Australia - English - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - tazobactam sodium, quantity: 536.6 mg (equivalent: tazobactam, qty mg); piperacillin sodium, quantity: 4.17 g (equivalent: piperacillin, qty g) - injection, powder for - excipient ingredients: - piperacillin/tazobactam kabi is indicated in the treatment of serious bacterial infections caused by susceptible strains of beta-lactamase producing organisms in the conditions listed below: 1. lower respiratory tract infections. 2. urinary tract infections (complicated and uncomplicated). 3. intra-abdominal infections. 4. skin and skin structure infections. 5. bacterial septicaemia. 6. gynaecological infections.,,children under the age of 12 years:,in hospitalised children aged 2 to 12 years, piperacillin/tazobactam kabi injection is indicated for the treatment of serious intra-abdominal infections. it has not been evaluated in this indication for paediatric patients below the age of 2 years.,while piperacillin/tazobactam kabi injection is indicated only for the conditions listed above, it may be used as a single agent in the treatment of mixed infections caused by piperacillin susceptible and beta-lactamase producing piperacillin-resistant organisms. appropriate culture and susceptibility tests should be performed before treatment in order to identify organisms causing infection to determine their susceptibilities to piperacillin/tazobactam. therapy with piperacillin/tazobactam, however, may be initiated before results of such tests are known when there is a reason to believe the infection may involve any of the beta-lactamase producing organisms listed above; however, once these results become available, appropriate therapy should be continued.,in serious infections, presumptive therapy with piperacillin/tazobactam kabi may be initiated before susceptibility test results are available.,combination therapy with piperacillin/tazobactam kabi and aminoglycosides may be used in the treatment of serious infections caused by pseudomonas aeruginosa. both drugs should be used in full therapeutic doses. as soon as results of culture and susceptibility tests become available, antimicrobial therapy should be adjusted.

Australia - English - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - piperacillin sodium, quantity: 2.085 g (equivalent: piperacillin, qty g); tazobactam sodium, quantity: 268.3 mg (equivalent: tazobactam, qty mg) - injection, powder for - excipient ingredients: - piperacillin/tazobactam kabi is indicated in the treatment of serious bacterial infections caused by susceptible strains of beta-lactamase producing organisms in the conditions listed below: 1. lower respiratory tract infections. 2. urinary tract infections (complicated and uncomplicated). 3. intra-abdominal infections. 4. skin and skin structure infections. 5. bacterial septicaemia. 6. gynaecological infections.,,children under the age of 12 years:,in hospitalised children aged 2 to 12 years, piperacillin/tazobactam kabi injection is indicated for the treatment of serious intra-abdominal infections. it has not been evaluated in this indication for paediatric patients below the age of 2 years.,while piperacillin/tazobactam kabi injection is indicated only for the conditions listed above, it may be used as a single agent in the treatment of mixed infections caused by piperacillin susceptible and beta-lactamase producing piperacillin-resistant organisms. appropriate culture and susceptibility tests should be performed before treatment in order to identify organisms causing infection to determine their susceptibilities to piperacillin/tazobactam. therapy with piperacillin/tazobactam, however, may be initiated before results of such tests are known when there is a reason to believe the infection may involve any of the beta-lactamase producing organisms listed above; however, once these results become available, appropriate therapy should be continued.,in serious infections, presumptive therapy with piperacillin/tazobactam kabi may be initiated before susceptibility test results are available.,combination therapy with piperacillin/tazobactam kabi and aminoglycosides may be used in the treatment of serious infections caused by pseudomonas aeruginosa. both drugs should be used in full therapeutic doses. as soon as results of culture and susceptibility tests become available, antimicrobial therapy should be adjusted.

Australia - English - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - tazobactam sodium, quantity: 547 mg (equivalent: tazobactam, qty 500 mg); piperacillin sodium, quantity: 4.253 g (equivalent: piperacillin, qty 4 g) - injection, powder for - excipient ingredients: - piperacillin and tazobactam is indicated in the treatment of serious bacterial infections caused by susceptible strains of beta-lactamase producing organisms in the conditions listed below: lower respiratory tract infections; urinary tract infections (complicated and uncomplicated); intra-abdominal infections; skin and skin structure infections; bacterial septicaemia; and gynaecological infections. children under the age of 12 years: in hospitalised children aged 2 to 12 years, piperacillin and tazobactam is indicated for the treatment of serious intra-abdominal infections. it has not been evaluated in this indication for paediatric patients below the age of two years. while piperacillin and tazobactam is indicated only for the conditions listed above, it may be used as a single agent in the treatment of mixed infections caused by piperacillin susceptible and beta-lactamase producing, piperacillin resistant organisms. appropriate culture and susceptibility tests should be performed before treatment in order t

Australia - English - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - piperacillin sodium, quantity: 4170 mg (equivalent: piperacillin, qty 4000 mg); tazobactam sodium, quantity: 540 mg (equivalent: tazobactam, qty 500 mg) - injection, powder for - excipient ingredients: nitrogen - piptaz-aft is indicated in the treatment of serious bacterial infections caused by susceptible strains of beta-lactamase producing organisms in the conditions listed below: 1. lower respiratory tract infections 2. urinary tract infections (complicated and uncomplicated) 3. intra-abdominal infections 4. skin and skin structure infections 5. bacterial septicaemia 6. gynaecological infections,children under the age of 12 years in hospitalised children aged 2 to 12 years, piptaz-aft is indicated for the treatment of serious intra-abdominal infections. it has not been evaluated in this indication for paediatric patients below the age of 2 years. while piptaz-aft is indicated only for the conditions listed above, it may be used as a single agent in the treatment of mixed infections caused by piperacillin susceptible and beta-lactamase producing, piperacillin-resistant organisms. appropriate culture and susceptibility tests should be performed before treatment in order to identify organisms causing infection to determine their susceptibilities to piptaz-aft. therapy with piptaz-aft, however, may be initiated before results of such tests are known when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above; however, once these results become available, appropriate therapy should be continued. in serious infections, presumptive therapy with piptaz-aft may be initiated before susceptibility test results are available. combination therapy with piptaz-aft and aminoglycosides may be used in the treatment of serious infections caused by pseudomonas aeruginosa. both drugs should be used in full therapeutic doses. as soon as results of culture and susceptibility tests become available, antimicrobial therapy should be adjusted.

Australia - English - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - piperacillin sodium, quantity: 4.2 g (equivalent: piperacillin, qty 4 g); tazobactam sodium, quantity: 0.54 g (equivalent: tazobactam, qty 0.5 g) - injection, powder for - excipient ingredients: - tazopip is indicated in the treatment of serious bacterial infections caused by susceptible strains of beta -lactamase producing organisms in the conditions as listed: 1. lower respiratory tract infections 2. urinary tract infections (complicated and uncomplicated). 3.intra- abdominal infections. 4. skin and skin structure infections. 5. bacterial septicaemia. 6. gynaecological infections. children under the age of 12 years: in hospitalised children aged 2 to 12 years, tazopip is indicated for the treatment of serious intra-abdominal infections. it has not been evaluated in this indication for paediatric patients below the age of 2 years. while tazopip is indicated only for the conditions listed above, it may be used as a single agent in the treatment of mixed infections caused by piperacillin susceptible and beta -lactamase producing piperacillin-resistant organisms. appropriate culture and susceptibility tests should be performed before treatment in order to identify organisms causing infection to determine

Australia - English - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - piperacillin sodium, quantity: 2.1 g (equivalent: piperacillin, qty 2 g); tazobactam sodium, quantity: 0.27 g (equivalent: tazobactam, qty 0.25 g) - injection, powder for - excipient ingredients: - tazopip is indicated in the treatment of serious bacterial infections caused by susceptible strains of beta -lactamase producing organisms in the conditions as listed: 1. lower respiratory tract infections 2. urinary tract infections (complicated and uncomplicated). 3.intra- abdominal infections. 4. skin and skin structure infections. 5. bacterial septicaemia. 6. gynaecological infections. children under the age of 12 years: in hospitalised children aged 2 to 12 years, tazopip is indicated for the treatment of serious intra-abdominal infections. it has not been evaluated in this indication for paediatric patients below the age of 2 years. while tazopip is indicated only for the conditions listed above, it may be used as a single agent in the treatment of mixed infections caused by piperacillin susceptible and beta -lactamase producing piperacillin-resistant organisms. appropriate culture and susceptibility tests should be performed before treatment in order to identify organisms causing infection to determine

Israel - English - Ministry of Health

pharmalogic ltd - piperacillin as sodium; tazobactam as sodium - powder for solution for infusion - piperacillin as sodium 4 g; tazobactam as sodium 500 mg - tazobactam - tazobactam - antibiotic for the treatment of systemic and/or local bacterial infections caused by susceptible organisms. pipoeracillin/tazobactam in combination with an aminoglycoside is indicated for suspected bacterial infections in neutropenic adults or children above 2 years . appencicitis complicated by rupture with peritonitis and/or abscess formation in children aged 2-12 years.

United States - English - NLM (National Library of Medicine)

eugia us llc - piperacillin sodium (unii: m98t69q7hp) (piperacillin anhydrous - unii:9i628532gx), tazobactam sodium (unii: uxa545abtt) (tazobactam - unii:se10g96m8w) - piperacillin anhydrous 2 g - piperacillin and tazobactam for injection is indicated in adults and pediatric patients (2 months of age and older) for the treatment of appendicitis (complicated by rupture or abscess) and peritonitis caused by beta-lactamase producing isolates of escherichia coli or the following members of the bacteroides fragilis group: b. fragilis , b. ovatus , b. thetaiotaomicron , or b. vulgatus . piperacillin and tazobactam for injection is indicated in adults and pediatric patients (2 months of age and older) for the treatment of nosocomial pneumonia (moderate to severe) caused by beta-lactamase producing isolates of staphylococcus aureus and by piperacillin and tazobactam-susceptible acinetobacter baumannii , haemophilus influenzae , klebsiella pneumoniae , and pseudomonas aeruginosa (nosocomial pneumonia caused by p. aeruginosa should be treated in combination with an aminoglycoside) [see dosage and administration (2)] . piperacillin and tazobactam for injection is indicated in adults for the treatment of uncomplicated and complicated skin and skin structure infections, including cellulitis, cutaneous abscesses and ischemic/diabetic foot infections caused by beta-lactamase producing isolates of staphylococcus aureus . piperacillin and tazobactam for injection is indicated in adults for the treatment of postpartum endometritis or pelvic inflammatory disease caused by beta-lactamase producing isolates of escherichia coli . piperacillin and tazobactam for injection is indicated in adults for the treatment of community-acquired pneumonia (moderate severity only) caused by beta-lactamase producing isolates of haemophilus influenzae . to reduce the development of drug-resistant bacteria and maintain the effectiveness of piperacillin and tazobactam for injection and other antibacterial drugs, piperacillin and tazobactam for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. piperacillin and tazobactam for injection is contraindicated in patients with a history of allergic reactions to any of the penicillins, cephalosporins, or beta-lactamase inhibitors. risk summary piperacillin and tazobactam cross the placenta in humans. however, there are insufficient data with piperacillin and/or tazobactam in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. no fetal structural abnormalities were observed in rats or mice when piperacillin and tazobactam was administered intravenously during organogenesis at doses 1 to 2 times and 2 to 3 times the human dose of piperacillin and tazobactam, respectively, based on body-surface area (mg/m2 ). however, fetotoxicity in the presence of maternal toxicity was observed in developmental toxicity and peri/postnatal studies conducted in rats (intraperitoneal administration prior to mating and throughout gestation or from gestation day 17 through lactation day 21) at doses less than the maximum recommended human daily dose based on body-surface area (mg/m2 ) (see data) . the background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data in embryo-fetal development studies in mice and rats, pregnant animals received intravenous doses of piperacillin and tazobactam up to 3,000/750 mg/kg/day during the period of organogenesis. there was no evidence of teratogenicity up to the highest dose evaluated, which is 1 to 2 times and 2 to 3 times the human dose of piperacillin and tazobactam, in mice and rats respectively, based on body-surface area (mg/m2 ). fetal body weights were reduced in rats at maternally toxic doses at or above 500/62.5 mg/kg/day, minimally representing 0.4 times the human dose of both piperacillin and tazobactam based on body-surface area (mg/m2 ). a fertility and general reproduction study in rats using intraperitoneal administration of tazobactam or the combination piperacillin and tazobactam prior to mating and through the end of gestation, reported a decrease in litter size in the presence of maternal toxicity at 640 mg/kg/day tazobactam (4 times the human dose of tazobactam based on body-surface area), and decreased litter size and an increase in fetuses with ossification delays and variations of ribs, concurrent with maternal toxicity at ≥640/160 mg/kg/day piperacillin and tazobactam (0.5 times and 1 times the human dose of piperacillin and tazobactam, respectively, based on body-surface area). peri/postnatal development in rats was impaired with reduced pup weights, increased stillbirths, and increased pup mortality concurrent with maternal toxicity after intraperitoneal administration of tazobactam alone at doses ≥320 mg/kg/day (2 times the human dose based on body surface area) or of the combination piperacillin and tazobactam at doses ≥640/160 mg/kg/day (0.5 times and 1 times the human dose of piperacillin and tazobactam, respectively, based on body-surface area) from gestation day 17 through lactation day 21. risk summary piperacillin is excreted in human milk; tazobactam concentrations in human milk have not been studied. no information is available on the effects of piperacillin and tazobactam on the breastfed child or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for piperacillin and tazobactam and any potential adverse effects on the breastfed child from piperacillin and tazobactam or from the underlying maternal condition. the safety and effectiveness of piperacillin and tazobactam for intra-abdominal infections, and nosocomial pneumonia have been established in pediatric patients 2 months of age and older. use of piperacillin and tazobactam in pediatric patients 2 months of age and older with intra-abdominal infections including appendicitis and/or peritonitis is supported by evidence from well-controlled studies and pharmacokinetic studies in adults and in pediatric patients. this includes a prospective, randomized, comparative, open-label clinical trial with 542 pediatric patients 2 to 12 years of age with intra-abdominal infections (including appendicitis and/or peritonitis), in which 273 pediatric patients received piperacillin and tazobactam [see  adverse reactions (6.1) and clinical pharmacology (12.3) ] . use of piperacillin and tazobactam in pediatric patients 2 months of age and older with nosocomial pneumonia is supported by evidence from well-controlled studies in adults with nosocomial pneumonia, a simulation study performed with a population pharmacokinetic model, and a retrospective, cohort study of pediatric patients with nosocomial pneumonia in which 140 pediatric patients were treated with piperacillin and tazobactam and 267 patients treated with comparators (which included ticarcillin-clavulanate, carbapenems, ceftazidime, cefepime, or ciprofloxacin) [see adverse reactions (6.1) and clinical pharmacology (12.3)]. the safety and effectiveness of piperacillin and tazobactam have not been established in pediatric patients less than 2 months of age [see clinical pharmacology (12) and dosage and administration (2)] . dosage of piperacillin and tazobactam in pediatric patients with renal impairment has not been determined. patients over 65 years are not at an increased risk of developing adverse effects solely because of age. however, dosage should be adjusted in the presence of renal impairment [see dosage and administration (2) ] . in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. piperacillin and tazobactam for injection contains 54 mg (2.35 meq) of sodium per gram of piperacillin in the combination product. at the usual recommended doses, patients would receive between 648 and 864 mg/day (28.2 and 37.6 meq) of sodium. the geriatric population may respond with a blunted natriuresis to salt loading. this may be clinically important with regard to such diseases as congestive heart failure. this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. in patients with creatinine clearance ≤ 40 ml/min and dialysis patients (hemodialysis and capd), the intravenous dose of piperacillin and tazobactam for injection should be reduced to the degree of renal function impairment [see dosage and administration (2) ] . dosage adjustment of piperacillin and tazobactam for injection is not warranted in patients with hepatic cirrhosis [see clinical pharmacology (12.3) ] .  as with other semisynthetic penicillins, piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients.

