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Drug Details

Tazocin 2g/0.25g and 4g/0.5g Powder for Solution for Injection or Infusion

• Drug Class Description
  Antibacterials for systemic use, Combinations of penicillins incl. beta-lactamase inhibitors - ATC code: J01C R05
• Generic Name
  piperacillin sodium , tazobactam sodium
• Presentation
  Powder for solution for infusion. White to off-white powder.
• Description
  Each vial contains piperacillin (as sodium salt) equivalent to 2 g and tazobactam (as sodium salt) equivalent to 0.25 g. Each vial of Tazocin 2 g / 0.25 g contains 5.58 mmol (128 mg) of sodium. Each vial contains piperacillin (as sodium salt) equivalent to 4 g and tazobactam (as sodium salt) equivalent to 0.5 g. Each vial of Tazocin 4 g / 0.5 g contains 11.16 mmol (256 mg) of sodium.
• Indications
  

  Tazocin is indicated for the treatment of the following infections in adults and children over 2 years of age:

  Adults and adolescents

  - Severe pneumonia including hospital-acquired and ventilator-associated pneumonia

  - Complicated urinary tract infections (including pyelonephritis)

  - Complicated intra-abdominal infections

  - Complicated skin and soft tissue infections (including diabetic foot infections)

  Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.

  Tazocin may be used in the management of neutropenic patients with fever suspected to be due to a bacterial infection.

  Children 2 to 12 years of age

  - Complicated intra-abdominal infections

  Tazocin may be used in the management of neutropenic children with fever suspected to be due to a bacterial infection.

  Consideration should be given to official guidance on the appropriate use of antibacterial agents.

• Adult Dosage
  

  Posology

  The dose and frequency of Tazocin depends on the severity and localisation of the infection and expected pathogens.

  Adult and adolescent patients

  Infections

  The usual dose is 4 g piperacillin / 0.5 g tazobactam given every 8 hours.

  For nosocomial pneumonia and bacterial infections in neutropenic patients, the recommended dose is 4 g piperacillin / 0.5 g tazobactam administered every 6 hours. This regimen may also be applicable to treat patients with other indicated infections when particularly severe.

  The following table summarises the treatment frequency and the recommended dose for adult and adolescent patients by indication or condition:

  Treatment frequency	Tazocin 4 g / 0.5 g
  Every 6 hours	Severe pneumonia
  	Neutropenic adults with fever suspected to be due to a bacterial infection.
  Every 8 hours	Complicated urinary tract infections (including pyelonephritis)
  	Complicated intra-abdominal infections
  	Skin and soft tissue infections (including diabetic foot infections)

  Renal impairment

  The intravenous dose should be adjusted to the degree of actual renal impairment as follows (each patient must be monitored closely for signs of substance toxicity; medicinal product dose and interval should be adjusted accordingly):

  Creatinine clearance (ml/min)	Tazocin (recommended dose)
  > 40	No dose adjustment necessary
  20-40	Maximum dose suggested: 4 g / 0.5 g every 8 hours
  < 20	Maximum dose suggested: 4 g / 0.5 g every 12 hours

  For patients on haemodialysis, one additional dose of piperacillin / tazobactam 2 g / 0.25 g should be administered following each dialysis period, because haemodialysis removes 30%-50% of piperacillin in 4 hours.

  Hepatic impairment

  No dose adjustment is necessary.

  Dose in elderly patients

  No dose adjustment is required for the elderly with normal renal function or creatinine clearance values above 40 ml/min.

  Treatment duration

  The usual duration of treatment for most indications is in the range of 5-14 days. However, the duration of treatment should be guided by the severity of the infection, the pathogen(s) and the patient's clinical and bacteriological progress.

  Route of administration

  Tazocin 2 g / 0.25 g is administered by intravenous infusion (over 30 minutes).

  Tazocin 4 g / 0.5 g is administered by intravenous infusion (over 30 minutes).

