TAZOBACTAM/PIPERACILLIN

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PIPERACILLIN/TAZOBACTAM
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Infant Data

Results



MEDICAL INFORMATIONS

INDICATIONS

Infective endocarditis: The following recommendations are based on a consensus of experts. The full pediatric guidelines can be found here: INDICATIONS Infective endocarditis: The following recommendations are based on a consensus of experts. The full pediatric guidelines can be found here: piperacillin-tazobactam Pediatric FDA Approved Indications : FDA APPROVED INDICATION Piperacillin/tazobactam is not approved for newborn infants. In children 2 months or older, it's approved for appendicitis (complicated by rupture or abscess) and peritonitis caused by piperacillin-resistant, β-lactamase producing strains of Escherichia coli or the following members of the Bacteroides fragilis group: B fragilis, B ovatus, B thetaiotaomicron, or B vulgatus. Additional approved indications in adults: uncomplicated and complicated skin and skin structure infections, including cellulitis, cutaneous abscesses and ischemic/diabetic food infections caused by β-lactamase producing isolates of Staphylococcus aureus; postpartum endometritis or pelvic inflammatory disease caused by β-lactamase producing isolates of E coli; community-acquired pneumonia (moderate severity only) caused by β-lactamase producing isolates of Haemophilus influenzae; moderate to severe nosocomial pneumonia caused by β-lactamase producing isolates of S aureus and by piperacillin/tazobactamsusceptible Acinetobacter baumanii, H influenzae, Klebsiella pneumoniae, and Pseudomonas aeruginosa; use concomitant aminoglycoside therapy when treating nosocomial pneumonia caused by P aeruginosa. Contraindications / Precautions : CONTRAINDICATIONS Contraindicated in patients with a history of hypersensitivity reactions to any of the penicillins, cephalosporins, or beta-lactamase inhibitors. PRECAUTIONS Concomitant Use: Probenecid not recommended unless benefit outweighs risk. Dermatologic: Serious cutaneous reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis) have been reported; close monitoring recommended and discontinue if lesions progress. Endocrine and metabolic: Hypokalemia may occur especially in patients with low potassium reserves and concomitant diuretic or cytotoxic therapy; monitoring recommended in patients with low potassium reserves. Use caution in patients requiring sodium restriction as product contains 2.84 mEq (65 mg) of sodium per g of piperacillin. Gastrointestinal: Clostridium difficile-associated diarrhea, including mild diarrhea to fatal colitis, has been reported and may occur more than 2 months after use; discontinuation of antibacterial use not directed against C. difficile may be required. Hematologic: Bleeding manifestations have been reported with piperacillin use, especially in patients with renal failure; monitoring recommended particularly with prolonged use (ie, 21 days or greater); discontinue use if occurs. Leukopenia and neutropenia have been reported, especially with prolonged use; usually reversible upon discontinuation; however, monitoring recommended. Immunologic:: Serious anaphylactic reactions, with some fatal cases, have been reported, especially in patients with history of penicillin, cephalosporin, or carbapenem hypersensitivity or history of sensitivity to multiple allergens. Neurologic: Neuromuscular excitability or convulsions may occur at higher than recommended doses, particularly in the presence of renal failure. Renal: Increased risk of nephrotoxicity in critically ill patients, including renal failure and delayed recovery of renal function; consider alternative therapy, otherwise monitoring required during treatment. Use caution in patients with renal failure; increased risk of neuromuscular excitability or convulsions with higher than recommended IV doses. Renal insufficiency (ie, CrCl less than or equal to 40 mL/min) and hemodialysis or continuous ambulatory peritoneal dialysis patients; dosage adjustments required. Respiratory: Use caution in patients with cystic fibrosis due to increased risk for fever and rash. Adverse Effects : ADVERSE EFFECTS Common adverse events (greater than 5%) in adults were diarrhea, constipation, nausea, headache, and insomnia Administration : ADMINISTRATION Infuse IV over at least 30 minutes at recommended concentrations in pediatric patients of 40, 60, and 200 mg/mL (piperacillin component) Monitoring : MONITORING Monitor electrolytes periodically in patients with low potassium reserves. Consider monitoring electrolytes periodically in patients with potentially low potassium reserves or those receiving cytotoxic therapy or diuretics. Periodic assessment of hematopoietic function, especially with prolonged therapy of 21 days or greater

