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 Ceftazidime for Injection (ZIDIWAY)  
 

QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Each vial contains ceftazidime 1g (as pentahydrate).

Each gram of ceftazidime contains approximately 52mg (2.26mmol) of sodium.

 



PHARMACEUTICAL FORM

 

Powder for solution for injection (Powder for injection).

White to cream coloured, crystalline powder

 



Therapeutic indications

 

Ceftazidime is indicated for the treatment of the following infections when known or likely to be due to one or more susceptible microorganisms and when parenteral therapy is required:

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 peritoneal dialysis and with continuous ambulatory peritoneal dialysis (CAPD)

Meningitis due to aerobic gram negative organisms

Whenever possible, 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.

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

 

 

Posology and method of administration

 

Posology

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

± 1g 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

Infants > 2 months 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

Neonates and infants < 2 months

Most uses

25 – 60 mg/kg/day in two divided doses

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 50ml/min.

In adults with renal insufficiency, an initial loading dose of 1g 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

Creatinine clearance ml/min

Approx. serum creatinine* μmol/l(mg/dl)

Recommended unit dose of ceftazidime (g)

Frequency of dosing (hourly)

50 – 31

150-200

(1.7-2.3)

1

12

30 – 16

200-350

(2.3-4.0)

1

24

15 – 6

350-500

(4.0-5.6)

0.5

24

<5

>500

(>5.6)

0.5

48

* 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 500mg 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.

Method of Administration

Ceftazidime may be given intravenously by slow bolus injection over a few minutes or by deep intramuscular injection into a large muscle mass, such as the upper outer quadrant of the gluteus maximus or lateral part of the thigh.

 

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