Zavicefta

Ceftazidime pentahydrate 2 g, avibactam Na 500 mg

Complicated intra-abdominal infection (cIAI) in combination w/ metronidazole; complicated UTI including pyelonephritis (cUTI); hospital-acquired pneumonia (HAP) including ventilator associated pneumonia (VAP); infections due to aerobic gm -ve organisms in patients w/ limited options. Patients w/ bacteremia that occurs in association w/, or is suspected to be associated w/ cIAI, cUTI or HAP/VAP.

Adult w/ CrCl >50 mL/min 1 vial (2 g ceftazidime/0.5 g avibactam) over 2 hr infusion every 8 hr. Treatment duration: cIAI 5-14 days. cUTI including pyelonephritis 5-10 days, may increase to 14 days for patient w/ bacteremia. HAP including VAP 7-14 days. Adult w/ CrCl 31-50 mL/min 1 g/0.25 g over 2 hr infusion every 8 hr, 16-30 mL/min 0.75 g/0.1875 g over 2 hr infusion every 12 hr, 6-15 mL/min 0.75 g/0.1875 g over 2 hr infusion every 24 hr, ESRD including on hemodialysis 0.75 g/0.1875 g over 2 hr infusion every 48 hr. Ped patient w/ CrCl >50 mL/min/1.73 m² cIAI; cUTI including pyelonephritis; HAP including VAP; infection due to aerobic gm -ve organism in patient w/ limited treatment option 6 mth-<18 yr 50 mg/kg/12.5 mg/kg over 2 hr infusion every 8 hr. Max: 2 g/0.5 g, 3-<6 mth 40 mg/kg/10 mg/kg over 2 hr infusion every 8 hr. Treatment duration (for all age group): cIAI & cUTI 5-14 days. HAP/VAP 7-14 days. Ped patient 2-<18 yr w/ CrCl 31-50 mL/min 25 mg/kg/6.25 mg/kg over 2 hr infusion every 8 hr. Max: 1 g/0.25 g, 16-30 mL/min 18.75 mg/kg/4.7 mg/kg over 2 hr infusion every 12 hr. Max: 0.75 g/0.1875 g, 6-15 mL/min 18.75 mg/kg/4.7 mg/kg over 2 hr infusion every 24 hr. Max: 0.75 g/0.1875 g, ESRD including on hemodialysis 18.75 mg/kg/4.7 mg/kg over 2 hr infusion every 48 hr. Max: 0.75 g/0.1875 g. Ped patient 6 mth-<2 yr w/ CrCl 31-50 mL/min/1.73 m² 25 mg/kg/6.25 mg/kg over 2 hr infusion every 8 hr, 16-30 mL/min/1.73 m² 18.75 mg/kg/4.7 mg/kg over 2 hr infusion every 12 hr, 3-<6 mth w/ CrCl 31-50 mL/min/1.73 m² 20 mg/kg/5 mg/kg over 2 hr infusion every 8 hr, 16-30 mL/min/1.73 m² 15 mg/kg/3.75 mg/kg over 2 hr infusion every 12 hr.

Hypersensitivity to ceftazidime, avibactam & cephalosporins. Immediate & severe hypersensitivity (eg, anaphylactic reaction) to any other type of β-lactam agents (eg, penicillins, monobactams or carbapenems).

Discontinue immediately in case of severe hypersensitivity reactions. History of non-severe hypersensitivity to other β-lactam agents. Consider antibacterial agent-associated colitis & pseudomembranous colitis in patients who present w/ diarrhea during or subsequent to administration; discontinue therapy & consider treatment for Clostridium difficile; do not give peristalsis-inhibiting medicinal products. Overgrowth of non-susceptible organisms (eg, enterococci, fungi) w/ prolonged use. False +ve may occur w/ Cu reduction methods (Benedict's, Fehling's, Clinitest). +ve direct antiglobulin test (DAGT or Coombs test) seroconversion & potential risk of hemolytic anemia. Patient on Na controlled diet. Concurrent treatment w/ high doses of cephalosporins & nephrotoxic medicinal products eg, aminoglycosides or potent diuretics (eg, furosemide). May influence ability to drive & use machines. Renal impairment (closely monitor estimated CrCl). Not to be used during pregnancy. Lactation. Childn <18 yr w/ HAP/VAP; 3-<12 mth; <3 mth.

+ve Coombs direct test. Candidiasis (including vulvovag & oral candidiasis); eosinophilia, thrombocytosis, thrombocytopenia; headache, dizziness; diarrhea, abdominal pain, nausea, vomiting; increased ALT/AST, blood alkaline phosphatase, γ-glutamyltransferase & blood LDH; maculopapular rash, urticaria, pruritus; infusion site thrombosis/phlebitis, pyrexia.

Ceftazidime: May adversely affect renal function w/ nephrotoxic medicinal products eg, aminoglycosides or potent diuretics (eg, furosemide). Possible antagonism w/ chloramphenicol. Avibactam: Potential alteration of elimination w/ probenecid.

Cephalosporins

J01DD52 - ceftazidime and beta-lactamase inhibitor ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.

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