Avitaz IV Infusion

Avitaz IV Infusion is indicated in-

• Complicated Intra-abdominal Infections (cIAI)
• Complicated Urinary Tract Infections (cUTI), including Pyelonephritis
• Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP)

Ceftazidime inhibits bacterial peptidoglycan cell wall synthesis following binding to penicillin binding proteins (PBPs), which leads to bacterial cell lysis and death. Avibactam is a non β-lactam, β-lactamase inhibitor that acts by forming a covalent adduct with the enzyme that is stable to hydrolysis. It inhibits both Ambler class A and class C β-lactamases and some class D enzymes, including extended-spectrum β-lactamases (ESBLs), KPC and OXA-48 carbapenemases, and AmpC enzymes. Avibactam does not inhibit class B enzymes (metallo-β-lactamases) and is not able to inhibit many class D enzymes.

Dosage in Adult Patients with Creatinine Clearance (CrCl) greater than 50 mL/min-

Infection	Dose	Frequency	Infusion Time	Duration of Treatment
Complicated Intra-abdominalnInfections [used in combination with metronidazole] (cIAI)	2.5 grams	Every 8 hours	2 hours	cIAI: 5 to 14 days cUTI: 7 to 14 days HABP/VABP: 7 to 14 days
Complicated Urinary Tract Infections including Pyelonephritis (cUTI)
Hospital-acquired Bacterial Pneumonia and Ventilator- associated Bacterial Pneumonia (HABP/VABP)

Dosage in Adult Patients with Creatinine Clearance (CrCl) less than 50 mL/min-

Estimated CrCl (mL/minute)	Dose	Frequency
31 to 50	1.25 grams (ceftazidime 1 gram and avibactam 0.25 grams) intravenously	Every 8 hours
16 to 30	0.94 grams (ceftazidime 0.75 grams and avibactam 0.19 grams) intravenously	Every 12 hours
6 to 15	0.94 grams (ceftazidime 0.75 grams and avibactam 0.19 grams) intravenously	Every 24 hours
Less than or equal to 5	0.94 grams (ceftazidime 0.75 grams and avibactam 0.19 grams) intravenously	Every 48 hours

Dosage in Patients 3 months to < 18 years

Infection	Age Range	Dose	Frequency	Infusion Time	Duration of Treatment
cIAI and cUTI including Pyelonephritis	2 years to less than18 years	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 Hours	cIAI: 5 to 14 days cUTI: 7 to14 days
	6 months to less than 2 years	62.5 mg/kg (Ceftazidime 50 mg/kg and avibactam 12.5 mg/kg)
	3 months to less than 6 months	50 mg/kg (Ceftazidime 40 mg/kg and avibactam 10 mg/kg)

In Pediatric Patients 2 to < 18 years with Renal Impairment-

Estimated eGFR (mL/min/1.73m2)	Dose	Frequency
31 to 50	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	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	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 5	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

Clinical interaction study of this IV infusion or avibactam alone with probenecid has not been conducted, co-administration of this IV infusion with probenecid is not recommended.

This is contraindicated in patients with known serious hypersensitivity to the components of (ceftazidime and avibactam), avibactam-containing products or other members of the cephalosporin class.

Adult cIAI, cUTI and HABP/VABP Patients: The most common adverse reactions in cIAI (≥ 5%, when used with metronidazole) patients are diarrhea, nausea and vomiting. The most common adverse reactions (3%) in cUTI patients are diarrhea and nausea. The most common adverse reactions (≥5%) in HABP/VABP patients were diarrhea and vomiting. Pediatric cIAI and cUTI Patients: The most common adverse reactions (>3%) in pediatric patients were vomiting, diarrhea, rash, and infusion site phlebitis

There are no adequate and well-controlled studies of this IV infusion, ceftazidime, or avibactam in pregnant women. No information is available on the effects of ceftazidime and avibactam on the breast-fed child or on milk production.

Decreased efficacy in adult cIAI patients with baseline CrCl of 30 to less than or equal to 50 mL/ min: Monitor CrCl at least daily in adult and pediatric patients with changing renal function and adjust the dose of this IV infusion accordingly.

Hypersensitivity reactions: Includes anaphylaxis and serious skin reactions. Cross-hypersensitivity may occur in patients with a history of penicillin allergy. If an allergic reaction occurs, discontinue this IV infusion.

Clostridium difficile-associated diarrhea (CDAD): CDAD has been reported with nearly all systemic antibacterial agents, including this IV infusion. Evaluate if diarrhea occurs.

Central Nervous System Reactions: Seizures and other neurologic events may occur, especially in patients with renal impairment. Adjust dose in patients with renal impairment.

Store at temperature not exceeding 25°C in a dry place. Protect from light & moisture.