In-house product
This combination 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)
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
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
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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.
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Store at temperature not exceeding 25°C in a dry place. Protect from light & moisture.
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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.
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