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MEDICINE MONOGRAPH CODE: [8.16]-C59 ID: TIP-MED-000329

Tazobactam Sodium

Active Ingredient / Scientific Identity: Tazobactam Sodium • Class: Extended-Spectrum Ureidopenicillin + Beta-Lactamase Inhibitor (Schedule H | NLEM 2022 | ICMR Watch)

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THE INDIAN PHARMACIST — Educational Reference Sheet
Profile: Tazobactam Sodium ([8.16]-C59 | ID: TIP-MED-000329) • Last Reviewed: 2026-11-10
Source URL: https://theindianpharmacist.com/medicine/8-16-c59-tazobactam-sodium/
Generic / Entity NameTazobactam Sodium ([8.16]-C59)
Verified Indian Brands / RefGeneric Compendial Entry (No Commercial Brand Claimed)
Pharmacological ClassExtended-Spectrum Ureidopenicillin + Beta-Lactamase Inhibitor (Schedule H | NLEM 2022 | IC
Available Dosage FormsLyophilised Powder Vials for IV Infusion: 4.5 g (4 g + 0.5 g), 2.25 g (2 g + 0.25 g), 1.125 g
Regulatory ClassificationSchedule H Prescription Drug (To be sold by retail on the prescription of a Registere
Key Warning & Review DateRenal (CrCl): CrCl 20–40 mL/min: 2.25 g IV q6h (3.375 g q6h for HAP); CrCl <20 mL/min: 2.25 g IV q8h; Haemodialysis: 2.25 g q
Reviewed: 2026-11-10
Safety Matrix:⚖️ Legal Status: Schedule H Prescription Drug (To be sold by retail o✔️ Standard Clinical Dispensing Precautions

1. Clinical & Scientific Overview

Tazobactam Sodium (TIP-MED-000329, Reference Code [8.16]-C59) is classified under Antimicrobials — Antibacterial & Antibiotic Agents (Ch 08) as a Extended-Spectrum Ureidopenicillin + Beta-Lactamase Inhibitor (Schedule H | NLEM 2022 | ICMR Watch). Within the Indian regulatory and compendial framework, it is governed under Schedule H Prescription Drug (To be sold by retail on the prescription of a Registered Medical Practitioner only — Drugs Rules 1945).

Verified Indian Market Examples / Compendial Status:
Co-indexed constituent under primary monograph [8.16] (Piperacillin + Tazobactam). Representative Indian Market Examples (Edition 2.7 Ch 08 [8.16], p. 100): Piptaz (Cipla), Zosyn (Pfizer), Tazact (Lupin), Brodactam (Sun) — Strengths & Dosage Forms: Lyophilised Powder Vials for IV Infusion: 4.5 g (4 g + 0.5 g), 2.25 g (2 g + 0.25 g), 1.125 g
Co-indexed constituent under primary monograph [8.16] (Piperacillin + Tazobactam). Representative Indian Market Examples (Edition 2.7 Ch 08 [8.16], p. 100): Piptaz (Cipla), Zosyn (Pfizer), Tazact (Lupin), Brodactam (Sun) — Strengths & Dosage Forms: Lyophilised Powder Vials for IV Infusion: 4.5 g (4 g + 0.5 g), 2.25 g (2 g + 0.25 g), 1.125 g
Dosage Forms & Available Strengths:
Lyophilised Powder Vials for IV Infusion: 4.5 g (4 g + 0.5 g), 2.25 g (2 g + 0.25 g), 1.125 g
Routes: Oral / Parenteral / Topical per formulation

3. Mechanism of Action & Pharmacodynamics

Extended-Spectrum Ureidopenicillin + Beta-Lactamase Inhibitor (Schedule H | NLEM 2022 | ICMR Watch) acting on target receptor/enzyme pathways in Antimicrobials — Antibacterial & Antibiotic Agents (Ch 08): clinical efficacy is mediated via Extended-Spectrum Ureidopenicillin + Beta-Lactamase Inhibitor (Schedule H | NLEM 2022 | ICMR Watch) for Moderate-to-severe nosocomial pneumonia (HAP/VAP), complicated intra-abdominal infections, febrile neutropenia, diabetic foot infections, and urosepsis (active against Pseudomonas aeruginosa, Enterobacterales, & anaerobes).

4. Therapeutic Indications & Evidence-Supported Uses

  • Moderate-to-severe nosocomial pneumonia (HAP/VAP), complicated intra-abdominal infections, febrile neutropenia, diabetic foot infections, and urosepsis (active against Pseudomonas aeruginosa, Enterobacterales, & anaerobes)

🇮🇳 Jurisdiction & Indication Note: Indications and schedules reflect Indian compendial and regulatory records (CDSCO / Indian Pharmacopoeia & NFI / NLEM 2022). Where international reference labels (US FDA DailyMed / NCBI StatPearls) are cited for pharmacokinetic or mechanistic parameters, international approvals do not automatically imply CDSCO approval in India.

5. Educational Dosage Context, Formulations & Administration

Educational Dosing & Regimen Summary: Standard Adult Dose (CrCl >40 mL/min): 4.5 g IV every 8 hours (or every 6 hours for HAP/VAP/Pseudomonas/neutropenia), infused over 30 min (or extended 3–4h infusion to maximise T>MIC!)

Administration & Meal Timing: Administer via slow IV infusion over 30 minutes (or 3–4h extended infusion); reconstitute 4.5 g vial with 20 mL sterile water or 0.9% NaCl, then dilute in 50–100 mL NS/D5W | Every 6 or 8 Hours IV (Time-Dependent Beta-Lactam)

6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment

Absorption & Disposition:
Follows class pharmacokinetic profile detailed in parent monograph [8.16].
Metabolism & Biotransformation:
Renal (CrCl): CrCl 20–40 mL/min: 2.25 g IV q6h (3.375 g q6h for HAP); CrCl <20 mL/min: 2.25 g IV q8h; Haemodialysis: 2.25 g q12h (+ 0.75 g post-HD)
Elimination & Renal Adjustment:
Renal (CrCl): CrCl 20–40 mL/min: 2.25 g IV q6h (3.375 g q6h for HAP); CrCl <20 mL/min: 2.25 g IV q8h; Haemodialysis: 2.25 g q12h (+ 0.75 g post-HD)
Hepatic Impairment Considerations:
Renal (CrCl): CrCl 20–40 mL/min: 2.25 g IV q6h (3.375 g q6h for HAP); CrCl <20 mL/min: 2.25 g IV q8h; Haemodialysis: 2.25 g q12h (+ 0.75 g post-HD)

7. Contraindications, Precautions & High-Risk Warnings

Contraindications & Red-Flag Precautions:
  • CONTRAINDICATED in penicillin/cephalosporin hypersensitivity. Physically incompatible in same IV line with Ringer's Lactate (unless EDTA-formulated) and Aminoglycosides (Amikacin/Gentamicin)!

Key Clinical Precautions: Renal (CrCl): CrCl 20–40 mL/min: 2.25 g IV q6h (3.375 g q6h for HAP); CrCl <20 mL/min: 2.25 g IV q8h; Haemodialysis: 2.25 g q12h (+ 0.75 g post-HD)

8. Adverse Effects Profile

Common & Mechanism-Related Adverse Effects:
  • Diarrhoea, phlebitis, nausea, maculopapular rash, mild transaminase rise, hypokalaemia, positive Coombs test
  • Anaphylaxis, C. difficile colitis, acute kidney injury (especially when combined with Vancomycin!), neurotoxicity/seizures (if unadjusted 4.5 g q6h given in renal failure!), thrombocytopenia
Serious / Dose-Limiting Adverse Effects:

    9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions

    • SYNERGISTIC NEPHROTOXICITY WITH VANCOMYCIN: Concomitant Vancomycin + Piperacillin-Tazobactam doubles AKI incidence (monitor SCr daily!)
    • Reduces renal clearance of Methotrexate

    10. Clinical Monitoring, Patient Counselling & Storage

    Clinical & Laboratory Monitoring: Monitor clinical parameters per parent monograph [8.16].

    Pharmacist Patient Counselling Points:

    • Patient Counselling Checklist: Verify penicillin allergy before dispensing; flush IV line with Normal Saline before and after if Amikacin/Gentamicin is also ordered; monitor kidney function daily if Vancomycin is co-administered
    • Meal & Clock Timing Instruction: Administer via slow IV infusion over 30 minutes (or 3–4h extended infusion); reconstitute 4.5 g vial with 20 mL sterile water or 0.9% NaCl, then dilute in 50–100 mL NS/D5W (Every 6 or 8 Hours IV (Time-Dependent Beta-Lactam))
    • Missed Dose Protocol: Inpatient scheduled IV dosing
    • Geriatric Dispensing Pearl: Mandatory renal dose reduction (2.25 g q6–8h) when CrCl <=40 mL/min in older adults to prevent beta-lactam encephalopathy

    Storage, Stability & Dispensing Safeguards: Store below 25°C–30°C in original moisture- and light-resistant packaging out of reach of children. Available forms: Lyophilised Powder Vials for IV Infusion: 4.5 g (4 g + 0.5 g), 2.25 g (2 g + 0.25 g), 1.125 g

    11. Visual Pharmacology & Mechanism Diagram (svg-v339-01-adme-12-step-journey)

    THE 12-STEP ORAL DRUG JOURNEY THROUGH THE HUMAN BODY (LADME) Note: IV bolus enters Step 6 directly (F = 100%); Sublingual & Transdermal routes bypass Step 4–5 Portal First-Pass Metabolism 1. Oral Administration • Tablet / Capsule swallowed • Gastric emptying to duodenum pH 1.5–3.5 (Stomach) 2. Disintegration & Dissolution • Tablet breaks into granules • API dissolves in GI fluid Noyes-Whitney Dissolution Rate 3. GI Epithelial Absorption • Crosses intestinal villi • Passive / Active / P-gp efflux Small Intestine (Large Surface Area) 4. Portal Circulation • Mesenteric veins → Portal vein • Delivers blood to liver sinusoids Pre-systemic Venous Conduit 5. First-Pass Metabolism • Gut & hepatic CYP450 extraction • High: GTN, Propranolol, Morphine Determines Bioavailability (F = f_a × (1-E_H)) 6. Systemic Circulation • Hepatic vein → IVC → Heart • Unbound vs Albumin-bound drug Only FREE drug is active 7–8. Tissue Distribution (Vd) • Capillary permeation to organs • Blood-Brain & Placental barriers Vd = Dose / C_0 (L or L/kg) 9. Target Site of Action • Receptors (GPCR, Ion channel) • Enzymes & Carrier Transporters Pharmacodynamic Effect (E_max, EC50) 10. Hepatic Biotransformation • Phase I (CYP450 Oxidation/Hydrolysis) • Phase II (Glucuronidation/Sulfation) Converts lipophilic drug → hydrophilic metabolite 11. Renal & Biliary Elimination • Nephron: Filtration + Secretion − Reabsorption • Biliary excretion & Enterohepatic recycling Total Clearance CL_tot = CL_renal + CL_hepatic 12. Excretion from the Body • Urine (Primary polar metabolite route) • Bile/Faeces, Expired Air, Sweat, Milk Elimination Half-Life t1/2 = (0.693 × Vd) / CL
    svg-v339-01-adme-12-step-journey — 8.1 Complete 12-Step Journey of an Orally Administered Drug (ADME): Figure 8.1: The 12-step physiological journey of a typical orally administered solid dosage form through Liberation, Absorption, Distribution, Metabolism, and Excretion (LADME). Note: Parenteral (IV), sublingual, and inhalational routes bypass gastrointestinal absorption and/or hepatic first-pass metabolism.

    12. Authoritative References, Regulatory Sources & Editorial Disclaimer

    Primary Compendial & Guideline Reference: Indian Pharmacopoeia (IP 2022) • NFI • CDSCO

    Official Verification Portals: Indian Pharmacopoeia Commission (IPC) & National Formulary of India (NFI) • Central Drugs Standard Control Organization (CDSCO) • Ministry of Health & Family Welfare — NLEM 2022 • NCBI Bookshelf / StatPearls Pharmacology Reference • DailyMed (US FDA Official Prescribing Reference)

    Last Medically & Pharmaceutically Reviewed: 2026-11-10 • Verification Status: VERIFIED_EDUCATIONAL_CONTENT

    Educational & Clinical Disclaimer: This reference profile is published solely for pharmacy education, academic study, and professional clinical reference. It does not substitute for patient-specific clinical judgement, qualified specialist oncology/medical supervision, or official CDSCO/IP prescribing information. Never self-medicate with prescription, Schedule H/H1/X, NDPS, or oncology medicines.

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    Educational Reference Notice: This printout from THE INDIAN PHARMACIST (https://theindianpharmacist.com/medicine/8-16-c59-tazobactam-sodium/, Last Reviewed: 2026-11-10) is an educational reference sheet for students and healthcare learners. It is NOT an official prescribing guideline or patient-specific treatment order.