FDA APPROVED INDICATION

  • Piperacillin/tazobactam is not approved for newborn infants. In children 2 months or older, it’s approved for appendicitis (complicated by rupture or abscess) and peritonitis caused by piperacillin-resistant, β-lactamase producing strains of Escherichia coli or the following members of the Bacteroides fragilis group: B fragilis, B ovatus, B thetaiotaomicron, or B vulgatus.
  • Additional approved indications in adults: uncomplicated and complicated skin and skin structure infections, including cellulitis, cutaneous abscesses and ischemic/diabetic food infections caused by β-lactamase producing isolates of Staphylococcus aureus; postpartum endometritis or pelvic inflammatory disease caused by β-lactamase producing isolates of E coli; community-acquired pneumonia (moderate severity only) caused by β-lactamase producing isolates of Haemophilus influenzae; moderate to severe nosocomial pneumonia caused by β-lactamase producing isolates of S aureus and by piperacillin/tazobactamsusceptible Acinetobacter baumanii, H influenzae, Klebsiella pneumoniae, and Pseudomonas aeruginosa; use concomitant aminoglycoside therapy when treating nosocomial pneumonia caused by P aeruginosa.

CONTRAINDICATIONS

  • Contraindicated in patients with a history of hypersensitivity reactions to any of the penicillins, cephalosporins, or beta-lactamase inhibitors.

PRECAUTIONS

  • Concomitant Use: Probenecid not recommended unless benefit outweighs risk.
  • Dermatologic:
    • Serious cutaneous reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis) have been reported; close monitoring recommended and discontinue if lesions progress.
  • Endocrine and metabolic:
    • Hypokalemia may occur especially in patients with low potassium reserves and concomitant diuretic or cytotoxic therapy; monitoring recommended in patients with low potassium reserves.
    • Use caution in patients requiring sodium restriction as product contains 2.84 mEq (65 mg) of sodium per g of piperacillin.
  • Gastrointestinal:
    • Clostridium difficile-associated diarrhea, including mild diarrhea to fatal colitis, has been reported and may occur more than 2 months after use; discontinuation of antibacterial use not directed against C. difficile may be required.
  • Hematologic:
    • Bleeding manifestations have been reported with piperacillin use, especially in patients with renal failure; monitoring recommended particularly with prolonged use (ie, 21 days or greater); discontinue use if occurs.
    • Leukopenia and neutropenia have been reported, especially with prolonged use; usually reversible upon discontinuation; however, monitoring recommended.
  • Immunologic::
    • Serious anaphylactic reactions, with some fatal cases, have been reported, especially in patients with history of penicillin, cephalosporin, or carbapenem hypersensitivity or history of sensitivity to multiple allergens.
  • Neurologic:
    • Neuromuscular excitability or convulsions may occur at higher than recommended doses, particularly in the presence of renal failure.
  • Renal:
    • Increased risk of nephrotoxicity in critically ill patients, including renal failure and delayed recovery of renal function; consider alternative therapy, otherwise monitoring required during treatment.
    • Use caution in patients with renal failure; increased risk of neuromuscular excitability or convulsions with higher than recommended IV doses.
    • Renal insufficiency (ie, CrCl less than or equal to 40 mL/min) and hemodialysis or continuous ambulatory peritoneal dialysis patients; dosage adjustments required.
  • Respiratory:
    • Use caution in patients with cystic fibrosis due to increased risk for fever and rash.

ADVERSE EFFECTS

Common adverse events (greater than 5%) in adults were diarrhea, constipation, nausea, headache, and insomnia

ADMINISTRATION

Infuse IV over at least 30 minutes at recommended concentrations in pediatric patients of 40, 60, and 200 mg/mL (piperacillin component)

MONITORING

Monitor electrolytes periodically in patients with low potassium reserves. Consider monitoring electrolytes periodically in patients with potentially low potassium reserves or those receiving cytotoxic therapy or diuretics. Periodic assessment of hematopoietic function, especially with prolonged therapy of 21 days or greater

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