Ceftobiprole parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Infusions of ceftobiprole
Drugs List
Therapeutic Indications
Uses
Community acquired pneumonia
Nosocomial pneumonia
Ceftobiprole is indicated for the treatment of hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP), and community-acquired pneumonia (CAP).
Unlicensed Uses
Complicated skin and soft tissue infections
Dosage
Adults
500 mg every 8 hours as a 2 hour intravenous infusion.
When treating CAP, a switch to oral antibiotics may be considered after 3 days of ceftobiprole treatment depending on the patient's response.
Patients with Renal Impairment
Supra-normal creatinine clearance (greater than 150 ml/minute)
Prolong the infusion duration to 4 hours.
Moderate renal impairment (creatinine clearance 30 to less than 50 ml/minute)
500 mg every 12 hours.
Severe renal impairment (creatinine clearance less than 30 ml/minute)
250 mg every 12 hours.
End-stage renal disease with or without intermittent haemodialysis
250 mg every 24 hours.
Ceftobiprole is haemodialysable.
Contraindications
Children under 18 years
Precautions and Warnings
Restricted sodium intake
Breastfeeding
End stage renal disease
Epileptic disorder
History of seizures
Pregnancy
Renal impairment - creatinine clearance below 50ml/minute
Reduce dose in patients with creatinine clearance below 50ml/min
Sodium content of formulation may be significant
Advise ability to drive/operate machinery may be affected by side effects
Before initiating therapy enquire about previous hypersensitivity reactions
Consult national/regional policy on the use of anti-infectives
Creatinine clearance above 150ml/min: Prolong infusion duration to 4 hours
Hypovolaemia occurring during therapy must be corrected
Monitor periodically for overgrowth of non-susceptible organisms
Consider pseudomembranous colitis if patient presents with diarrhoea
May affect results of some laboratory tests
Discontinue at once if pseudomembranous colitis occurs
Discontinue if haemolytic anaemia occurs
Discontinue if severe hypersensitivity reactions occur
Ceftobiprole has not been shown to be effective in the treatment of VAP. The manufacturer suggests it should be used with caution in patients with HAP who subsequently require ventilation. Caution should also be used in CAP patients with HIV, neutropenia, myelosuppression and immunocompromised patients.
Seizures have been associated with ceftobiprole use, most commonly in patients with existing CNS/seizure disorders. Therefore caution is advised in these patients.
Pregnancy and Lactation
Pregnancy
Use ceftobiprole with caution during pregnancy.
The manufacturer does not recommend using ceftobiprole during pregnancy. At the time of writing there is limited published information regarding the use of ceftobiprole during pregnancy. Potential risks are unknown.
Lactation
Use ceftobiprole with caution during breastfeeding.
The manufacturer advises that the patient either discontinues ceftobiprole or discontinues breastfeeding. Animal data reports significant levels of ceftobiprole in breast milk, however presence in human milk is unknown.
Side Effects
Abdominal pain
Agitation
Agranulocytosis
Anaemia
Anaphylaxis
Anxiety
Asthma
Convulsions
Diarrhoea
Dizziness
Dysgeusia
Dyspepsia
Dyspnoea
Elevated triglyceride levels
Eosinophilia
Fungal infection
Headache
Hypersensitivity reactions
Hypokalaemia
Hyponatraemia
Increase in serum glucose
Increases in hepatic enzymes
Injection site reactions
Insomnia
Leukopenia
Muscle spasm
Nausea
Nightmares
Panic attack
Peripheral oedema
Pharyngolaryngeal pain
Positive Coombs test
Possible alteration of laboratory tests
Pruritic rash
Pseudomembranous colitis
Rash
Renal failure
Serum creatinine increased
Somnolence
Thrombocytopenia
Thrombocytosis
Urticaria
Vomiting
Effects on Laboratory Tests
A positive direct antiglobulin test may occur during treatment with cephalosporins. Haemolytic anaemia cannot be ruled out during ceftobiprole treatment. Patients experiencing anaemia during or after treatment with ceftobiprole should be investigated.
Some other cephalosporins interfere with the alkaline picrate assay to measure serum creatinine (Jaffe reaction), which may lead to erroneously high creatinine measurements. It is unknown if ceftobiprole interferes with this test. The manufacturer suggests an enzymatic method of measuring serum creatinine should be used.
The manufacturer suggests an enzymatic methods to detect glucosuria should be used because of the potential interference with tests using the copper reduction technique.
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: June 2019
Reference Sources
Summary of Product Characteristics: Zevtera 500 mg powder for concentrate for solution for infusion. Basilea Medical Ltd. Revised February 2018.
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