ceftaroline (Rx)

Brand and Other Names:Teflaro
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Dosing & Uses

AdultPediatric

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
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Interactions

Interaction Checker

and ceftaroline

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            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

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            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

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            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.

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            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%)

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            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

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.