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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  03/25/2004
 
Trade Name:  Cipro
 
Generic Name or Proper Name (*):  ciprofloxacin
 
Indications Studied:  Complicated UTI and pyelonephritis
 
Label Changes Summary:  * Indicated for the treatment of complicated urinary tract infections (cUTIs) and pyelonephritis in pediatric patients 1  17 years of age * Not drug of first choice due to increased adverse events compared to controls including events related to joints and/or surrounding tissues * Information on PK and dose in pediatric patients 1  17 years of age * The most frequent adverse events observed within 6 weeks of treatment initiation during the cUTI clinical trial were gastrointestinal 15% compared to 9% and musculoskeletal 9.3% compared to 6% in ciprofloxacin-treated compared to control-treated patients, respectively
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Bayer
 
Pediatric Exclusivity Granted Date:  12/18/2003
 
NNPS:  FALSE
 
Therapeutic Category:  Antibiotic
 
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