Ceftolozane with tazobactam parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Infusions of ceftolozane (as ceftolozane sulfate) with tazobactam (as tazobactam sodium).
Drugs List
Therapeutic Indications
Uses
Complicated intra-abdominal infections: treatment
Complicated urinary tract infections
Hospital-acquired pneumonia (HAP)
Pyelonephritis
Dosage
Adults
Complicated intra-abdominal infection
1g ceftolozane/500mg tazobactam every 8 hours. The manufacturer suggests a treatment duration of 4 to 14 days.
If anaerobic pathogens are suspected, use in combination with metronidazole. See information for metronidazole for more details.
Complicated urinary tract infection
1g ceftolozane/500mg tazobactam every 8 hours. The manufacturer suggests a treatment duration of 7 days.
Acute pyelonephritis
1g ceftolozane/500mg tazobactam every 8 hours. The manufacturer suggests a treatment duration of 7 days.
Hospital-acquired pneumonia (HAP) including ventilator-associated penumonia
2g ceftolozane/1g tazobactam every 8 hours. The manufacturer suggests a treatment duration of 8 to 14 days.
Patients with Renal Impairment
Creatinine clearance estimated using Cockcroft-Gault formula.
Creatinine clearance 30 to 50 ml/minute
500mg ceftolozane/250mg tazobactam every 8 hours.
Creatinine clearance 15 to 29 ml/minute
250mg ceftolozane/125mg tazobactam every 8 hours.
End stage renal disease on haemodialysis
Single loading dose of 500mg ceftolozane/250mg tazobactam. Follow after 8 hours with a maintenance dose of 100mg ceftolozane/50mg tazobactam administered every 8 hours for remainder of treatment.
On haemodialysis days, administer dose at earliest possible time following completion of haemodialysis.
Administration
Intravenous infusion over 1 hour.
Contraindications
Children under 18 years
Precautions and Warnings
Restricted sodium intake
Breastfeeding
End stage renal disease
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
Concentrate must be diluted and used as an infusion
Monitor for signs of superinfection with non-susceptible organisms
Monitor periodically for overgrowth of non-susceptible organisms
Consider pseudomembranous colitis if patient presents with diarrhoea
Test interference: May cause false positive Coombs test
Discontinue if severe hypersensitivity reactions occur
Discontinue therapy if marked diarrhoea occurs
Pregnancy and Lactation
Pregnancy
Use ceftolozane with tazobactam with caution during pregnancy.
The manufacturer suggests ceftolozane with tazobactam should only be used if the expected benefit outweighs the possible risks. Tazobactam crosses the placenta. It is not known if ceftolozane crosses the placenta. Animal studies with tazobactam have shown reproductive toxicity without evidence of teratogenic effects. At the time of writing there is limited published information on the use of ceftolozane with tazobactam in pregnant women. Potential risks are unknown.
Lactation
Use ceftolozane with tazobactam with caution during breastfeeding.
The manufacturer suggests a decision must be made whether to discontinue breastfeeding or discontinue ceftolozane with tazobactam taking into account the benefit of therapy and the benefit of breastfeeding the child. At the time of writing, it is unknown whether ceftolozane and tazobactam are excreted in human milk. A risk to newborns cannot be excluded.
The Drugs and Lactation Data (LactMed) suggests ceftolozane with tazobactam is acceptable for use during breastfeeding. No serious adverse effects have been reported for other cephalosporin antibiotics, occasionally disruption of the child's gastrointestinal flora, resulting in diarrhoea or thrush have been reported.
Side Effects
Abdominal distension
Abdominal pain
Alanine aminotransferase increased
Anaemia
Angina pectoris
Anxiety
Aspartate aminotransferase increased
Atrial fibrillation
Clostridium difficile diarrhoea
Constipation
Diarrhoea
Dizziness
Dyspepsia
Dyspnoea
Flatulence
Gamma glutamyl transferase (GGT) increased
Gastritis
Headache
Hyperglycaemia
Hypokalaemia
Hypomagnesaemia
Hypophosphataemia
Hypotension
Increase in alkaline phosphatase
Injection site reactions
Insomnia
Ischaemic stroke
Nausea
Oropharyngeal candidiasis
Paralytic ileus
Phlebitis
Positive Coombs test
Pyrexia
Rash
Renal failure
Renal impairment
Tachycardia
Thrombocytosis
Urinary tract infections
Urticaria
Vaginal candidiasis
Venous thrombosis
Vomiting
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: August 2019
Reference Sources
Summary of Product Characteristics: Zerbaxa 1 g/0.5 g powder for concentrate for solution for infusion. Merck Sharp and Dohme Ltd. August 2019.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Ceftolozane and tazobactam. Last revised: 03 December 2018
Last accessed: 05 August 2019
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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