AVYCAZ (avibactam sodium)

The mean pharmacokinetic parameters for ceftazidime and avibactam in healthy adult male subjects with normal renal function after single and multiple 2-hour intravenous infusions of AVYCAZ 2.5 grams (ceftazidime 2 grams and avibactam 0.5 grams) administered every 8 hours are summarized in Table 14. Pharmacokinetic parameters of ceftazidime and avibactam were similar for single and multiple dose administration of AVYCAZ and were similar to those determined when ceftazidime or avibactam were admin...

14. 1 Complicated Intra-abdominal Infections Adult Patients A total of 1058 adults hospitalized with cIAI were randomized and received trial medications in a multinational, multi-center, double-blind trial comparing AVYCAZ 2.5 grams (ceftazidime 2 grams and avibactam 0.5 grams) intravenously every 8 hours plus metronidazole (0.5 grams intravenously every 8 hours) to meropenem (1 gram intravenously every 8 hours) for 5 to 14 days of therapy. Complicated intra-abdominal infections included appendicitis, cholecystitis, diverticulitis, gastric/duodenal perforation, perforation of the intestine, an...

The following adverse reactions are discussed in greater detail in the Warnings and Precautions section: Hypersensitivity Reactions [see Warnings and Precautions ( 5.2 ) ] Clostridi oid e s difficile -Associated Diarrhea [see Warnings and Precautions ( 5.3 ) ] Central Nervous System Reactions [see Warnings and Precautions ( 5.4 ) ] Adult Patients : The most common adverse reactions in cIAI (≥ 5%, when used with metronidazole) patients are diarrhea, nausea and vomiting. The most common adverse...

AVYCAZ is contraindicated in patients with known serious hypersensitivity to the components of AVYCAZ (ceftazidime and avibactam), avibactam containing products, or other members of the cephalosporin class [see Warnings and Precautions ( 5.2 )] . AVYCAZ is contraindicated in patients with known serious hypersensitivity to the components of AVYCAZ (ceftazidime and avibactam), avibactam-containing p...

Decreased Clinical Response in A dult cIAI P atients with B aseline CrC l of 30 to L ess T han or E qual to 50 mL/ min : Monitor CrCl at least daily in adult and pediatric patients with changing renal function and adjust the dosage of AVYCAZ accordingly. ( 5.1 ) Hypersensitivity R eactions : Includes anaphylaxis and serious skin reactions. Cross sensitivity may occur in patients with a history of penicillin allergy. If an allergic reaction occurs, discontinue AVYCAZ. ( 5.2 ) Clostrid io i des di...

7 DRUG INTERACTIONS 7.1 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...