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Piperacillin

J01C - Beta-lactam antibacterials, penicillins ATC J01CR05 Small molecule approved 1981 Parenteral Natural product

🧬 Cross-allergy: Penicillins

JFDA label: Prizma

Mechanism of Action

Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs); which in turn inhibit the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested.

Indications

Approved

  • Infection

Antimicrobial Spectrum

Expected / intrinsic spectrum (EUCAST breakpoints & labels) — not local resistance. Source: EUCAST v16 · curated · openfda-label.

Bacteria

OrganismActivityMIC
Acinetobacter baumannii Active
Anaerobes Susceptible 24.0 mg/L
Bacteroides distasonis Active
Bacteroides fragilis Active
Bacteroides thetaiotaomicron Active
Citrobacter koseri Active
Clostridium difficile Active
Clostridium perfringens Active
Enterobacter cloacae Susceptible 8.0 mg/L
Enterobacterales Susceptible 8.0 mg/L
Enterococcus faecalis Active
Enterococcus spp. Susceptible 0.0015 mg/L
Escherichia coli Susceptible 8.0 mg/L
Haemophilus influenzae Susceptible 0.257 mg/L
Klebsiella pneumoniae Susceptible 8.0 mg/L
Moraxella catarrhalis Susceptible -1.0 mg/L
Morganella morganii Active
Neisseria gonorrhoeae Active
Prevotella melaninogenica Active
Proteus mirabilis Active
Proteus vulgaris Active
Providencia rettgeri Active
Providencia stuartii Active
Pseudomonas aeruginosa Susceptible 16.0 mg/L
Pseudomonas aeruginosa Susceptible 0.001 mg/L
Salmonella enterica Active
Serratia marcescens Active
Staphylococcus aureus Active
Staphylococcus epidermidis Active
Streptococcus agalactiae Active
Streptococcus pneumoniae Active
Streptococcus pyogenes Active
Vibrio spp. Susceptible 11.0 mg/L
Pseudomonas aeruginosa Resistant 16.0 mg/L

Class profile

gramStatusBoth
spectrumBreadthExtended
atypicalCoverageNo
isBactericidal1
moaCategoryCell wall synthesis inhibitor (beta-lactam, anti-pseudomonal penicillin)
pdIndexTime-dependent
postAntibioticEffectNone
mrsaCoverage0
resistanceMechanismsBeta-lactamase production (AmpC),Reduced outer membrane permeability (OprD loss),Efflux pumps (MexAB-OprM)

Contraindications

Source: Lexicomp

  • Hypersensitivity to any of the penicillins and/or cephalosporins or any component of the formulation Absolute
  • hypersensitivity to local anesthetics of the amide type (when reconstituted with lidocaine for IM use) Absolute

Adverse Reactions

Very Common >10%Common 1–10%Uncommon 0.1–1% Rare 0.01–0.1%Very Rare <0.01%Not Known

Cardiac disorders (1)

Not Known Local thrombophlebitis

Nervous system disorders (4)

Not Known Confusion · drowsiness · myoclonus · seizure

Renal and urinary disorders (2)

Not Known Acute interstitial nephritis · acute renal failure

Blood and lymphatic system disorders (6)

Not Known Abnormal platelet aggregation (high doses) · agranulocytosis · hemolytic anemia · pancytopenia · positive direct Coombs test · prolonged prothrombin time (high doses)

Immune system disorders (3)

Not Known Anaphylaxis · hypersensitivity reaction · Jarisch-Herxheimer reaction

Metabolism and nutrition disorders (2)

Not Known Electrolyte disturbance · hypokalemia

Skin and subcutaneous tissue disorders (3)

Not Known Skin rash · toxic epidermal necrolysis · urticaria

General disorders and administration site conditions (1)

