TAZACT 4.5 GM is a sterile, lyophilized powder for intravenous (IV) infusion, combining Piperacillin Sodium (a broad-spectrum penicillin antibiotic) and Tazobactam Sodium (a beta-lactamase inhibitor). It is used for moderate to severe infections caused by beta-lactamase-producing bacteria.
Composition
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Active Ingredients per vial:
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Piperacillin Sodium (equivalent to 4 g Piperacillin).
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Tazobactam Sodium (equivalent to 0.5 g Tazobactam).
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Excipients:Â Sodium citrate, sodium bicarbonate (for pH adjustment).
Mechanism of Action
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Piperacillin:
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Inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs).
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Broad-spectrum coverage against Gram-positive, Gram-negative, and anaerobic bacteria.
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Tazobactam:
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Irreversibly inhibits beta-lactamase enzymes, protecting Piperacillin from degradation.
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Extends activity against ESBL-producing Enterobacteriaceae and some resistant strains.
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Dosage & Administration
Standard Adult Dose:
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4.5 g (4g + 0.5g) IV every 6–8 hours (infused over 30 minutes).
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Severe Infections (e.g., nosocomial pneumonia): Up to 4.5 g every 6 hours.
Pediatric Dose (≥2 months):
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90–112.5 mg/kg every 6–8 hours (max 4.5 g per dose).
Renal Dose Adjustment:
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CrCl 20–40 mL/min: 3.375 g every 6 hours.
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CrCl <20 mL/min: 2.25 g every 6–8 hours.
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Hemodialysis: Administer after dialysis.
Administration:
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Reconstitute with 20 mL sterile water/NS, then dilute in 50–100 mL compatible IV fluid.
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Infuse over 30 minutes (prolonged infusion may be used for critical infections).
Uses (Indications)
✔ Intra-abdominal infections (with metronidazole for anaerobes).
✔ Nosocomial pneumonia (HAP/VAP).
✔ Complicated skin & soft tissue infections.
✔ Complicated urinary tract infections (cUTIs).
✔ Septicemia (bloodstream infections).
Storage
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Unreconstituted powder: Store below 25°C; protect from moisture.
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Reconstituted solution:
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Stable for 24 hours at 2–8°C (discard unused portions).
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Do not freeze.
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Recommendations
✔ Monitor renal function, liver enzymes, and CBC during prolonged therapy.
✔ Not effective against MRSA (add vancomycin/linezolid if suspected).
✔ Avoid prolonged use to prevent superinfections (e.g., C. difficile).
Important Note
Contraindications:
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Hypersensitivity to penicillins, cephalosporins, or beta-lactamase inhibitors.
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History of severe anaphylactic reactions to beta-lactams.
Side Effects:
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Common:Â Diarrhea, headache, nausea, rash.
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Serious:
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C. difficile-associated diarrhea.
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Hematologic effects (leukopenia, thrombocytopenia).
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Hypokalemia (with high doses).
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Drug Interactions:
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Probenecid: ↑ Piperacillin levels (avoid concurrent use).
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Anticoagulants: May ↑ bleeding risk (monitor INR).
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Vecuronium: ↑ Neuromuscular blockade.
Pregnancy & Lactation:
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Category BÂ (use only if clearly needed).
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Breastfeeding:Â Low excretion in milk (caution advised).
Presentation
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Single-dose vial (4.5 g powder for reconstitution).
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