Ceftazidime with avibactam parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Infusions of ceftazidime (as ceftazidime pentahydrate) with avibactam (as avibactam sodium).
Drugs List
Therapeutic Indications
Uses
Complicated intra-abdominal infections: treatment
Complicated urinary tract infections
Infections caused by Gram-negative bacteria
Nosocomial pneumonia
Dosage
If Gram-positive organism known or suspected use in combination with an appropriate antibacterial agent.
Adults
Complicated intra-abdominal infections
Ceftazidime with avibactam 2g/500mg every 8 hours for 5 to 14 days. Use in combination with metronidazole when anaerobic organism is known or suspected.
Complicated urinary tract infection, including pyelonephritis
Ceftazidime with avibactam 2g/500mg every 8 hours for 5 to 10 days. Total duration may include follow on with suitable oral therapy.
Nosocomial pneumonia, including ventilator associated pneumonia
Ceftazidime with avibactam 2g/500mg every 8 hours for 7 to 14 days.
Treatment of infections caused by aerobic Gram-negative organisms where there are limited treatment options
Ceftazidime with avibactam 2g/500mg every 8 hours.
Use in combination with metronidazole when anaerobic organism is known or suspected. Length of treatment should be influenced by the infection. Limited experience of using ceftazidime with avibactam for more than 14 days.
Children
Complicated intra-abdominal infections
Children aged 6 months to 18 years:Ceftazidime with avibactam 50mg/kg/12.5mg/kg every 8 hours for 5 to 14 days. Maximum dose: 2g/500mg.
Children aged 3 to 6 months: Ceftazidime with avibactam 40mg/kg/10mg/kg every 8 hours for 5 to 14 days.
Complicated urinary tract infection, including pyelonephritis
Children aged 6 months to 18 years: Ceftazidime with avibactam 50mg/kg/12.5mg/kg every 8 hours for 5 to 14 days. Maximum dose: 2g/500mg.
Children aged 3 to 6 months: Ceftazidime with avibactam 40mg/kg/10mg/kg every 8 hours for 5 to 14 days.
Nosocomial pneumonia, including ventilator associated pneumonia
Children aged 6 months to 18 years: Ceftazidime with avibactam 50mg/kg/12.5mg/kg every 8 hours for 7 to 14 days. Maximum dose: 2g/500mg.
Children aged 3 to 6 months: Ceftazidime with avibactam 40mg/kg/10mg/kg every 8 hours for 7 to 14 days.
Treatment of infections caused by aerobic Gram-negative organisms where there are limited treatment options
Children aged 6 months to 18 years: Ceftazidime with avibactam 50mg/kg/12.5mg/kg every 8 hours. Maximum dose: 2g/500mg.
Children aged 3 to 6 months: Ceftazidime with avibactam 40mg/kg/10mg/kg every 8 hours.
Patients with Renal Impairment
Creatinine clearance 51 to equal to or less than 80ml/minute
(See Dosage; Adult).
Creatinine clearance 31 to 50ml/minute
Adults: Ceftazidime with avibactam 1g/250mg every 8 hours.
Children aged 2 to 18 years: 25mg/kg/6.25mg/kg to a maximum of 1g/0.25g every 8 hours.
Children aged 6 months to 2 years: 25mg/kg/6.25mg/kg every 8 hours.
Children aged 3 months to 6 months: 20mg/kg/5mg/kg every 8 hours.
Creatinine clearance 16 to 30ml/minute
Adults: Ceftazidime with avibactam 750mg/187.5mg every 12 hours.
Children aged 2 to 18 years: 18.75mg/kg/4.75mg/kg to a maximum of 0.75g/0.1875g every 12 hours.
Children aged 6 months to 2 years: 18.75mg/kg/4.7mg/kg every 12 hours.
Children aged 3 months to 6 months: 15mg/kg/3.75mg/kg every 12 hours.
Creatinine clearance 6 to 15ml/minute
Adults: Ceftazidime with avibactam 750mg/187.5mg every 24 hours.
Children aged 2 to 18 years: 18.75mg/kg/4.75mg/kg to a maximum of 0.75g/0.1875g every 24 hours.
