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Zavicefta

Zavicefta

ceftazidime + avibactam

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Ceftazidime pentahydrate 2,000 mg, avibactam Na 500 mg
Indications/Uses
In combination w/ metronidazole for adults & paed patients ≥3 yr w/ complicated intra-abdominal infection (cIAI). Adults & paed patients ≥3 yr w/ complicated UTI including pyelonephritis (cUTI). Adults w/ hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP). Adults w/ bacteremia associated w/ or suspected to be associated w/ cIAI, cUTI, HAP including VAP.
Dosage/Direction for Use
Adult 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 if w/ bacteraemia. HAP including VAP 1 vial every 8 hr over 2 hr for 7-14 days. Bacteraemia associated w/ or suspected to be associated w/ cIAI, cUTI, HAP including VAP 1 vial every 8 hr over 2 hr. Duration: In accordance w/ infection site. Renal impairment CrCl 31-50 mL/min 1,000 mg/250 mg every 8 hr over 2 hr, 16-30 mL/min 750 mg/187.5 mg every 12 hr over 2 hr, 6-15 mL/min 750 mg/187.5 mg every 24 hr over 2 hr, ESRD including on haemodialysis 750 mg/187.5 mg every 48 hr over 2 hr. Childn 6 mth to <18 yr cIAI, cUTI including pyelonephritis 50 mg/12.5 mg/kg every 8 hr over 2 hr for 5-14 days. Max: 2,000 mg/500 mg, 3-6 mth 40 mg/10 mg/kg every 8 hr over 2 hr for 5-14 days. Renal impairment Childn 2 to <18 yr, CrCL 31-50 mL/min 25 mg/6.25 mg/kg every 8 hr over 2 hr to max: 1,000 mg/250 mg, 16-30 mL/min 18.75 mg/4.7 mg/kg every 12 hr over 2 hr to max: 750 mg/187.5 mg, 6-15 mL/min 18.75 mg/4.7 mg/kg every 24 hr over 2 hr to max: 750 mg/187.5 mg. ESRD including on haemodialysis 18.75 mg/4.7 mg/kg every 48 hr over 2 hr to max: 750 mg/187.5 mg. Childn w/ renal impairment 31-50 mL/min, 3 to <6 mth 20 mg/5 mg/kg every 8 hr over 2 hr, 6 mth to <2 yr 25 mg/6.25 mg/kg every 8 hr over 2 hr, 16-30 mL/min, 3 to < 6 mth 15 mg/3.75 mg/kg every 12 hr over 2, 6 mth to < 2 yr 18.75 mg/4.7 mg/kg every 12 hr over 2 hr.
Contraindications
Hypersensitivity to ceftazidime pentahydrate, avibactam Na or any cephalosporins. Severe hypersensitivity (eg, anaphylactic & severe skin reaction) to any other β-lactams eg, penicillins, monobactams or carbapenems.
Special Precautions
Discontinue use if hypersensitivity reactions; severe cutaneous ARs eg, SJS, TEN, DRESS; acute generalised exanthematous pustulosis occur. Hypersensitivity reactions to penicillins, cephalosporins, carbapenems or other β-lactam agents. Clostridium difficile-associated diarrhoea; nephrotoxicity; overgrowth of non-susceptible organisms; risk of drug-resistant bacteria development. May cause +ve direct antiglobulin or Coombs' test, drug-induced immune haemolytic anaemia. Prolonged use. Patients on controlled Na diet. Not to be given w/ medicinal products inhibiting peristalsis. Concurrent use w/ nephrotoxic drugs eg, aminoglycosides or potent diuretics (eg, furosemide). Interference w/ Cu reduction methods for glycosuria detection. May affect ability to drive & use machines. Renal impairment. Pregnancy & lactation. Paed patients <3 mth.
Adverse Reactions
Positive direct Coombs' test. Candidiasis; eosinophilia, thrombocytosis, thrombocytopenia; headache, dizziness; diarrhoea, abdominal pain, nausea, vomiting; increased ALT, AST, γ-glutamyltransferase, blood alkaline phosphatase & LDH; maculopapular rash, urticaria, pruritus; infusion site thrombosis & phlebitis, pyrexia.
Drug Interactions
Altered elimination w/ probenecid. Adversely affected renal function w/ nephrotoxic drugs eg, aminoglycosides or potent diuretics (eg, furosemide). Antagonism w/ chloramphenicol.
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 infusion (vial)
Packing/Price
20 mL x 10 × 1's
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