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Ceftazidime parenteral

Updated 2 Feb 2023 | Cephalosporins

Presentation

Parenteral formulations of ceftazidime.

Drugs List

  • ceftazidime 1g powder for solution for injection
  • ceftazidime 2g powder for solution for injection
  • ceftazidime 3g powder for solution for injection
  • ceftazidime 500mg powder for solution for injection
  • FORTUM 1g powder for solution for injection
  • FORTUM 2g powder for solution for injection
  • FORTUM 500mg powder for solution for injection
  • Therapeutic Indications

    Uses

    Bacterial meningitis
    Biliary tract infection
    Bone and joint infection
    Infections intra-abdominal
    Otitis externa
    Otitis media
    Perioperative prophylaxis of infection in transurethral prostatectomy
    Peritonitis associated with dialysis
    Respiratory tract infections - upper and lower
    Septicaemia
    Skin and soft tissue infections
    Treatment of respiratory infections in patients with cystic fibrosis
    Urinary tract infection

    Unlicensed Uses

    Chronic Burkholderia cepacia infection in cystic fibrosis

    Dosage

    Adults

    By intermittent administration
    Broncho-pulmonary infections in cystic fibrosis: 100 to 150mg/kg/day every 8 hours. Maximum dose is 9g daily.
    Febrile neutropenia: 2g every 8 hours.
    Nosocomial pneumonia: 2g every 8 hours.
    Bacterial meningitis: 2g every 8 hours.
    Bacteraemia: 2g every 8 hours.
    Bone and joint infections: 1g to 2g every 8 hours.
    Complicated skin and soft tissue infections: 1g to 2g every 8 hours.
    Complicated intra-abdominal infections: 1g to 2g every 8 hours.
    Peritonitis associated with dialysis in patients on CAPD: 1g to 2g every 8 hours.
    Chronic suppurative otitis media: 1g to 2g every 8 hours.
    Malignant otitis externa: 1g to 2g every 8 hours.
    Complicated urinary tract infections: 1g to 2g every 8 or 12 hours.
    Peri-operative prophylaxis for transurethral resection of prostate: 1g at anaesthesia induction, and a second dose at catheter removal.

    By continuous infusion
    Febrile neutropenia: Loading dose of 2g followed by a continuous infusion of 4g to 6g every 24 hours.
    Nosocomial pneumonia: Loading dose of 2g followed by a continuous infusion of 4g to 6g every 24 hours.
    Broncho-pulmonary infections in cystic fibrosis: Loading dose of 2g followed by a continuous infusion of 4g to 6g every 24 hours.
    Bacterial meningitis: Loading dose of 2g followed by a continuous infusion of 4g to 6g every 24 hours.
    Bacteraemia: Loading dose of 2g followed by a continuous infusion of 4g to 6g every 24 hours.
    Bone and joint infections: Loading dose of 2g followed by a continuous infusion of 4g to 6g every 24 hours.
    Complicated skin and soft tissue infections: Loading dose of 2g followed by a continuous infusion of 4g to 6g every 24 hours.
    Complicated intra-abdominal infections: Loading dose of 2g followed by a continuous infusion of 4g to 6g every 24 hours.
    Peritonitis associated with dialysis in patients on CAPD: Loading dose of 2g followed by a continuous infusion of 4g to 6g every 24 hours.

    Elderly

    (See Dosage; Adults).
    The dose should not normally exceed 3g per day, especially in those aged over 80 years.

    Children

    Children aged 2 months and older
    Children weighing 40kg or more
    (See Dosage; Adult)
    Children weighing less than 40kg
    By intermittent administration
    Complicated urinary tract infections: 100 to 150mg/kg/day in three divided doses. The maximum dose is 6g daily.
    Chronic suppurative otitis media: 100 to 150mg/kg/day in three divided doses. The maximum dose is 6g daily.
    Malignant otitis externa: 100 to 150mg/kg/day in three divided doses. The maximum dose is 6g daily.
    Bone and joint infections: 100 to 150mg/kg/day in three divided doses. The maximum dose is 6g daily.
    Complicated skin and soft tissue infections: 100 to 150mg/kg/day in three divided doses. The maximum dose is 6g daily.
    Complicated intra-abdominal infections: 100 to 150mg/kg/day in three divided doses. The maximum dose is 6g daily.
    Peritonitis associated with dialysis in patients on CAPD: 100 to 150mg/kg/day in three divided doses. The maximum dose is 6g daily.
    Neutropenic children: 150mg/kg/day in three divided doses. The maximum dose is 6g daily.
    Broncho-pulmonary infections in cystic fibrosis: 150mg/kg/day in three divided doses. The maximum dose is 6g daily.
    Bacterial meningitis: 150mg/kg/day in three divided doses. The maximum dose is 6g daily.
    Bacteraemia: 150mg/kg/day in three divided doses. The maximum dose is 6g daily.

