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MEDICINE MONOGRAPH CODE: [8.18]-C61 ID: TIP-MED-000331

Cefotaxime Sodium

Active Ingredient / Scientific Identity: Cefotaxime Sodium • Class: Third-Generation Parenteral Cephalosporins (Schedule H1 / H | ICMR Watch)

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THE INDIAN PHARMACIST — Educational Reference Sheet
Profile: Cefotaxime Sodium ([8.18]-C61 | ID: TIP-MED-000331) • Last Reviewed: 2026-11-10
Source URL: https://theindianpharmacist.com/medicine/8-18-c61-cefotaxime-sodium/
Generic / Entity NameCefotaxime Sodium ([8.18]-C61)
Verified Indian Brands / RefGeneric Compendial Entry (No Commercial Brand Claimed)
Pharmacological ClassThird-Generation Parenteral Cephalosporins (Schedule H1 / H | ICMR Watch)
Available Dosage FormsCefoperazone + Sulbactam IV Vials: 1.5 g (1g + 0.5g), 3.0 g (2g + 1g). Cefotaxime IV/IM Vials: 250 mg, 500 mg,
Regulatory ClassificationSchedule H1 Prescription Drug (Mandatory Red-Bordered Rx Warning & 3-Year Register un
Key Warning & Review DateRenal: Cefoperazone is 75% biliary excreted, BUT Sulbactam is 85% renally excreted -> halve Sulbactam dose if CrCl <30 mL/min
Reviewed: 2026-11-10
Safety Matrix:⚖️ Legal Status: Schedule H1 Prescription Drug (Mandatory Red-Bordere✔️ Standard Clinical Dispensing Precautions

1. Clinical & Scientific Overview

Cefotaxime Sodium (TIP-MED-000331, Reference Code [8.18]-C61) is classified under Antimicrobials — Antibacterial & Antibiotic Agents (Ch 08) as a Third-Generation Parenteral Cephalosporins (Schedule H1 / H | ICMR Watch). Within the Indian regulatory and compendial framework, it is governed under Schedule H1 Prescription Drug (Mandatory Red-Bordered Rx Warning & 3-Year Register under Rule 65 of Drugs Rules 1945).

Verified Indian Market Examples / Compendial Status:
Co-indexed constituent under primary monograph [8.18] (Cefoperazone + Sulbactam & Cefotaxime Sodium). Representative Indian Market Examples (Edition 2.7 Ch 08 [8.18], p. 101): Cefoperazone + Sulbactam: Magnex / Magnex Forte (Pfizer), Zostum (Zuventus), Cefobeta. Cefotaxime: Taxim (Alkem), Omnatax (Abbott) — Strengths & Dosage Forms: Cefoperazone + Sulbactam IV Vials: 1.5 g (1g + 0.5g), 3.0 g (2g + 1g). Cefotaxime IV/IM Vials: 250 mg, 500 mg, 1000 mg (1 g)
Co-indexed constituent under primary monograph [8.18] (Cefoperazone + Sulbactam & Cefotaxime Sodium). Representative Indian Market Examples (Edition 2.7 Ch 08 [8.18], p. 101): Cefoperazone + Sulbactam: Magnex / Magnex Forte (Pfizer), Zostum (Zuventus), Cefobeta. Cefotaxime: Taxim (Alkem), Omnatax (Abbott) — Strengths & Dosage Forms: Cefoperazone + Sulbactam IV Vials: 1.5 g (1g + 0.5g), 3.0 g (2g + 1g). Cefotaxime IV/IM Vials: 250 mg, 500 mg, 1000 mg (1 g)
Dosage Forms & Available Strengths:
Cefoperazone + Sulbactam IV Vials: 1.5 g (1g + 0.5g), 3.0 g (2g + 1g). Cefotaxime IV/IM Vials: 250 mg, 500 mg, 1000 mg (1 g)
Routes: Oral / Parenteral / Topical per formulation

3. Mechanism of Action & Pharmacodynamics

Third-Generation Parenteral Cephalosporins (Schedule H1 / H | ICMR Watch) acting on target receptor/enzyme pathways in Antimicrobials — Antibacterial & Antibiotic Agents (Ch 08): clinical efficacy is mediated via Third-Generation Parenteral Cephalosporins (Schedule H1 / H | ICMR Watch) for Cefoperazone+Sulbactam: Hospital-acquired hepatobiliary, intra-abdominal, respiratory, and urinary infections (including Acinetobacter via Sulbactam). Cefotaxime: Bacterial meningitis, spontaneous bacterial peritonitis (SBP in cirrhosis — drug of choice!), neonatal sepsis, severe pneumonia.

4. Therapeutic Indications & Evidence-Supported Uses

  • Cefoperazone+Sulbactam: Hospital-acquired hepatobiliary, intra-abdominal, respiratory, and urinary infections (including Acinetobacter via Sulbactam)
  • Cefotaxime: Bacterial meningitis, spontaneous bacterial peritonitis (SBP in cirrhosis — drug of choice!), neonatal sepsis, severe pneumonia

🇮🇳 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: Cefoperazone+Sulbactam: 1.5–3.0 g IV every 12 hours (Max Sulbactam 4 g/day). Cefotaxime: 1–2 g IV every 8 hours (Up to 2 g IV every 4–6 hours in bacterial meningitis)

Administration & Meal Timing: Administer by slow IV injection over 3–5 minutes or IV infusion over 15–60 minutes | Every 12 Hours (Cefoperazone+Sulbactam) or Every 6–8 Hours (Cefotaxime)

6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment

Absorption & Disposition:
Follows class pharmacokinetic profile detailed in parent monograph [8.18].
Metabolism & Biotransformation:
Renal: Cefoperazone is 75% biliary excreted, BUT Sulbactam is 85% renally excreted -> halve Sulbactam dose if CrCl <30 mL/min! Cefotaxime: Halve dose if CrCl <20 mL/min. Hepatic: Cap Cefoperazone at max 2 g/day in biliary obstruction
Elimination & Renal Adjustment:
Renal: Cefoperazone is 75% biliary excreted, BUT Sulbactam is 85% renally excreted -> halve Sulbactam dose if CrCl <30 mL/min! Cefotaxime: Halve dose if CrCl <20 mL/min. Hepatic: Cap Cefoperazone at max 2 g/day in biliary obstruction
Hepatic Impairment Considerations:
Renal: Cefoperazone is 75% biliary excreted, BUT Sulbactam is 85% renally excreted -> halve Sulbactam dose if CrCl <30 mL/min! Cefotaxime: Halve dose if CrCl <20 mL/min. Hepatic: Cap Cefoperazone at max 2 g/day in biliary obstruction

7. Contraindications, Precautions & High-Risk Warnings

Contraindications & Red-Flag Precautions:
  • CEFOPERAZONE MTT SIDE-CHAIN COAGULOPATHY & DISULFIRAM WARNING: Cefoperazone contains an MTT side chain that inhibits Vitamin K epoxide reductase causing HYPOPROTHROMBINAEMIA & SEVERE BLEEDING (give prophylactic Vitamin K1 10 mg weekly!) and causes a severe DISULFIRAM REACTION with alcohol! Schedule H1 register required!

Key Clinical Precautions: Renal: Cefoperazone is 75% biliary excreted, BUT Sulbactam is 85% renally excreted -> halve Sulbactam dose if CrCl <30 mL/min! Cefotaxime: Halve dose if CrCl <20 mL/min. Hepatic: Cap Cefoperazone at max 2 g/day in biliary obstruction

8. Adverse Effects Profile

Common & Mechanism-Related Adverse Effects:
  • Diarrhoea (common with Cefoperazone due to 75% biliary excretion!), phlebitis, rash, transient eosinophilia
  • Coagulopathy / major GI or surgical bleeding (INR elevation on Cefoperazone!), anaphylaxis, C. difficile colitis, neurotoxicity in renal failure
Serious / Dose-Limiting Adverse Effects:

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

    • Cefoperazone + Warfarin/Heparin/DOACs/Antiplatelets = severe bleeding risk (monitor PT/INR every 2–3 days!); Cefoperazone + Alcohol (within 72h) = flushing, tachycardia, vomiting; Aminoglycosides = physical incompatibility

    10. Clinical Monitoring, Patient Counselling & Storage

    Clinical & Laboratory Monitoring: Monitor clinical parameters per parent monograph [8.18].

    Pharmacist Patient Counselling Points:

    • Patient Counselling Checklist: Check PT/INR and administer Vitamin K prophylaxis if Cefoperazone+Sulbactam (Magnex) is given for >5 days or to malnourished/liver/elderly patients; record in Schedule H1 register
    • Meal & Clock Timing Instruction: Administer by slow IV injection over 3–5 minutes or IV infusion over 15–60 minutes (Every 12 Hours (Cefoperazone+Sulbactam) or Every 6–8 Hours (Cefotaxime))
    • Missed Dose Protocol: Hospital scheduled IV administration
    • Geriatric Dispensing Pearl: High risk of vitamin K-deficient bleeding on Cefoperazone in older adults; monitor INR closely

    Storage, Stability & Dispensing Safeguards: Store below 25°C–30°C in original moisture- and light-resistant packaging out of reach of children. Available forms: Cefoperazone + Sulbactam IV Vials: 1.5 g (1g + 0.5g), 3.0 g (2g + 1g). Cefotaxime IV/IM Vials: 250 mg, 500 mg, 1000 mg (1 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/8-18-c61-cefotaxime-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.