AHFS Class:
8:12.06.20 Fifth Generation Cephalosporins
Generic Name
Product information, dosage expression, and preparation instructions may vary by country; specific product labeling should be consulted.
Ceftobiprole medocaril sodium is available as a lyophilized powder or cake in single-dose vials containing 667 mg of ceftobiprole medocaril sodium (equivalent to 500 mg of ceftobiprole).2904 Each vial also contains citric acid monohydrate 26.3 mg as a buffer and sodium hydroxide for pH adjustment.2904
Reconstitute the powder by adding 10 mL of an appropriate diluent to the vial to yield approximately 10.6 mL of solution containing ceftobiprole medocaril sodium 66.7 mg/mL (equivalent to 50 mg/mL of ceftobiprole).2904 For adults and pediatric patients 12 years of age and older, sterile water for injection or 5% dextrose may be used for reconstitution.2904 For pediatric patients under 12 years of age, reconstitute only with 5% dextrose.2904 After adding the diluent to the vial, shake vigorously until complete dissolution of the contents; this may take up to 10 minutes.2904 Allow any foam formed to dissipate before visually inspecting the solution to ensure particulate matter is absent.2904 The reconstituted solution must be further diluted in an appropriate infusion solution prior to administration.2904
The dose, diluent, concentration, and final volume of the final diluted solution for infusion depends on the age and renal function of the patient.2904 For adults and pediatric patients 12 years of age or older, sodium chloride 0.9% or dextrose 5% may be used to dilute the dose to a final concentration not exceeding 2.67 mg/mL (of ceftobiprole medocaril sodium).2904 For pediatric patients under 12 years of age, only dextrose 5% should be used to dilute to a final concentration not exceeding 5.33 mg/mL (of ceftobiprole medocaril sodium).2904
To prepare a diluted solution for infusion in infusion bags, bottles, or syringes, transfer the required volume of reconstituted solution from the vial to the container of infusion solution.2904 To prepare a diluted solution in a 50-mL syringe (for doses not exceeding 267 mg), withdraw the required volume of reconstituted solution from the vial and then withdraw the required volume of dextrose 5% into the syringe for infusion.2904 Gently invert 5 to 10 times to mix.2904 Avoid vigorous agitation to prevent foaming.2904
Preparation of diluted solutions for infusion for patients without renal impairment and those with renal impairment are provided in Table 1 and 2, respectively.
Table 1. Preparation of Diluted Ceftobiprole Medocaril Sodium Solution for Infusion for Patients without Renal Impairment2904
| Patient Age Group | Volume of Reconstituted Solution to be Withdrawn from the Vial | Volume of Infusion Solution to be Administered | Infusion Solution | Final Concentration of the Diluted Solution |
|---|---|---|---|---|
| Adults (=18 years of age) | 10 mL | 250 mL | Sodium chloride 0.9% or dextrose 5% | 2.67 mg/mL |
| Pediatric Patients 12 to 18 Years of Age | Calculate according to weight based dosage | Do not exceed 250 mL | Sodium chloride 0.9% or dextrose 5% | 2.67 mg/mL |
| Pediatric Patients 3 months to 12 Years of Age | Calculate according to weight based dosage | Do not exceed 125 mL | Dextrose 5% | 5.33 mg/mL |
Table 2. Preparation of Diluted Ceftobiprole Medocaril Sodium Solution for Infusion for Patients with Renal Impairment2904
| Patient Age Group | Volume of Reconstituted Solution to be Withdrawn from the Vial | Volume of Infusion Solution to be Administered | Infusion Solution | Final Concentration of the Diluted Solution |
|---|---|---|---|---|
| Adults (=18 years of age) with Clcr 30 mL/minute) | 5 mL | 125 mL | Sodium chloride 0.9% or dextrose 5% | 2.67 mg/mL |
| Pediatric Patients 12 to 18 Years of Age with eGFR 15 to 50 ml/min/1.73 m2 a | Calculate according to weight based dosage | Do not exceed 250 mL | Sodium chloride 0.9% or dextrose 5% | 2.67 mg/mL |
| Pediatric Patients 2 to 12 Years of Age with eGFR 15 to 50 ml/min/1.73 m2 a | Calculate according to weight based dosage | Do not exceed 125 mL | Dextrose 5% | 5.33 mg/mL |
aCalculate estimated glomerular filtration rate (eGFR) using a validated GFR estimating equation for the approved age of the pediatric population.
Equivalency
NOTE: Concentration and dosage of ceftobiprole medocaril sodium are expressed in terms of ceftobiprole medocaril sodium (prodrug) in the United States; in other countries, concentrations may be expressed in terms of ceftobiprole (active moiety).772; 2006; 2904
Ceftobiprole medocaril sodium 667 mg is equivalent to 500 mg of ceftobiprole.2904 Ceftobiprole medocaril sodium 333 mg is equivalent to 250 mg of ceftobiprole.2904
Ceftobiprole medocaril sodium 10 mg/kg is equivalent to 7.5 mg/kg of ceftobiprole.2904 Ceftobiprole medocaril sodium 13.3 mg/kg is equivalent to 10 mg/kg of ceftobiprole.2904
pH
Reconstituted solution: 4.5 to 5.5.2904
Sodium Content
Each vial containing 667 mg of ceftobiprole medocaril sodium (equivalent to 500 mg of ceftobiprole) contains approximately 32 mg of sodium.2904 Sodium content may vary depending on the product; specific product labeling should be consulted.
Trade Name(s)
Zevtera
Ceftobiprole medocaril sodium is administered by intravenous infusion over 2 hours.2904
Ceftobiprole medocaril sodium is a white, yellowish to slightly brownish powder or cake.2904 Intact vials should be stored at 2 to 8°C protected from light.2904 Store in carton until time of use.2904
Reconstituted solutions, if not diluted immediately, may be stored refrigerated for up to 24 hours, and at room temperature for up to 1 hour.2904 Discard any unused reconstituted solution.2904
Diluted solutions for infusion may be stored at room temperature or refrigerated at 2 to 8°C for the time periods indicated in Table 3.2904 Do not freeze.2904 Do not expose to direct sunlight; however, protection from light is not necessary during administration.2904 Refrigerated solutions should be allowed to come to room temperature prior to administration.2904 Diluted solutions should be clear to slightly opalescent and yellowish in color.2904 Discard if discoloration or visible particles are present.2904
Table 3: Storage Time for Ceftobiprole Medocaril Sodium Diluted Infusion Solutions2904
| Concentration | Diluent Used for Reconstitution | Infusion Solution | Storage Time 25°C, Not Protected from Light | Storage Time 2 to 8°C, Protected from Light |
|---|---|---|---|---|
| 2.67 mg/mL | Dextrose 5% | Dextrose 5% | 6 hours | 94 hours |
| 2.67 mg/mL | Dextrose 5% | Sodium Chloride 0.9% | 4 hours | 24 hours |
| 2.67 mg/mL | Sterile Water for Injection | Dextrose 5% | 6 hours | 94 hours |
| 2.67 mg/mL | Sterile Water for Injection | Sodium Chloride 0.9% | 6 hours | 94 hours |
| 5.33 mg/mL | Dextrose 5% | Dextrose 5% | 6 hours | 24 hours |
Ceftobiprole medocaril sodium must not be mixed or administered simultaneously with calcium-containing solutions.2904
Y-Site Injection Compatibility (1:1 Mixture)
Additional Compatibility Information
Ceftobiprole medocaril sodium must not be mixed or administered simultaneously with calcium-containing solutions.2904
For a list of references cited in the text of this monograph, search the monograph titled References.