD-Rx | 5 tablets | — | AB | FDA listed | — |
| Levofloxacin 750 mgthis 76420-0817-14 | Asclemed | 14 tablets | — | AB | FDA listed | — |
| Levofloxacin 750 mg 80425-0077-01 | Advanced | 14 tablets | — | AB | FDA listed | — |
| Levofloxacin 750 mg 80425-0388-01 | Advanced | 7 tablets | — | AB | FDA listed | — |
| Levofloxacin 750 mg 68180-0242-01 | Lupin | 100 tablets | — | — | Discontinued | — |
| Levofloxacin 750 mg 85534-0098-00 | HAWAII | 5 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ 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?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 76420-0817-05 | 5 TABLET, FILM COATED in 1 BOTTLE (76420-817-05) | 2024-05-13 | Active |
| 76420-0817-07 | 7 TABLET, FILM COATED in 1 BOTTLE (76420-817-07) | 2024-05-13 | Active |
| 76420-0817-10 | 10 TABLET, FILM COATED in 1 BOTTLE (76420-817-10) | 2024-05-13 | Active |
| 76420-0817-14 You're viewing this | 14 TABLET, FILM COATED in 1 BOTTLE (76420-817-14) | 2024-05-13 | Active |
| 76420-0817-20 | 20 TABLET, FILM COATED in 1 BOTTLE (76420-817-20) | 2024-05-13 | Active |
| 76420-0817-30 | 30 TABLET, FILM COATED in 1 BOTTLE (76420-817-30) | 2024-05-13 | Active |
| 76420-0817-50 | 50 TABLET, FILM COATED in 1 BOTTLE (76420-817-50) | 2024-05-13 | Active |
| 76420-0817-55 | 500 TABLET, FILM COATED in 1 BOTTLE (76420-817-55) | 2024-05-13 | Active |
| 76420-0817-60 | 60 TABLET, FILM COATED in 1 BOTTLE (76420-817-60) | 2024-05-13 | Active |
| 76420-0817-90 | 90 TABLET, FILM COATED in 1 BOTTLE (76420-817-90) | 2024-05-13 | Active |
You're viewing one of 10 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 76420-0817-14?
What is the difference between NDC 76420-0817-14 and NDC 76420-0817-05?
What NDC number is used to bill for this package of Levofloxacin 750 mg Tablet, Film Coated?
🧭 About this NDC listing & data coverage
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. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Does this product come in other package sizes?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 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 to 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 to 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 tablets are 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 and other antibacterial drugs, levofloxacin 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 tablets are 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 tablets are 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 tablets are 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 tablets are 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 tablets are 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 tablets are 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 tablets are 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 mon…
⏱️ 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 for cUTI due to Escherichia c…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Levofloxacin tablets USP, 250 mg are terra pink colored capsule shaped, biconvex film-coated tablets, debossed with ‘13’ on one side and ‘T’ on the other side. Levofloxacin tablets USP, 500 mg are peach colored capsule shaped, biconvex film-coated tablets, debossed with ‘12’ on one side and ‘T’ on the other side. Levofloxacin tablets USP, 750 mg are white capsule shaped, biconvex film-coated tablets, debossed with ‘11’ on one side and ‘T’ on the other side.
Tablets: 250 mg, 500 mg, and 750 mg
⛔ Contraindications ▾
4 CONTRAINDICATIONS Levofloxacin tablets are contraindicated in persons with known hypersensitivity to levofloxacin, or other quinolone antibacterials [see Warnings and Precautions (5.3) ]. Known hypersensitivity to levofloxacin tablets 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 (6.1) ]. 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 (6.2) 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 Reactions (6 , 6…
🤒 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 ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 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 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 Infestations moniliasis 1 Psychiatric Disorde…
🔄 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 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 (6.2) 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 (6.1) , 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 been…
👥 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 to 4% and 15 to 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 Pharmacolo…
🤰 Pregnancy ▾
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 to 4% and 15 to 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.
🧒 Pediatric Use ▾
8.4Pediatric Use Quinolones, including levofloxacin, cause arthropathy and osteochondrosis in juvenile animals of several species. [see Warnings and Precautions (5.12) and Animal Toxicology and/or Pharmacology (13.2) ] . 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 of levofloxacin tablets in pediatric patients below the age of six months have not been established.
