Levofloxacin
Product Images NDC 61919-867

Product Visual Gallery

This gallery contains 30 technical images submitted to the FDA as part of the official labeling for Levofloxacin (NDC 61919-867). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Direct Rx, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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Image Description (Figure1)

Chemical structure diagram of Levofloxacin monohydrate showing its molecular formula (C18H20F N3O4 · ½ H2O) and molecular weight (370.38). The image displays bonds, atoms, and functional groups characteristic of Levofloxacin.*

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Image Description (Figure2)

A pharmacokinetic line graph comparing plasma concentration (mcg/mL) versus time (hours) for Levofloxacin 500 mg administered orally (p.o.) and intravenously (i.v.). The graph shows concentration peaks and decline over 36 hours for both dosage forms.*

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Image Description (Figure3)

Pharmacokinetic line graph showing plasma concentration (mcg/mL) of Levofloxacin over time (hours) comparing 750 mg tablet (oral) and 750 mg intravenous infusion (90 min). The chart illustrates plasma concentration changes post-administration for both dosage forms up to 36 hours.*

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Image Description (Levofloxacin 500(2))

Levofloxacin 500 mg 7 tablets packaging label with yellow background panel prominently displaying the product name and strength. The label identifies the generic for Levaquin and states each tablet contains 500 mg levofloxacin USP. Additional information includes labeler Direct RX, lot number, expiration date (12/18), dosage form, and manufacturer details with barcodes on the right side of the label.*

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Image Description (Levofloxacin 500)

Levofloxacin 500mg tablet bottle label, containing 14 tablets, labeled as generic for Levaquin. The label states each tablet contains 500 mg levofloxacin, USP, and is packaged and distributed by Direct RX in Alpharetta, GA. Includes lot number and expiration date fields, and general medication storage instructions.*

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Image Description (Levofloxacin 750)

Label for Levofloxacin 750 mg tablets, containing 7 tablets per package. The label indicates the product is generic for LEVAQUIN, with each tablet containing 750 mg of levofloxacin USP. The labeler is Direct RX, located in Alpharetta, GA. Various manufacturing and lot information are printed on the label.*

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Image Description (Table 1)

A table presenting dosage information for Levofloxacin in adult patients with normal renal function (creatinine clearance ≥ 50 mL/min). It lists types of infections, recommended dosages every 24 hours in milligrams, and treatment duration in days, covering various infections such as nosocomial pneumonia, community acquired pneumonia, bacterial sinusitis, bronchitis, skin infections, prostatitis, urinary tract infections, and plague. The table also includes dosage guidance for pediatric patients.*

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Image Description (Table10)

A data table titled 'Mean ± SD Levofloxacin PK Parameters' presenting pharmacokinetic parameters for different dosing regimens of Levofloxacin oral tablets, including single and multiple doses at 250 mg, 500 mg, and 750 mg strengths. The table includes variables such as Cmax, Tmax, AUC, clearance, volume of distribution, half-life, and renal clearance. It also shows effects of gender and age on 500 mg single dose oral tablet parameters.*

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Image Description (Table10a)

Table presenting pharmacokinetic parameters for a 500 mg oral single dose tablet of Levofloxacin in patients with varying degrees of renal insufficiency and under different conditions such as hemodialysis and CAPD. It includes clearance/bioavailability values and volume of distribution/bioavailability with age and health status categories for subjects.*

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Image Description (Table11)

A data table titled 'Susceptibility Test Interpretive Criteria for Levofloxacin' listing pathogens and their minimum inhibitory concentrations (mcg/mL) and disk diffusion zone diameter (mm) breakpoints for susceptibility (S), intermediate (I), and resistance (R). It includes various bacterial species such as Enterobacteriaceae, Enterococcus faecalis, Staphylococcus species, Pseudomonas aeruginosa, and others, with footnotes explaining susceptibility categorizations and testing notes.*

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Image Description (Table12)

