Zavicefta Dosage/Direction for Use

Dosage in Adults with Creatinine Clearance (CrCl >50 mL/min): The recommended dosage of 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 15.
Treatment Duration for Adult Patients: (See Table 15.)

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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 paediatric patients with creatinine clearance (CrCl) >50 mL/min/1.73 m²: The recommended dosage of Zavicefta in paediatric patients (3 months to <18 years) is based on the age and weight of the patient. Zavicefta is administered every 8 hours by intravenous infusion over 2 hours, see Table 16 (see also Precautions and Pharmacology: Pharmacodynamics under Actions). The duration of therapy should be guided by the severity, site of infection and the patient's clinical and bacteriological progress. (See Table 16.)

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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 Zavicefta for patients with an estimated creatinine clearance (CrCl) ≤50 mL/min are outlined in Table 17 as follows.
Dosage in adults and paediatric patients with creatinine clearance (CrCl) ≤50 mL/min: (See Table 17.)

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Dosage in paediatric patients <2 years of age with creatinine clearance (CrCl) ≤50 mL/min/1.73 m² (See Table 18.)

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There is insufficient information to recommend a dosage regimen for paediatric 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.
Haemodialysis: Both ceftazidime and avibactam are haemodialysable; thus, Zavicefta should be administered after haemodialysis on haemodialysis day.
Haemofiltration: There is insufficient data to make specific dosage adjustment recommendations for patients undergoing continuous veno-venous haemofiltration.
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.
Paediatric patients: Safety and efficacy in paediatric patients <18 years of age have not been established for HAP/VAP and is based on extrapolation (see Precautions).
Safety and efficacy in paediatric patients <3 months old have not been established.
Method of administration: 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). For paediatric patients, the infusion volume may be adjusted (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.