Zavicefta

Zavicefta

ceftazidime + avibactam

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Ceftazidime 2 g, avibactam 0.5 g
Indications/Uses
Adults, infants ≥3 mth, childn & adolescents w/ complicated intra-abdominal infection (cIAI) (in combination w/ metronidazole); complicated UTI (cUTI) including pyelonephritis; hospital-acquired pneumonia (HAP) including ventilator associated pneumonia (VAP). Adults w/ bacteraemia that occurs in association w/ or is suspected to be associated w/ cIAI, cUTI or HAP/VAP.
Dosage/Direction for Use
IV Adult w/ CrCl >50 mL/min cIAI 1 vial every 8 hr over 2 hr for 5-14 days. cUTI including pyelonephritis 1 vial every 8 hr over 2 hr for 5-10 days, may be increased up to 14 days in patient w/ bacteraemia. HAP/VAP 1 vial every 8 hr over 2 hr for 7-14 days. Childn 6 mth-<18 yr cIAI, cUTI including pyelonephritis 50 mg/kg/12.5 mg/kg (max: 2 g/0.5 g) every 8 hr over 2 hr for 5-14 days. HAP/VAP 50 mg/kg/12.5 mg/kg (max: 2 g/0.5 g) every 8 hr over 2 hr for 7-14 days. Childn 3-<6 mth cIAI, cUTI including pyelonephritis 40 mg/kg/10 mg/kg every 8 hr over 2 hr for 5-14 days. HAP/VAP 40 mg/kg/10 mg/kg every 8 hr over 2 hr for 7-14 days. Renal impairment: Adult w/ CrCl 31-50 mL/min 1 g/0.25 g every 8 hr over 2 hr, 16-30 mL/min 0.75 g/0.1875 g every 12 hr over 2 hr, 6-15 mL/min 0.75 g/0.1875 g every 24 hr over 2 hr, ESRD including on haemodialysis 0.75 g/0.1875 g every 48 hr over 2 hr. Paed patient (2-<18 yr) w/ CrCl 31-50 mL/min 25 mg/kg/6.25 mg/kg (max: 1 g/0.25 g) every 8 hr over 2 hr, 16-30 mL/min 18.75 mg/kg/4.7 mg/kg (max: 0.75 g/0.1875 g) every 12 hr over 2 hr, 6-15 mL/min 18.75 mg/kg/4.7 mg/kg (max: 0.75 g/0.1875 g) every 24 hr over 2 hr, ESRD including on haemodialysis 18.75 mg/kg/4.7 mg/kg (max: 0.75 g/0.1875 g) every 48 hr over 2 hr. Paed patient (6mth-<2 yr) w/ CrCl 31-50 mL/min 25 mg/kg/6.25 mg/kg every 8 hr over 2 hr, 16-30 mL/min 18.75 mg/kg/4.7 mg/kg every 12 hr over 2 hr. Paed patient (3-<6 mth) w/ CrCl 31-50 mL/min 20 mg/kg/5 mg/kg every 8 hr over 2 hr, 16-30 mL/min 15 mg/kg/3.75 mg/kg every 12 hr over 2 hr.
Contraindications
Hypersensitivity to ceftazidime, avibactam & cephalosporins. Immediate & severe hypersensitivity (eg, anaphylactic reaction) to any other type of β-lactam antibacterials (eg, penicillins, monobactams or carbapenems).
Special Precautions
Discontinue immediately & initiate adequate emergency measures in case of severe hypersensitivity reactions. Patients w/ history of non-severe hypersensitivity to other β-lactam agents. Consider antibacterial agent-associated colitis & pseudo-membranous colitis in patients who present w/ diarrhea during or subsequent to Zavicefta administration; discontinue therapy & consider treatment for Clostridium difficile; do not give peristalsis-inhibiting medicinal products. Concurrent treatment w/ high doses of cephalosporins & nephrotoxic medicinal products eg, aminoglycosides or potent diuretics (eg, furosemide). May require treatment interruption or other appropriate measures for overgrowth of non-susceptible organisms (eg, enterococci, fungi) due to prolonged use. May slightly interfere w/ Cu reduction methods (eg, Benedict's, Fehling's, Clinitest). May interfere w/ blood cross-matching &/or may cause drug-induced immune haemolytic anaemia; investigate the possibility of patients experiencing anaemia during or after treatment. Patients on a controlled Na diet. Undesirable effects may occur (eg, dizziness) which may influence the ability to drive & use machines. Closely monitor patients w/ renal & hepatic impairment. Patients undergoing continuous veno-venous haemofiltration; peritoneal dialysis. Pregnancy & lactation; interruption of breast-feeding is recommended. Paed patients w/ nosocomial pneumonia. Childn <18 yr for HAP/VAP; <2 yr w/ CrCl <16 mL/min/1.73 m2; <3 mth.
Adverse Reactions
+ve Coombs direct test. Candidiasis (including vulvovag & oral candidiasis); eosinophilia, thrombocytosis, thrombocytopenia; dizziness, headache; vomiting, nausea, diarrhoea, abdominal pain; increased ALT, AST, blood alkaline, γ-glutamyltransferase & blood LDH; urticaria, pruritus, maculo-papular rash; infusion site thrombosis & phlebitis, pyrexia.
Drug Interactions
May adversely affect renal function w/ concurrent treatment of high-dose cephalosporins & nephrotoxic medicinal products eg, aminoglycoside or potent diuretics (eg, furosemide). Possible antagonism w/ chloramphenicol. Potential alteration of avibactam elimination when co-dosed w/ probenecid.
MIMS Class
Cephalosporins
ATC Classification
J01DD52 - ceftazidime and beta-lactamase inhibitor ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
Form
Zavicefta powd for conc for soln for infusion
Packing/Price
20 mL x 10 × 1's
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