Overview
11. DESCRIPTION Ceftaroline fosamil for injection is a sterile, semi-synthetic, prodrug of the cephalosporin antibacterial class of beta-lactams (β- lactams). Chemically, the prodrug, ceftaroline fosamil monoacetate is (6 R ,7 R )-7-{(2 Z )-2-(ethoxyimino)-2-[5-(phosphonoamino)-1,2,4-thiadiazol-3-yl]acetamido}-3-{[4-(1-methylpyridin-1-ium-4-...
Mechanism of Action
12. CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Ceftaroline is a cephalosporin antibacterial drug [see Microbiology ( 12.4 )] . 12.2 Pharmacodynamics As with other beta-lactam antimicrobial agents, the time that unbound plasma concentration of ceftaroline exceeds the minimum inhibitory concentration (MIC) of the infecting organism has been shown to best correlate with efficacy in a neutropenic murine thigh infection model with S. aureus and S. pneumoniae . Exposure-response analysis of Phase 2/3 ABSSSI trials supports the recommended dosage regimen of ceftaroline fosamil for injection 600 mg every 12 hours by IV infusion over 1 hour.
Indications
- 1. INDICATIONS AND USAGE Ceftaroline fosamil for injection is a cephalosporin antibacterial indicated in adult and pediatric patients for the treatment of the following infection caused by designated susceptible bacteria: Acute bacterial skin and skin structure infections (ABSSSI) in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age) ( 1.1 ) Community-acquired bacterial pneumonia (CABP) in adult and pediatric patients 2 months of age and older ( 1.
Common Doses
- 600 mg
- 400 mg
- 12 mg
- 8 mg
Dosage
2. DOSAGE AND ADMINISTRATION Dosage of Ceftaroline Fosamil for Injection by Indication in Adult and Pediatric Patients ( 2.1 , 2.2) Indication Age Range Dosage Infusion Time Duration Acute Bacterial Skin and Skin Structure Infections (ABSSSI) 18 years and older 600 mg every 12 hours 5 to 60 minutes 5 to 14 days ≥2 years to 33 kg) 400 mg every 8 hours OR 600 mg every 12 hours 5 to 60 minutes 5 to 14 days ≥2 years to 33 kg) 400 mg every 8 hours OR 600 mg every12 hours 5 to 60 minutes 5 to 14 days ≥2 years to 33 kg) 400 mg every 8 hours OR 600 mg every 12 hours Pediatric Patients Less Than 2...
Contraindications
- 4. 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. Known serious hypersensitivity to ceftaroline or other members of the cephalosporin class. ( 4 )
Side Effects
- 6. 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 )] The most common adverse reactions occurring in >2 % of adult patients and ≥3% of pediatric patients are diarrhea, nausea, and rash.
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.