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - piperacillin sodium, quantity: 4.253 g; tazobactam sodium, quantity: 0.547 g (equivalent: tazobactam, qty 0.5 g) - injection, powder for - excipient ingredients: - pipertaz sandoz is used to treat serious bacterial infections caused by susceptible strains of beta-lactamase producing organisms in the conditions listed below: 1) lower respiratory tract infections; 2) urinary tract infections (complicated and uncomplicated); 3) intra-abdominal infections; 4) skin and skin structure infections; 5) bacterial septicaemia; 6) gynaecological infections. children under the age of 12 years: in hospitalised children aged 2 to 12 years, pipertaz sandoz is indicated for the treatment of serious intra-abdominal infections. it has not been evaluated in children below the age of 2 years. while pipertaz sandoz (piperacillin/tazobactam) is indicated only for the conditions listed above, it may be used as a single agent in the treatment of mixed infections caused by piperacillin susceptible and beta-lactamase producing, piperacillin-resistant organisms. appropriate culture and susceptibility tests should be performed before treatment in order to identify organisms causing infection to det

United States - English - NLM (National Library of Medicine)

wockhardt usa llc. - piperacillin sodium (unii: m98t69q7hp) (piperacillin anhydrous - unii:9i628532gx), tazobactam sodium (unii: uxa545abtt) (tazobactam - unii:se10g96m8w) - piperacillin anhydrous 2 g in 10 ml - piperacillin and tazobactam for injection, usp is indicated in adults and pediatric patients (2 months of age and older) for the treatment of appendicitis (complicated by rupture or abscess) and peritonitis caused by beta-lactamase producing isolates of escherichia coli or the following members of the bacteroides fragilis group: b. fragilis , b. ovatus , b. thetaiotaomicron , or b. vulgatus . piperacillin and tazobactam for injection, usp is indicated in adults and pediatric patients (2 months of age and older) for the treatment of nosocomial pneumonia (moderate to severe) caused by beta-lactamase producing isolates of staphylococcus aureus and by piperacillin/tazobactam-susceptible acinetobacter baumannii , haemophilus influenzae , klebsiella pneumoniae , and pseudomonas aeruginosa (nosocomial pneumonia caused by p. aeruginosa