A data table titled "Quality Control Ranges for Susceptibility Testing" listing microorganisms, their QC numbers, minimum inhibitory concentrations (MIC) in mcg/mL, and disk diffusion zone diameters in mm. It includes entries for Enterococcus faecalis, Escherichia coli, Haemophilus influenzae, Pseudomonas aeruginosa, Staphylococcus aureus, and Streptococcus pneumoniae with corresponding QC numbers, MIC ranges, and zone diameters.*

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Image Description (Table13)

A data table titled 'Clinical Success Rates and Bacteriological Eradication Rates (Nosocomial Pneumonia)' comparing the effectiveness of Levofloxacin and Imipenem/Cilastatin against various pathogens, including MSSA, P. aeruginosa, S. marcescens, E. coli, K. pneumoniae, H. influenzae, and S. pneumoniae. The table lists the number of patients and percentage outcomes for microbiologic and clinical success for each treatment and pathogen, with footnotes regarding methicillin-susceptible S. aureus, combination therapy, and factors affecting outcome differences.*

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Image Description (Table14)

A data table titled 'Table 14: Bacteriological Eradication Rates Across 2 Community Acquired Pneumonia Clinical Studies' showing pathogen names, number of pathogens, and corresponding bacteriological eradication rates in percentage.*

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Image Description (Table15)

A data table titled 'Clinical and Bacterial Success Rates for Levofloxacin-Treated MDRSP in Community Acquired Pneumonia Patients.' It presents clinical and bacteriological success rates, with patient counts and percentages, across various bacterial resistance categories including penicillin-resistant, 2nd generation cephalosporin resistant, macrolide-resistant, trimethoprim/sulfamethoxazole resistant, and tetracycline-resistant isolates.*

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Image Description (Table16)

A data table titled 'Clinical Success and Bacteriologic Eradication Rates for Resistant Streptococcus Pneumoniae (Community Acquired Pneumonia).' It shows clinical success and bacteriologic eradication rates across various resistance types, including resistance to 2, 3, 4, and 5 antibacterials, and bacteremia with MDRSP, with rates expressed as fractions and percentages.*

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Image Description (Table17)

A data table titled 'Bacteriological Eradication Rates (Community-Acquired Pneumonia)' listing eradication rates for various bacteria: S. pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, and Chlamydophila pneumoniae with percentages ranging from 87% to 100%.*

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Image Description (Table18)

A data table titled 'Clinical Success Rate by Pathogen at the TOC in Microbiologically Evaluable Subjects Who Underwent Antral Puncture (Acute Bacterial Sinusitis).' It shows the success rates of Levofloxacin 750 mg for 5 days and 500 mg for 10 days against three pathogens: Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis, with respective numerical success rates and percentages. Additional notes indicate that 40% of subjects had specimens obtained by sinus endoscopy, and the efficacy data for those subjects were comparable to the table results.*

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Image Description (Table19)

Table showing bacteriological eradication rates for chronic bacterial prostatitis comparing Levofloxacin (N=136) and Ciprofloxacin (N=125) across pathogens E. coli, E. faecalis, and S. epidermidis. It includes the number of cases and percentage eradication for each antibiotic.*

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Image Description (Table1a)

A text panel from a Levofloxacin product, listing pathogen-related information that guides use. It includes references to methicillin-susceptible bacteria like Staphylococcus aureus and Streptococcus pneumoniae, and details on therapy for infections by various pathogens such as Haemophilus influenzae, Klebsiella pneumoniae, and others. Also covers therapy indications for urinary tract infections and exposure to Yersinia pestis infection.*

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Image Description (Table2)

A table outlining dosages of Levofloxacin for pediatric patients aged 6 months and older by infection type. It includes dose amounts, frequency, and duration for inhalational anthrax and plague, separated by patient weight categories (above or below 50 kg). Additional footnotes provide administration guidance and safety information relevant to specific infections.*

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Image Description (Table20)

