AVYCAZ

AVYCAZ- ceftazidime and avibactam sodium powder, for solution
Allergan, Inc.

1 INDICATIONS AND USAGE

1. 1 Complicated Intra- a bdominal Infections (cIAI)

AVYCAZ (ceftazidime and avibactam) in combination with metronidazole, is indicated for the treatment of complicated intra-abdominal infections (cIAI) in adult and pediatric patients aged 3 months and older caused by the following susceptible Gram-negative microorganisms: Escherichia coli , Klebsiella pneumoniae , Proteus mirabilis , Enterobacter cloacae , Klebsiella oxytoca , Citrobacter freundii complex, and Pseudomonas aeruginosa.

1. 2 Complicated Urinary Tract Infections (cUTI), including Pyelonephritis

AVYCAZ (ceftazidime and avibactam) is indicated for the treatment of complicated urinary tract infections (cUTI) including pyelonephritis in adult and pediatric patients aged 3 months and older caused by the following susceptible Gram-negative microorganisms: Escherichia coli , Klebsiella pneumoniae , Enterobacter cloacae , Citrobacter freundii complex, Proteus mirabilis , and Pseudomonas aeruginosa.

1.3 Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP)

AVYCAZ (ceftazidime and avibactam) is indicated for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in adult and pediatric patients aged 3 months and older caused by the following susceptible Gram-negative microorganisms: Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa, and Haemophilus influenzae.

1. 4 Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of AVYCAZ and other antibacterial drugs, AVYCAZ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage in Adult Patients

The recommended dosage of AVYCAZ is 2.5 grams (ceftazidime 2 grams and avibactam 0.5 grams) administered every 8 hours by intravenous (IV) infusion over 2 hours in patients 18 years of age and older with CrCl greater than 50 mL/min. For treatment of cIAI, metronidazole should be given concurrently. The guidelines for dosage of AVYCAZ in patients with creatinine clearance (CrCl) greater than 50 mL/min are listed in Table 1.

Table 1. Dosage of AVYCAZ 2.5 grams (ceftazidime 2 grams and avibactam 0.5 grams) by Indication
Infection Dos e Frequency Infusion Time (hours) Duration of Treatment
Complicated Intra-abdominalInfections [used in combination withmetronidazole] (cIAI) 2.5 grams Every 8 hours 2 cIAI: 5 to 14 dayscUTI: 7 to 14 daysHABP/VABP: 7 to 14 days
Complicated Urinary TractInfections including Pyelonephritis (cUTI)
Hospital-acquired BacterialPneumonia and Ventilator-associatedBacterial Pneumonia (HABP/VABP)

2.2 Recommended Dosage in Pediatric Patients

The recommended dosage of AVYCAZ in pediatric patients aged 2 years to less than 18 years and an estimated glomerular filtration rate (eGFR) greater than 50 mL/min/1.73 m2 and in pediatric patients aged 3 months to less than 2 years without renal impairment is described in Table 2. AVYCAZ is administered every 8 hours by intravenous infusion over 2 hours. For treatment of cIAI, metronidazole should be given concurrently.

Table 2. Dosage of AVYCAZ (ceftazidime and avibactam) in Pediatric Patients aged 3 months to less than 18 years
Infection Age Range Dose Frequency Infusion Time (hours) Duration of treatment
cIAI*, cUTI including Pyelonephritis, and HABP/VABP 2 years to less than 18 yearsa AVYCAZ 62.5 mg/kg to a maximum of 2.5 grams (Ceftazidime 50 mg/kg and avibactam 12.5 mg/kg to a maximum dose of ceftazidime 2 grams and avibactam 0.5 grams) Every 8 hours 2 cIAI: 5 to 14 dayscUTI: 7 to 14 days HABP/VABP: 7 to 14 days
6 months to less than 2 years AVYCAZ 62.5 mg/kg (Ceftazidime 50 mg/kg and avibactam 12.5 mg/kg)
3 months to less than 6 months AVYCAZ 50 mg/kg (Ceftazidime 40 mg/kg and avibactam 10 mg/kg)
a For pediatric patients (aged 2 years and older) with eGFR less than or equal to 50 mL/min/1.73m2 ,dosage adjustments are recommended [ see Dosage and Administration (2.3)]. * AVYCAZ was used in combination with metronidazole in cIAI pediatric patients [see Clinical Studies (14.1)]

