Zavicefta

Ceftazidime pentahydrate 2 g, avibactam Na 0.5 g

Adults & paed patients ≥3 mth w/ complicated intra-abdominal infection, complicated UTI (cUTI) including pyelonephritis, hospital-acquired pneumonia (HAP) including ventilator associated pneumonia (VAP); infections due to aerobic gm -ve organisms w/ limited treatment options. Adults w/ bacteraemia that occurs in association w/ or is suspected to be associated w/ cIAI, cUTI or HAP/VAP.

IV Infuse over 120 min. Adult w/ estimated CrCl >50 mL/min cIAI 2 g/0.5 g over 2 hr every 8 hr for 5-14 days. cUTI including pyelonephritis 2 g/0.5 g over 2 hr every 8 hr for 5-10 days. HAP/VAP 2 g/0.5 g over 2 hr every 8 hr for 7-14 days. Bacteraemia associated w/ or suspected to be associated w/ cIAI, cUTI or HAP/VAP 2 g/0.5 g over 2 hr every 8 hr. Treatment duration: In accordance w/ infection site. Aerobic gm -ve infections in patient w/ limited treatment options 2 g/0.5 g over 2 hr every 8 hr. Paed patient w/ estimated CrCl > 50 mL/min/1.73 m² 6 mth to <18 yr cIAI, cUTI including pyelonephritis 50 mg/kg/12.5 mg/kg over 2 hr every 8 hr for 5-14 days. Max: 2 g/0.05 g. HAP/VAP or infections due to aerobic gm -ve organisms in patients w/ limited treatment options 50 mg/kg/12.5 mg/kg over 2 hr every 8 hr for 7-14 days. Max: 2 g/0.05 g, 3 to <6 mth cIAI, cUTI including pyelonephritis 40 mg/kg/10 mg/kg every 8 hr for 5-14 days. HAP/VAP 40 mg/kg/10 mg/kg over 2 hr every 8 hr for 7-14 days. Aerobic gm -ve infections in patients w/ limited treatment options 40 mg/kg/10 mg/kg every 8 hr. Treatment duration: Guided by severity of infection, pathogens & patient's clinical & bacteriological progress. Renal impairment: Adult w/ estimated CrCl 31-50 mL/min 1 g/0.25 g over 2 hr every 8 hr, 16-30 mL/min 0.75 g/0.1875 g over 2 hr every 12 hr, 6-15 mL/min 0.75 g/0.1875 g over 2 hr every 24 hr, ESRD including on haemodialysis 0.75 g/0.1875 g over 2 hr every 48 hr. Paed patients 2 to <18 yr w/ estimated CrCl 31-50 mL/min/1.73 m² 25 mg/kg/6.25 mg/kg over 2 hr every 8 hr (max: 1 g/0.25 g), CrCl 16-30 mL/min 18.75 mg/kg/4.7 mg/kg over 2 hr every 12 hr, CrCl 6-15 mL/min 18.75 mg/kg/4.7 mg/kg over 2 hr every 24 hr, ESRD including on haemodialysis 18.75 mg/kg/4.7 mg/kg over 2 hr every 48 hr (max: 0.75 g/0.1875 g). Paed patient 6 mth to <2 yr w/ CrCl 31-50 mL/min/1.73 m² 25 mg/kg/6.25 mg/kg over 2 hr every 8 hr, 16-30 mL/min/1.73 m² 18.75 mg/kg/4.7 mg/kg every over 2 hr every 12 hr. Paed patient 3 to <6 mth w/ CrCl 31-50 mL/min/1.73 m² 20 mg/kg/5 mg/kg over 2 hr every 8 hr, 16-30 mL/min/1.73 m² 15 mg/kg/3.75 mg/kg over 2 hr every 12 hr.

Hypersensitivity to ceftazidime pentahydrate, avibactam Na or cephalosporins. Severe hypersensitivity (eg, anaphylactic & severe skin reaction) to any other β-lactams (eg, penicillins, monobactams or carbapenems).

Discontinue treatment immediately in case of hypersensitivity reactions. Interrupt treatment in case of overgrowth of non-susceptible organisms (eg, enterococci, fungi) due to prolonged use. Consider discontinuation of therapy & administration of treatment for Clostridioides difficile in patients who present w/ diarrhoea. Not to give medicinal products that inhibit peristalsis. Patients w/ history of non-severe hypersensitivity to penicillins, monobactams or carbapenems. Investigate patients experiencing anaemia during or after treatment for possibility of haemolytic anaemia. Development of +ve direct antiglobulin test or Coombs test causing interference w/ cross-matching of blood &/or drug induced immune haemolytic anaemia. Concurrent treatment w/ nephrotoxic medicinal products eg, aminoglycosides or potent diuretics (eg, furosemide). False +ve results for detection of glycosuria w/ Cu reduction methods (Benedict's, Fehling's, Clinitest). Patients on controlled Na diet. May affect ability to drive & use machines. Neurological sequelae, including tremor, myoclonus, non-convulsive status epilepticus, convulsion, encephalopathy & coma in patients w/ renal impairment w/o dose reduction. Closely monitor estimated CrCl in patients w/ renal impairment. Pregnancy & lactation. Paed patients <3 mth; <2 yr w/ CrCl <16 mL/min/1.73 m². Risk of overdosing in paed patients 3 to <12 mth.

+ve Coombs direct test. Candidiasis (including vulvovag & oral candidiasis); eosinophilia, thrombocytosis, thrombocytopenia; headache, dizziness; diarrhoea, abdominal pain, nausea, vomiting; increased ALT, AST, blood alkaline phosphatase, γ-glutamyltransferase, & blood LDH; maculo-papular 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.

S