Pharmacokinetics following intravenous administration The pharmacokinetics of levofloxacin following a single intravenous dose were investigated in pediatric patients ranging in age from six months to 16 years. Pediatric patients cleared levofloxacin faster than adult patients resulting in lower plasma exposures than adults for a given mg/kg dose [see Clinical Pharmacology (12.3) and Clinical Studies (14.9) ] . Dosage in Pediatric Patients with Inhalational Anthrax or Plague For the recommended levofloxacin tablet dosage in pediatric patients with inhalational anthrax or plague, see Dosage and Administration (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. Adverse Reactions In clinical trials, 1534 pediatric patients (6 months to 16 years of age) were treated with oral and intravenous levofloxacin.
Pediatric patients 6 months to 5 years of age received levofloxacin 10 mg/kg twice a day and pediatric patients greater than 5 years of age received 10 mg/kg once a day (maximum 500 mg per day) for approximately 10 days. Levofloxacin tablets can only be administered to pediatric patients with inhalational anthrax (post-exposure) or plague who are 30 kg or greater due to the limitations of the available strengths [see Dosage and Administration (2.2) ] . A subset of pediatric patients 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.
Pediatric patients treated with levofloxacin had a significantly higher incidence of musculoskeletal disorders when compared to the non-fluoroquinolone-treated children as illustrated in Table 7. Levofloxacin tablets can only be administered to pediatric patients with inhalational anthrax (post-exposure) or plague who are 30 kg or greater due to the limitations of the available strengths [see Dosage and Administration (2.2) ]. 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: ceftriaxon…
🧓 Geriatric Use ▾
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 (6.2) ] . 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) ]. Epidemiologic studies report an increased rate of aortic aneurysm and dissection within two months following use of fluoroquinolones, particularly in elderly patients [see Warnings and Precautions (5.9) ].
Elderly patients may be more susceptible to drug-associated effects on the QT interval. Therefore, precaution should be taken when using levofloxacin 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 (5.11) ]. The pharmacokinetic properties of levofloxacin in younger adults and elderly adults do not differ significantly when creatinine clearance is taken into consideration.
However, since the drug is known to be substantially excreted by the kidney, the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Clinical Pharmacology (12.3) ] .
🆘 Overdosage ▾
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 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 ± 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 1.5 ± 0.6 47.5 ± 9.8 182 ± 35 83 ± 18 6 ± 0.9 140 ± 33 Elderly 8 7 ± 1.6 1.4 ± 0.5 74.7 ± 23.3 121 ± 33 67 ± 19 7.6 ± 2 91 ± 29 500 mg oral single dose tablet, patients with renal impairment: CLCR 50 to 80 mL/min 7.5 ± 1.8 1.5 ± 0.5 95.6 ± 11.8 88 ± 10 ND 9.1 ± 0.9 57 ± 8 CLCR 20 to 49 mL/min 7.1 ± 3.1 2.1 ± 1.3 182.1 ± 62.6 51 ± 19 ND 27 ± 10 26 ± 13 CLCR <20 mL/min 8.2 ± 2.6 1.1 ± 1 263.5 ± 72.5 33 ± 8 ND 35 ± 5 13 ± 3 Hemodialysis 5.7 ± 1 2.8 ±
2.2ND ND ND 76 ± 42 ND CAPD 6.9 ± 2.3 1.4 ±
1.1ND ND ND 51 ± 24 ND 1 clearance/bioavailability 2 volume of distribution/bioavailability 3 healthy males 18 to 53 years of age 4 healthy male and female subjects 18 to 54 years of age 5 healthy males 22 to 75 years of age 6 healthy females 18 to 80 years of age 7 young healthy male and female subjects 18 to 36 years of age 8 healthy elderly male and female subjects 66 to 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 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. Oral administration of a 500 mg dose of levofloxacin 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 compara…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Levofloxacin is a member of the fluoroquinolone class of antibacterial agents [see Microbiology (12.4) ] .