End stage renal disease including patients on haemodialysis
Adults: Ceftazidime with avibactam 750mg/187.5mg every 48 hours.
Children aged 2 to 18 years: 18.75mg/kg/4.75mg/kg to a maximum of 0.75g/0.1875g every 48 hours.
Ceftazidime and avibactam are removed by haemodialysis. Administration of ceftazidime with avibactam should occur after haemodialysis if given on haemodialysis days.
Additional Dosage Information
Administer by intravenous infusion over 2 hours.
Contraindications
Children under 3 months
Precautions and Warnings
Children aged 3 months to 1 year
Restricted sodium intake
Breastfeeding
Pregnancy
Renal impairment - creatinine clearance below 51ml/minute
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
Do not mix with other drugs or substances
Consider pseudomembranous colitis if patient presents with severe diarrhoea
Monitor for haemolytic anaemia
Monitor renal function in patients with renal impairment
Reduce dose in patients with creatinine clearance below 51ml/min
Advise patient to contact their physician if worsening of anaemia symptoms
Prolonged use may result in superinfection with non-susceptible organisms
Test interference: May cause false positive Coombs test
May affect results of some laboratory tests
Discontinue if diarrhoea associated to Clostridioides difficile occurs
Discontinue if hypersensitivity reactions occur
May cause a positive direct antiglobulin test (DAGT or Coombs test) which may interfere with the cross matching of blood. Investigate patients who develop anaemia for possibility of haemolytic anaemia.
Pregnancy and Lactation
Pregnancy
Use ceftazidime with avibactam with caution during pregnancy.
The manufacturer does not recommend using ceftazidime with avibactam unless the potential benefit outweighs the possible risk. Animal studies with ceftazidime do not indicate direct or indirect harmful effects. Animal studies with avibactam have shown reproductive toxicity without evidence of teratogenic effects.
Lactation
Use ceftazidime with avibactam with caution during breastfeeding.
The manufacturer advises that the patient either discontinues ceftazidime with avibactam or discontinues breastfeeding. Available data indicates ceftazidime is expressed in human breast milk, but in small quantities. The presence of avibactam in human breast milk is unknown. Effects on exposed infants are unknown.
Occasionally disruption of the infant's gastrointestinal flora, resulting in diarrhoea or thrush have been reported with cephalosporins. LactMed (2018) indicates that ceftazidime with avibactam is acceptable during breastfeeding.
Side Effects
Abdominal pain
Acute kidney injury
Agranulocytosis
Alanine aminotransferase increased
Anaphylactoid reaction
Angioedema
Antibiotic-associated colitis
Aspartate aminotransferase increased
Blood urea increased
Candidiasis
Diarrhoea
Dizziness
Drug rash with eosinophilia and systemic symptoms (DRESS)
Dysgeusia
Eosinophilia
Erythema multiforme
Gamma glutamyl transferase (GGT) increased
Haemolytic anaemia
Headache
Hypersensitivity reactions
Increase in alkaline phosphatase
Increase in lactate dehydrogenase
Interstitial nephritis
Jaundice
Leukopenia
Lymphocytosis
Maculopapular rash
Nausea
Neutropenia
Oral infection
Paraesthesia
Phlebitis (injection site)
Positive Coombs test
Pruritus
Pseudomembranous colitis
Pyrexia
Rash
Serum creatinine increased
Stevens-Johnson syndrome
Thrombocytopenia
Thrombocytosis
Thrombosis (injection site)
Toxic epidermal necrolysis
Urticaria
Vomiting
Vulvovaginal infections
Effects on Laboratory Tests
Ceftazidime with avibactam may cause false positive results if copper reduction methods, such as Benedict's, Fehling's or Clinitest, are used to detect glycosuria. Enzyme-based tests for glycosuria are not affected.
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: March 2021
Reference Sources
Summary of Product Characteristics: Zavicefta 2g/0.5g powder for concentration for solution for infusion. Pfizer Ltd. Revised February 2021.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 16 March 2021
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Ceftazidime and Avibactam. Last revised: 03 December 2018
Last accessed: 16 March 2021
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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