A data table titled 'Bacteriological Eradication at Test-of-Cure' comparing Levofloxacin 750 mg and Ciprofloxacin 400 mg across different populations. It presents eradication rates as counts and percentages for mITT and Microbiologically Evaluable Populations, detailing overall and subgroup results for cUTI and AP, including confidence intervals for overall differences.*

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Image Description (Table21)

A table titled 'Bacteriological Eradication Rates for Individual Pathogens Recovered From Patients Randomized to Levofloxacin 750 mg QD for 5 Days Treatment.' It lists three pathogens—Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis—with their respective bacteriological eradication rates and percentages after treatment.*

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Image Description (Table22)

A data table titled 'Table 22: Bacteriological Eradication Overall (cUTI or AP) at Test-of-Cure' comparing Levofloxacin 250 mg once daily for 10 days versus Ciprofloxacin 500 mg twice daily for 10 days. It presents eradication rates in the mITT Population and Microbiologically Evaluable Population with corresponding counts and percentages, including footnotes explaining posttherapy duration, population definitions, and criteria for evaluability.*

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Image Description (Table3)

A data table titled "Dosage Adjustment in Adult Patients With Renal Impairment (Creatinine Clearance < 50 mL/min)" detailing Levofloxacin dosage adjustments based on renal function and dialysis status. Dosage adjustments vary by dosage amount (750 mg, 500 mg, 250 mg) and renal clearance levels, including specific guidance for hemodialysis or chronic ambulatory peritoneal dialysis (CAPD).*

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Image Description (Table6)

A table listing common adverse reactions (≥1%) reported in clinical trials with Levofloxacin. It categorizes reactions by system/organ class such as infections, psychiatric, nervous, respiratory, gastrointestinal, skin, reproductive, and general disorders, along with percentage incidence out of 7537 subjects.*

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Image Description (Table7)

A data table titled 'Less Common (0.1 to 1%) Adverse Reactions Reported in Clinical Trials With Levofloxacin (N=7537)' listing adverse reactions by system or organ class. Categories include Infections and Infestations, Blood and Lymphatic System Disorders, Immune System Disorders, Metabolism and Nutrition Disorders, Psychiatric Disorders, Nervous System Disorders, and Respiratory, Thoracic and Mediastinal Disorders. The table details specific adverse reactions such as anemia, allergic reaction, hyperglycemia, anxiety, tremor, and epistaxis.*

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Image Description (Table7a)

A data table listing adverse reactions associated with Levofloxacin. Categories include cardiac disorders, vascular disorders, gastrointestinal disorders, hepatobiliary disorders, skin and subcutaneous tissue disorders, musculoskeletal and connective tissue disorders, and renal and urinary disorders, with specific conditions noted under each category.*

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Image Description (Table8)

A data table titled 'Postmarketing Reports of Adverse Drug Reactions' listing system/organ classes alongside specific adverse reactions. The table includes categories such as Blood and Lymphatic System Disorders, Immune System Disorders, Psychiatric Disorders, Nervous System Disorders, and Eye Disorders, with related adverse effects detailed for each class.*

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Image Description (Table8a)

A data table listing various adverse effects grouped by system disorders related to Levofloxacin use. Categories include eye disorders, ear and labyrinth disorders, cardiac disorders, vascular disorders, respiratory, thoracic, and mediastinal disorders, hepatobiliary disorders, skin and subcutaneous tissue disorders, musculoskeletal and connective tissue disorders, renal and urinary disorders, general disorders and administration site conditions, and investigations. Each category lists specific conditions or abnormalities observed, with references to warnings and precautions sections.*

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Image Description (Table9)

A data table titled 'Incidence of Musculoskeletal Disorders in Pediatric Clinical Trial' comparing Levofloxacin and Non-Fluoroquinolone groups. It shows the number of cases and percentages at 60 days and 1 year follow-up periods, along with p-values indicating statistical significance. Footnotes provide details on treatments and statistical tests used.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.