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
Warnings
Contraindications
Hypersensitivity to ceftaroline or other cephalosporins
Cautions
Clostridium difficile–associated diarrhea has been reported (evaluate diarrhea if it occurs)
Discontinue therapy if hypersensitivity occurs; anaphylaxis reported
Direct Coombs test seroconversion reported and may be indicative of drug-induced hemolytic anemia
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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Patient Handout
Formulary
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Adding plans allows you to:
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