Cephalosporins類抗生素 (五代)

Pneumonia, community-acquired(CAP): In patients >2 months caused by S. pneumoniae, S. aureus, H. influenzae, K. pneumoniae, K. oxytoca, and E. coli.
Skin and skin structure infections(SSTI): Acute bacterial infections in adults and pediatric patients (>34 weeks gestational age and 12 days postnatal age)<20210426> caused by S. aureus, S. pyogenes, S. agalactiae, E. coli, K. pneumoniae, and K. oxytoca.
#仿單變更2020 #仿單變更2021

Antibiotic, Cephalosporin (Fifth Generation)

The pharmacokinetics in pediatric patients from 2 months to <18 years of age were similar to those in adult patients.
Distribution:
1. Vd: Median: 20.3 L (range: 18.3-21.6 L)
2. Protein binding: ~20%
Metabolism:
Ceftaroline fosamil (inactive prodrug) undergoes rapid conversion to bioactive ceftaroline in plasma by phosphatase enzyme; Ceftaroline is hydrolyzed to form inactive ceftaroline M-1 metabolite
Excretion:
Urine (~88%); feces (~6%)
Pharmacodynamics:
1. Half-life elimination: 1.6 ± 0.38 hours (single dose); 2.66 ± 0.4 hours (multiple dose)
2. Time to peak: ~1 hour

Known serious hypersensitivity to ceftaroline, other members of the cephalosporin class, or any component of the formulation

Adverse events have been observed in some animal reproduction studies.

It is not known if ceftaroline fosamil is excreted in breast milk. The manufacturer recommends that caution be exercised when administering ceftaroline fosamil to nursing women.

Common:
Rash, SCAR(Severe Cutaneous Adverse Reactions), including SJS, TEN, DRESS, AGEP. <2020/10/27>, diarrhea, nausea, vomiting, fever, clostridium difficile diarrhea, ALT/SGPT level raised , AST/SGOT level raised, hepatitis, anaphylaxis, hypersensitivity reaction, seizure, renal failure
Post-marketing:
Encephalopathy, Eosinophilic pneumonia <20210426>

1. 600mg Q12H (slow IV infusion over 5-60 minutes)
2. High dose is only used to treat adult patients with confirmed or suspected cSSTI caused by S.aureus (MIC for ceftaroline = 2 to 4 mL/L), the dose is 600mg Q8H infusion about 120 minutes.<20230413>

For moderate to severe renal impairment patients, neurotoxicity (including encephalopathy) risk may be increased. Ensure dose adjusted for renal function, and discontinue therapy if patient develops neurotoxicity.<20210426>

CrCl	Adult	12-18 years old (weight >33kg)	12-18 years old (weight <33kg)	2-12 years old
CrCl >50 mL/min	No dosage adjustment necessary
CrCl 30-50 mL/min	400mg Q12H (infusion over 5-60 minutes)	400mg Q12H (infusion over 5-60 minutes)	8mg/kg Q8H (infusion over 5-60 minutes), maximum 300mg/dose	8mg/kg Q8H (infusion over 5-60 minutes), maximum 300mg/dose
CrCl 15-30 mL/min	300mg Q12H (infusion over 5-60 minutes)	300mg Q12H (infusion over 5-60 minutes)	6mg/kg Q8H (infusion over 5-60 minutes), maximum 200mg/dose	6mg/kg Q8H (infusion over 5-60 minutes), maximum 200mg/dose
CrCl <15 mL/min	200mg Q12H
ESRD patients receiving hemodialysis	200mg Q12H (dose should be given after hemodialysis on dialysis days)

There are no dosage adjustments provided in the manufacturer's labeling.

Store at 30°C