2.3 Dosage Adjustments in Adult and Pediatric Patients ( Aged 2 Years and Older) with Renal Impairment

The recommended AVYCAZ dosage in adult and pediatric patients aged 2 years and older with varying degrees of renal function is presented in Table 3 and Table 4, respectively. For patients with changing renal function, monitor CrCl in adults or eGFR in pediatric patients at least daily and adjust the dosage of AVYCAZ accordingly [ see Warnings and Precautions (5.1), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. There is insufficient information to recommend a dosing regimen for pediatric patients less than 2 years of age with renal impairment.

Adult Patients

Table 3 . Dosage of AVYCAZ in Adult Patients with Renal Impairment
Estimated Creatinine Clearance (mL/minute) a Dose for AVYCAZ (ceftazidime and avibactam) b Frequency
31 to 50 AVYCAZ 1.25 grams (ceftazidime 1 gram and avibactam 0.25 grams) intravenously Every 8 hours
16 to 30 AVYCAZ 0.94 grams (ceftazidime 0.75 grams and avibactam 0.19 grams) intravenously Every 12 hours
6 to 15c AVYCAZ 0.94 grams (ceftazidime 0.75 grams and avibactam 0.19 grams) intravenously Every 24 hours
Less than or equal to 5c AVYCAZ 0.94 grams (ceftazidime 0.75 grams and avibactam 0.19 grams) intravenously Every 48 hours
a As calculated using the Cockcroft-Gault formula b All doses of AVYCAZ are administered over 2 hoursc Both ceftazidime and avibactam are hemodialyzable; thus, administer AVYCAZ after hemodialysis on hemodialysis days

Pediatric Patients

Table 4 . Dosage of AVYCAZ in Pediatric Patients Aged 2 years and older with Renal Impairment a
Estimated eGFR b (mL/min/1.73m 2 ) Dose for AVYCAZ (ceftazidime and avibactam) c Frequency
31 to 50 AVYCAZ 31.25 mg/kg to a maximum of 1.25 grams (Ceftazidime 25 mg/kg and avibactam 6.25 mg/kg to a maximum dose of ceftazidime 1 gram and avibactam 0.25 grams) Every 8 hours
16 to 30 AVYCAZ 23.75 mg/kg to a maximum of 0.94 grams (Ceftazidime 19 mg/kg and avibactam 4.75 mg/kg to a maximum dose of ceftazidime 0.75 grams and avibactam 0.19 grams) Every 12 hours
6 to 15 AVYCAZ 23.75 mg/kg to a maximum of 0.94 grams (Ceftazidime 19 mg/kg and avibactam 4.75 mg/kg to a maximum dose of ceftazidime 0.75 grams and avibactam 0.19 grams) Every 24 hours
Less than or equal to 5d AVYCAZ 23.75 mg/kg to a maximum of 0.94 grams (Ceftazidime 19 mg/kg and avibactam 4.75 mg/kg to a maximum dose of ceftazidime 0.75 grams and avibactam 0.19 grams) Every 48 hours
a Dosing was derived based on the population PK modeling, which assumed similar proportional effects of renal impairment in adults and pediatric patients aged 2 years and older [see Clinical Pharmacology (12.3)] b As calculated using the Schwartz bedside formulac All doses of AVYCAZ are administered over 2 hoursd Both ceftazidime and avibactam are hemodialyzable; thus, administer AVYCAZ after hemodialysis on hemodialysis days

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2023. All Rights Reserved.