Drug Detail:Ceftaroline (Ceftaroline [ sef-ta-roe-leen ])
Drug Class: Next generation cephalosporins
Usual Adult Dose for Pneumonia
600 mg IV every 12 hours
Duration of therapy:
- Acute bacterial skin and skin structure infections (ABSSSI): 5 to 14 days
- Community-acquired bacterial pneumonia (CABP): 5 to 7 days
Uses:
- For the treatment of ABSSSI due to susceptible isolates of Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, S agalactiae, Escherichia coli, Klebsiella pneumoniae, and K oxytoca
- For the treatment of CABP due to susceptible isolates of S pneumoniae (including cases with concurrent bacteremia), S aureus (methicillin-susceptible isolates only), Haemophilus influenzae, K pneumoniae, K oxytoca, and E coli
Usual Adult Dose for Skin and Structure Infection
600 mg IV every 12 hours
Duration of therapy:
- Acute bacterial skin and skin structure infections (ABSSSI): 5 to 14 days
- Community-acquired bacterial pneumonia (CABP): 5 to 7 days
Uses:
- For the treatment of ABSSSI due to susceptible isolates of Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, S agalactiae, Escherichia coli, Klebsiella pneumoniae, and K oxytoca
- For the treatment of CABP due to susceptible isolates of S pneumoniae (including cases with concurrent bacteremia), S aureus (methicillin-susceptible isolates only), Haemophilus influenzae, K pneumoniae, K oxytoca, and E coli
Usual Pediatric Dose for Skin and Structure Infection
Less than 2 months (gestational age at least 34 weeks and postnatal age at least 12 days): 6 mg/kg IV every 8 hours
2 months to less than 2 years: 8 mg/kg IV every 8 hours
2 years to less than 18 years (up to 33 kg): 12 mg/kg IV every 8 hours
2 years to less than 18 years (greater than 33 kg): 400 mg IV every 8 hours OR 600 mg IV every 12 hours
Duration of therapy: 5 to 14 days
Comments:
- Drug levels in cerebrospinal fluid have not been evaluated in pediatric patients younger than 2 months.
- No information available for dosing this drug in infants less than 34 weeks gestational age and younger than 12 days postnatal age.
Use: For the treatment of ABSSSI due to susceptible isolates of S aureus (including methicillin-susceptible and -resistant isolates), S pyogenes, S agalactiae, E coli, K pneumoniae, and K oxytoca
Usual Pediatric Dose for Pneumonia
2 months to less than 2 years: 8 mg/kg IV every 8 hours
2 years to less than 18 years (up to 33 kg): 12 mg/kg IV every 8 hours
2 years to less than 18 years (greater than 33 kg): 400 mg IV every 8 hours OR 600 mg IV every 12 hours
Duration of therapy: 5 to 14 days
Use: For the treatment of CABP due to susceptible isolates of S pneumoniae (including cases with concurrent bacteremia), S aureus (methicillin-susceptible isolates only), H influenzae, K pneumoniae, K oxytoca, and E coli
Renal Dose Adjustments
Adults:
- Estimated CrCl greater than 50 mL/min: No adjustment recommended.
- Estimated CrCl greater than 30 to 50 mL/min: 400 mg IV every 12 hours
- Estimated CrCl 15 to 30 mL/min: 300 mg IV every 12 hours
- ESRD (CrCl less than 15 mL/min): 200 mg IV every 12 hours
Pediatrics:
- CrCl greater than 50 mL/min/1.73 m2: No adjustment recommended.
- CrCl less than 50 mL/min/1.73 m2: Data not available
Comments:
- Adults: CrCl estimated using the Cockcroft-Gault formula.
- Pediatrics: CrCl estimated using the Schwartz equation.
Liver Dose Adjustments
Data not available
Precautions
CONTRAINDICATIONS:
Known serious hypersensitivity to the active component or other cephalosporins
ABSSSI: Safety and efficacy have not been established in patients less than 34 weeks gestational age and younger than 12 days postnatal age.
CABP: Safety and efficacy have not been established in patients younger than 2 months.
Consult WARNINGS section for additional precautions.
Dialysis
Adults:
- Hemodialysis: 200 mg IV every 12 hours
Pediatrics: Data not available
Comments:
- Because this drug is hemodialyzable, it should be administered after hemodialysis on hemodialysis days.
Other Comments
Administration advice:
- Administer via IV infusion over 5 to 60 minutes in adults and pediatric patients at least 2 months of age; administer via IV infusion over 30 to 60 minutes in pediatric patients younger than 2 months.
- Therapy duration should be guided by severity and site of infection and by patient's clinical and bacteriological progress.
Storage requirements:
- Unreconstituted vials: Store at 25C (77F); excursions permitted to 15C to 30C (59F to 86F).
- Constituted solution in Baxter Mini-Bag Plus: Store solutions (concentration range: 4 to 12 mg/mL) for up to 6 hours at room temperature or for up to 24 hours at 2C to 8C (36F to 46F).
- Constituted solution in infusion bag: Use within 6 hours when stored at room temperature or within 24 hours when stored at 2C to 8C (36F to 46F).
Reconstitution/preparation techniques:
- After constitution, further dilution is required; final volume for infusion into patients should be between 50 to 250 mL.
- The manufacturer product information should be consulted.
IV compatibility:
- Compatible: Sterile water for injection; 0.9% sodium chloride injection; 5% dextrose injection; 2.5% dextrose injection; 0.45% sodium chloride injection; lactated ringer's injection
- Compatibility with other drugs not established; should not mix with or physically add to solutions containing other drugs.
General:
- To reduce the development of drug-resistant organisms and maintain effective therapy, this drug should be used only to treat or prevent infections proven or strongly suspected to be caused by susceptible bacteria.
- Appropriate specimens for microbiological testing recommended before therapy to isolate and identify infecting organisms and to establish susceptibility to this drug.
- Culture and susceptibility information should be considered when selecting/modifying antibacterial therapy or, if no data are available, local epidemiology and susceptibility patterns may be considered when selecting empiric therapy.
Patient advice:
- Avoid missing doses and complete the entire course of therapy.
- Contact healthcare provider if severe watery or bloody diarrhea occurs.