Not Known Fever

Dosing

Source: Lexicomp

Community-acquired pneumonia: IM, IV: Usual dosage: 6 to 8 g daily (100 to 125 mg/kg daily) in divided doses every 6 to 12 hours Severe infections (eg, gynecologic, intra-abdominal, nosocomial pneumonia, septicemia, skin/soft tissue): IV: Usual dosage: 12 to 18 g daily (200 to 300 mg/kg daily) in divided doses every 4 to 6 hours (maximum: 24 g daily) Urethritis (gonococcal, uncomplicated): IM: 2 g once (Note: Administer probenecid 30 minutes prior to piperacillin) Urinary tract infection (complicated): IV: Usual dosage: 8 to 16 g daily (125 to 200 mg/kg daily) in divided doses every 6 to 8 hours Urinary tract infection (uncomplicated): IM, IV: Usual dosage: 6 to 8 g daily (100 to 125 mg/kg daily) in divided doses every 6 to 12 hours
Usual dosage range: Children ≥12 years and Adolescents: IM, IV: Refer to adult dosing.
Refer to adult dosing. Dosage adjustment may be necessary for renal impairment.
Adults: IV: CrCl >40 mL/minute or serum creatinine 1.5 to 3 mg/dL: No dosage adjustment necessary. CrCl 20-40 mL/minute or serum creatinine 3.1 to 5 mg/dL: Urinary tract infection (uncomplicated): No dosage adjustment necessary. Urinary tract infection (complicated): 3 g every 8 hours Severe systemic infection: 4 g every 8 hours CrCl 5 mg/dL: Urinary tract infection (complicated/uncomplicated): 3 g every 12 hours Severe systemic infection: 4 g every 12 hours Hemodialysis: Severe systemic infection: 2 g every 8 hours; administer 1 g supplemental dose after each dialysis session; dialyzable (30% to 50%)
No dosage adjustment provided in manufacturer’s labeling.

Warnings & Precautions

Source: Lexicomp

Anaphylactoid/hypersensitivity reactions

Serious and occasionally severe or fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy, especially with a history of beta-lactam hypersensitivity, history of sensitivity to multiple allergens, or previous IgE-mediated reactions (eg, anaphylaxis, angioedema, urticaria). Use with caution in asthmatic patients. Discontinue if hypersensitivity occurs; initiate appropriate rescue treatment for serious hypersensitivity reactions.

Bleeding disorders

Particularly in patients with renal impairment, bleeding disorders have been observed; discontinue if thrombocytopenia or bleeding occurs.

Leukopenia/neutropenia

During prolonged use, leukopenia and neutropenia have been reported.

Superinfection

Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment. Disease-related concerns:

Cardiovascular disease

Use with caution particularly in sodium-restricted patients receiving prolonged therapy; formulation contains 42.5 mg of sodium per gram. Monitor electrolyte status and cardiac function with prolonged therapy.

Cystic fibrosis

An increased frequency of fever and rash has been reported in patients with cystic fibrosis.

Infectious mononucleosis

Patients with infectious mononucleosis have developed rash during therapy with other penicillins (eg, ampicillin, amoxicillin).

Renal impairment

Use with caution in patients with renal impairment, due to sodium load and adverse effects (hematologic, neuropsychological changes); dosage adjustment recommended.

Seizure disorders

High drug levels, particularly in the presence of renal impairment, may increase risk of seizures. Use with caution in patients with a history of seizure disorder.

Syphilis

Symptoms of syphilis may be masked or delayed in patients receiving high-dose antimicrobial treatment of gonorrhea; patients with gonorrhea should be evaluated for syphilis prior to initiating antimicrobial treatment and if syphilis is suspected, continue serologic testing monthly for at least 4 months.

Pregnancy & Lactation

Pregnancy

Adverse events have not been observed in animal reproduction studies. Piperacillin crosses the placenta and distributes into the amniotic fluid (Brown, 1990; Heikkilä, 1991). Due to pregnancy-induced physiologic changes, some pharmacokinetic parameters of piperacillin may be altered. At term, the apparent volume of distribution of piperacillin is increased and peak concentrations are significantly lower. Total clearance is normal to increased at term (Heikkilä, 1991; Voight, 1985). These changes continue into the early postpartum period (Charles, 1985; Martens, 1987).

Lactation

Small amounts of piperacillin are excreted in breast milk. The manufacturer recommends that caution be exercised when administering piperacillin to nursing women. Nondose-related effects could include modification of bowel flora.

