Zavicefta Dosage/Direction for Use

It is recommended that Ceftazidime (as pentahydrate)/Avibactam (as sodium) (Zavicefta) should be used to treat infections due to aerobic Gram-negative organisms in adults and pediatric patients aged 3 months and older with limited treatment options only after consultation with a physician with appropriate experience in the management of infectious diseases (see Precautions).
Dosage in Adults with Creatinine Clearance (CrCL >50 mL/min): The recommended dosage of Ceftazidime (as pentahydrate)/Avibactam (as sodium) (Zavicefta) in adults is 1 vial where each vial contains 2 g ceftazidime and 0.5 g avibactam administered by intravenous (IV) infusion over 2 hours. Treatment is repeated every 8 hours. The duration of treatment is provided in Table 14.
Treatment Duration for Adult Patients: see Table 14.

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The duration of treatment should be guided by the severity of the infection, the pathogen(s) and the patient's clinical and bacteriological progress.
Dosage in pediatric patients with creatinine clearance (CrCL) >50 mL/min/1.73 m²: The recommended dosage of Ceftazidime (as pentahydrate)/Avibactam (as sodium) (Zavicefta) in pediatric patients (3 months to <18 years) is based on the age and weight of the patient. Ceftazidime (as pentahydrate)/Avibactam (as sodium) (Zavicefta) is administered every 8 hours by intravenous infusion over 2 hours, see Table 15. The duration of therapy should be guided by the severity, site of infection and the patient's clinical and bacteriological progress. (See Table 15.)

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Special populations: Elderly patients: No dosage adjustment is considered necessary in elderly patients (≥65 years). The dose regimen should be adjusted if renal impairment is present (see Pharmacology: Pharmacokinetics under Actions).
Patients with renal impairment: The following dose adjustment is recommended in patients with renal impairment (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Dose adjustments for Ceftazidime (as pentahydrate)/Avibactam (as sodium) (Zavicefta) for patients with an estimated creatinine clearance (CrCl) ≤50 mL/min are outlined in Table 16 as follows. The only information on dosing of Ceftazidime pentahydrate/Avibactam sodium (Zavicefta) for patients requiring dialysis is in the setting of intermittent hemodialysis. For other types of dialysis, it is suggested that the dose/frequency of ceftazidime-avibactam should follow local label/local guidelines for dosing of ceftazidime. For example, for a dose of 500 mg ceftazidime the dose of ceftazidime-avibactam would be 500 mg ceftazidime/125 mg avibactam.
Dosage in adults and pediatric patients with creatinine clearance (CrCL) ≤50 mL/min: See Table 16.

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Dosage in pediatric patients <2 years of age with creatinine clearance (CrCl) ≤ 50 mL/min/1.73 m²: See Table 17.

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There is insufficient information to recommend a dosage regimen for pediatric patients < 2 years of age that have a CrCL < 16 mL/min/1.73 m².
In patients with impaired renal function, regular monitoring of estimated creatinine clearance is advised as in some patients, especially early in the course of their infection, the creatinine clearance estimated from serum creatinine can change quickly.
Hemodialysis: Both ceftazidime and avibactam are hemodialyzable; thus, Ceftazidime (as pentahydrate)/Avibactam (as sodium) (Zavicefta) should be administered after hemodialysis on hemodialysis day.
Hemofiltration: There is insufficient data to make specific dosage adjustment recommendations for patients undergoing continuous venovenous hemofiltration.
Peritoneal dialysis: There is insufficient data to make specific dosage adjustment recommendations for patients undergoing peritoneal dialysis.
Patients with hepatic impairment: No dosage adjustment is considered necessary in patients with hepatic impairment (see Pharmacology: Pharmacokinetics under Actions). Close clinical monitoring for safety and efficacy is advised.
Pediatric population: Safety and efficacy in pediatric patients <18 years of age have not been established for HAP/VAP and is based on extrapolation (see Precautions).
Safety and efficacy in pediatric patients <3 months old have not been established.
Method of administration: Intravenous use.
Ceftazidime (as pentahydrate)/Avibactam (as sodium) (Zavicefta) is administered to adults by intravenous infusion over 2 hours in an appropriate infusion volume (see Special Precautions for Disposal and Other Handling under Cautions for Usage).
Constitution and compatibility: For instructions on reconstitution and dilution of the medicinal product before administration (see Special Precautions for Disposal and Other Handling under Cautions for Usage).