    By continuous infusion
    Febrile neutropenia: Loading dose of 60mg/kg to 100mg/kg followed by a continuous infusion of 100 to 200mg/kg/day. The maximum dose is 6g daily.
    Nosocomial pneumonia: Loading dose of 60mg/kg to 100mg/kg followed by a continuous infusion of 100 to 200mg/kg/day. The maximum dose is 6g daily.
    Broncho-pulmonary infections in cystic fibrosis: Loading dose of 60mg/kg to 100mg/kg followed by a continuous infusion of 100 to 200mg/kg/day. The maximum dose is 6g daily.
    Bacterial meningitis: Loading dose of 60mg/kg to 100mg/kg followed by a continuous infusion of 100 to 200mg/kg/day. The maximum dose is 6g daily.
    Bacteraemia: Loading dose of 60mg/kg to 100mg/kg followed by a continuous infusion of 100 to 200mg/kg/day. The maximum dose is 6g daily.
    Bone and joint infections: Loading dose of 60mg/kg to 100mg/kg followed by a continuous infusion of 100 to 200mg/kg/day. The maximum dose is 6g daily.
    Complicated skin and soft tissue infections: Loading dose of 60mg/kg to 100mg/kg followed by a continuous infusion of 100 to 200mg/kg/day. The maximum dose is 6g daily.
    Complicated intra-abdominal infections: Loading dose of 60mg/kg to 100mg/kg followed by a continuous infusion of 100 to 200mg/kg/day. The maximum dose is 6g daily.
    Peritonitis associated with dialysis in patients with CAPD: Loading dose of 60mg/kg to 100mg/kg followed by a continuous infusion of 100 to 200mg/kg/day. The maximum dose is 6g daily.

    Children aged up to 2 months
    By intermittent administration
    25mg/kg to 60mg/kg daily in two divided doses.

    The following alternative dosing schedule may be suitable:
    Infections due to sensitive gram-positive or gram-negative bacteria
    Children aged 1 month to 18 years: 25mg/kg every 8 hours; dose doubled in severe infection, febrile neutropenia and meningitis (up to a maximum of 6g daily). By intravenous injection or infusion.

    Pseudomonal lung infection in cystic fibrosis
    Children aged 1 month to 18 years: 50mg/kg every 8 hours (up to a maximum 9g daily). By intravenous injection or infusion or by deep intramuscular injection.

    Chronic Burkholderia cepacia infection in cystic fibrosis (unlicensed)
    Children aged 1 month to 18 years: 1g twice daily. By inhalation of nebulised solution.

    Neonates

    25mg/kg to 60mg/kg daily in two divided doses. In the neonates the serum half life can be 3 to 4 times that in adults.

    The following alternative dosing schedule may be suitable:
    Infections due to sensitive gram-positive or gram-negative bacteria
    By intravenous injection or infusion
    Neonate aged 21 to 28 days: 25mg/kg every 8 hours; dose doubled in severe infection and meningitis.
    Neonate aged 7 to 21 days: 25mg/kg every 12 hours; dose doubled in severe infection and meningitis.
    Neonate aged under 7 days: 25mg/kg every 24 hours; dose doubled in severe infection and meningitis.

    Patients with Renal Impairment

    Ceftazidime is excreted by the kidneys, almost exclusively by glomerular filtration. In patients with moderate to severe renal impairment the dose of ceftazidime should be reduced to compensate for the slower excretion.

    Creatinine clearance greater than 50ml/minute
    No dosage adjustment necessary (See Dosage; Adults).

    Creatinine clearance less than 50ml/minute
    In patients with suspected renal insufficiency, an initial loading dose of 1 g of ceftazidime may be given. An estimate of GFR should be made to determine the appropriate maintenance dose.

    Recommended maintenance doses are as follows:
    Creatinine clearance 31 to 50ml/minute: 1g every 12 hours.
    Creatinine clearance 16 to 30 ml/minute: 1g every 24 hours.
    Creatinine clearance 6 to 15 ml/minute: 500mg every 24 hours.
    Creatinine clearance less than 5ml/minute: 500mg every 48 hours.

    Patients with severe infections, and especially those with neutropenia, who would normally be given 6g/day if they had normal renal function, may have the above doses increased by 50% or the dose frequency increased. In these cases the ceftazidime serum levels should be monitored and trough levels should not exceed 40mg/litre.

    Haemodialysis
    The serum half-life of ceftazidime during haemodialysis ranges from 3 to 5 hours. The appropriate maintenance dose of ceftazidime should be repeated following each haemodialysis period.

    For patients on continuous arteriovenous haemodialysis or high-flux haemofiltration in intensive therapy units, the recommended dose is 1g daily either as a single dose or in divided doses. For low-flux haemofiltration the recommended dose is dependent on the creatinine clearance.

    Peritoneal dialysis
    A loading dose of 1g may be administered and followed by 500mg every 24 hours.
    For the treatment of intra-peritoneal infections, ceftazidime may be incorporated into the dialysis fluid (usually 125mg to 250mg per 2 litres of dialysis fluid).

    Children with renal impairment
    The creatinine clearance should be adjusted for body surface area or lean body mass and the dosing frequency reduced as for adults.

