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Drug Details

Ceftazidime 1.0 g powder for solution for injection/infusion

• Drug Class Description
  Third-generation cephalosporins - ATC code: JOIDD02
• Generic Name
  ceftazidime pentahydrate
• Presentation
  Powder for solution for injection and infusion. White to cream-coloured powder.
• Description
  1 vial with 1.2813 g of powder contains 1.1648 g of ceftazidime pentahydrate corresponding to 1.0 g of ceftazidime.
• Indications
  

  Ceftazidime is indicated for the parenteral treatment of the following infections when caused by pathogens susceptible to ceftazidime

  - Respiratory tract infections, including lower respiratory tract infections in patients with cystic fibrosis

  - Urinary tract infections: ceftazidime may also be used for peri-operative prophylaxis during trans-urethral prostatectomy

  - Skin and soft tissue infections

  - Biliary tract infections

  - Intra-abdominal infections

  - Bone and joint infections

  - Infections associated with peritoneal dialysis and with continuous ambulatory peritoneal dialysis (CAPD)

  - Meningitis due to aerobic gram-negative organisms

  It is recommended that the results of bacterial cultures and susceptibility tests are known before commencing treatment. This is especially important if ceftazidime is to be used as monotherapy.

  Ceftazidime should be used in combination with an additional antibacterial agent(s) when treating infections that are likely to be due to a mixture of susceptible and resistant bacterial species. For example, combination therapy with an antibacterial agent that is active against anaerobes should be considered when the infection is thought to be due to aerobic and anaerobic bacteria.

  Ceftazidime may also be used in combination with another antibacterial agent (such as an aminoglycoside) to treat infections in patients with severe neutropenia.

  Consideration should be given to official guidance regarding the appropriate use of antibacterial agents.

• Adult Dosage
  

  The range of usual dose regimens in patients with normal renal function for the age groups defined is as follows:

  Age Group	Infection	Usual Dose
  Adults	Most uses	1 g 8-hourly OR 2 g 12-hourly
  	Severe infections and infections in neutropenic patients	2 g 8-hourly OR 3 g 12 hourly
  	UTI	500 mg 12-hourly OR 1 g 12-hourly
  	Prophylaxis for prostatectomy	1 g at induction ± 1 g at catheter removal
  	Cystic fibrosis	100-150 mg/kg/day in three divided doses; not to exceed 9 g/day
  Elderly	All infections, especially in those> 80 years	Not to exceed 3 g daily total 1
  Infants > 2 months, toddlers and children	Most uses	30-100 mg/kg/day in two or three divided doses
  	Severe infections	up to 150 mg/kg/day (max 6 g total per day) in three divided doses
  Term new born infants and infants < 2 months	Most uses	25-60 mg/kg/day in two divided doses 2

  ¹ In acutely ill elderly patients the clearance of ceftazidime is usually decreased

  ² Plasma elimination half life of ceftazidime can be 3 to 4 times that of adults.

  The duration of therapy depends on the patient response. In general treatment should be continued for at least 48 hours after clinical recovery.

  Dosage in renal insufficiency: Ceftazidime is almost exclusively excreted by glomerular filtration and the dose should be reduced when the glomerular filtration rate (GFR) is less than 50 ml/min.

  In adults with renal insufficiency, an initial loading dose of 1 g of ceftazidime may be given, followed by an appropriate maintenance dose as in the table:

  Recommended maintenance doses of ceftazidime in adults with renal insufficiency

  

  * These values are guidelines and may not accurately predict renal function in all patients especially in the elderly in whom the serum creatinine concentration may overestimate renal function.

  In patients with renal insufficiency and severe infections, especially in neutropenics, who would normally receive 6g of ceftazidime daily were it not for renal insufficiency, the unit dose given in the table above may be increased by 50% or the dosing frequency increased appropriately. In such patients it is recommended that ceftazidime serum levels should be monitored and trough levels should not exceed 40 mg/litre.

  In children with renal insufficiency the creatinine clearance should be adjusted for body surface area or lean body mass and the dosing frequency reduced as for adults.

  In patients on 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 in renal failure on continuous arteriovenous haemodialysis or high-flux haemofiltration in intensive therapy units, it is recommended that the dosage should be 1g daily in divided doses. For low-flux haemofiltration it is recommended that the dosage should be that suggested under impaired renal function.

  In patients on peritoneal dialysis: Ceftazidime may also be used in patients who are undergoing peritoneal dialysis and continuous ambulatory peritoneal dialysis (CAPD) at a dose adjusted according to renal function. In such patients, a loading dose of 1g of ceftazidime may be given, followed by 500 mg every 24 hours. In addition, for intra-peritoneal infections, ceftazidime can be incorporated into the dialysis fluid (usually 125 to 250 mg for 2 L of dialysis fluid).

  Dosage in hepatic insufficiency: No dose adjustment is required unless there is concomitant renal insufficiency.

• Child Dosage
  

  see adults

• Contra Indications
  

  Hypersensitivity to ceftazidime, to any of the cephalosporins or to sodium carbonate.

