Ceftobiprole Medocaril Dosage

Medically reviewed by Drugs.com. Last updated on May 12, 2025.

Usual Adult Dose for Bacteremia

Days 1 to 8: 667 mg IV every 6 hours
Day 9 onwards: 667 mg IV every 8 hours

Duration of Therapy: Up to 42 days

Comments:

• The prepared IV infusion solution should be administered over 2 hours at a concentration of 2.67 mg/mL.

Use: For the treatment of patients with Staphylococcus aureus bloodstream infections (SAB), including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates

Usual Adult Dose for Endocarditis

Days 1 to 8: 667 mg IV every 6 hours
Day 9 onwards: 667 mg IV every 8 hours

Duration of Therapy: Up to 42 days

Comments:

• The prepared IV infusion solution should be administered over 2 hours at a concentration of 2.67 mg/mL.

Use: For the treatment of patients with Staphylococcus aureus bloodstream infections (SAB), including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates

Usual Adult Dose for Pneumonia

667 mg IV every 8 hours
Duration of therapy: 5 to 14 days

Comments:

• The prepared IV infusion solution should be administered over 2 hours at a concentration of 2.67 mg/mL.

Uses:

• For the treatment of patients with community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of S aureus (methicillin-susceptible isolates), Streptococcus pneumoniae, Haemophilus influenzae, H parainfluenzae, Escherichia coli, and Klebsiella pneumoniae
• For the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of S aureus (methicillin-susceptible and methicillin-resistant isolates), S pyogenes, and K pneumoniae

Usual Adult Dose for Skin and Structure Infection

667 mg IV every 8 hours
Duration of therapy: 5 to 14 days

Comments:

• The prepared IV infusion solution should be administered over 2 hours at a concentration of 2.67 mg/mL.

Uses:

• For the treatment of patients with community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of S aureus (methicillin-susceptible isolates), Streptococcus pneumoniae, Haemophilus influenzae, H parainfluenzae, Escherichia coli, and Klebsiella pneumoniae
• For the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of S aureus (methicillin-susceptible and methicillin-resistant isolates), S pyogenes, and K pneumoniae

Usual Pediatric Dose for Pneumonia

3 months to less than 12 years: 20 mg/kg IV every 8 hours

• Maximum dose: 667 mg/dose

12 to less than 18 years: 13.3 mg/kg IV every 8 hours

• Maximum dose: 667 mg/dose

Duration of Therapy: 7 to 14 days

Comments:

• The prepared IV infusion solution should be administered over 2 hours at a concentration of:
• For patients aged 3 months to less than 12 years: 5.33 mg/mL
• For patients aged 12 to less than 18 years: 2.67 mg/mL

Use: For the treatment of patients with CABP caused by susceptible isolates of S aureus (methicillin-susceptible isolates), S pneumoniae, H influenzae, H parainfluenzae, E coli, and K pneumoniae

Renal Dose Adjustments

ADULT PATIENTS:
CrCl greater than 150 mL/min: 667 mg IV every 6 hours

SAB:

• CrCl 30 to less than 50 mL/min:
• Days 1 to 8: 667 mg IV every 8 hours
• Day 9 onwards: 667 mg IV every 12 hours
• CrCl 15 to less than 30 mL/min:
• Days 1 to 8: 333 mg IV every 8 hours
• Day 9 onwards: 333 mg IV every 12 hours
• CrCl less than 15 mL/min: 333 mg IV every 24 hours

ABSSSI or CABP:

• CrCl 30 to less than 50 mL/min: 667 mg IV every 12 hours
• CrCl 15 to less than 30 mL/min: 333 mg IV every 12 hours
• CrCl less than 15 mL/min: 333 mg IV every 24 hours

Duration of Therapy:

• SAB: Up to 42 days
• ABSSSI and CABP: 5 to 14 days

PEDIATRIC PATIENTS:
3 months to less than 2 years:

• Renal dysfunction: Data not available

2 to less than 6 years:

• Estimated GFR 30 to less than 50 mL/min/1.73 m2: 13.3 mg/kg IV every 12 hours
• Maximum dose: 667 mg/dose
• Estimated GFR 15 to less than 30 mL/min/1.73 m2: 13.3 mg/kg IV every 24 hours
• Maximum dose: 333 mg/dose
• Estimated GFR less than 15 mL/min/1.73 m2: Data not available

6 to less than 12 years:

• Estimated GFR 30 to less than 50 mL/min/1.73 m2: 10 mg/kg IV every 12 hours
• Maximum dose: 667 mg/dose
• Estimated GFR 15 to less than 30 mL/min/1.73 m2: 10 mg/kg IV every 24 hours
• Maximum dose: 333 mg/dose
• Estimated GFR less than 15 mL/min/1.73 m2: Data not available

12 to less than 18 years:

• Estimated GFR 30 to less than 50 mL/min/1.73 m2: 10 mg/kg IV every 12 hours
• Maximum dose: 667 mg/dose
• Estimated GFR 15 to less than 30 mL/min/1.73 m2: 10 mg/kg IV every 12 hours
• Maximum dose: 333 mg/dose
• Estimated GFR less than 15 mL/min/1.73 m2: Data not available

Duration of Therapy: 7 to 14 days

Comments:

• CrCl is based on calculated CrCl in adult patients; estimated GFR should be calculated using a validated GFR estimating equation for the approved age of the pediatric population.
• Augmented renal clearance (CrCl greater than 150 mL/min):
• Adult patients: Use in adults with augmented renal clearance is expected to decrease drug exposure, which may reduce drug efficacy; the dosing frequency should be increased in these patients.
• Pediatric patients: The effect of augmented renal clearance function on the pharmacokinetics (PKs) of this drug in pediatrics is unknown.
• The prepared IV infusion solution should be administered over 2 hours at a concentration of:
• Adult and pediatric patients 12 years and older: 2.67 mg/mL
• Pediatric patients aged 2 to less than 12 years: 5.33 mg/mL
• Insufficient information is available to recommend dosage adjustments in pediatric patients younger than 2 years with any degree of renal dysfunction or 2 years and older with an estimated GFR less than 15 mL/min/1.73 m2.

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Known history of severe hypersensitivity to the active component or any of the ingredients, or to other members of the cephalosporin class

Safety and efficacy for the treatment of CABP have not been established in patients younger than 3 months. Safety and efficacy for the treatment of ABSSSI and SAB have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Hemodialysis:

• Adult Patients:
• SAB: 333 mg IV every 24 hours for up to 42 days
• ABSSSI or CABP: 333 mg IV every 24 hours for 5 to 14 days
• Pediatric Patients: Data not available

Comments:

• Because this drug is removed by hemodialysis, it should be administered after intermittent hemodialysis on hemodialysis days.
• The effect on the PKs of this drug is unknown in pediatric patients receiving hemodialysis.

Other Comments

667 mg of ceftobiprole medocaril sodium is equivalent to 500 mg of ceftobiprole
333 mg of ceftobiprole medocaril sodium is equivalent to 250 mg of ceftobiprole
20 mg/kg of ceftobiprole medocaril sodium is equivalent to 15 mg/kg of ceftobiprole
13.3 mg/kg of ceftobiprole medocaril sodium is equivalent to 10 mg/kg of ceftobiprole
10 mg/kg of ceftobiprole medocaril sodium is equivalent to 7.5 mg/kg of ceftobiprole

Administration advice:

• Administer by IV infusion over 2 hours.
• The infusion solution does not need to be protected from light during administration.
• Do not mix or administer simultaneously with calcium-containing solutions.
• Do not mix with, or coadminister through, the same IV line or cannula with other drug products.

Storage requirements:

• Powder for reconstitution in vials: Store refrigerated at 2C to 8C (36F to 46F), protected from light; store in carton until time of use.
• Reconstituted solution in vials: If immediate dilution is not possible, may store refrigerated for up to 24 hours or at room temperature for up to 1 hour
• Diluted solution in infusion bags: Can store at room temperature or refrigerated at 2C to 8C (36F to 46F); do not expose to direct sunlight and do not freeze.
• For adult and pediatric patients 12 years and older:
• If reconstituted and further diluted with 5% dextrose solution for injection: May store infusion solutions at 25C (77F), NOT protected from light, for 6 hours; may store infusion solutions at 2C to 8C (36F to 46F), protected from light, for 94 hours
• If reconstituted with 5% dextrose solution for injection and further diluted with 0.9% sodium chloride solution for injection: May store infusion solutions at 25C (77F), NOT protected from light, for 4 hours; may store infusion solutions at 2C to 8C (36F to 46F), protected from light, for 24 hours
• If reconstituted with sterile water for injection and further diluted with 5% dextrose solution for injection or 0.9% sodium chloride solution for injection: May store infusion solutions at 25C (77F), NOT protected from light, for 6 hours; may store infusion solutions at 2C to 8C (36F to 46F), protected from light, for 94 hours
• For pediatric patients younger than 12 years (reconstituted and further diluted with 5% dextrose solution for injection): May store infusion solutions at 25C (77F), NOT protected from light, for 6 hours; may store infusion solutions at 2C to 8C (36F to 46F), protected from light, for 24 hours

Reconstitution/preparation techniques:

• This drug must first be reconstituted in the vial and then further diluted before administration.
• If stored in the refrigerator, equilibrate the infusion solution to room temperature before administration.
• The manufacturer product information should be consulted.

IV compatibility:

• Compatible: Sterile water for injection, 5% dextrose injection, 0.9% sodium chloride injection
• Compatibility with other drugs and infusion solutions (other than those listed above) has not been established.
• Incompatible: Calcium-containing solutions

General:

• To reduce the development of drug-resistant organisms and maintain effective therapy, this drug should be used only to treat or prevent infections proven or strongly suspected to be caused by susceptible bacteria.
• Culture and susceptibility information should be considered when selecting/modifying antibacterial therapy or, if no data are available, local epidemiology and susceptibility patterns may be considered when selecting empiric therapy.

Patient advice:

• Avoid missing doses and complete the entire course of therapy; administer exactly as directed.
• Discontinue this drug if a hypersensitivity reaction occurs; inform your health care provider about any previous hypersensitivity to this drug, other beta-lactams (including cephalosporins), or other allergens.
• Inform your health care provider if CNS adverse reactions (including seizures) occur so they can decide whether this drug should be stopped.
• Contact your health care provider if severe watery or bloody diarrhea develops.

See also:

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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