Ceftaroline Fosamil (2 brand names, 1 dosage form, 1 route)
Available dosage forms: POWDER.
Routes of administration: INTRAVENOUS.
Brand Names
- CEFTAROLINE FOSAMIL
- TEFLARO
Contraindications
Ceftaroline fosamil for injection is contraindicated in patients with known serious hypersensitivity to ceftaroline or other members of the cephalosporin class. Anaphylaxis has been reported with ceftaroline.
Adverse Reactions
The following serious adverse reactions are described in greater detail in the Warnings and Precautions section Hypersensitivity Reactions [see Warnings and Precautions (5.1)] Clostridioides difficile-Associated diarrhea [see Warnings and Precautions (5.2)] Neurological Adverse Reactions [see Warnings and Precautions (5.3)] Direct Coombs’ Test Seroconversion [see Warnings and Precautions (5.4)]
Mechanism of Action
Ceftaroline is a cephalosporin antibacterial drug [see Microbiology (12.4)].
Overdosage
Ceftaroline fosamil for injection overdosage has occurred in patients with renal impairment. Reactions have included neurological sequelae, including encephalopathy [see Dosage and Administration (2.3), Warnings and Precautions (5.3) and Adverse Reactions (6.2)]. In the event of overdose, ceftaroline fosamil for injection should be discontinued and general supportive treatment given. Ceftaroline can be removed by hemodialysis. In subjects with ESRD administered 400 mg of ceftaroline fosamil for injection, the mean total recovery of ceftaroline in the dialysate following a 4-hour hemodialysis session started 4 hours after dosing was 76.5 mg (21.6% of the dose). However, no information is available on the use of hemodialysis to treat overdosage [see Clinical Pharmacology (12.3)].