Avycef (2 gm+0.5 gm)/vial

INDICATIONS

This combination 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)

PHARMACOLOGY

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 & ADMINISTRATION

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 dayscUTI: 7 to 14 daysHABP/VABP: 7 to 14 days


Complicated Urinary Tract Infectionsincluding 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 ofTreatment


cIAI and cUTIincluding Pyelonephritis
2 years to lessthan18 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 dayscUTI: 7 to14 days


6 months to lessthan 2 years
62.5 mg/kg (Ceftazidime 50 mg/kg and avibactam 12.5 mg/kg)


3 months to lessthan 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 avibactam4.75 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 avibactam4.75 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 avibactam4.75 mg/kg to a maximum dose of ceftazidime 0.75 grams and avibactam 0.19 grams)
Every 48 hours

INTERACTION

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.

SIDE EFFECTS

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

PREGNANCY & LACTATION

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.

PRECAUTIONS & WARNINGS

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.

STORAGE CONDITIONS

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