LEVOFLOXACIN (Page 6 of 15)

6.1 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 7,537 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 tablets 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 = 7,274

N = 3,758 (women)

# pool of studies included IV and oral administration

System/Organ Class Adverse Reaction % (N = 7,537)
Infections and Infestations moniliasis 1
Psychiatric Disorders insomnia * [see Warnings and Precautions (5.4)] 4
Nervous System Disorders headache dizziness [see Warnings and Precautions (5.4)] 6 3
Respiratory, Thoracic and Mediastinal Disorders dyspnea [see Warnings and Precautions (5.7)] 1
Gastrointestinal Disorders nausea diarrhea constipation abdominal pain vomiting dyspepsia 7 5 3 2 2 2
Skin and Subcutaneous Tissue Disorders rash [see Warnings and Precautions (5.7)] pruritus 2 1
Reproductive System and Breast Disorders Vaginitis 1
General Disorders and Administration Site Conditions edema injection site reaction chest pain 1 1 1
Table 5: Less Common (0.1 to 1%) Adverse Reactions Reported in Clinical Trials with Levofloxacin (N = 7,537)
System/Organ Class Adverse Reaction
Infections and Infestations genital moniliasis
Blood and Lymphatic System Disorders anemia thrombocytopenia granulocytopenia [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 ( 5.13)] hyperkalemia
Psychiatric Disorders anxiety agitation confusion depression nightmare * [see Warnings and Precautions ( 5.4)] sleep disorder * anorexia abnormal dreaming *
Nervous System Disorders tremor convulsions [see Warnings and Precautions ( 5.4)] paresthesia [see Warnings and Precautions ( 5.3)] vertigo hypertonia hyperkinesias abnormal gait
Table 5: Less Common (0.1 to 1%) Adverse Reactions Reported in Clinical Trials with Levofloxacin (N = 7,537)
somnolence * syncope
Respiratory, Thoracic and Mediastinal Disorders epistaxis
Cardiac Disorders cardiac arrest palpitation ventricular tachycardia ventricular arrhythmia
Vascular Disorders phlebitis
Gastrointestinal Disorders gastritis stomatitis pancreatitis esophagitis gastroenteritis glossitis pseudomembranous/ C. difficile colitis [see Warnings and Precautions ( 5.10)]
Hepatobiliary Disorders abnormal hepatic function increased hepatic enzymes increased alkaline phosphatase
Skin and Subcutaneous Tissue Disorders urticaria [see Warnings and Precautions ( 5.7)]
Musculoskeletal and Connective Tissue Disorders arthralgia tendinitis [see Warnings and Precautions ( 5.2)] myalgia skeletal pain
Renal and Urinary Disorders abnormal renal function acute renal failure [see Warnings and Precautions ( 5.6)]

*N = 7,274

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.

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