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Levofloxacin in 5% Dextrose Injection, USP Index Section

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS

1 INDICATIONS AND USAGE

1.1 Nosocomial Pneumonia

1.2 Community-Acquired Pneumonia: 7–14 day Treatment Regimen

1.3 Community-Acquired Pneumonia: 5-day Treatment Regimen

1.4 Complicated Skin and Skin Structure Infections

1.5 Uncomplicated Skin and Skin Structure Infections

1.6 Chronic Bacterial Prostatitis

1.7 Inhalational Anthrax (Post-Exposure)

1.8 Plague

1.9 Complicated Urinary Tract Infections: 5-day Treatment Regimen

1.10 Complicated Urinary Tract Infections: 10-day Treatment Regimen

1.11 Acute Pyelonephritis: 5 or 10-day Treatment Regimen

1.12 Uncomplicated Urinary Tract Infections

1.13 Acute Bacterial Exacerbation of Chronic Bronchitis

1.14 Acute Bacterial Sinusitis: 5-day and 10–14 day Treatment Regimens

1.15 Usage

2 DOSAGE AND ADMINISTRATION

2.1 Dosage in Adult Patients with Normal Renal Function

2.2 Dosage in Pediatric Patients

2.3 Dosage Adjustment in Adults with Renal Impairment

2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins

2.5 Administration Instructions

2.6 Preparation of Intravenous Product

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects

5.2 Tendinitis and Tendon Rupture

5.3 Peripheral Neuropathy

5.4 Central Nervous System Effects

5.5 Exacerbation of Myasthenia Gravis

5.6 Other Serious and Sometimes Fatal Adverse Reactions

5.7 Hypersensitivity Reactions

5.8 Hepatotoxicity

5.9 Risk of Aortic Aneurysm and Dissection

5.10 Clostridium difficile-Associated Diarrhea

5.11 Prolongation of the QT Interval

5.12 Musculoskeletal Disorders in Pediatric Patients and Arthropathic Effects in Animals

5.13 Blood Glucose Disturbances

5.14 Photosensitivity/Phototoxicity

5.15 Development of Drug Resistant Bacteria

6 ADVERSE REACTIONS

6.1 Serious and Otherwise Important Adverse Reactions

6.2 Clinical Trial Experience

6.3 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins

7.2 Warfarin

7.3 Antidiabetic Agents

7.4 Non-Steroidal Anti-Inflammatory Drugs

7.5 Theophylline

7.6 Cyclosporine

7.7 Digoxin

7.8 Probenecid and Cimetidine

7.9 Interactions with Laboratory or Diagnostic Testing

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

8.7 Hepatic Impairment

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

12.4 Microbiology

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

14.1 Nosocomial Pneumonia

14.2 Community-Acquired Pneumonia: 7–14 day Treatment Regimen

14.3 Community-Acquired Pneumonia: 5-day Treatment Regimen

14.4 Acute Bacterial Sinusitis: 5-day and 10–14 day Treatment Regimens

14.5 Complicated Skin and Skin Structure Infections

14.6 Chronic Bacterial Prostatitis

14.7 Complicated Urinary Tract Infections and Acute Pyelonephritis: 5-day Treatment Regimen

14.8 Complicated Urinary Tract Infections and Acute Pyelonephritis: 10-day Treatment Regimen

14.9 Inhalational Anthrax (Post-Exposure)

14.10 Plague

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*
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