    Administration

    Ceftazidime may be administered by deep intramuscular injection into a large muscle mass (upper outer quadrant of gluteus maximus or lateral part of thigh), by intravenous injection over a few minutes or by intravenous infusion over 15 to 30 minutes.

    The manufacturer suggests the recommended route of administration is by intravenous intermittent injection or intravenous continuous infusion. Intramuscular administration should only be considered when the intravenous route is not possible or less appropriate for the patient.

    Contraindications

    None known

    Precautions and Warnings

    Restricted sodium intake
    History of colitis
    History of gastrointestinal disorder
    Pregnancy
    Renal impairment - creatinine clearance below 50ml/minute
    Severe hepatic impairment

    Reduce dose in patients with renal impairment
    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
    Not all available brands are licensed for all indications
    Not all routes are licensed for all age groups
    Monitor for signs of superinfection with non-susceptible organisms
    Monitor liver function on prolonged therapy
    Monitor renal function in patients with renal impairment
    Perform blood counts on prolonged use of this treatment
    Consider pseudomembranous colitis if patient presents with diarrhoea
    Prolonged use may result in superinfection with non-susceptible organisms
    Test interference: May cause false positive Coombs test
    Slight interference with copper reduction tests for glycosuria
    Discontinue if hypersensitivity reactions occur
    Discontinue therapy if marked diarrhoea occurs

    Ceftazidime has not been shown to be nephrotoxic. However, the total daily dosage should be reduced when ceftazidime is administered to patients with acute or chronic renal insufficiency in order to avoid potential clinical consequences such as, seizures.

    Caution should be used when administering ceftazidime alongside other antibiotics or potent diuretics as these combinations may have an adverse effect on renal function.

    Pregnancy and Lactation

    Pregnancy

    Use ceftazidime with caution during pregnancy.

    The manufacturers state that ceftazidime should only be used when the benefits of therapy outweigh the possible risks. Animal studies do not indicate any harmful effects of ceftazidime with respect to pregnancy. At the time of writing there is limited data from the use of ceftazidime in pregnant women. Risks are unknown.

    Lactation

    Ceftazidime is considered safe for use during breastfeeding.

    The manufacturers state ceftazidime may be used when breastfeeding. Ceftazidime is excreted in human milk in small quantities but at therapeutic doses no effects on the breast-fed infant are anticipated.

    Side Effects

    Abdominal pain
    Acute renal failure
    Agranulocytosis
    Anaphylaxis
    Angioedema
    Blood urea increased
    Bronchospasm
    Candidiasis
    Colitis
    Coma
    Confusion
    Convulsions
    Diarrhoea
    Dizziness
    Encephalopathy
    Eosinophilia
    Erythema multiforme
    Fever
    Gamma glutamyl transferase (GGT) increased
    Haemolytic anaemia
    Hallucinations
    Headache
    Hepatitis
    Hypersensitivity reactions
    Hypertonia
    Hypotension
    Increase in alkaline phosphatase
    Increase in blood urea nitrogen
    Increase in lactate dehydrogenase
    Increase in serum ALT/AST
    Inflammation (injection site)
    Interstitial nephritis
    Jaundice
    Leucopenia
    Local pain (injection site)
    Lymphocytosis
    Maculopapular rash
    Myoclonus
    Nausea
    Neurological effects
    Neutropenia
    Paraesthesia
    Phlebitis (injection site)
    Positive Coombs test
    Pruritus
    Pseudomembranous colitis
    Rash
    Renal tubular necrosis
    Serum creatinine increased
    Stevens-Johnson syndrome
    Taste disturbances
    Thrombocytopenia
    Thrombocytosis
    Thrombophlebitis (injection site)
    Toxic epidermal necrolysis
    Tremor
    Urticaria
    Vaginitis
    Vomiting

    Effects on Laboratory Tests

    May cause a positive Coombs test in about 5% of patients which may interfere with the cross matching of blood.

    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 2013

    Reference Sources

    Summary of Product Characteristics: Ceftazidime 1g powder for solution for injection/infusion. Sandoz Ltd. Revised April 2011.
    Summary of Product Characteristics: Ceftazidime 2g powder for solution for injection/infusion. Sandoz Ltd. Revised April 2011.

    Summary of Product Characteristics: Ceftazidime 3g Powder for solution for injection or infusion. Stragen UK Ltd. Revised December 2020.

    Summary of Product Characteristics: Ceftazidime 2g Powder for solution for injection or infusion. Villerton Invest SA. Revised October 2011.

    Summary of Product Characteristics: Ceftazidime 1g Powder for solution for injection. Wockhardt UK Ltd. Revised July 2011.
    Summary of Product Characteristics: Ceftazidime 2g Powder for solution for injection or infusion. Wockhardt UK Ltd. Revised July 2011.

    Summary of Product Characteristics: Fortum 500 Injection. GlaxoSmithKline UK. Revised September 2012.
    Summary of Product Characteristics: Fortum 1g Injection. GlaxoSmithKline UK. Revised September 2012.
    Summary of Product Characteristics: Fortum 2g and 3g Injection. GlaxoSmithKline UK. Revised September 2012.

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 09 August 2022

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