Ceftaroline: Pediatric drug information

For additional information see "Ceftaroline: Drug information" and "Ceftaroline: Patient drug information"

For abbreviations, symbols, and age group definitions show table

Brand Names: US

Teflaro

Therapeutic Category

Antibiotic, Cephalosporin (Fifth Generation)

Dosing: Neonatal

General dosing: Limited data available: IV:

**Ceftaroline Dosing for Preterm and Term Neonates^a**
Body weight	Postnatal age	Dose: IV
Note: Doses of 8 to 8.5 mg/kg/dose every 8 hours were used in one retrospective case series of 16 preterm neonates <32 weeks GA and <28 days PNA with late-onset sepsis; no patients were <7 days of age at initiation of ceftaroline (Callies 2023). ^a Bradley 2020; Bradley 2023.
≤2 kg	≤7 days	6 mg/kg/dose every 12 hours
≤2 kg	8 to 60 days	6 mg/kg/dose every 8 hours
>2 kg	≤7 days	6 mg/kg/dose every 8 hours
>2 kg	8 to 60 days	6 mg/kg/dose every 8 hours

Skin and soft tissue infection: Neonates GA ≥34 weeks and PNA ≥12 days: IV: 6 mg/kg/dose every 8 hours; treatment duration is variable (5 to 14 days); dependent on severity of infection and clinical response.

Dosing: Altered kidney function: Neonatal:

The following adjustments have been recommended based on extremely limited data and physiologically based pharmacokinetic modeling, and are based on a usual dose of 6 mg/kg/dose every 8 hours (Ref). Note: The manufacturer suggests that no dosage adjustment is necessary for CrCl >50 mL/minute/1.73 m².

eGFR ≥60 mL/minute/1.73 m²: No dosage adjustment necessary.

eGFR 30 to <60 mL/minute/1.73 m²: IV: 4 mg/kg/dose every 8 hours.

eGFR 15 to <30 mL/minute/1.73 m²: IV: 3.5 mg/kg/dose every 8 hours.

eGFR <15 mL/minute/1.73 m²: IV: 2.5 mg/kg/dose every 8 hours.

Dosing: Pediatric

Bloodstream infection, methicillin-resistant Staphylococcus aureus

Bloodstream infection, methicillin-resistant Staphylococcus aureus (MRSA): Very limited data available:

Infants 2 to <6 months: IV: 10 mg/kg/dose every 8 hours (Ref).

Infants ≥6 months, Children, and Adolescents: IV: 15 mg/kg/dose every 8 hours; maximum dose: 600 mg/dose (Ref).

Note: There are generally insufficient data to guide duration of therapy; duration should be individualized based on source of infection and response to therapy; 7 to 14 days has been suggested for bacteremia without a focus; others have suggested ≥14 days for catheter-associated bloodstream infection. Longer durations are necessary for patients with endocarditis or osteoarticular infection (Ref).

Cystic fibrosis, acute pulmonary exacerbation

Cystic fibrosis, acute pulmonary exacerbation: Limited data available: Children and Adolescents: IV: 15 mg/kg/dose every 8 hours; maximum dose: 600 mg/dose (Ref). Treatment duration varies and is dependent on patient-specific factors including response to therapy; typical duration is 10 to 21 days (Ref).

Osteoarticular infection, acute

Osteoarticular infection, acute (eg, bacterial arthritis, osteomyelitis): Limited data available: Children and Adolescents: IV: 15 mg/kg/dose every 8 hours, infused over 1 to 2 hours; maximum dose: 600 mg/dose. Minimum total duration is 10 to 14 days for bacterial arthritis and 21 to 28 days for osteomyelitis; however, duration may be longer and should be individualized based on several factors, including causative pathogen, response to therapy, and normalization of inflammatory markers (Ref).

Pneumonia, community-acquired

Pneumonia, community-acquired:

Infants ≥2 months and Children <2 years: IV: 8 mg/kg/dose every 8 hours for 5 to 14 days.

Children ≥2 years and Adolescents <18 years:

≤33 kg: IV: 12 mg/kg/dose every 8 hours for 5 to 14 days.