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Levofloxacin Tablets USP, 250 mg are terra pink colored capsule shaped, biconvex film-coated tablets, debossed with ‘13’ on one side and ‘T’ on the other side. Bottles of 5 NDC 76420-815-05 (repackaged from NDC 65862-536-XX) Bottles of 7 NDC 76420-815-07 (repackaged from NDC 65862-536-XX) Bottles of 10 NDC 76420-815-10 (repackaged from NDC 65862-536-XX) Bottles of 14 NDC 76420-815-14 (repackaged from NDC 65862-536-XX) Bottles of 20 NDC 76420-815-20 (repackaged from NDC 65862-536-XX) Bottles of 30 NDC 76420-815-30 (repackaged from NDC 65862-536-XX) Bottles of 50 NDC 76420-815-50 (relabeled from NDC 65862-536-50) Bottles of 60 NDC 76420-815-60 (repackaged from NDC 65862-536-XX) Bottles of 90 NDC 76420-815-90 (repackaged from NDC 65862-536-XX) Bottles of 1000 NDC 76420-815-00 (relabeled from NDC 65862-536-99) Levofloxacin Tablets USP, 500 mg are peach colored capsule shaped, biconvex film-coated tablets, debossed with ‘12’ on one side and ‘T’ on the other side.
Bottles of 5 NDC 76420-816-05 (repackaged from NDC 65862-537-XX) Bottles of 7 NDC 76420-816-07 (repackaged from NDC 65862-537-XX) Bottles of 10 NDC 76420-816-10 (repackaged from NDC 65862-537-XX) Bottles of 14 NDC 76420-816-14 (repackaged from NDC 65862-537-XX) Bottles of 20 NDC 76420-816-20 (repackaged from NDC 65862-537-XX) Bottles of 30 NDC 76420-816-30 (repackaged from NDC 65862-537-XX) Bottles of 50 NDC 76420-816-50 (relabeled from NDC 65862-537-50) Bottles of 60 NDC 76420-816-60 (repackaged from NDC 65862-537-XX) Bottles of 90 NDC 76420-816-90 (repackaged from NDC 65862-537-XX) Bottles of 1000 NDC 76420-816-00 (relabeled from NDC 65862-537-99) Levofloxacin Tablets USP, 750 mg are white capsule shaped, biconvex film-coated tablets, debossed with ‘11’ on one side and ‘T’ on the other side.
Bottles of 5 NDC 76420-817-05 (repackaged from NDC 65862-538-XX) Bottles of 7 NDC 76420-817-07 (repackaged from NDC 65862-538-XX) Bottles of 10 NDC 76420-817-10 (repackaged from NDC 65862-538-XX) Bottles of 14 NDC 76420-817-14 (repackaged from NDC 65862-538-XX) Bottles of 20 NDC 76420-817-20 (relabeled from NDC 65862-538-20) Bottles of 30 NDC 76420-817-30 (repackaged from NDC 65862-538-XX) Bottles of 50 NDC 76420-817-50 (repackaged from NDC 65862-538-XX) Bottles of 60 NDC 76420-817-60 (repackaged from NDC 65862-538-XX) Bottles of 90 NDC 76420-817-90 (repackaged from NDC 65862-538-XX) Bottles of 500 NDC 76420-817-55 (relabeled from NDC 65862-538-05) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] in well-closed containers.
📋 Description ▾
11 DESCRIPTION Levofloxacin tablets are synthetic antibacterial agents 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 molecular 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 pale or bright yellow, 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, 500 mg and 750 mg (as expressed in the anhydrous form): croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, and titanium dioxide. In addition 250 mg contains iron oxide red and 500 mg contains iron oxide red and iron oxide yellow. Meets USP dissolution test 4 Chemical Structure
💬 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…
💬 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 tablets, 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 are 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 burning tingling numbness weakness 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 tablets. 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 hear voices, see things, or sense things that are not there (hallucinations) feel restless or agitated tremors feel anxious or nervous confusion depression reduced awareness of surroundings trouble sleeping nightmares feel lightheaded or dizzy feel more suspicious (paranoia) suicidal thoughts or acts headaches that will not go away, with or without blurred vision memory problems false or strange thoughts or beliefs (delusions) The CNS changes may be permanent.
4. Worsening of myasthenia gravis (a problem…