Dosing & Uses
Dosage Forms & Strengths
injectable, powder for reconstitution
- 400mg/vial
- 600mg/vial
Community-Acquired Bacterial Pneumonia
Indicated for treatment of community-acquired bacterial pneumonia (CABP)
600 mg IV q12hr x5-7 days
Skin & Skin Structure Infections
Indicated for acute bacterial skin and skin structure infections (ABSSSI), including MRSA
600 mg IV q12hr x5-14 days
Dosage Modifications
Renal impairment
- CrCl 30-50 mL/min: 400 mg IV q12hr
- CrCl 15 to ≤30 mL/min: 300 mg IV q12hr
- ESRD (including hemodialysis): 200 mg IV q12hr
Dosing Considerations
Susceptible isolates
-
CABP
- Gram-positive and Gram-negative microorganisms: Streptococcus pneumoniae (including cases with concurrent bacteremia), Staphylococcus aureus (methicillin-susceptible isolates only), Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli
-
ABSSSI
- Gram-positive and Gram-negative microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, and Klebsiella oxytoca
Dosage Forms & Strengths
injectable, powder for reconstitution
- 400mg/vial
- 600mg/vial
Community-Acquired Bacterial Pneumonia
Indicated in children aged ≥2 months for treatment of community-acquired bacterial pneumonia (CABP)
2 months to <2 years: 8 mg/kg IV q8hr x5-14 days
≥2 years to <18 years (≤33 kg): 12 mg/kg IV q8hr x5-14 days
≥2 years to <18 years (>33 kg): 400 mg q8hr OR 600 mg q12hr IV x5-14 days
≥18 years: 600 mg IV q12hr x5-7 days
Skin & Skin Structure Infections
Indicated in pediatric patients (≥34 weeks gestation and at least 12 days postnatal age) for treatment of acute bacterial skin and skin structure infections (ABSSSI)
Birth to <2 months: 6 mg/kg IV q8hr x5-14 days
2 months to <2 years: 8 mg/kg IV q8hr x5-14 days
2 years to <18 years (≤33 kg): 12 mg/kg IV q8hr x5-14 days
2 years to <18 years (>33 kg): 400 mg q8hr OR 600 mg q12hr IV x5-14 days
≥18 years: 600 mg IV q12hr x5-14 days
Dosage Modifications
Renal impairment
- CrCl >50 mL/min/1.73 m2 (estimated by Schwartz equation): No dose adjustment required
- CrCl <50 mL/min/1.73 m2: Insufficient information to recommend dose
Dosing Considerations
Susceptible isolates
-
CABP
- Gram-positive and Gram-negative microorganisms: Streptococcus pneumoniae (including cases with concurrent bacteremia), Staphylococcus aureus (methicillin-susceptible isolates only), Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli
-
ABSSSI
- Gram-positive and Gram-negative microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, and Klebsiella oxytoca
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Adverse Effects
1-10% (Adults)
Diarrhea (5%)
Nausea (4%)
Rash (3%)
Constipation (2%)
Vomiting (2%)
Increased transaminases (2%)
Hypokalemia (2%)
Phlebitis (2%)
<2%
- Blood and lymphatic system disorders: Anemia, eosinophilia, neutropenia, thrombocytopenia
- Cardiac disorders: Bradycardia, palpitations
- Gastrointestinal disorders: Abdominal pain
- General disorders and administration site conditions: Pyrexia
- Hepatobiliary disorders: Hepatitis
- Immune system disorders: Hypersensitivity, anaphylaxis
- Infections and infestations: Clostridium difficile colitis
- Metabolism and nutrition disorders: Hyperglycemia, hyperkalemia
- Nervous system disorders: Dizziness, convulsion
- Renal and urinary disorders: Renal failure
- Skin and subcutaneous tissue disorders: Urticaria
1-10% (Pediatrics)
Diarrhea (8%)
Rash (7%)
Vomiting (5%)
Nausea (3%)
Pyrexia (3%)
Increased ALT/AST (<3%)
Headache (<3%)
Pruritus (<3%)
Postmarketing Reports (Pediatrics)
Agranulocytosis
Leukopenia
Eosinophilic pneumonia
Encephalopathy, seizures
Warnings
Contraindications
Hypersensitivity to drug, excipients or other cephalosporins
Cautions
If anemia develops during or after treatment, consider drug-induced hemolytic anemia; perform diagnostic studies including a direct Coombs’ test; if drug-induced hemolytic anemia suspected, consider discontinuation; administer supportive care to patient (i.e. transfusion) if clinically indicated
Prescribing drug in absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to patient and increases risk of development of drug-resistant bacteria
Neurological adverse reactions reported during postmarketing surveillance in patients treated with cephalosporins; reactions include encephalopathy and seizures; most cases occurred in patients with renal impairment who did not receive appropriate dosage adjustment; if neurological adverse reactions occur, consider discontinuing therapy or making appropriate dosage adjustments in patients with renal impairment
Hypersensitivity reactions
- Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions reported in patients receiving beta-lactam antibacterial drugs
