ceftobiprole

Contraindicated in:

Known serious hypersensitivity to cephalosporins.

Use Cautiously in:

Ventilator-associated bacterial pneumonia (↑ risk of mortality);
Seizure disorders;
Renal impairment (↓ dose if CCr <50 mL/min);
Augmented renal clearance (↑ dosing frequency if CCr >150 mL/min);
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established in children <18 yr (bacteremia or acute bacterial skin/skin structure infections) or <3 mo (community-acquired pneumonia).
Geri: Dose adjustment may be necessary in older adults for age-related ↓ in renal function.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: rash

GI: ↑liver enzymes, nausea, abdominal pain, CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD), diarrhea, vomiting

GU: ↑serum creatinine

Hemat: anemia, leukopenia

Local: phlebitis

Neuro: dizziness, dysgeusia, headache, insomnia, SEIZURES

Resp: dyspnea

Misc: fever, fungal infection, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Interactions ⬆ ⬇

Drug-drug:

May ↑ levels and risk of toxicity of organic anion transporting polypeptide (OATP) 1B1 substrates and OATP 1B3 substrates.

Availability ⬆ ⬇

Powder for injection: 667 mg/vial

Route/Dosage ⬆ ⬇

Bacteremia

IV (Adults ): Days 1–8: 667 mg every 6 hr; Day 9 and thereafter: 667 mg every 8 hr. Treatment duration is up to 42 days.

Renal Impairment

IV (Adults ): CCr >150 mL/min: 667 mg every 6 hr for up to 42 days. CCr 30–<50 mL/min: Days 1–8: 667 mg every 8 hr; Day 9 and thereafter: 667 mg every 12 hr. Treatment duration is up to 42 days. CCr 15–<30 mL/min: Days 1–8: 333 mg every 8 hr; Day 9 and thereafter: 333 mg every 12 hr. Treatment duration is up to 42 days. CCr <15 mL/min and Hemodialysis: 333 mg every 24 hr for up to 42 days. Administer dose after hemodialysis on hemodialysis days.

Acute Bacterial Skin/Skin Structure Infections

IV (Adults ): 667 mg every 8 hr for 5–14 days.

Renal Impairment

IV (Adults ): CCr >150 mL/min: 667 mg every 6 hr for 5–14 days. CCr 30–<50 mL/min: 667 mg every 12 hr for 5–14 days. CCr 15–<30 mL/min: 333 mg every 12 hr for 5–14 days. CCr <15 mL/min and Hemodialysis: 333 mg every 24 hr for 5–14 days. Administer dose after hemodialysis on hemodialysis days.

Community-Acquired Pneumonia

IV (Adults ): 667 mg every 8 hr for 5–14 days.
IV (Children 12–<18 yr): 13.3 mg/kg (max = 667 mg) every 8 hr for 7–14 days.
IV (Children 3 mo-<12 yr): 20 mg/kg (max = 667 mg) every 8 hr for 7–14 days.

Renal Impairment

IV (Adults ): CCr >150 mL/min: 667 mg every 6 hr for 5–14 days. CCr 30–<50 mL/min: 667 mg every 12 hr for 5–14 days. CCr 15–<30 mL/min: 333 mg every 12 hr for 5–14 days. CCr <15 mL/min and Hemodialysis: 333 mg every 24 hr for 5–14 days. Administer dose after hemodialysis on hemodialysis days.

Renal Impairment

(Children 12–<18 yr): CCr 30–<50 mL/min: 10 mg/kg (max = 667 mg) every 12 hr for 7–14 days. CCr 15–<30 mL/min: 10 mg/kg (max = 333 mg) every 12 hr for 7–14 days.

Renal Impairment

(Children 6–<12 yr): CCr 30–<50 mL/min: 10 mg/kg (max = 667 mg) every 12 hr for 7–14 days. CCr 15–<30 mL/min: 10 mg/kg (max = 333 mg) every 24 hr for 7–14 days.

Renal Impairment

(Children 2–<6 yr): CCr 30–<50 mL/min: 13.3 mg/kg (max = 667 mg) every 12 hr for 7–14 days. CCr 15–<30 mL/min: 13.3 mg/kg (max = 333 mg) every 24 hr for 7–14 days.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Inhibits bacterial cell wall synthesis.

Therapeutic effects:

Bactericidal action against susceptible bacteria.

Spectrum:

Active against: Staphylococcus aureus (including methicillin-susceptible and -resistant strains), Streptococcus pneumoniae, Streptococcus pyogenes, Escherichia coli, Haemophilus influenzae, Haemophilus influenzae, Haemophilus parainfluenzae, and Klebsiella pneumoniae.

Classifications ⬆ ⬇

Therapeutic Classification: anti-infectives

Pharmacologic Classification: cephalosporin derivatives

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Well distributed to tissues.

Metabolism/Excretion: Minimally metabolized. Primarily excreted as unchanged drug in urine.

Half-Life: 3.3 hr.

Time/Action Profile ⬆ ⬇

( plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	rapid	end of infusion	6–8 hr

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy. Advise to take the full course of treatment, even if symptoms improve.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Advise patient that hypersensitivity reactions can occur and to notify health care professional or seek immediate medical attention if needed.
Advise patient that seizures and other adverse CNS reactions can occur and to notify health care professional if any are experienced.
Caution patient to notify health care provider if fever and diarrhea occur, especially if stool contains blood, pus, or mucus. Advise patient not to treat diarrhea without consulting health care provider. May occur up to several weeks after discontinuation of medication.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or breastfeeding.

section name header

Indications ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Availability ⬆ ⬇

Route/Dosage ⬆ ⬇

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Classifications ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Pronunciation ⬆