CEFTAZIDIME Powder for solution for injection Ref.[6601] Active ingredients: Ceftazidime

Posology

Table 1. Adults and children ≥40 kg:

¹ In adults with normal renal function 9 g/day has been used without adverse effects.
* When associated with, or suspected to be associated with, any of the infections listed in section 4.1.

Table 2. Children <40 kg:

¹ In neonates and infants ≤2 months, the serum half life of ceftazidime can be three to four times that in adults.
* Where associated with or suspected to be associated with any of the infections listed in section 4.1.

Paediatric population

The safety and efficacy of Ceftazidime administered as continuous infusion to neonates and infants ≤2 months has not been established.

Elderly

In view of age related reduced clearance of Ceftazidime in elderly patients, the daily dose should not normally exceed 3 g in those over 80 years of age.

Hepatic impairment

Available data do not indicate the need for dose adjustment in mild or moderate liver function impairment. There are no study data in patients with severe hepatic impairment (see also section 5.2). Close clinical monitoring for safety and efficacy is advised.

Renal impairment

Ceftazidime is excreted unchanged by the kidneys. Therefore, in patients with impaired renal function, the dosage should be reduced (see also section 4.4).

An initial loading dose of 1 g should be given. Maintenance doses should be based on creatinine clearance:

Table 3. Recommended maintenance doses of Ceftazidime in renal impairment – intermittent infusion:

Adults and children ≥40 kg:

In patients with severe infections the unit dose should be increased by 50% or the dosing frequency increased.

In children the creatinine clearance should be adjusted for body surface area or lean body mass.

Children <40 kg:

* The serum creatinine values are guideline values that may not indicate exactly the same degree of reduction for all patients with reduced renal function.
** Estimated based on body surface area, or measured.

Close clinical monitoring for safety and efficacy is advised.

Table 4. Recommended maintenance doses of Ceftazidime in renal impairment – continuous infusion:

Adults and children ≥40 kg:

Caution is advised in dose selection. Close clinical monitoring for safety and efficacy is advised.

Children <40 kg:

The safety and effectiveness of Ceftazidime administered as continuous infusion in renally impaired children <40 kg has not been established. Close clinical monitoring for safety and efficacy is advised.

If continuous infusion is used in children with renal impairment, the creatinine clearance should be adjusted for body surface area or lean body mass.

Haemodialysis

The serum half-life during haemodialysis ranges from 3 to 5 h.

Following each haemodialysis period, the maintenance dose of ceftazidime recommended in the below table should be repeated.

Peritoneal dialysis

Ceftazidime may be used in peritoneal dialysis and continuous ambulatory peritoneal dialysis (CAPD).

In addition to intravenous use, ceftazidime can be incorporated into the dialysis fluid (usually 125 to 250 mg for 2 litres of dialysis solution).

For patients in renal failure on continuous arterio-venous haemodialysis or high-flux haemofiltration in intensive therapy units: 1 g daily either as a single dose or in divided doses. For low-flux haemofiltration, follow the dose recommended under renal impairment.

For patients on veno-venous haemofiltration and veno-venous haemodialysis, follow the dosage recommendations in the tables 5 & 6 below.

Table 5. Continuous veno-venous haemofiltration dose guidelines:

¹ Maintenance dose to be administered every 12h.

Table 6. Continuous veno-venous haemodialysis dose guidelines:

¹ Maintenance dose to be administered every 12h.

Method of administration

The dose depends on the severity, susceptibility, site and type of infection and on the age and renal function of the patient.

Ceftazidime should be administered by intravenous injection or infusion, or by deep intramuscular injection. Recommended intramuscular injection sites are the upper outer quadrant of the gluteus maximus or lateral part of the thigh. Ceftazidime solutions may be given directly into the vein or introduced into the tubing of a giving set if the patient is receiving parenteral fluids.

The standard 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.

Overdose can lead to neurological sequelae including encephalopathy, convulsion and coma.

Symptoms of overdose can occur if the dose is not reduced appropriately in patients with renal impairment (see sections 4.2 and 4.4).

Serum levels of ceftazidime can be reduced by haemodialysis or peritoneal dialysis.

Shelf life: Unopened – 3 years.

For reconstituted solution, chemical and physical in-use stability has been demonstrated for eight hours at 25°C and 24 hours at 4°C. From a microbiological point of view, once opened, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.

Unopened: Do not store above 25°C. Keep the vials in the outer carton.

After reconstitution: Store at 2-8°C (see 6.3 Shelf Life).

Packs of one, five or ten Type II colourless glass 10ml vials stoppered with coated rubber stopper, capped with flip-off cap.

Not all pack sizes may be marketed.

For single use. Discard any unused contents.

Instructions for reconstitution: See table for addition volumes and solution concentrations, which may be useful when fractional doses are required.

PREPARATION OF SOLUTION

Ceftazidime may be reconstituted for intramuscular use with 0.5% or 1% Lidocaine Hydrochloride.

Ceftazidime (at the given concentration) has been shown to be compatible with the following diluent solutions:

Solvents for 40mg/ml ceftazidime concentration:

Sodium Chloride 0.9%
Ringer Solution
Ringer Lactate Solution
Glucose 5%
Glucose 10%
Glucose 5% and Sodium Chloride 0.9%
Glucose 5% and Sodium Chloride 0.45%
Glucose 5% and Sodium Chloride 0.2%
Dextran 40%/10% and Sodium Chloride 0.9%
Dextran 70%/6% and Sodium Chloride 0.9%
Lidocaine Hydrochloride 0.5%
Lidocaine Hydrochloride 1%

Solutions range from light yellow to amber depending on concentration, diluent and storage conditions used.

All sizes of vials as supplied are under reduced pressure. As the product dissolves, carbon dioxide is released and a positive pressure develops. For ease of use, it is recommended that the following technique of reconstitution is adopted.

1. Insert the syringe needle through the vial closure and inject the recommended volume of diluent. The vacuum may assist entry of the diluent. Remove the syringe needle.
2. Shake to dissolve: carbon dioxide is released and a clear solution will be obtained in about 1 to 2 minutes.
3. Invert the vial. With the syringe plunger fully depressed, insert the needle through the vial closure and withdraw the total volume of solution into the syringe (the pressure in the vial may aid withdrawal). Ensure that the needle remains within the solution and does not enter the head space. The withdrawn solution may contain small bubbles of carbon dioxide; they may be disregarded.

These solutions may be given directly into the vein or introduced into the tubing of a giving set if the patient is receiving parental fluids.