Piperacillin and Tazobactam

Interactions

Piperacillin and Tazobactam interacts in the following cases:

Renal impairment

Adult and adolescent patients

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

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

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

Paediatric population (2-12 years of age)

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)Piperacillin/Tazobactam (recommended dose)
>50No dose adjustment needed.
≤5070 mg piperacillin/8.75 mg tazobactam/kg every eight hours.

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

Oral anticoagulants

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

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.

Vancomycin

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

However, a limited number of retrospective studies have detected an increased incidence of acute kidney injury in patients concomitantly administered piperacillin/tazobactam and vancomycin as compared to vancomycin alone.

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 piperacillin/tazobactam 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 piperacillin/tazobactam. 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 piperacillin/tazobactam should be confirmed by other diagnostic methods.

Pregnancy

There are no or a limited amount of data from the use of piperacillin/tazobactam in pregnant women. Studies in animals have shown developmental toxicity, but no evidence of teratogenicity, at doses that are maternally toxic. Piperacillin and tazobactam cross the placenta. Piperacillin/tazobactam should only be used during pregnancy if clearly indicated, i.e. only if the expected benefit outweighs the possible risks to the pregnant woman and foetus.

Nursing mothers

Piperacillin is excreted in low concentrations in breast milk; tazobactam concentrations in human milk have not been studied. Women who are breast-feeding should be treated only if the expected benefit outweighs the possible risks to the woman and child.

Carcinogenesis, mutagenesis and fertility

Fertility

A fertility study in rats showed no effect on fertility and mating after intraperitoneal administration of tazobactam or the combination piperacillin/tazobactam.

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

Adverse reactions


The most commonly reported adverse reaction is diarrhoea (occurring in 1 patient out of 10) are diarrhoea, nausea, vomiting and rash.

Among the most serious adverse reactions pseudo-membranous colitis and toxic epidermal necrolysis occur in 1 to 10 patients in 10,000. The frequencies for pancytopenia, anaphylactic shock and Stevens-Johnson syndrome cannot be estimated from the currently available data.

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
Very common
≥1/10
Common
≥1/100 to <1/10
Uncommon
≥1/1,000 to
<1/100
Rare
≥1/10,000 to
<1/1,000
Frequency not
known (cannot be
estimated from
available data)
Infections and
infestations
 candidiasis* pseudomembranous
colitis
 
Blood and
lymphatic system
disorders
 thrombocytopenia,
anaemia*
leukopeniaagranulocytosispancytopenia*,
neutropenia,
haemolytic
anaemia*,
eosinophilia*,
thrombocytosis*
Immune system
disorders
    anaphylactoid
reaction*,
anaphylactic
reaction*,
anaphylactoid
shock*, anaphylactic
shock*,
hypersensitivity*
Metabolism and
nutrition
disorders
  hypokalaemia  
Psychiatric
disorders
 insomnia  delirium*
Nervous system
disorders
 headache, insomnia   
Vascular
disorders
  hypotension,
thrombophlebitis,
phlebitis, flushing
  
Respiratory,
thoracic and
mediastinal
disorders
   epistaxiseosinophilic
pneumonia
Gastrointestinal
disorders
diarrhoeaabdominal pain,
vomiting, nausea,
constipation,
dyspepsia
 stomatitis 
Hepatobiliary
disorders
    hepatitis*, jaundice
Skin and
subcutaneous
tissue disorders
 rash, prurituserythema
multiforme*,
urticaria, rash
maculopapular*
toxic epidermal
necrolysis*
Stevens-Johnson
syndrome*,
dermatitis
exfoliative, drug
reaction with
eosinophilia and
systemic symptoms
(DRESS)*, acute
generalised
exanthematous
pustulosis (AGEP)*,
dermatitis bullous
purpura
Musculoskeletal
and connective
tissue disorders
  arthralgia, myalgia  
Renal and urinary
disorders
    renal failure,
tubulointerstitial
nephritis*
General
disorders and
administration
site conditions
 pyrexia, injection
site reaction
chills  
Investigations alanine
aminotransferase
increased, aspartate
aminotransferase
increased, protein
total decreased,
blood albumin
decreased, Coombs
direct test positive,
blood creatinine
increased, blood
alkaline
phosphatase
increased, blood
urea increased,
activated partial
thromboplastin time
prolonged
blood glucose
decreased, blood
bilirubin increased,
prothrombin time
prolonged
 bleeding time
prolonged, gamma-
glutamyltransferase
increased

* ADR identified post marketing

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

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