Fifth-generation cephalosporin (broad incl MRSA) Pregnancy: There are no available data on the use of ceftobiprole in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Published observational data with cephalosporins in pregnancy have not established drug-associated risks but cannot definitively establish the absence of risk. Intravenous administration to pregnant rats and monkeys during organogenesis showed no evidence of adverse fetal developmental outcomes at approximately 1.4 and 0.9 times the maximum recommended human dose respectively.

Ceftobiprole

Brand names: Mabelio, Zevtera

Ceftobiprole is a broad-spectrum parenteral cephalosporin antibacterial with anti-MRSA activity, used for hospital- and community-acquired pneumonia and, where licensed, certain other serious infections.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 667 mg of ceftobiprole medocaril sodium (equivalent to 500 mg of ceftobiprole)

Route: Intravenous infusion over 2 hours, at a concentration of 2.67 mg/mL

Frequency: Every 8 hours for acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP); for Staphylococcus aureus bacteraemia (SAB) every 6 hours on Days 1 to 8, then every 8 hours from Day 9

US labelling (ZEVTERA, ceftobiprole medocaril sodium for injection), adults. Every dose is the same strength — 667 mg of ceftobiprole medocaril sodium, equivalent to 500 mg of ceftobiprole — and only the interval and duration change: SAB 667 mg every 6 hours on Days 1 to 8 then every 8 hours from Day 9, for up to 42 days; ABSSSI 667 mg every 8 hours for 5 to 14 days; CABP 667 mg every 8 hours for 5 to 14 days. Each prepared infusion solution is given over 2 hours at 2.67 mg/mL in adults. AUGMENTED RENAL CLEARANCE: in adults with CrCl greater than 150 mL/min, increase to 667 mg every 6 hours. WARNING FROM THE LABEL: increased mortality was seen with unapproved use in ventilator-associated bacterial pneumonia (35/103 [34%] versus 24/102 [24%] with comparator); safety and effectiveness in VABP have not been established and this use is not approved. PAEDIATRIC (US labelling, CABP only, 3 months to less than 18 years, for 7 to 14 days): 12 years to less than 18 years — 13.3 mg/kg (up to 667 mg/dose) every 8 hours, infused over 2 hours at 2.67 mg/mL; 3 months to less than 12 years — 20 mg/kg (up to 667 mg/dose) every 8 hours, infused over 2 hours at 5.33 mg/mL. 13.3 mg/kg of ceftobiprole medocaril sodium is equivalent to 10 mg/kg of ceftobiprole and 20 mg/kg of ceftobiprole medocaril sodium is equivalent to 15 mg/kg of ceftobiprole. Safety and effectiveness have not been established for CABP under 3 months of age, or for ABSSSI and SAB at any paediatric age. The two paediatric bands carry different mg/kg doses, so no single per-kg figure is published in the structured field — verify the paediatric regimen against a children's formulary before use. SOURCE: no UK SPC was fetched in this bundle — verify against the UK SPC.

Dose adjustments

Renal

Reduce the dosage in adults with CrCl less than 50 mL/min, including patients with CrCl less than 15 mL/min on haemodialysis; increase the dosage to 667 mg every 6 hours in adults with augmented renal clearance (CrCl greater than 150 mL/min). Reduce the dosage in paediatric patients aged 2 years to less than 18 years with eGFR less than 50 and 15 mL/min/1.73 m2 or greater. SOURCE DEFECT: the renal dosing table (Table 3) is truncated in the fetched text after the first row ('SAB, CrCl 30 to less than 50 mL/min, 667 mg, every 8 …'), so the individual reduced doses could not be read — obtain the full renal table from the label or SPC. For reference, 667 mg of ceftobiprole medocaril sodium is equivalent to 500 mg of ceftobiprole and 333 mg is equivalent to 250 mg of ceftobiprole.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Known history of severe hypersensitivity to ceftobiprole (ZEVTERA) or to other members of the cephalosporin class

Side effects

Nausea, vomiting and diarrhoea (most common across SAB, ABSSSI and CABP)
Hepatic enzyme and bilirubin increased (SAB, ABSSSI and CABP)
Anaemia, hypokalaemia, leukopenia, blood creatinine increased, hypertension and pyrexia (most common in SAB, at least 4% of adults)
Headache, injection site reaction, rash and dysgeusia (ABSSSI, at least 2% of adults); insomnia, abdominal pain, phlebitis and dizziness (CABP)
Serious labelled reactions — increased mortality with unapproved use in ventilator-associated bacterial pneumonia, hypersensitivity reactions, seizures and other CNS reactions, and Clostridioides difficile-associated diarrhoea

Interactions

Dipstick tests — may give false-positive results for urine protein, ketones or occult blood; use alternate clinical laboratory methods to confirm positive tests
Serological testing — may interfere with tests such as the Coombs test; haemolytic anaemia was not seen in adult or paediatric studies but cannot be ruled out, so investigate anaemia occurring during or after treatment

Clinical monograph

How it works

Its active form is a beta-lactam that binds penicillin-binding proteins, including PBP2a in MRSA, to inhibit cell-wall synthesis and produce a bactericidal effect.

Prescribing in practice

Avoid in patients with a history of immediate hypersensitivity to penicillins or other beta-lactams because of the risk of cross-reactivity.
Its broad spectrum including MRSA and many Gram-negative organisms means use should be reserved and guided by stewardship and susceptibility data.
Dose adjustment is required in renal impairment, in line with the SPC.

Monitoring

Monitor renal function and clinical response, and review therapy in line with microbiology advice during the course.

Counselling the patient

This antibiotic is given by infusion under clinical supervision.
Report any rash, swelling, breathing difficulty, or severe or persistent diarrhoea.

Evidence & guidelines

Ceftobiprole's efficacy in pneumonia and other serious infections was demonstrated in dedicated phase III trial programmes.

Reference: BSAC; UKHSA AMR; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways