Fortum復達欣

Fortum

ceftazidime

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Ceftazidime pentahydrate
Indications/Uses
Treatment of infections in adults & childn including neonates (from birth): Nosocomial pneumonia, broncho-pulmonary infections in cystic fibrosis, bacterial meningitis, chronic suppurative otitis media, malignant otitis externa, complicated UTI, complicated skin & soft tissue infections, complicated intra-abdominal infections, bone & joint infections, peritonitis associated w/ dialysis in patient on CAPD. Patients w/ bacteraemia that occurs in association w/, or is suspected to be associated w/, any of the infections listed above. Management of neutropenic patients w/ fever that is suspected to be due to a bacterial infection. Peri-operative prophylaxis of UTI for patients undergoing transurethral resection of the prostate (TURP).
Dosage/Direction for Use
Adults & childn ≥40 kg Intermittent administration Broncho-pulmonary infections in cystic fibrosis 100-150 mg/kg/day every 8 hr. Max: 9 g/day. Febrile neutropenia, nosocomial pneumonia, bacterial meningitis, bacteraemia 2 g every 8 hr. Bone & joint infections, complicated skin & soft tissue infections, complicated intra-abdominal infections, peritonitis associated w/ dialysis in patients on CAPD 1-2 g every 8 hr. Complicated UTI 1-2 g every 8 hr or 12 hr. Peri-operative prophylaxis for TURP 1 g at induction of anaesth, & a 2nd dose at catheter removal. Chronic suppurative otitis media, malignant otitis externa 1-2 g every 8 hr. Continuous infusion Febrile neutropenia, nosocomial pneumonia, broncho-pulmonary infections in cystic fibrosis, bacterial meningitis, bacteraemia, bone & joint infections, complicated skin & soft tissue infections, complicated intra-abdominal infections, peritonitis associated w/ dialysis in patients on CAPD Loading dose 2 g followed by a continuous infusion of 4-6 g every 24 hr. Infant & toddlers >2 mth & childn <40 kg Intermittent administration Complicated UTI, chronic suppurative otitis media, malignant otitis externa 100-150 mg/kg/day in 3 divided doses, max 6 g/day. Neutropenic childn, broncho-pulmonary infections in cystic fibrosis, bacterial meningitis, bacteraemia 150 mg/kg/day in 3 divided doses, max 6 g/day. Bone & joint infections, complicated skin & soft tissue infections, complicated intra-abdominal infections, peritonitis associated w/ dialysis in patients on CAPD 100-150 mg/kg/day in 3 divided doses, max 6 g/day. Continuous infusion Febrile neutropenia, nosocomial pneumonia, broncho-pulmonary infections in cystic fibrosis, bacterial meningitis, bacteraemia, bone & joint infections, complicated skin & soft tissue infections, complicated intra-abdominal infections, peritonitis associated w/ dialysis in patients w/ CAPD Loading dose 60-100 mg/kg followed by a continuous infusion 100-200 mg/kg/day, max 6 g/day. Neonate & infant ≤2 mth Intermittent administration Most infections 25-60 mg/kg/day in 2 divided doses. Elderly >80 yr Daily dose should not normally exceed 3 g. Renal impairment Initial loading dose of 1 g. Maintenance: Based on CrCl. Intermittent administration Adult & childn ≥40 kg CrCl 31-50 mL/min 1 g 12 hrly; 16-30 mL/min 1 g 24 hrly; 6-15 mL/min 0.5 g 24 hrly; <5 mL/min 0.5 g 48 hrly. Childn <40 kg CrCl 31-50 mL/min 25 mg/kg 12 hrly; 16-30 mL/min 25 mg/kg 24 hrly; 6-15 mL/min 12.5 mg/kg 24 hrly; <5 mL/min 12.5 mg/kg 48 hrly. Continuous infusion Adult & childn ≥40 kg CrCl 31-50 mL/min Loading dose 2 g followed by 1-3 g/24 hr; 16-30 mL/min Loading dose 2 g followed by 1 g/24 hr; ≤15 mL/min Not evaluated.
Contraindications
Hypersensitivity to ceftazidime pentahydrate, any excipients of Fortum or to other cephalosporins. Severe hypersensitivity to any other type of β-lactam antibacterial agent (penicillins, monobactams & carbapenems).
Special Precautions
History of non-severe hypersensitivity to other β-lactam agents. Not suitable for use as a single agent for the treatment of some types of infections. Antibacterial agent-associated colitis & pseudomembranous colitis. Concurrent treatment w/ high doses of cephalosporins & nephrotoxic medicinal products eg, aminoglycosides or potent diuretics (eg, furosemide). Overgrowth of nonsusceptible organisms (eg, Enterococci, fungi). Slight interference (false-positive) may occur w/ copper reduction methods (Benedict’s, Fehling’s, Clinitest). Positive Coombs' test. Consider Na content in patients who are on a controlled Na diet. Renal impairment. Pregnancy.
Adverse Reactions
Eosinophilia & thrombocytosis. Phlebitis or thrombophlebitis w/ IV administration. Diarrhoea. Transient elevation in 1 or more hepatic enzymes. Maculopapular or urticarial rash. Pain &/or inflammation after IM inj. Positive Coombs' test.
Drug Interactions
Concurrent treatment w/ nephrotoxic drugs may adversely affect renal function. Possible antagonism w/ chloramphenicol.
MIMS Class
ATC Classification
J01DD02 - ceftazidime ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
Form
Fortum powd for inj 1 g
Packing/Price
1's
Form
Fortum powd for inj 2 g
Packing/Price
1's
Form
Fortum powd for inj 500 mg
Packing/Price
1's
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