  Previous immediate and/or severe hypersensitivity reaction to a penicillin or to any other type of beta-lactam drug.

• Special Precautions
  

  Before therapy with ceftazidime is instituted, careful inquiry should be made to determine whether the patient has had any previous hypersensitivity reactions to ceftazidime, cephalosporins, penicillins, or other beta-lactam drugs. Ceftazidime is contraindicated in patients who have had a previous hypersensitivity reaction to any cephalosporin. It is also contraindicated in patients who have had a previous immediate and/or any severe hypersensitivity reaction to any penicillin or to any other beta-lactam drug. Ceftazidime should be given with caution to patients who have had any other type of hypersensitivity reaction to a penicillin or any other beta-lactam drug.

  Antibiotic-associated diarrhoea, colitis and pseudomembranous colitis have all been reported with the use of ceftazidime. These diagnoses should be considered in any patient who develops diarrhoea during or shortly after treatment. Ceftazidime should be discontinued if severe and/or bloody diarrhoea occurs during treatment and appropriate therapy instituted. Anti-peristaltics are contraindicated.

  Ceftazidime should be used with caution in individuals with a previous history of gastro-intestinal disease, particularly colitis.

  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.

  Cephalosporin antibiotics should be given with caution to patients receiving concurrent treatment with nephrotoxic drugs such as aminoglycoside antibiotics or potent diuretics (such as frusemide) as these combinations may have an adverse effect on renal function and have been associated with ototoxicity.

  As with other cephalosporins, prolonged use of ceftazidime may result in the overgrowth of non-susceptible organisms, such as enterococci and Candida spp.

  During long-term treatment with ceftazidime, it is recommended that blood counts and tests for renal and hepatic function should be performed at regular intervals.

  Ceftazidime does not interfere with enzyme-based tests for glycosuria. Slight interference with copper reduction methods (Benedict's, Fehling's, Clinitest) may be observed.

  Ceftazidime does not interfere in the alkaline picrate assay for creatinine

  The development of a positive Coombs' test associated with the use of ceftazidime in about 5% of patients may interfere with the cross-matching of blood.

  The sodium content of the medicinal product (13 mg sodium per dose for 250 mg Ceftazidime, 26 mg sodium per dose for 500 mg Ceftazidime, 52 mg sodium per dose for 1 g Ceftazidime and 104 mg sodium per dose for 2.0 g Ceftazidime) should be taken into account when prescribing to patients requiring sodium restriction.

• Interactions
  

  Nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics or potent diuretics, such as furosemide (frusemide). Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics.

  In vitro, chloramphenicol has been shown to be antagonistic with respect to ceftazidime and other cephalosporins. The clinical relevance of this finding is unknown, but if concurrent administration of ceftazidime with chloramphenicol (or other bacteriostatic agents: e.g. tetracycline or sulfonamides) is proposed, the possibility of antagonism should be considered.

  In common with other antibiotics, ceftazidime may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives. Therefore, alternative non-hormonal methods of contraception are recommended.

• Adverse Drug Reactions
  

  The most common adverse reactions during ceftazidime treatment are local reactions following intravenous injection, allergic reactions, and effects on the gastro-intestinal tract.

  Adverse reactions are ranked under heading of frequency, the most frequent first, using the following convention: very common (> 1/10); common (> 1/100 to < 1/10); uncommon (> 1/1,000 to < 1/100); rare (> 1/10,000 to < 1/1,000) very rare (< 1/10,000), not known (cannot be estimated from the available data)

  	Adverse drug reactions
  System organ class	Common	Uncommon	Very rare	Not known
  Infections and infestations		Candidiasis, oral thrush and vaginitis
  Blood and lymphatic system disorders	Eosinophilia, thrombocytosis	Leucopenia, neutropenia, thrombocytopenia	Agranulocytosis, lymphocytosis, haemolytic anaemia
  Immune system disorders			Anaphylaxis (including bronchospasm and/or hypotension)
  Nervous system disorders		Headache, dizziness	Paraesthesiae	There have been reports of neurological sequelae, including tremor, myoclonia, convulsions encephalopathy and coma, in patients with renal impairment in whom the dose of ceftazidime has not been appropriately reduced.
  Gastrointestinal disorders	Diarrhea	Nausea, vomiting, abdominal pain and colitis	Bad taste	As with other cephalosporins, colitis may be associated with Clostridium difficile and may present as pseudomembranous colitis.
  Hepato-biliary disorders	Elevations in one or more hepatic enzymes: AST (SGOT), ALT (SGPT), LDH, GGT and alkaline phosphatase		Jaundice
  Skin and subcutaneous tissue disorders	Rash, urticaria	Pruritus	Erythema multiforme, fever, toxic epidermal necrolysis, Stevens Johnson syndrome, angioedema
  Renal and urinary disorders		Transient elevations of blood urea, blood urea nitrogen and/or serum creatinine have been observed occasionally.
  General disorders and administration site conditions	Phlebitis or thrombophlebitis, pain and/or inflammation at the site of injection	Fever
  Investigations	Positive Coombs` test