Safety profile of sparfloxacin in the treatment of respiratory tract infections.
A total of 2081 adult patients with community-acquired lower respiratory tract infections participated in Phase III clinical trials of sparfloxacin. A total of 1040 patients were randomised to sparfloxacin and 1041 patients received a comparator regimen. Sparfloxacin was administered as a 400 mg loading dose on day 1 followed by 200 mg once daily to patients with community-acquired pneumonia and as a 200 mg loading dose on day 1 followed by 100 mg daily to patients with acute exacerbations of chronic obstructive pulmonary disease. Comparator regimens were amoxycillin/clavulanic acid 500/125 mg tid, amoxycillin 1000 mg tid, a combination of amoxycillin 1000 mg tid plus ofloxacin 200 mg bid or erythromycin 1000 mg bid. The incidence of adverse events, the incidence and severity of antibacterial-related adverse events and the incidence of antibacterial discontinuation due to adverse events were no different among patients treated with sparfloxacin compared with those who received a comparator antibacterial agent. Sparfloxacin appears to be as well tolerated as other oral antibacterial regimens commonly used to treat lower respiratory tract infections.
Rubinstein
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Infectious Diseases Unit, Sheba Medical Center, Tel Aviv University Sackler School of Medicine, Tel-Hashomer, Israel.
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000890:Anti-Infective Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D017326:Clinical Trials, Phase III as Topic; D017714:Community-Acquired Infections / Q000188:drug therapy; D004334:Drug Administration Schedule; D005260:Female; D024841:Fluoroquinolones; D006801:Humans; D008173:Lung Diseases, Obstructive / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D018410:Pneumonia, Bacterial / Q000188:drug therapy; D015363:Quinolones / Q000009:adverse effects* / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012141:Respiratory Tract Infections / Q000188:drug therapy*
D000890:Anti-Infective Agents; D024841:Fluoroquinolones; D015363:Quinolones; C061363:sparfloxacin