   

   

• Child Dosage
  

  Paediatric population (2-12 years of age)

  Infections

  The following table summarises the treatment frequency and the dose per body weight for paediatric patients 2-12 years of age by indication or condition:

  Dose per weight and treatment frequency	Indication / condition
  80 mg Piperacillin / 10 mg Tazobactam per kg body weight / every 6 hours	Neutropenic children with fever suspected to be due to bacterial infections*
  100 mg Piperacillin / 12.5 mg Tazobactam per kg body weight / every 8 hours	Complicated intra-abdominal infections*

  * Not to exceed the maximum 4 g / 0.5 g per dose over 30 minutes.

  Renal impairment

  The intravenous dose should be adjusted to the degree of actual renal impairment as follows (each patient must be monitored closely for signs of substance toxicity; medicinal product dose and interval should be adjusted accordingly):

  Creatinine clearance (ml/min)	Tazocin (recommended dose)
  > 50	No dose adjustment needed.
  50	70 mg piperacillin / 8.75 mg tazobactam / kg every 8 hours.

  For children on haemodialysis, one additional dose of 40 mg piperacillin / 5 mg tazobactam / kg should be administered following each dialysis period.

  Use in children aged below 2 years

  The safety and efficacy of Tazocin in children 0- 2 years of age has not been established.

  No data from controlled clinical studies are available.

• Contra Indications
  

  Hypersensitivity to the active substances, any other penicillin-antibacterial agent or to any of the excipients.

  History of acute severe allergic reaction to any other beta-lactam active substances (e.g. cephalosporin, monobactam or carbapenem).

• Special Precautions
  

  The selection of piperacillin / tazobactam to treat an individual patient should take into account the appropriateness of using a broad-spectrum semi-synthetic penicillin based on factors such as the severity of the infection and the prevalence of resistance to other suitable antibacterial agents.

  Before initiating therapy with Tazocin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, other beta-lactam agents (e.g. cephalosporin, monobactam or carbapenem) and other allergens. Serious and occasionally fatal hypersensitivity (anaphylactic/anaphylactoid [including shock]) reactions have been reported in patients receiving therapy with penicillins, including piperacillin / tazobactam. These reactions are more likely to occur in persons with a history of sensitivity to multiple allergens. Serious hypersensitivity reactions require the discontinuation of the antibiotic, and may require administration of epinephrine and other emergency measures.

  Antibiotic-induced pseudomembranous colitis may be manifested by severe, persistent diarrhoea which may be life-threatening. The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment. In these cases Tazocin, should be discontinued.

  Therapy with Tazocin may result in the emergence of resistant organisms, which might cause super-infections.

  Bleeding manifestations have occurred in some patients receiving beta-lactam antibiotics. These reactions sometimes have been associated with abnormalities of coagulation tests, such as clotting time, platelet aggregation and prothrombin time, and are more likely to occur in patients with renal failure. If bleeding manifestations occur, the antibiotic should be discontinued and appropriate therapy instituted.

  Leukopenia and neutropenia may occur, especially during prolonged therapy; therefore, periodic assessment of haematopoietic function should be performed.

  As with treatment with other penicillins, neurological complications in the form of convulsions may occur when high doses are administered, especially in patients with impaired renal function.

  Each vial of Tazocin 2 g / 0.25 g contains 5.58 mmol (128 mg) of sodium and Tazocin 4 g / 0.5 g contains 11.16 mmol (256 mg) of sodium. This should be taken into consideration for patients who are on a controlled sodium diet.

  Hypokalaemia may occur in patients with low potassium reserves or those receiving concomitant medicinal products that may lower potassium levels; periodic electrolyte determinations may be advisable in such patients.

• Interactions
  

  Non-depolarising muscle relaxants

  Piperacillin when used concomitantly with vecuronium has been implicated in the prolongation of the neuromuscular blockade of vecuronium. Due to their similar mechanisms of action, it is expected that the neuromuscular blockade produced by any of the non-depolarising muscle relaxants could be prolonged in the presence of piperacillin.

