Adverse reactions occurring in ≥3% of pediatric patients aged 2 months to <18 years of age (pooled pediatric data)1 |
||
Adverse Reaction |
TEFLARO
(N=257) |
Pooled Comparators*
(N=102) |
Gastrointestinal disorders | ||
Diarrhea | 8% | 10% |
Nausea | 3% | 1% |
Constipation | 5% | 12% |
General and administrative site disorders | ||
Pyrexia | 3% | 2% |
Skin and subcutaneous tissue disorders | ||
Rash | 7% | 4% |
Adverse reactions occurring in ≥3% of pediatric patients aged 2 months to <18 years of age (pooled pediatric data)1 | ||
TEFLARO (N=257) |
Pooled Comparators* (N=102) |
|
Gastrointestinal disorders | ||
Diarrhea | ||
8% | 10% | |
Nausea | ||
3% | 1% | |
Constipation | ||
5% | 12% | |
General and administrative site disorders | ||
Pyrexia | ||
3% | 2% | |
Skin and subcutaneous tissue disorders | ||
Rash | ||
7% | 4% |
Comparators included vancomycin or cefazolin with or without aztreonam in the ABSSSI trial and ceftriaxone alone or ceftriaxone plus vancomycin in the CABP trials.1
No safety concerns were identified beyond those already known to be cephalosporin class effects1 |
Comparators included vancomycin or cefazolin with or without aztreonam in the ABSSSI trial and ceftriaxone alone or ceftriaxone plus vancomycin in the CABP trials.1
In a single study of pediatric patients with a gestational age of ≥34 weeks and a postnatal age of 12 days to less than 2 months of age (N=11), the safety findings were similar to those observed in adult and pediatric patients 2 months of age and older. |
Please also see full Prescribing Information.
Please also see full Prescribing Information.