>33 kg: IV: 400 mg every 8 hours or 600 mg every 12 hours for 5 to 14 days.

Adolescents ≥18 years: 600 mg every 12 hours for 5 to 7 days.

Note: Treatment duration depends on severity of infection and clinical response; the manufacturer recommends 5 to 14 days. For uncomplicated pneumonia, the usual total duration of therapy is 5 to 10 days (including any oral step-down therapy); complicated infection (eg, empyema, necrotizing infection, pulmonary abscess) may require longer duration (Ref).

Skin and soft tissue infection

Skin and soft tissue infection (SSTI):

Standard dose (Ref):

Infants <2 months: IV: 6 mg/kg/dose every 8 hours.

Infants ≥2 months and Children <2 years: IV: 8 mg/kg/dose every 8 hours.

Children ≥2 years and Adolescents <18 years:

≤33 kg: IV: 12 mg/kg/dose every 8 hours.

>33 kg: IV: 400 mg every 8 hours or 600 mg every 12 hours.

Adolescents ≥18 years: IV: 600 mg every 12 hours.

High dose (Ref): Note: Recommended only when SSTI is suspected or confirmed to be caused by Staphylococcus aureus with a ceftaroline minimum inhibitory concentration (MIC) of 2 or 4 mg/L; recommendations are based on pharmacokinetic analyses.

Infants ≥2 months and Children <2 years: IV: 10 mg/kg/dose every 8 hours.

Children ≥2 years and Adolescents <18 years: IV: 12 mg/kg/dose every 8 hours; maximum dose: 600 mg/dose.

Adolescents ≥18 years: IV: 600 mg every 8 hours.

Note: Treatment duration depends on severity of infection and clinical response; the manufacturer recommends 5 to 14 days. Typical recommended duration for SSTI is 5 to 7 days, but may be longer in certain clinical scenarios; in a clinical trial comparing ceftaroline to vancomycin or cefazolin, the median duration (including oral step-down therapy) was 10 days (range: 2 to 23 days) (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Altered kidney function:

Note: The manufacturer suggests that no dosage adjustment is necessary for CrCl >50 mL/minute/1.73 m².

Infants <2 months: Note: Based on usual dosing regimen of 6 mg/kg/dose every 8 hours. Dosage adjustments based on physiologically based pharmacokinetic modeling (Ref).

eGFR ≥60 mL/minute/1.73 m²: No dosage adjustment necessary.

eGFR 30 to <60 mL/minute/1.73 m²: IV: 4 mg/kg/dose every 8 hours.

eGFR 15 to <30 mL/minute/1.73 m²: IV: 3.5 mg/kg/dose every 8 hours.

eGFR <15 mL/minute/1.73 m²: IV: 2.5 mg/kg/dose every 8 hours.

Infants ≥2 months and Children <2 years: IV: Note: Based on usual dosing regimen of 8 mg/kg/dose every 8 hours. Dosage adjustments based on physiologically based pharmacokinetic modeling (Ref).

eGFR ≥60 mL/minute/1.73 m²: No dosage adjustment necessary.

eGFR 30 to <60 mL/minute/1.73 m²: IV: 5 mg/kg/dose every 8 hours.

eGFR 15 to <30 mL/minute/1.73 m²: IV: 4 mg/kg/dose every 8 hours.

eGFR <15 mL/minute/1.73 m²: IV: 3 mg/kg/dose every 8 hours.

Children ≥2 years and Adolescents: IV:

