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MEDICINE MONOGRAPH CODE: [8.19]-C62 ID: TIP-MED-000332

Ertapenem

Active Ingredient / Scientific Identity: Ertapenem • Class: Broad-Spectrum Parenteral Carbapenem Beta-Lactam Antibiotics — ICMR 'Reserve / Watch' Group (Schedule H1 | HIGH-ALERT)

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THE INDIAN PHARMACIST — Educational Reference Sheet
Profile: Ertapenem ([8.19]-C62 | ID: TIP-MED-000332) • Last Reviewed: 2026-11-10
Source URL: https://theindianpharmacist.com/medicine/8-19-c62-ertapenem/
Generic / Entity NameErtapenem ([8.19]-C62)
Verified Indian Brands / RefGeneric Compendial Entry (No Commercial Brand Claimed)
Pharmacological ClassBroad-Spectrum Parenteral Carbapenem Beta-Lactam Antibiotics — ICMR 'Reserve / Watch' Grou
Available Dosage FormsMeropenem IV Vials: 500 mg, 1000 mg (1 g). Ertapenem IV/IM Vial: 1000 mg (1 g). Imipenem + Cilastatin IV Vial:
Regulatory ClassificationSchedule H1 Prescription Drug (Mandatory Red-Bordered Rx Warning & 3-Year Register un
Key Warning & Review DateRenal (Meropenem): CrCl 26–50 mL/min: 1 g q12h; CrCl 10–25 mL/min: 500 mg q12h; CrCl <10 mL/min: 500 mg q24h. Ertapenem: 500
Reviewed: 2026-11-10
Safety Matrix:⚖️ Legal Status: Schedule H1 Prescription Drug (Mandatory Red-Bordere✔️ Standard Clinical Dispensing Precautions

1. Clinical & Scientific Overview

Ertapenem (TIP-MED-000332, Reference Code [8.19]-C62) is classified under Antimicrobials — Antibacterial & Antibiotic Agents (Ch 08) as a Broad-Spectrum Parenteral Carbapenem Beta-Lactam Antibiotics — ICMR 'Reserve / Watch' Group (Schedule H1 | HIGH-ALERT). 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 [8.19] (Meropenem, Ertapenem & Imipenem + Cilastatin (Reserve Carbapenems)). Representative Indian Market Examples (Edition 2.7 Ch 08 [8.19], p. 102): Meropenem: Meronem (Pfizer), Mero (Aristo), Merocrit (Cipla). Ertapenem: Invanz (MSD), Ertamac. Imipenem + Cilastatin: Tienam (MSD), Cilacar-I — Strengths & Dosage Forms: Meropenem IV Vials: 500 mg, 1000 mg (1 g). Ertapenem IV/IM Vial: 1000 mg (1 g). Imipenem + Cilastatin IV Vial: 500 mg + 500 mg
Co-indexed constituent under primary monograph [8.19] (Meropenem, Ertapenem & Imipenem + Cilastatin (Reserve Carbapenems)). Representative Indian Market Examples (Edition 2.7 Ch 08 [8.19], p. 102): Meropenem: Meronem (Pfizer), Mero (Aristo), Merocrit (Cipla). Ertapenem: Invanz (MSD), Ertamac. Imipenem + Cilastatin: Tienam (MSD), Cilacar-I — Strengths & Dosage Forms: Meropenem IV Vials: 500 mg, 1000 mg (1 g). Ertapenem IV/IM Vial: 1000 mg (1 g). Imipenem + Cilastatin IV Vial: 500 mg + 500 mg
Dosage Forms & Available Strengths:
Meropenem IV Vials: 500 mg, 1000 mg (1 g). Ertapenem IV/IM Vial: 1000 mg (1 g). Imipenem + Cilastatin IV Vial: 500 mg + 500 mg
Routes: Oral / Parenteral / Topical per formulation

3. Mechanism of Action & Pharmacodynamics

Broad-Spectrum Parenteral Carbapenem Beta-Lactam Antibiotics — ICMR 'Reserve / Watch' Group (Schedule H1 | HIGH-ALERT) acting on target receptor/enzyme pathways in Antimicrobials — Antibacterial & Antibiotic Agents (Ch 08): clinical efficacy is mediated via Broad-Spectrum Parenteral Carbapenem Beta-Lactam Antibiotics — ICMR 'Reserve / Watch' Group (Schedule H1 | HIGH-ALERT) for Culture-proven or high-risk ESBL-producing Gram-negative sepsis, complicated intra-abdominal/UTI infections, nosocomial pneumonia, febrile neutropenia, and bacterial meningitis (Meropenem 2 g q8h ONLY!). Ertapenem is Once-Daily for ESBL urosepsis/OPAT (no activity against Pseudomonas or Acinetobacter!).

4. Therapeutic Indications & Evidence-Supported Uses

  • Culture-proven or high-risk ESBL-producing Gram-negative sepsis, complicated intra-abdominal/UTI infections, nosocomial pneumonia, febrile neutropenia, and bacterial meningitis (Meropenem 2 g q8h ONLY!)
  • Ertapenem is Once-Daily for ESBL urosepsis/OPAT (no activity against Pseudomonas or Acinetobacter!)

🇮🇳 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: Meropenem: 1 g IV q8h over 30m or 3h extended infusion (Meningitis: 2 g IV q8h). Ertapenem: 1 g IV/IM Once Daily (500 mg OD if CrCl <=30 mL/min). Imipenem+Cilastatin: 500 mg IV q6h

Administration & Meal Timing: Administer via IV infusion; Meropenem extended 3-hour infusion optimises time above MIC (fT>MIC) in critically ill ICU patients | Meropenem: q8h. Ertapenem: q24h (OD). Imipenem: q6–8h

6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment

Absorption & Disposition:
Follows class pharmacokinetic profile detailed in parent monograph [8.19].
Metabolism & Biotransformation:
Renal (Meropenem): CrCl 26–50 mL/min: 1 g q12h; CrCl 10–25 mL/min: 500 mg q12h; CrCl <10 mL/min: 500 mg q24h. Ertapenem: 500 mg OD if CrCl <=30 mL/min
Elimination & Renal Adjustment:
Renal (Meropenem): CrCl 26–50 mL/min: 1 g q12h; CrCl 10–25 mL/min: 500 mg q12h; CrCl <10 mL/min: 500 mg q24h. Ertapenem: 500 mg OD if CrCl <=30 mL/min
Hepatic Impairment Considerations:
Renal (Meropenem): CrCl 26–50 mL/min: 1 g q12h; CrCl 10–25 mL/min: 500 mg q12h; CrCl <10 mL/min: 500 mg q24h. Ertapenem: 500 mg OD if CrCl <=30 mL/min

7. Contraindications, Precautions & High-Risk Warnings

Contraindications & Red-Flag Precautions:
  • SCHEDULE H1 & SEIZURE / VALPROATE WARNING: Contraindicated in beta-lactam anaphylaxis. Imipenem carries a high seizure risk (use Meropenem in CNS/stroke/meningitis!). Carbapenems have NO activity against MRSA, VRE, or NDM carbapenem-resistant organisms

Key Clinical Precautions: Renal (Meropenem): CrCl 26–50 mL/min: 1 g q12h; CrCl 10–25 mL/min: 500 mg q12h; CrCl <10 mL/min: 500 mg q24h. Ertapenem: 500 mg OD if CrCl <=30 mL/min

8. Adverse Effects Profile

Common & Mechanism-Related Adverse Effects:
  • Diarrhoea, nausea, infusion-site phlebitis, rash, headache, thrombocytosis, mild transaminase elevation
  • Generalised tonic-clonic seizures (Imipenem >> Meropenem), C. difficile pseudomembranous colitis, anaphylaxis, CRE selection
Serious / Dose-Limiting Adverse Effects:

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

    • CRITICAL CONTRAINDICATED INTERACTION WITH VALPROATE (SODIUM VALPROATE / DIVALPROEX): Carbapenems cause a catastrophic 60%–90% DROP in serum Valproic Acid concentrations within 24 hours, precipitating uncontrollable breakthrough status epilepticus! Switch antiepileptic (to Levetiracetam) or use an alternative antibiotic!

    10. Clinical Monitoring, Patient Counselling & Storage

    Clinical & Laboratory Monitoring: Monitor clinical parameters per parent monograph [8.19].

    Pharmacist Patient Counselling Points:

    • Patient Counselling Checklist: COUNTER INTERACTION RED FLAG: Never dispense Meropenem, Ertapenem, or Imipenem to a patient taking Valproate (Encorate/Valparin) without immediately alerting the physician to switch to Levetiracetam — Valproate levels fall to zero within 24 hours!
    • Meal & Clock Timing Instruction: Administer via IV infusion; Meropenem extended 3-hour infusion optimises time above MIC (fT>MIC) in critically ill ICU patients (Meropenem: q8h. Ertapenem: q24h (OD). Imipenem: q6–8h)
    • Missed Dose Protocol: ICU/inpatient scheduled IV dosing
    • Geriatric Dispensing Pearl: Always calculate Cockcroft–Gault CrCl in older adults to prevent carbapenem-induced myoclonus and seizures

    Storage, Stability & Dispensing Safeguards: Store below 25°C–30°C in original moisture- and light-resistant packaging out of reach of children. Available forms: Meropenem IV Vials: 500 mg, 1000 mg (1 g). Ertapenem IV/IM Vial: 1000 mg (1 g). Imipenem + Cilastatin IV Vial: 500 mg + 500 mg

    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/8-19-c62-ertapenem/, 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.