Pharmacokinetics in children

In healthy adults, the following pharmacokinetic parameters apply after administration of multiple doses of 2 g/0.5 g of ceftazidim/avibactam every 8 hours for 2 hours via infusion:

	Ceftazidim	Avibactam
Vd,ss (l)	17	22
T1/2(hour)	2	2

 

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Complicated intra-abdominal or urinary tract infections, nosocomial pneumonia, other serious infections from susceptible pathogens when other treatment options are limited.

Intravenous Postmenstrual age 26 weeks up to 31 weeks Ceftazidim/avibactam: 40/10 mg/kg/dag in 2 doses. Infuse over 2 hours Duration of treatment: 5-14 days depending on type and severity of infection Postmenstrual age 31 weeks up to 45 weeks Ceftazidim/avibactam: 60/15 mg/kg/dag in 3 doses. Infuse over 2 hours Duration of treatment: 5-14 days depending on type and severity of infection Postmenstrual age 45 weeks up to 53 weeks [1] Ceftazidim/avibactam: 90/22,5 mg/kg/dag in 3 doses. Infuse over 2 hours Duration of treatment: 5-14 days depending on type and severity of infection Term neonate [1] Ceftazidim/avibactam: 60/15 mg/kg/dag in 3 doses. Infuse over 2 hours Duration of treatment: 5-14 days depending on type and severity of infection 1 month up to 3 months [1] Ceftazidim/avibactam: 90/22,5 mg/kg/dag in 3 doses. Infuse over 2 hours Duration of treatment: 5-14 days depending on type and severity of infection 3 months up to 6 months [1] Ceftazidim/avibactam: 120/30 mg/kg/dag in 3 doses. Infuse over 2 hours Duration of treatment: 5-14 days depending on type and severity of infection 6 months up to 18 years [1] Ceftazidim/avibactam: 150/37,5 mg/kg/dag in 3 doses, max: 6000/1500 mg/dag. Infuse over 2 hours Duration of treatment: 5-14 days depending on type and severity of infection

Renal impaiment in children > 3 months

CrCl	0 to 3 months	3  to 6 months	6 months to 2 years	≥ 2 years
> 50 ml/min/1,73 m2	No data available	Dose adjustment not needed	Dose adjustment not needed	Dose adjustment not needed
31-50 ml/min/1,73 m2	No data available	60 /15  mg/kg/day in 3 doses	75 /18,75 mg/kg/day in 3 doses,	75 /18,75 mg/kg/day in 3 doses, max 1 g/0,25 g per dose
16-30 ml/min/1,73 m2	No data available	30 / 7,5 mg/kg/dag in 2 doses	37,5 / 9,4 mg/kg/day in 2 doses	37,5 / 9,4 mg/kg/day in 2 doses, max 0,75 g/0,1875 g per dose
6-15 ml/min/1,73 m2	No data available	No data available	No data available	18,75/ 4,7 mg/kg/ day in 1 dose, max 0,75 g/0,1875 g per dose
Endstage renal disease, including hemodialysis	No data available	No data available	No data available	18,75/ 4,7 mg/kg/ DOSE every 48 hours, max 0,75 g/0,1875 g per dose

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Overall, the safety profile in children is similar to the safety profile that was
observed in adult patients with cIAI and cUTI.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Be aware of dosing errors and subsequent overdose when reconstituting the drug. Consult SmPC for specific advice on reconstitution in children < 12 months of age. [SmPC Zavicefta]

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

• ANTIINFECTIVES FOR SYSTEMIC USE
• ANTIBACTERIALS FOR SYSTEMIC USE

OTHER BETA-LACTAM ANTIBACTERIALS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

First-generation cephalosporins
	Cefazolin Related Medicines Menu">	J01DB04
	Cephalexin Related Medicines Menu">	J01DB01

Second-generation cephalosporins
	Cefuroxime (as the sodium salt), cefuroxime (as cefuroxime axetil) Related Medicines Menu">	J01DC02

Third-generation cephalosporins
	Cefixim Related Medicines Menu">	J01DD08
	Cefotaxime (as the sodium salt) Related Medicines Menu">	J01DD01
	Ceftazidime Related Medicines Menu">	J01DD02
	Ceftriaxone Related Medicines Menu">	J01DD04

Carbapenems
	Meropenem Related Medicines Menu">	J01DH02

Reference

1. Pfizer Ireland Pharmaceuticals, SmPC Zavicefta® (EU/1/16/1109/001) Rev 17, 16-12-2024, www.ema.europa.eu

Changes

Therapeutic Drug Monitoring

Overdose