**Ceftaroline Fosamil IV Dose Adjustments for Altered Kidney Function in Children 2 to <12 Years, and Children ≥12 Years and Adolescents <18 Years Weighing <33 kg^a**
CrCl^b	If the usual recommended dose is 12 mg/kg/dose every 8 hours (maximum dose: 400 mg/dose)	If the usual recommended dose is 12 mg/kg/dose every 8 hours (maximum dose: 600 mg/dose)
^a Recommendations based on EMA product labeling and Chan 2021.
^b Estimated using Schwartz equation for infants, children, and adolescents <18 years of age.
^c Dialyzable; 21.6% to 73% recovered in dialysate (Sunzel 2015; manufacturer's labeling); if administered in a patient receiving hemodialysis, administer after dialysis on dialysis days.
>50 mL/minute/1.73 m²	No dosage adjustment necessary	No dosage adjustment necessary
30 to ≤50 mL/minute/1.73 m²	8 mg/kg/dose every 8 hours (maximum dose: 300 mg/dose)	10 mg/kg/dose every 8 hours (maximum dose: 400 mg/dose)
15 to <30 mL/minute/1.73 m²	6 mg/kg/dose every 8 hours (maximum dose: 200 mg/dose)	8 mg/kg/dose every 8 hours (maximum dose: 300 mg/dose)
End-stage renal disease, including hemodialysis^c	No recommendation available; dosage adjustment likely necessary	No recommendation available; dosage adjustment likely necessary

**Ceftaroline Fosamil IV Dose Adjustments for Altered Kidney Function in Children ≥12 Years and Adolescents Weighing ≥33 kg^a**
CrCl^b	If the usual recommended dose is 600 mg every 12 hours	If the usual recommended dose is 12 mg/kg/dose every 8 hours (maximum dose: 600 mg/dose)
^a Recommendations based on EMA product labeling and Chan 2021.
^b Estimated using Schwartz equation for infants, children, and adolescents <18 years of age and the Cockcroft-Gault formula for adolescents ≥18 years of age.
^c Dialyzable; 21.6% to 73% recovered in dialysate (Sunzel 2015; manufacturer's labeling); if administered in a patient receiving hemodialysis, administer after dialysis on dialysis days.
>50 mL/minute/1.73 m²	No dosage adjustment necessary	No dosage adjustment necessary
30 to ≤50 mL/minute/1.73 m²	400 mg every 12 hours	10 mg/kg/dose every 8 hours (maximum dose: 400 mg/dose)
15 to <30 mL/minute/1.73 m²	300 mg every 12 hours	8 mg/kg/dose every 8 hours (maximum dose: 300 mg/dose)
End-stage renal disease, including hemodialysis^c	200 mg every 12 hours	No recommendation available; dosage adjustment necessary; recommended adult dose is 200 mg every 8 hours.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). However, ceftaroline is primarily renally eliminated.

Dosing: Adult

(For additional information see "Ceftaroline: Drug information")

Note: Reserve for patients with or at risk for methicillin-resistant S. aureus infection who cannot receive preferred agents (Ref).

Bloodstream infection

Bloodstream infection (alternative agent) (off-label use):

Pathogen-directed therapy for methicillin-resistant S. aureus: IV: 600 mg every 8 hours (Ref). For persistent or refractory cases or isolates with reduced susceptibility, use as part of an appropriate combination regimen (Ref). Treat uncomplicated S. aureus bacteremia for ≥14 days from day of first negative blood culture, with longer courses warranted for endocarditis or metastatic sites of infection (Ref).

Pneumonia

Pneumonia:

Community-acquired pneumonia (alternative agent): Inpatients without risk factors for Pseudomonas aeruginosa:

IV: 600 mg every 12 hours as part of an appropriate combination regimen. Total duration (including oral step-down therapy) is a minimum of 7 days for methicillin-resistant S. aureus (MRSA) infection; patients should be clinically stable with normal vital signs before therapy is discontinued (Ref). Note: Switch to a narrower beta-lactam if MRSA is not isolated (Ref).

Hospital- acquired or ventilator-associated pneumonia (alternative agent) (off-label use): As a component of empiric therapy or as pathogen-directed therapy for methicillin-resistant S. aureus: IV: 600 mg every 12 hours (Ref). Duration of therapy varies based on disease severity and response to therapy; treatment is typically given for 7 days (Ref).

Skin and soft tissue infection

Skin and soft tissue infection (alternative agent): IV: 600 mg every 12 hours. Total duration of therapy is ≥5 days (including oral step-down therapy); may extend up to 14 days depending on severity and clinical response (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Altered kidney function:

**Ceftaroline Fosamil Dose Adjustments for Altered Kidney Function^a: IV**
CrCl^b	If the usual recommended dose is 600 mg IV every 12 hours	If the usual recommended dose is 600 mg IV every 8 hours
^aRecommendations are based on manufacturer's labeling, Riccobene 2014, and Sunzel 2015 (every 12-hour regimens) or expert opinion derived from Dryden 2016 (every 8-hour regimens).
^bEstimated using the Cockcroft-Gault formula.
^cDialyzable (22% to 73% recovered in dialysate [manufacturer's labeling; Sunzel 2015]): When scheduled doses fall on a dialysis day, one of the twice-daily doses should be administered after dialysis (Sunzel 2015).
>50 mL/minute	No dosage adjustment necessary	No dosage adjustment necessary
>30 to ≤50 mL/minute	400 mg every 12 hours	400 mg every 8 hours
≥15 to ≤30 mL/minute	300 mg every 12 hours	300 mg every 8 hours
<15 mL/minute	200 mg every 12 hours	200 mg every 8 hours
Hemodialysis, intermittent (thrice weekly)^c	200 mg every 12 hours	200 mg every 8 hours
Peritoneal dialysis	200 mg every 12 hours	200 mg every 8 hours

Augmented renal clearance (measured urinary CrCl ≥130 mL/minute/1.73 m²):

Note: Augmented renal clearance (ARC) is a condition that occurs in certain critically ill patients without organ dysfunction and with normal serum creatinine concentrations. Young patients (<55 years of age) admitted post trauma or major surgery are at highest risk for ARC, as well as those with sepsis, burns, or hematologic malignancies. An 8- to 24-hour measured urinary CrCl is necessary to identify these patients (Ref).

IV: 600 mg every 8 hours infused over 2 hours (Ref).

CRRT:

Note: Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Recommendations are based on high-flux dialyzers and effluent flow rates of 20 to 25 mL/kg/hour (or ~1,500 to 3,000 mL/hour), unless otherwise noted. Appropriate dosing requires consideration of adequate drug concentrations (eg, site of infection) and consideration of initial loading doses. Close monitoring of response and adverse reactions (eg, neurotoxicity) due to drug accumulation is important.

IV:

If the usual recommended dose is 600 mg every 12 hours: 400 mg every 12 hours (Ref).

If the usual recommended dose is 600 mg every 8 hours: 400 mg every 8 hours (Ref).

PIRRT (eg, sustained, low-efficiency diafiltration):

Note: Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Appropriate dosing requires consideration of adequate drug concentrations (eg, site of infection) and consideration of initial loading doses. Close monitoring of response and adverse reactions (eg, neurotoxicity) due to drug accumulation is important.

IV:

If the usual recommended dose is 600 mg every 12 hours: 400 mg every 12 hours (Ref).

If the usual recommended dose is 600 mg every 8 hours: 400 mg every 8 hours (Ref).

Non-PIRRT days: Dose according to patient's residual CrCl (Ref).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). However, ceftaroline is primarily renally eliminated.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%: Hematologic & oncologic: Positive direct Coombs test (10% to 18%; no evidence of hemolysis)

1% to 10%:

Cardiovascular: Bradycardia (adults: <2%), palpitations (adults: <2%), phlebitis (adults: 2%)

Dermatologic: Pruritus (infants, children, and adolescents: <3%), skin rash (3% to 7%), urticaria (adults: <2%)

Endocrine & metabolic: Hyperglycemia (adults: <2%), hyperkalemia (adults: <2%), hypokalemia (adults: 2%)

Gastrointestinal: Abdominal pain (adults: <2%), Clostridioides difficile colitis (adults: <2%), constipation (adults: 2%), diarrhea (5% to 8%), nausea (3% to 4%), vomiting (2% to 5%)

Hematologic & oncologic: Anemia (adults: <2%), eosinophilia (adults: <2%), neutropenia (adults: <2%; risk may be increased with high doses and prolonged use [>14 days]) (Sullivan 2019; Varada 2015), thrombocytopenia (adults: <2%)

Hepatic: Hepatitis (adults: <2%), increased serum alanine aminotransferase (infants, children, and adolescents: <3%), increased serum aspartate aminotransferase (infants, children, and adolescents: <3%), increased serum transaminases (adults: 2%)

