Levofloxacin (Page 6 of 17)

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 levofloxacinin 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 levofloxacinfor a wide variety of infectious diseases [see INDICATIONS AND USAGE (1)]. Patients received levofloxacindoses 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 levofloxacindoses of 750 mg once daily, 250 mg once daily, and 500 mg once or twice daily. Discontinuation of levofloxacindue 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 (5.6)]

4

Nervous System Disorders

headache

dizziness [see WARNINGS AND PRECAUTIONS (5.6)]

6

3

Respiratory, Thoracic and Mediastinal Disorders

dyspnea [see WARNINGS AND PRECAUTIONS (5.3)]

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 (5.3)]

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=7537)

*
N = 7274

System/Organ Class

Adverse Reaction

Infections and Infestations

genital moniliasis

Blood and Lymphatic System Disorders

anemia

thrombocytopenia

granulocytopenia

[see WARNINGS AND PRECAUTIONS (5.4)]

Immune System Disorders

allergic reaction [see WARNINGS AND PRECAUTIONS (5.3, 5.4)]

Metabolism and Nutrition Disorders

hyperglycemia

hypoglycemia

[see WARNINGS AND PRECAUTIONS (5.11)]

hyperkalemia

Psychiatric Disorders

anxiety

agitation

confusion

depression

hallucination

nightmare *

[see WARNINGS AND PRECAUTIONS (5.6)]

sleep disorder *

anorexia

abnormal dreaming *

Nervous System Disorders

tremor

convulsions

[see WARNINGS AND PRECAUTIONS (5.6)]

paresthesia [see WARNINGS AND PRECAUTIONS (5.8)]

vertigo

hypertonia

hyperkinesias

abnormal gait

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 (5.7)]

Hepatobiliary Disorders

abnormal hepatic function

increased hepatic enzymes

increased alkaline phosphatase

Skin and Subcutaneous Tissue Disorders

urticaria [see WARNINGS AND PRECAUTIONS (5.3)]

Musculoskeletal and Connective Tissue Disorders

arthralgia

tendinitis

[see WARNINGS AND PRECAUTIONS (5.1)]

myalgia

skeletal pain

Renal and Urinary Disorders

abnormal renal function

acute renal failure [see WARNINGS AND PRECAUTIONS (5.4)]

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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