- Before therapy is instituted, make careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or carbapenems
- Maintain clinical supervision if product is to be given to a penicillin-or other beta-lactam-allergic patient; cross sensitivity among beta-lactam antibacterial agents has been clearly established; if allergic reaction occurs, discontinue therapy and institute appropriate treatment and supportive measures
Clostridium difficile-associated diarrhea (CDAD)
- CDAD reported for nearly all systemic antibacterial agents and may range in severity from mild diarrhea to fatal colitis; treatment with antibacterial agents alters normal flora of colon and may permit overgrowth of C. difficile
- C. difficile produces toxins A and B which contribute to development of CDAD; hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy
- CDAD must be considered in all patients who present with diarrhea following antibiotic use; careful medical history is necessary because CDAD has been reported to occur more than 2 months after administration of antibacterial agents
- If CDAD is suspected or confirmed, antibacterials not directed against C. difficile should be discontinued, if possible; institute appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation as clinically indicated
Pregnancy & Lactation
Pregnancy
No data in pregnant women are available
Animal studies
- In developmental toxicity studies conducted in animals, no malformations or other adverse developmental effects were observed in offspring of rats exposed at up to 4 times the maximum recommended human dose (MRHD) during the period of organogenesis through lactation
- In rabbits exposed to ceftaroline during organogenesis at levels approximately equal to the MRHD, no drug-induced fetal malformations were observed despite maternal toxicity
Lactation
No data are available regarding presence in human milk, or the effects on breastfed infants or on milk production
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Beta-lactam cephalosporin with activity against aerobic and anaerobic gram-positive and aerobic gram-negative bacteria
Demonstrates activity in vivo against resistant methicillin-resistant Staphylococcus aureus (MRSA) strains and in vitro against vancomycin-resistant and linezolid-resistant S aureus
Absorption
Peak plasma concentration: 21.3 mcg/mL
Peak plasma time: 1 hr
Distribution
Vd: 20.3 L
Protein bound: 20%
Metabolism
Ceftaroline fosamil converted to bioactive ceftaroline in plasma by phosphatase enzyme; undergoes hydrolysis
Elimination
Clearance: 9.6 L/hr
Half-life: 2.6 hr
Excretion: urine (88%)
Administration
IV Compatibilities
Solution: 0.9% NaCl; D5W; 2.5% dextrose/0.45% NaCl; Lactated Ringer’s solution
IV Preparation
Reconstitute vial by adding 20 mL sterile water for injection, 0.9% NaCl, D5W, or lactated ringer’s injection; mix gently and ensure all powder has dissolved completely
Resulting approximate concentrations: 400 mg vial (20 mg/mL); 600 mg vial (30 mg/mL)
Color of solution ranges from clear to light-to-dark yellow depending on concentration and storage conditions
Dilution of reconstituted solution
- Withdraw total volume from vial and add to 50-250 mL of 0.9% NaCl, D5W, 2.5% dextrose/0.45% NaCl, or lactated ringer’s solution; use the same diluent that was used for reconstituting (unless sterile water for injection was used)
Dilution of the constituted solution in 50 mL infusion bags
- Preparation of 600 mg dose in (for adult patients): Withdraw 20 mL from bag before adding constituted drug; resulting concentration ~12 mg/mL
- Preparation of 400 mg dose (for adult and pediatric patients weighing >33 kg): Withdraw 20 mL from bag before adding constituted drug; resulting concentration ~8 mg/mL
-
Preparation for children weighing ≤33 kg
- Preparation of dose in infusion bag for pediatric patients weighing ≤33 kg: Amount of solution withdrawn from the constituted vial for dilution in the infusion bag will vary according to the weight and age of the child; infusion solution concentration should not exceed 12 mg/mL ceftaroline
IV Administration
Administer IV injection via volumetric infusion pump
Adults and children aged >2 months: Infuse over 5-60 minutes
Children aged <2 months: Infuse over 30-60 minutes
Storage
Unopened vials: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)
Stability of diluted drug in infusion bag or 50-mL bag
- Room temperature: 6 hr
- Refrigerated 2-8°C (36-46°F): 24 hr
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Formulary
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