Hypersensitivity: Anaphylaxis (adults: <2%), hypersensitivity reaction (adults: <2%)

Nervous system: Dizziness (adults: <2%), headache (infants, children, and adolescents: <3%), seizure (adults: <2%)

Renal: Renal failure syndrome (adults: <2%)

Miscellaneous: Fever (≤3%)

Postmarketing:

Gastrointestinal: Clostridioides difficile associated diarrhea

Hematologic & oncologic: Agranulocytosis (risk may be increased with high doses and prolonged use [>14 days]) (Sullivan 2019; Varada 2015), leukopenia

Nervous system: Encephalopathy (Srinivasan 2021)

Respiratory: Eosinophilic pneumonia (Desai 2013)

Contraindications

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

Warnings/Precautions

Concerns related to adverse effects:

• Hemolytic anemia: Seroconversion from a negative to a positive direct Coombs’ test has been reported. Hemolytic anemia was not reported in clinical studies; however, if anemia develops during or after treatment, consider drug-induced hemolytic anemia. Diagnostic tests should include a direct Coombs’ test. If hemolytic anemia is suspected, discontinue the drug and institute supportive care as clinically indicated.

• Hypersensitivity: Serious hypersensitivity (anaphylactic) and skin reactions have occurred with ceftaroline. Use with caution in patients with a history of penicillin, cephalosporin, or carbapenem allergy. Maintain clinical supervision if given to penicillin or beta-lactam allergic patients; cross sensitivity among beta-lactam antibacterial agents has been reported. If a serious reaction occurs, discontinue the drug and institute supportive measures as clinically indicated.

• Neurotoxicity: Neurological reactions have been reported, including encephalopathy and seizures. Risk may be increased in the presence of renal impairment; ensure dose adjusted for renal function, and discontinue therapy if patient develops neurotoxicity; effects are often reversible upon discontinuation of therapy.

• Neutropenia: Neutropenia and agranulocytosis have been reported; risk may be increased with high doses and prolonged therapy (>14 days), patients with kidney dysfunction, and patients on concurrent antibiotics associated with neutropenia. Monitor CBC at baseline and at least weekly; limit duration of therapy when possible (Sullivan 2019; Varada 2015).

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis (including fatalities); CDAD has been observed >2 months postantibiotic treatment.

Disease-related concerns:

• Renal impairment: Use with caution in patients with renal impairment (CrCl ≤50 mL/minute); dosage adjustments recommended.

• Seizure disorders: Use with caution in patients with a history of seizure disorder; high levels, particularly in the presence of renal impairment, may increase risk of seizures.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous [preservative free]:

Teflaro: 400 mg (1 ea); 600 mg (1 ea)

Generic Equivalent Available: US

Pricing: US

Solution (reconstituted) (Teflaro Intravenous)

400 mg (per each): $280.22

600 mg (per each): $280.22

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Pediatric

IV: Dilute prior to administration. Administer by IV infusion; infusion time is determined by age.

Neonates (GA ≥34 weeks and PNA ≥12 days) and Infants <2 months: Infuse over 30 to 60 minutes.

Infants ≥2 months, Children, and Adolescents: Infuse over 5 to 60 minutes. Note: Infusion over 60 to 120 minutes is recommended for patients with acute osteoarticular infection (Ref). Infuse over 120 minutes in patients with cystic fibrosis; has also been infused over 120 minutes in patients with complicated community-acquired pneumonia (Ref). A 120-minute infusion is also recommended in European product labeling for high-dose therapy of complicated skin and soft tissue infections confirmed or suspected to be caused by S. aureus isolates with minimum inhibitory concentration ≥2 mg/L (Ref).

Administration: Adult

IV: Administer by slow IV infusion over 5 to 60 minutes. Note: Some studies utilizing 8-hour regimens administered each infusion over 120 minutes, which may be beneficial for organisms with minimum inhibitory concentrations ≥2 mg/L (Ref).

