FDA Label for Levofloxacin

View Indications, Usage & Precautions

    1. WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS
    2. 1 INDICATIONS & USAGE
    3. 1.1 NOSOCOMIAL PNEUMONIA
    4. 1.2 COMMUNITY-ACQUIRED PNEUMONIA: 7-14 DAY TREATMENT REGIMEN
    5. 1.3 COMMUNITY-ACQUIRED PNEUMONIA: 5-DAY TREATMENT REGIMEN
    6. 1.4 COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS
    7. 1.5 UNCOMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS
    8. 1.6 CHRONIC BACTERIAL PROSTATITIS
    9. 1.7 INHALATIONAL ANTHRAX (POST-EXPOSURE)
    10. 1.8 PLAGUE
    11. 1.9 COMPLICATED URINARY TRACT INFECTIONS: 5-DAY TREATMENT REGIMEN
    12. 1.10 COMPLICATED URINARY TRACT INFECTIONS: 10-DAY TREATMENT REGIMEN
    13. 1.11 ACUTE PYELONEPHRITIS: 5 OR 10-DAY TREATMENT REGIMEN
    14. 1.12 UNCOMPLICATED URINARY TRACT INFECTIONS
    15. 1.13 ACUTE BACTERIAL EXACERBATION OF CHRONIC BHRONCHITIS
    16. 1.14 ACUTE BACTERIAL SINUSITIS: 5-DAY AND 10-14DAY TREATMENT REGIMENS
    17. 1.15 USAGE
    18. 2.1 DOSAGE IN ADULT PATIENTS WITH NORMAL RENAL FUNCTION
    19. 2.2 DOSAGE IN PEDIATRIC PATIENTS
    20. 2.3 DOSAGE ADJUSTMENT IN ADULTS WITH RENAL IMPAIRMENT
    21. 2.4 DRUG INTERACTION WITH CHELATION AGENTS: ANTACIDS, SUCRALFATE, METAL CATIONS, MULTIVITAMINS
    22. 2.5 ADMINISTRATION INSTRUCTIONS
    23. 3 DOSAGE FORMS & STRENGTHS
    24. 4 CONTRAINDICATIONS
    25. 5.1 DISABLING AND POTENTIALLY IRREVERSIBLE SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS AND TENDON RUPTURE, PERIPHERAL NEUROPATHY, AND CENTRAL NERVOUS SYSTEM EFFECTS
    26. 5.2 TENDINITIS AND TENDON RUPTURE
    27. 5.3 PERIPHERAL NEUROPATHY
    28. 5.4 CENTRAL NERVOUS SYSTEM EFFECTS
    29. 5.5 EXACERBATION OF MYASTHENIA GRAVIS
    30. 5.6 OTHER SERIOUS AND SOMETIMES FATAL ADVERSE REACTIONS
    31. 5.7 HYPERSENSITIVITY REACTIONS
    32. 5.8 HEPATOTOXICITY
    33. 5.9 CLOSTRIDIUM DIFFICILE- ASSOCIATED DIARRHEA
    34. 5.10 PROLONGATION OF THE QT INTERVAL
    35. 5.11 MUSCULOSKELETAL DISORDERS IN PEDIATRIC PATIENTS AND ARTHROPATHIC EFFECTS IN ANIMALS
    36. 5.12 BLOOD GLUCOSE DISTURBANCES
    37. 5.13 PHOTOSENSITIVITY/ PHOTOTOXICITY
    38. 5.14 DEVELOPMENT OF DRUG RESISTANT BACTERIA
    39. 6.1 SERIOUS AND OTHERWISE IMPORTANT ADVERSE REACTIONS
    40. 6.2 CLINICAL TRIAL EXPERIENCE
    41. 6.3 POSTMARKETING EXPERIENCE
    42. 7.1 CHELATION AGENTS: ANTACIDS, SUCRALFATE, METAL CATIONS, MULTIVITAMINS
    43. 7.2 WARFARIN
    44. 7.3 ANTIDIABETIC AGENTS
    45. 7.4 NON-STEROIDAL ANTI-INFLAMMATORY DRUGS
    46. 7.5 THEOPHYLLINE
    47. 7.6 CYCLOSPORINE
    48. 7.7 DIGOXIN
    49. 7.8 PROBENECID AND CIMETIDINE
    50. 7.9 INTERACTIONS WITH LABORATORY OR DIAGNOSTIC TESTING
    51. 8.1 PREGNANCY
    52. 8.3 NURSING MOTHERS
    53. 8.4 PEDIATRIC USE
    54. 8.5 GERIATRIC USE
    55. 8.6 RENAL IMPAIRMENT
    56. 8.7 HEPATIC IMPAIRMENT
    57. 10 OVERDOSAGE
    58. 11 DESCRIPTION
    59. 12.1 MECHANISM OF ACTION
    60. 12.3 PHARMACOKINETICS
    61. 12.4 MICROBIOLOGY
    62. 13.1 CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
    63. 13.2  ANIMAL TOXICOLOGY & OR PHARMACOLOGY
    64. 14.1 NOSOCOMIAL PNEUMONIA
    65. 14.2 COMMUNITY-ACQUIRED PNEUMONIA: 7-14 DAY TREATMENT REGIMEN
    66. 14.3 COMMUNITY-ACQUIRED PNEUMONIA: 5-DAY TREATMENT REGIMEN
    67. 14.4 ACUTE BACTERIAL SINUSITIS: 5-DAY AND 10-14 DAY TREATMENT REGIMENS
    68. 14.5 COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS
    69. 14.6 CHRONIC BACTERIAL PROSTATITIS
    70. 14.7 COMPLICATED URINARY TRACT INFECTIONS AND ACUTE PYELONEPHRITIS: 5-DAY TREATMENT REGIMEN
    71. 14.8 COMPLICATED URINARY TRACT INFECTIONS AND ACUTE PYELONEPHRITIS: 10-DAY TREATMENT REGIMEN
    72. 14.9 INHALATIONAL ANTHRAX (POST-EXPOSURE)
    73. 14.10 PLAGUE
    74. 15 REFERENCES
    75. 16 HOW SUPPLIED
    76. 17 PATIENT COUNSELING INFORMATION
    77. 17.1 SERIOUS ADVERSE REACTIONS
    78. 17.2 ANTIBACTERIAL RESISTANCE
    79. 17.3 ADMINISTRATION WITH FOOD, FLUIDS, AND CONCOMITANT MEDICATIONS
    80. 17.4 DRUG INTERACTIONS WITH INSULIN, ORAL HYPOGLYCEMIC AGENTS, AND WARFARIN
    81. 17.5 PLAGUE AND ANTHRAX STUDIES
    82. 17.6 FDA-APPROVED MEDICATION GUIDE
    83. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Levofloxacin Product Label

The following document was submitted to the FDA by the labeler of this product Aidarex Pharmaceuticals Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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