Levofloxacin (Page 5 of 15)

5.15 Development of Drug Resistant Bacteria

Prescribing levofloxacin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria [see Patient Counseling Information (17)].

6 ADVERSE REACTIONS

6.1 Serious and Otherwise Important 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)] .

6.2 Clinical 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
* N = 7274 N = 3758 (women)
System/Organ Class Adverse Reaction % (N = 7537)
Infections and Infestations moniliasis 1
Psychiatric Disorders insomnia* [see Warnings and Precautions (5.4)] 4
Nervous System Disorders headachedizziness [see Warnings and Precautions (5.4)] 63
Respiratory, Thoracic and Mediastinal Disorders dyspnea [see Warnings and Precautions (5.7)] 1
Gastrointestinal Disorders nauseadiarrheaconstipationabdominal painvomitingdyspepsia 753222
Skin and Subcutaneous Tissue Disorders rash [see Warnings and Precautions (5.7)] pruritus 21
Reproductive System and Breast Disorders vaginitis 1
General Disorders and Administration Site Conditions edemainjection site reactionchest pain 111
Table 5: Less Common (0.1 to 1%) Adverse Reactions Reported in Clinical Trials with Levofloxacin (N = 7537)
* N = 7274 In clinical trials using multiple-dose therapy, ophthalmologic abnormalities, including cataracts and multiple punctate lenticular opacities, have been noted in patients undergoing treatment with quinolones, including levofloxacin. The relationship of the drugs to these events is not presently established.
System/Organ Class Adverse Reaction
Infections and Infestations genital moniliasis
Blood and Lymphatic System Disorders anemiathrombocytopeniagranulocytopenia[see Warnings and Precautions (5.6)]
Immune System Disorders allergic reaction [see Warnings and Precautions (5.6, 5.7)]
Metabolism and Nutrition Disorders hyperglycemia hypoglycemia[see Warnings and Precautions (5.12)] hyperkalemia
Psychiatric Disorders anxietyagitationconfusiondepressionhallucinationnightmare* [see Warnings and Precautions (5.4)] sleep disorder* anorexiaabnormal dreaming*
Nervous System Disorders tremorconvulsions[see Warnings and Precautions (5.4)] paresthesia [see Warnings and Precautions (5.3)] vertigohypertoniahyperkinesiasabnormal gaitsomnolence* syncope
Respiratory, Thoracic and Mediastinal Disorders epistaxis
Cardiac Disorders cardiac arrestpalpitationventricular tachycardiaventricular arrhythmia
Vascular Disorders phlebitis
Gastrointestinal Disorders gastritisstomatitispancreatitisesophagitisgastroenteritisglossitispseudomembranous/C. difficile colitis [see Warnings and Precautions (5.9)]
Hepatobiliary Disorders abnormal hepatic functionincreased hepatic enzymesincreased alkaline phosphatase
Skin and Subcutaneous Tissue Disorders urticaria [see Warnings and Precautions (5.7)]
Musculoskeletal and Connective Tissue Disorders arthralgiatendinitis[see Warnings and Precautions (5.2)] myalgiaskeletal pain
Renal and Urinary Disorders abnormal renal functionacute renal failure [see Warnings and Precautions (5.6)]

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