Storage/Stability

Store unused vials at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Diluted solutions in D2.5W, ¹/₂NS, D5W, LR, or NS (in infusion bags or Mini-Bag Plus) should be used within 6 hours when stored at room temperature or within 24 hours if refrigerated at 2°C to 8°C (36°F to 46°F).

Use

Treatment of acute bacterial skin and skin structure infections caused by susceptible isolates of Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, and Klebsiella oxytoca (FDA approved in all ages); treatment of community-acquired pneumonia caused by Streptococcus pneumoniae (including cases with concurrent bacteremia), S. aureus (methicillin-susceptible isolates only), Haemophilus influenzae, K. pneumoniae, K. oxytoca, and E. coli (FDA approved in ages ≥2 months and adults); has also been used for the treatment of acute pulmonary exacerbations of cystic fibrosis, treatment of osteoarticular infections, and treatment of bacteremia caused by methicillin-resistant Staphylococcus aureus (MRSA).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program

Aminoglycosides: Cephalosporins may enhance the nephrotoxic effect of Aminoglycosides. Cephalosporins may decrease the serum concentration of Aminoglycosides. Risk C: Monitor therapy

Bacillus clausii: Antibiotics may diminish the therapeutic effect of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider therapy modification

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination

Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination

Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination

Furosemide: May enhance the nephrotoxic effect of Cephalosporins. Risk C: Monitor therapy

Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy

Mycophenolate: Antibiotics may decrease serum concentrations of the active metabolite(s) of Mycophenolate. Specifically, concentrations of mycophenolic acid (MPA) may be reduced. Risk C: Monitor therapy

Probenecid: May increase the serum concentration of Cephalosporins. Risk C: Monitor therapy

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider therapy modification

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider therapy modification

Vitamin K Antagonists (eg, warfarin): Cephalosporins may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy

Pregnancy Considerations

Adverse events have been observed in some animal reproduction studies.

Monitoring Parameters

Renal function periodically; CBC; number and type of stools/day for diarrhea; monitor for signs of hypersensitivity including anaphylaxis.

Mechanism of Action

Inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs) 1 through 3. This action blocks the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls and inhibits cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysis and murein hydrolases) while cell wall assembly is arrested. Ceftaroline has a strong affinity for PBP2a, a modified PBP in MRSA, and PBP2x in S. pneumoniae, contributing to its spectrum of activity against these bacteria.

Pharmacokinetics (Adult Data Unless Noted)

Note: The pharmacokinetics of ceftaroline in pediatric patients from 2 months to <18 years of age were similar to those in adult patients.

Distribution: V_d: Median: 20.3 L (range: 18.3 to 21.6 L)

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

Half-life elimination: 1.6 ± 0.38 hours (single dose); 2.66 ± 0.4 hours (multiple dose)

Time to peak: ~1 hour

Excretion: Urine (~88%); feces (~6%)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: AUC increased 52% in moderate renal impairment (CrCl >30 to 50 mL/minute) and 115% in severe renal impairment (CrCl 15 to 30 mL/minute) as compared to patients with normal renal function.

Older adult: The AUC was ~33% higher in elderly patients, mainly because of changes in renal function.

Anti-infective considerations:

Parameters associated with efficacy: Time dependent, associated with time free drug concentration (fT) > minimum inhibitory concentration (MIC):

Organism specific:

Gram-positive organisms (eg, S. aureus, S. pneumoniae): Goal: ≥ ~30% fT > MIC (1-log kill) (Andes 2006; MacGowan 2013).

Gram-negative organisms (eg, E. coli, K. pneumoniae): Goal: ≥41% fT > MIC (1-log kill) (Andes 2006).

Population specific:

Critically ill patients in the ICU: Minimum goal: ≥50% fT > MIC; preferred goal: ≥100% fT > MIC (Abdul-Aziz 2020; Al-Shaer 2020; Roberts 2014); some experts favor ≥100% fT >4 times the MIC (Guilhaumou 2019).

Expected drug exposure in normal renal function:

Pediatric patients: Steady state: C_max (peak): IV (1-hour infusion):

Preterm neonates: 6 mg/kg/dose every 8 hours:

GA 36 to <40 weeks: 12.4 to 12.8 mg/L (Riccobene 2017).

