The tolerability profile of prophylactic norfloxacin in neutropenic patients.
Norfloxacin has been compared to placebo (136 patients), sulfamethoxazole plus trimethoprim (SXT, 72 patients) and oral vancomycin plus colistin (V/C, 61 patients) for the prevention of alimentary tract-associated infections during and after induction chemotherapy. These patients were evaluated for the safety and tolerability of each regimen by clinical and laboratory means. Most neutropenics involved, regardless of the regimen, experienced at least one adverse experience. The majority were felt to be unrelated to prophylactic study drug therapy. Of 139 patients who received norfloxacin, only two had drug-related adverse experiences, compared to two of 35 receiving SXT, five of 28 for VC, and none of 67 receiving placebo. In evaluating adverse experiences considered possibly drug related, 19 occurred on norfloxacin compared to 13 for placebo. Among neurologic adverse experiences, only one possibly related to norfloxacin occurred (confusion), while three occurred on placebo (confusion, decreased auditory acuity and hallucinations). Generally, no significant differences were seen between any of the regimens except for a higher frequency of diarrhea in those receiving V/C.
Corrado
M L
ML
Merck Sharp and Dohme Research Laboratories, West Point, Pennsylvania.
Struble
W E
WE
Hesney
M
M
D000380:Agranulocytosis / Q000150:complications*; D001424:Bacterial Infections / Q000517:prevention & control*; D002986:Clinical Trials as Topic; D003091:Colistin / Q000009:adverse effects; D003967:Diarrhea / Q000139:chemically induced; D005767:Gastrointestinal Diseases / Q000517:prevention & control; D006801:Humans; D007938:Leukemia / Q000150:complications / Q000188:drug therapy; D009503:Neutropenia / Q000150:complications*; D009643:Norfloxacin / Q000009:adverse effects*; D012871:Skin Diseases / Q000139:chemically induced; D013420:Sulfamethoxazole / Q000009:adverse effects; D014295:Trimethoprim / Q000009:adverse effects; D014640:Vancomycin / Q000009:adverse effects
D014640:Vancomycin; D014295:Trimethoprim; D013420:Sulfamethoxazole; D009643:Norfloxacin; D003091:Colistin