Piperacillin & Tazobactam

Piperacillin & Tazobactam

[1 vial $22.00]

ADMINISTRATION ROUTES:

• IV

ALTERNATIVE NAMES:

• Tazocin

ICU INDICATIONS:

1. treatment of infections caused by susceptible organisms
2. broad spectrum cover of hospital-acquired infections

PRESENTATION AND ADMINISTRATION:

• IV:
  4.5g vial of powder (4gm piperacillin and 500mg tazobactam)
  Reconstitute with at least 20ml of Water for Injection, normal saline, 5% glucose or glucose and sodium chloride and administer via slow IV injection over 3-5 minutes.
  Alternatively, further dilute to desired volume (e.g. 100ml) with compatible fluid and infuse over 20 to 30 minutes. Prepare immediately before use.  Dilutions should be used immediately. Store at room temperature
  Compatible with the following IV fluids:
  Normal saline,  5% glucose,  Glucose and Sodium Chloride

DOSAGE:

• IV:
  4.5gm 8 hourly

DOSAGE IN RENAL FAILURE AND RENAL REPLACEMENT THERAPY:

• Dose in renal impairment [GFR (ml/min)]
  <10: 4.5g every 12 hours
  10-20: 4.5g every 12 hours
  20-50: dose as in normal renal function
• Dose in renal replacement therapy
  CAPD: 4.5g every 12 hours
  HD: 4.5g every 12 hours
  CVVHDF: 4.5g every 12 hours

DOSAGE IN PAEDIATRICS:

• IV:
  50-75mg/kg 6-8 hourly

CLINICAL PHARMACOLOGY:

• Piperacillin/tazobactam has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections.
  Aerobic and facultative gram-positive microorganisms:
  Staphylococcus aureus (excluding methicillin and oxacillin-resistant isolates)
  Aerobic and facultative gram-negative microorganisms:
  Acinetobacter baumanii
  Escherichia coli
  Haemophilus influenzae (excluding beta-lactamase negative, ampicillin-resistant isolate)
  Klebsiella pneumoniae
  Pseudomonas aeruginosa (given in combination with an aminoglycoside to which the isolate is susceptible)
  Gram-negative anaerobes:
  Bacteroides fragilis group (B. fragilis, B. ovatus, B. thetaiotaomicron, and B. vulgatus)
• The following in vitro data are available; but their clinical significance is unknown.
  At least 90% of the following microorganisms exhibit an in vitro minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoint for piperacillin/tazobactam. However, the safety and effectiveness of piperacillin/tazobactam in treating clinical infections due to these bacteria have not been established in adequate and well-controlled clinical trials.
  Aerobic and facultative gram-positive microorganisms:
  Enterococcus faecalis (ampicillin or penicillin-susceptible isolates only) Staphylococcus epidermidis (excluding methicillin and oxacillin resistant isolates) Streptococcus agalactiae*
  Streptococcus pneumoniae* (penicillin-susceptible isolates only)
  Streptococcus pyogenes*
  Viridans group streptococci*
  Aerobic and facultative Gram-negative microorganisms:
  Citrobacter koseri
  Moraxella catarrhalis
  Morganella morganii
  Neisseria gonorrhoeae
  Proteus mirabilis
  Proteus vulgaris
  Serratia marcescens
  Providencia stuartii
  Providencia rettgeri
  Salmonella enterica
  Gram-positive anaerobes:
  Clostridium perfringens
  Gram-negative anaerobes:
  Bacteroides distasonis
  Prevotella melaninogenica

CONTRAINDICATIONS:

1. hypersensitivity to carbapenems

WARNINGS

• SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN REPORTED IN PATIENTS RECEIVING THERAPY WITH  BETA-LACTAMS. THESE REACTIONS ARE MORE APT TO OCCUR IN PERSONS WITH A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS. THERE HAVE BEEN REPORTS OF PATIENTS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED SEVERE HYPERSENSITIVITY REACTIONS WHEN TREATED WITH ANOTHER BETA-LACTAM. BEFORE INITIATING THERAPY WITH IMIPENEM IV, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OTHER BETA-LACTAMS, AND OTHER ALLERGENS.

PRECAUTIONS

• General:
  Seizures and other CNS adverse experiences, such as confusional states and myoclonic activity, have been reported during treatment with imipenem
  Pseudomembranous colitis has been reported with nearly all antibacterial agents, including imipenem-cilastatin sodium, and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea subsequent to the administration of antibacterial agents.
• Laboratory Tests:
  No tests in addition to routine ICU tests are required.
• Drug/Laboratory Test Interactions
  None noted.
• Pregnancy
  There are no adequate and well-controlled studies in pregnant women.  Imipenem  IV should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and foetus.
• Nursing Mothers
  It is not known whether imipenem-cilastatin sodium is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when imipenem is administered to a nursing woman.
• Paediatric Use
  Use of Imipenem in paediatric patients, neonates to 16 years of age, is supported by evidence from adequate and well-controlled studies of Imipenem in adults and by smaller clinical studies and published literature in pediatric patients.

IMPORTANT DRUG INTERACTIONS FOR THE ICU

• Generalized seizures have been reported in patients who received ganciclovir and Imipenem. These drugs should not be used concomitantly unless the potential benefits outweigh the risks.

ADVERSE REACTIONS

• Body as a whole:
  Polyarthralgia, asthenia/weakness, drug fever.
• Gastrointestinal:
  Pseudomembranous colitis, diarrhoea, nausea, vomiting, hemorrhagic colitis, hepatitis (including fulminant hepatitis), jaundice, gastroenteritis, abdominal pain, glossitis, tongue papillar hypertrophy, staining of the teeth and/or tongue, heartburn, pharyngeal pain, increased salivation.
• Hematologic:
  Pancytopenia, bone marrow depression, thrombocytopenia, neutropenia, leukopenia, hemolytic anemia.
• CNS:
  Seizures, encephalopathy, tremor, confusion, myoclonus, paresthesia, vertigo, headache, psychic disturbances including hallucinations.
• Respiratory:
  Chest discomfort, dyspnea, hyperventilation, thoracic spine pain.
• Cardiovascular:
  Palpitations, tachycardia.
• Skin:
  Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, angioneurotic edema, flushing, cyanosis, hyperhidrosis, skin texture changes, candidiasis, pruritus vulvae.
• Renal:
  Acute renal failure, oliguria/anuria, polyuria, urine discoloration.