GA 32 to <36 weeks: 11.9 to 12.1 mg/L (Riccobene 2017).

GA 30 to <32 weeks: 11.4 mg/L (Riccobene 2017).

Neonates and infants <2 months of age: 6 mg/kg/dose every 8 hours: 13.4 to 14.1 mg/L (Riccobene 2017).

Infants and children 2 months to <2 years of age: 8 mg/kg/dose every 8 hours: 18.8 to 19.6 mg/L (Riccobene 2017).

Children 2 to <12 years of age: 12 mg/kg/dose every 8 hours (maximum dose: 400 mg/dose): 27.1 to 27.6 mg/L (Riccobene 2017).

Children and adolescents 12 to <18 years of age:

12 mg/kg/dose every 8 hours (maximum dose: 400 mg/dose): 19.7 mg/L (Riccobene 2017).

600 mg every 12 hours: 28.6 mg/L (Riccobene 2017).

Pediatric patients with cystic fibrosis: C_max(peak):

Single dose: IV: 10 mg/kg, maximum dose: 600 mg (1-hour infusion).

Children 6 to <12 years of age: 25.5 ± 4.5 mg/L (Le 2017).

Adolescents 12 to <18 years of age: 27.9 ± 4.2 mg/L (Le 2017).

Adults: C_max(peak):

Single dose: 600 mg (1-hour infusion): IV:

BMI <30 kg/m²: 22.3 ± 5.9 to 22.6 ± 2 mg/L (Justo 2015; Matzneller 2016).

BMI 30 to 34.9 kg/m²: 19.2 ± 3.8 mg/L (Justo 2015).

BMI 35 to 39.9 kg/m²: 17.5 ± 2.4 mg/L (Justo 2015).

BMI ≥40 kg/m²: 14.3 ± 1.4 mg/L (Justo 2015).

Multiple dose: 600 mg every 12 hours (1-hour infusion): IV: 22 ± 4 mg/L (Matzneller 2016).

Postantibiotic effect: Gram-positive organisms (eg, enterococci, S. pneumoniae, S. aureus): ≤2 hours (Pankuch 2009).

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(AE) United Arab Emirates: Zinforo;
(AR) Argentina: Zinforo;
(AT) Austria: Zinforo;
(AU) Australia: Zinforo;
(BE) Belgium: Zinforo;
(BG) Bulgaria: Zinforo;
(BR) Brazil: Zinforo;
(CH) Switzerland: Zinforo;
(CL) Chile: Zinforo;
(CO) Colombia: Zinforo;
(CZ) Czech Republic: Zinforo;
(DE) Germany: Zinforo;
(DO) Dominican Republic: Zinforo;
(EG) Egypt: Zinforo;
(ES) Spain: Zinforo;
(FR) France: Zinforo;
(GB) United Kingdom: Zinforo;
(GR) Greece: Zinforo;
(HK) Hong Kong: Zinforo;
(HU) Hungary: Zinforo;
(ID) Indonesia: Zinforo;
(IE) Ireland: Zinforo;
(IN) India: Zinforo;
(IT) Italy: Zinforo;
(JO) Jordan: Zinforo;
(KW) Kuwait: Zinforo;
(LB) Lebanon: Zinforo;
(MX) Mexico: Zinforo;
(MY) Malaysia: Zinforo;
(NZ) New Zealand: Zinforo;
(PH) Philippines: Zinforo;
(PL) Poland: Zinforo;
(PR) Puerto Rico: Teflaro;
(PT) Portugal: Zinforo;
(QA) Qatar: Zinforo;
(RO) Romania: Zinforo;
(RU) Russian Federation: Zinforo;
(SA) Saudi Arabia: Zinforo;
(SE) Sweden: Zinforo;
(SG) Singapore: Zinforo;
(SK) Slovakia: Zinforo;
(TH) Thailand: Zinforo;
(TN) Tunisia: Zinforo;
(TR) Turkey: Omvelin;
(TW) Taiwan: Zinforo;
(UY) Uruguay: Zinforo;
(ZA) South Africa: Zinforo

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Ceftaroline: Pediatric drug information