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 AND 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 BRONCHITIS
    16. 1.14 ACUTE BACTERIAL SINUSITIS: 5-DAY AND 10-14 DAY 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 AND 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 RISK OF AORTIC ANEURYSM AND DISSECTION
    34. 5.10 CLOSTRIDIUM DIFFICILE-ASSOCIATED DIARRHEA
    35. 5.11 PROLONGATION OF THE QT INTERVAL
    36. 5.12 MUSCULOSKELETAL DISORDERS IN PEDIATRIC PATIENTS AND ARTHROPATHIC EFFECTS IN ANIMALS
    37. 5.13 BLOOD GLUCOSE DISTURBANCES
    38. 5.14 PHOTOSENSITIVITY/PHOTOTOXICITY
    39. 5.15 DEVELOPMENT OF DRUG RESISTANT BACTERIA
    40. 6.1 SERIOUS AND OTHERWISE IMPORTANT ADVERSE REACTIONS
    41. 6.2 CLINICAL TRIAL EXPERIENCE
    42. 6.3 POSTMARKETING EXPERIENCE
    43. 7.1 CHELATION AGENTS: ANTACIDS, SUCRALFATE, METAL CATIONS, MULTIVITAMINS
    44. 7.2 WARFARIN
    45. 7.3 ANTIDIABETIC AGENTS
    46. 7.4 NON-STEROIDAL ANTI-INFLAMMATORY DRUGS
    47. 7.5 THEOPHYLLINE
    48. 7.6 CYCLOSPORINE
    49. 7.7 DIGOXIN
    50. 7.8 PROBENECID AND CIMETIDINE
    51. 7.9 INTERACTIONS WITH LABORATORY OR DIAGNOSTIC TESTING
    52. 8.1 PREGNANCY
    53. 8.3 NURSING MOTHERS
    54. 8.4 PEDIATRIC USE
    55. 8.5 GERIATRIC USE
    56. 8.6 RENAL IMPAIRMENT
    57. 8.7 HEPATIC IMPAIRMENT
    58. 10 OVERDOSAGE
    59. 11 DESCRIPTION
    60. 12.1 MECHANISM OF ACTION
    61. 12.3 PHARMACOKINETICS
    62. 12.4 MICROBIOLOGY
    63. 13.1 CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
    64. 13.2 ANIMAL TOXICOLOGY AND/OR PHARMACOLOGY
    65. 16 HOW SUPPLIED/STORAGE AND HANDLING
    66. 14.1 NOSOCOMIAL PNEUMONIA
    67. 14.2 COMMUNITY-ACQUIRED PNEUMONIA: 7-14 DAY TREATMENT REGIMEN
    68. 14.3 COMMUNITY-ACQUIRED PNEUMONIA: 5-DAY TREATMENT REGIMEN
    69. 14.4 ACUTE BACTERIAL SINUSITIS: 5-DAY AND 10-14 DAY TREATMENT REGIMENS
    70. 14.5 COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS
    71. 14.6 CHRONIC BACTERIAL PROSTATITIS
    72. 14.7 COMPLICATED URINARY TRACT INFECTIONS AND ACUTE PYELONEPHRITIS: 5-DAY TREATMENT REGIMEN
    73. 14.8 COMPLICATED URINARY TRACT INFECTIONS AND ACUTE PYELONEPHRITIS: 10-DAY TREATMENT REGIMEN
    74. 14.9 INHALATIONAL ANTHRAX (POST-EXPOSURE)
    75. 14.10 PLAGUE
    76. 17 PATIENT COUNSELING INFORMATION
    77. MEDICATION GUIDE
    78. PRINCIPAL DISPLAY PANEL

Levofloxacin Product Label

The following document was submitted to the FDA by the labeler of this product Pharmaceutical Associates, Inc.. 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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