Zavicef is an antibacterial combination product consisting of the semisynthetic cephalosporin ceftazidime pentahydrate and the beta-lactamase inhibitor avibactam sodium for intravenous administration.
The ceftazidime component of Zavicef is a broad-spectrum cephalosporin antibiotic with in vitro activity against certain gram-negative and gram-positive bacteria. The bactericidal action of ceftazidime is mediated through binding to essential penicillin-binding proteins (PBPs). The avibactam component of Zavicef is a non-beta-lactam beta-lactamase inhibitor that inactivates certain beta-lactamases that degrade ceftazidime. Avibactam does not decrease the activity of ceftazidime against ceftazidime-susceptible organisms.
Zavicef 2.5 g IV Injection for Infusion: Each vial contains Ceftazidime Pentahydrate USP equivalent to Ceftazidime 2 g and Avibactam Sodium INN equivalent to Avibactam 0.5 g.
Zavicef is indicated in adults and pediatric patients aged 3 months and older for the treatment of the following infections:
● Complicated intra-abdominal infections (cIAI)
● Complicated urinary tract infections (cUTI), including pyelonephritis
● Hospital-acquired bacterial pneumonia (HABP), including ventilator-associated bacterial pneumonia (VABP)
Dosage in adults with creatinine clearance (CrCL) > 50 mL/min
|
Type of infection |
Dose |
Frequency |
Infusion time |
Duration of treatment |
|
Complicated intra-abdominal infection (cIAI) |
2.5 grams |
Every 8 hours |
2 hours |
5 to 14 days |
|
Complicated urinary tract infection (cUTI), including pyelonephritis |
7 to 14 days |
|||
|
Hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP) |
7 to 14 days |
Dosage adjustments in adult patients with renal impairment
|
Estimated Creatinine Clearance (mL/minute)a |
Doseb |
Frequency |
|
31 to 50 |
Zavicef 1.25 grams (ceftazidime 1 gram and avibactam 0.25 grams) intravenously |
Every 8 hours |
|
16 to 30 |
Zavicef 0.94 grams (ceftazidime 0.75 grams and avibactam 0.19 grams) intravenously |
Every 12 hours |
|
6 to 15c |
Zavicef 0.94 grams (ceftazidime 0.75 grams and avibactam 0.19 grams) intravenously |
Every 24 hours |
|
≤ 5c |
Zavicef 0.94 grams (ceftazidime 0.75 grams and avibactam 0.19 grams) intravenously |
Every 48 hours |
a - As calculated using the Cockcroft-Gault formula.
b - All doses of Zavicef are administered over 2 hours.
c - Both ceftazidime and avibactam are hemodialyzable; thus, administer Zavicef after hemodialysis on hemodialysis
days.
Dosage in pediatric patients
| Type of Infection | Age Range | Dose | Frequency | Infusion Time | Duration of Treatment |
| Complicated intra-abdominal infection (cIAI)* Complicated urinary tract infection (cUTI), including pyelonephritis |
2 years to less than 18 years | Zavicef 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 to 14 days |
| 6 months to less than 2 years | Zavicef 62.5 mg/kg (Ceftazidime 50 mg/kg and avibactam 12.5 mg/kg) | ||||
| 3 months to less than 6 months | Zavicef 50 mg/kg (Ceftazidime 40 mg/kg and avibactam 10 mg/kg |
*For treatment of cIAI, metronidazole should be given concurrently.
Dosage adjustments in pediatric patients with renal impairment
|
Estimated eGFR (mL/min/1.73m2)a |
Doseb |
Frequency |
|
31 to 50 |
Zavicef 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 |
Zavicef 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 |
Zavicef 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 |
|
≤ 5c |
Zavicef 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 |
a - As calculated using the Schwartz bedside formula.
b - All doses of Zavicef are administered over 2 hours.
c - Both ceftazidime and avibactam are hemodialyzable; thus, administer Zavicef after hemodialysis on hemodialysis
days.
Preparation of Zavicef doses for Adult and Pediatric Patients (Weighing 40 kg or More)
|
Dose |
Volume to Withdraw from Constituted Vial for Further Dilution to 50 to 250a mL |
|
2.5 grams (2 grams and 0.5 grams) |
12 mL (entire contents) |
|
1.25 grams (1 gram and 0.25 grams) |
6 mL |
|
0.94 grams (0.75 grams and 0.19 grams) |
4.5 mL |
|
a. Dilution to 250 mL should only be used for the 2.5 grams dose |
|
Zavicef is contraindicated in patients with known serious hypersensitivity to the components of Zavicef (ceftazidime and avibactam), avibactam-containing products, or other members of the cephalosporin class.
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 Zavicef 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 Zavicef.
Clostridium difficile- associated diarrhea (CDAD): CDAD has been reported with nearly all systemic antibacterial agents, including Zavicef. 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.
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.
Clinical interaction study of Zavicef or avibactam alone with probenecid has not been conducted, and co-administration of Zavicef with probenecid is not recommended.
Pregnancy: There are no adequate and well-controlled studies of Zavicef, ceftazidime, or avibactam in pregnant women.
Lactation: No information is available on the effects of ceftazidime and avibactam on the breast-fed child or on milk production.
Zavicef 2.5 g IV Injection for Infusion: Each box contains 1 vial of 2.5 grams (ceftazidime 2 grams and avibactam 0.5 grams) with 1 ampoule of 10 mL sterile water for injection.
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