Tazocin

 (4 gm+0.5 gm)/vial IV Infusion
Radiant Pharmaceuticals Ltd.

4.5 gm vial: ৳ 1,800.00

Indications
  • Approved indications:
    • Treatment of moderate to severe infections caused by susceptible bacteria, including:
      • Intra-abdominal infections (e.g., peritonitis, abscess)
      • Skin and soft tissue infections
      • Complicated urinary tract infections (including pyelonephritis)
      • Community-acquired and hospital-acquired pneumonia
      • Septicemia and bacteremia
      • Gynecological infections
      • Bone and joint infections
      • Febrile neutropenia (as empiric therapy)
  • Important off-label uses:
    • Severe infections caused by multidrug-resistant Gram-negative organisms (as per susceptibility)
    • Empiric treatment in critically ill patients with suspected polymicrobial infections
Dosage & Administration
  • Route: Intravenous (IV) infusion; intramuscular (IM) use limited.
  • Adults:
    • Usual dose: 3.375 g (piperacillin 3 g + tazobactam 0.375 g) every 6 hours IV over 30 minutes.
    • Severe infections: Dose may increase up to 4.5 g (piperacillin 4 g + tazobactam 0.5 g) every 6 to 8 hours.
    • Maximum dose: up to 18 g piperacillin per day.
  • Pediatrics:
    • IV dosing based on body weight, commonly 80–100 mg/kg (piperacillin component) every 6–8 hours.
    • Adjustments according to severity and site of infection.
  • Elderly:
    • Use standard dosing unless renal impairment present; adjust dose as per renal function.
  • Renal impairment:
    • Dose adjustment required based on creatinine clearance:
      • ClCr 20–40 mL/min: extend dosing interval to every 8–12 hours.
      • ClCr <20 mL/min: extend dosing interval to every 12–24 hours; avoid IM use.
  • Hepatic impairment:
    • No significant dosage adjustment needed.
Mechanism of Action (MOA)

Piperacillin is a broad-spectrum ureidopenicillin antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to cell lysis and death. Tazobactam is a beta-lactamase inhibitor that irreversibly inhibits many beta-lactamases produced by bacteria, preventing the enzymatic degradation of piperacillin and thereby extending its spectrum of activity against beta-lactamase-producing organisms. Together, they provide synergistic bactericidal activity against a wide range of Gram-positive, Gram-negative, and anaerobic bacteria.

Pharmacokinetics
  • Absorption: Not applicable (administered IV/IM); poor oral absorption.
  • Distribution: Widely distributed into body tissues and fluids including lungs, bile, bone, and abscesses; volume of distribution approx. 0.16 L/kg.
  • Metabolism: Minimal hepatic metabolism; tazobactam partially metabolized.
  • Elimination: Primarily renal excretion of unchanged drug; both piperacillin and tazobactam are eliminated via kidneys.
  • Half-life:
    • Piperacillin: ~0.7 to 1.2 hours
    • Tazobactam: ~0.7 to 1.2 hours
  • Onset: Rapid after IV infusion.
  • Steady state: Achieved within 24–48 hours with multiple dosing.
Pregnancy Category & Lactation
  • Pregnancy: FDA category B; animal studies show no risk, but controlled human data are limited. Use only if clearly needed.
  • Lactation: Piperacillin and tazobactam are excreted in breast milk in small amounts; caution advised during breastfeeding.
Therapeutic Class
  • Combination antibiotic: Extended-spectrum penicillin + beta-lactamase inhibitor
Contraindications
  • Known hypersensitivity to piperacillin, tazobactam, penicillins, or beta-lactam antibiotics
  • History of severe allergic reactions (e.g., anaphylaxis) to beta-lactams
  • Cross-reactivity caution with cephalosporins and carbapenems
Warnings & Precautions
  • Use with caution in patients with a history of penicillin allergy or hypersensitivity reactions
  • Monitor for signs of hypersensitivity reactions, including anaphylaxis
  • Risk of Clostridioides difficile-associated diarrhea and superinfection with prolonged use
  • Monitor renal function regularly; dose adjustment required in renal impairment
  • Caution in patients with hepatic dysfunction or seizure history
  • May cause electrolyte disturbances (e.g., sodium load); monitor electrolytes in high doses
  • Use carefully in patients with bleeding disorders due to platelet dysfunction risk
Side Effects
  • Common:
    • Gastrointestinal: diarrhea, nausea, vomiting
    • Injection site reactions
    • Rash, urticaria
  • Serious but less common:
    • Hypersensitivity reactions including anaphylaxis
    • Clostridioides difficile-associated diarrhea
    • Hematologic: neutropenia, thrombocytopenia, eosinophilia
    • Hepatic enzyme elevations
    • Electrolyte imbalance
  • Rare:
    • Seizures (particularly in renal impairment or overdose)
    • Stevens-Johnson syndrome, toxic epidermal necrolysis
Drug Interactions
  • May increase anticoagulant effects of warfarin and increase bleeding risk
  • Enhanced nephrotoxicity with aminoglycosides
  • Possible reduced efficacy of oral contraceptives (theoretical)
  • Increased risk of seizures with concomitant penicillins and probenecid or imipenem
  • Sodium load may interact with sodium-restricted diets or drugs affecting electrolyte balance
Recent Updates or Guidelines
  • Recent guidelines emphasize using piperacillin-tazobactam as empiric therapy for hospital-acquired infections and multidrug-resistant organisms, especially Pseudomonas aeruginosa
  • Recommendations to adjust dosing in renal impairment to reduce toxicity
  • Newer dosing strategies include extended or continuous infusions to optimize pharmacodynamics in critically ill patients
  • Ongoing surveillance for resistance patterns recommended
Storage Conditions
  • Store at 20°C to 25°C (68°F to 77°F)
  • Protect from moisture and light
  • After reconstitution, store solution refrigerated at 2°C to 8°C (36°F to 46°F) and use within 24 hours
  • Do not freeze reconstituted solution
  • Use aseptic technique to prepare and administer