  Oral anticoagulants

  During simultaneous administration of heparin, oral anticoagulants and other substances that may affect the blood coagulation system including thrombocyte function, appropriate coagulation tests should be performed more frequently and monitored regularly.

  Methotrexate

  Piperacillin may reduce the excretion of methotrexate; therefore, serum levels of methotrexate should be monitored in patients to avoid substance toxicity.

  Probenecid

  As with other penicillins, concurrent administration of probenecid and piperacillin / tazobactam produces a longer half-life and lower renal clearance for both piperacillin and tazobactam; however, peak plasma concentrations of either substances are unaffected.

  Aminoglycosides

  Piperacillin, either alone or with tazobactam, did not significantly alter the pharmacokinetics of tobramycin in subjects with normal renal function and with mild or moderate renal impairment. The pharmacokinetics of piperacillin, tazobactam, and the M1 metabolite were also not significantly altered by tobramycin administration.

  The inactivation of tobramycin and gentamicin by piperacillin has been demonstrated in patients with severe renal impairment.

  Vancomycin

  No pharmacokinetic interactions have been noted between piperacillin / tazobactam and vancomycin.

  Effects on laboratory tests

  Non-enzymatic methods of measuring urinary glucose may lead to false-positive results, as with other penicillins. Therefore, enzymatic urinary glucose measurement is required under Tazocin therapy.

  A number of chemical urine protein measurement methods may lead to false-positive results. Protein measurement with dip sticks is not affected.

  The direct Coombs test may be positive.

  Bio-Rad Laboratories Platelia Aspergillus EIA tests may lead to false-positive results for patients receiving Tazocin. Cross-reactions with non-Aspergillus polysaccharides and polyfuranoses with Bio-Rad Laboratories Platelia Aspergillus EIA test have been reported.

  Positive test results for the assays listed above in patients receiving Tazocin should be confirmed by other diagnostic methods.

• Adverse Drug Reactions
  

  The most commonly reported adverse reactions (occurring in 1 to 10 patients in 100) are diarrhoea, vomiting, nausea and rash.

  In the following table, adverse reactions are listed by system organ class and MedDRA-preferred term. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

  System Organ Class	Common 1/100 to < 1/10	Uncommon 1/1,000 to < 1/100	Rare 1/10,000 to < 1/1,000	Very rare (< 1/10,000)
  Infections and infestations		candidal superinfection
  Blood and lymphatic system disorders		leukopenia, neutropenia, thrombocytopenia	anaemia, haemolytic anaemia, purpura, epistaxis, bleeding time prolonged, eosinophilia	agranulocytosis, pancytopenia, activated partial thromboplastin time prolonged, prothrombin time prolonged, Coombs direct test positive, thrombocythaemia
  Immune system disorders		hypersensitivity	anaphylactic/anaphylactoid reaction (including shock)
  Metabolism and nutrition disorders				hypokalaemia, blood glucose decreased, blood albumin decreased, blood protein total decreased
  Nervous system disorders		headache, insomnia
  Vascular disorders		hypotension, thrombophlebitis, phlebitis	flushing
  Gastrointestinal disorders	diarrhoea, vomiting, nausea	jaundice, stomatitis, constipation, dyspepsia	pseudo-membranous colitis, abdominal pain
  Hepatobiliary disorders		alanine aminotransferase increased, aspartate aminotransferase increased	hepatitis, blood bilirubin increased, blood alkaline phosphatase increased, gamma-glutamyltransferase increased
  Skin and subcutaneous tissue disorders	rash, including maculopapular rash	urticaria, pruritus	erythema multiforme, dermatitis bullous, exanthema	toxic epidermal necrolysis, Stevens-Johnson syndrome
  Musculoskeletal and connective tissue disorders			arthralgia, myalgia
  Renal and urinary disorders		blood creatinine increased	renal failure, tubulointerstitial nephritis	blood urea increased
  General disorders and administration site conditions		pyrexia, injection-site reaction	chills

  Piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients.