Avycaz

Avycaz is an antibacterial combination drug used to treat complicated intra-abdominal infections (cIAI), used in combination with metronidazole; and complicated urinary tract infections (cUTI), including pyelonephritis.

Common side effects include:

• headache,
• dizziness,
• vomiting,
• nausea,
• abdominal pain,
• diarrhea,
• constipation, and
• anxiety.

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

Recommended Dosage in Pediatric Patients with cIAI or cUTI

• The recommended dosage of Avycaz in pediatric patients aged 2 to < 18 years with cIAI or cUTI and an estimated glomerular filtration rate (eGFR) greater than 50 mL/min/1.73 m² and in pediatric patients aged 3 months to < 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.
• There is insufficient information to recommend a dosing regimen for pediatric patients with HABP/VABP.

Table 2. Dosage of Avycaz (ceftazidime and avibactam) in Patients 3 months to < 18 years

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

• The recommended Avycaz dosage in adult and pediatric patients 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.
• 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

Pediatric Patients

Table 4. Dosage of Avycaz for cUTI and cIAI in Pediatric Patients 2 years and older with Renal Impairment^a

Probenecid

• In vitro, avibactam is a substrate of OAT1 and OAT3 transporters which might contribute to the active uptake from the blood compartment, and thereby its excretion.
• As a potent OAT inhibitor, probenecid inhibits OAT uptake of avibactam by 56% to 70% in vitro and, therefore, has the potential to decrease the elimination of avibactam when co-administered.
• Because a clinical interaction study of Avycaz or avibactam alone with probenecid has not been conducted, co-administration of Avycaz with probenecid is not recommended.

Drug/Laboratory Test Interactions

• The administration of ceftazidime may result in a false-positive reaction for glucose in the urine with certain methods. It is recommended that glucose tests based on enzymatic glucose oxidase reactions be used.

• There are no adequate and well-controlled studies of Avycaz, ceftazidime, or avibactam in pregnant women.
• Ceftazidime is excreted in human milk in low concentrations. It is not known whether avibactam is excreted into human milk, although avibactam was shown to be excreted in the milk of rats.
• No information is available on the effects of ceftazidime and avibactam on the breast-fed child or on milk production.