Monitoring

EfficacyCulture and susceptibility testing; clinical resolution (temperature, WBC, CRP, procalcitonin)
ToxicityRenal function (dose adjustment in renal impairment); hepatic function for hepatically cleared agents; signs of C. difficile infection (diarrhoea)
Clinical pearlCulture results guide de-escalation to narrower-spectrum therapy. Review antibiotic appropriateness at 48–72 h (antimicrobial stewardship).
CounselingComplete the full course. Report persistent diarrhoea, rash, or lack of improvement after 48–72 h.

Chemistry & Properties

2D structure
FormulaC23H27N5O7S
Molecular weight517.56 g/mol
IUPAC name(2S,5R,6R)-6-[[(2R)-2-[(4-ethyl-2,3-dioxopiperazine-1-carbonyl)amino]-2-phenylacetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid
CAS61477-96-1
PubChem CID43672
InChIKeyIVBHGBMCVLDMKU-GXNBUGAJSA-N
logP-0.24 (XLogP 0.5)
Polar surface area156.43 Ų
H-bond acceptors / donors7 / 3
Drug-likeness (QED)0.34
Lipinski violations1
SMILESCCN1CCN(C(=O)N[C@@H](C(=O)N[C@@H]2C(=O)N3[C@@H]2SC(C)(C)[C@@H]3C(=O)O)c2ccccc2)C(=O)C1=O

Biology & Pharmacokinetics

Pharmacokinetics predicted

Bioavailability70.0%
Half-life1.056 h
Volume of distribution0.273 L/kg
Protein binding39.3%
BBB penetrantNo

Enzyme interactions

EnzymeRoleDetail
CYP2C19Substrate

Transporters

BCRP (Inhibitor)BSEP (Inhibitor)BSEP (Inhibitor)MRP1 (Inhibitor)MRP2 (Inhibitor)MRP3 (Inhibitor)MRP4 (Inhibitor)OAT1 (Inhibitor)OAT3 (Inhibitor)OATP1B1 (Inhibitor)OATP1B3 (Inhibitor)OATP1B3 (Inhibitor)P-gp (Inhibitor)PEPT1 (Inhibitor)P-gp (Substrate)PEPT1 (Substrate)

Drug–drug interactions (24, DDInter)

Interacting drugSeverityManagement
Methotrexate major
Vancomycin major
Amikacin moderate
Amikacin (liposome) moderate
Chloramphenicol moderate
Demeclocycline moderate
Dicoumarol moderate
Doxycycline moderate
Ethinylestradiol moderate
Gentamicin moderate
Iodide I-123 moderate
Iodide I-131 moderate
Kanamycin moderate
Minocycline moderate
Mycophenolic acid moderate
Oxytetracycline moderate
Pemetrexed moderate
Picosulfuric acid moderate
Streptomycin moderate
Tetracycline moderate
Warfarin moderate
Clarithromycin minor
Erythromycin minor
Heparin minor

Registered Products (9)

BrandForm / strengthPackAgentCitizen (JOD)
Piperacillin/Tazobactam Powder for Injection 0.25 g, 2 g 1 vial Nabulsi Drug Store
Piperacillin/Tazobactam Tablet 2000 mg, 250 mg 12 vial Petra Drug Store
Piperacillin/Tazobactam Vial 4000 mg, 500 mg 12 vial Petra Drug Store
Piperacillin/Tazobactam Sandoz Vial 0.5 g, 4 g 1 vial pack varies Nabulsi Drug Store
Piperacillin/Tazobactam Sandoz Vial 0.5 g, 4 g 10 vial pack varies Nabulsi Drug Store
Prizma Vial 4 g, 500 mg 1 vial Hikma Pharmaceuticals Co.Ltd/Jordan
Prizma Vial Vial 2 g, 0.25 g 1 vial Hikma Pharmaceuticals Co.Ltd/Jordan
Yanoven 2G + Vial 2 g, 0.25 g 1 amp Adonis Drug Store
Yanoven 4G + Vial 4 g, 0.5 g 1 vial Adonis Drug Store