1. Clinical & Scientific Overview
Ceftazidime + Avibactam (TIP-MED-000534, Reference Code [R-15]) is classified under
Reserve Antimicrobials (WHO AWaRe Reserve) as a 3rd-Generation Cephalosporin + Non-Beta-Lactam Diazabicyclooctane (DBO) Beta-Lactamase Inhibitor.
Within the Indian regulatory and compendial framework, it is governed under Schedule H1 Reserve Antibiotic.
Zavicefta (Pfizer Ltd), Cazavi (Cipla Ltd), Avicaz (Lupin Ltd)
Powder for Concentrate for IV Infusion: Ceftazidime 2 g + Avibactam 0.5 g (2.5 g vial)
Statutory Restriction, High-Alert & Dispensing Safeguards
Indian Regulatory & Statutory Control Basis: Schedule H1 Reserve Antibiotic
High-Alert Clinical Risk, Dependence & Narrow Therapeutic Index Warnings: Indian epidemiology note: Many Indian CRE isolates co-produce NDM metallo-beta-lactamase; for NDM + OXA-48 co-producers, Ceftazidime-Avibactam must be co-administered with Aztreonam (synergy therapy); requires strict renal CrCl dose adjustment.
Mandatory Dispensing Register & Institutional Custody Protocol: Verify molecular carbapenemase genotype (Xpert Carba-R: KPC/OXA-48 vs NDM) before initiation; infuse over 2 hours every 8 hours.
3. Mechanism of Action & Pharmacodynamics
Ceftazidime inhibits PBP3 peptidoglycan cross-linking; Avibactam reversibly acylates Ambler Class A (ESBL, KPC), Class C (AmpC), and selected Class D (OXA-48) serine beta-lactamases (does NOT inhibit Class B metallo-beta-lactamases like NDM-1 unless paired with Aztreonam).
4. Therapeutic Indications & Evidence-Supported Uses
- Carbapenem-resistant Enterobacterales (KPC and OXA-48 producers) and MDR Pseudomonas aeruginosa in cIAI, cUTI, and hospital-acquired pneumonia
5. Educational Dosage Context, Formulations & Administration
Educational Dosing & Regimen Summary: Specialist-Supervised Educational Reference Summary: Dosing of Ceftazidime + Avibactam must be individualised by a qualified specialist according to clinical indication, organ function, and institutional protocol (Powder for Concentrate for IV Infusion: Ceftazidime 2 g + Avibactam 0.5 g (2.5 g vial)).
Administration & Meal Timing: Routes: Intravenous Infusion (over 2 hours). Verify molecular carbapenemase genotype (Xpert Carba-R: KPC/OXA-48 vs NDM) before initiation; infuse over 2 hours every 8 hours.
6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment
Exhibits 3rd-generation cephalosporin + non-beta-lactam diazabicyclooctane (dbo) beta-lactamase inhibitor pharmacokinetic disposition; verify baseline renal and hepatic clearance and check for active or prolonged-half-life metabolites before repeat dosing.
Hepatic Phase I (CYP450) and/or Phase II conjugation or specific non-renal clearance as detailed in clinical warnings.
Verify eGFR / CrCl before initiation; see specific metabolite and renal clearance notes above.
Assess baseline Child-Pugh status and hepatic transaminases prior to therapy.
7. Contraindications, Precautions & High-Risk Warnings
- Known severe hypersensitivity to Ceftazidime + Avibactam or formulation excipients
- Unsupervised outpatient self-administration or dispensing without mandatory statutory prescription verification
- Specific clinical contraindications detailed under High-Alert Warnings & Statutory Restrictions
Key Clinical Precautions: Indian epidemiology note: Many Indian CRE isolates co-produce NDM metallo-beta-lactamase; for NDM + OXA-48 co-producers, Ceftazidime-Avibactam must be co-administered with Aztreonam (synergy therapy); requires strict renal CrCl dose adjustment.
8. Adverse Effects Profile
- Indian epidemiology note: Many Indian CRE isolates co-produce NDM metallo-beta-lactamase; for NDM + OXA-48 co-producers, Ceftazidime-Avibactam must be co-administered with Aztreonam (synergy therapy); requires strict renal CrCl dose adjustment.
- Dose-dependent target-organ pharmacodynamic effects requiring clinical observation
- Indian epidemiology note: Many Indian CRE isolates co-produce NDM metallo-beta-lactamase; for NDM + OXA-48 co-producers, Ceftazidime-Avibactam must be co-administered with Aztreonam (synergy therapy); requires strict renal CrCl dose adjustment.
- High-alert toxicity, dependence/diversion risk, or severe organ-specific adverse events if administered outside protocol
9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions
- Indian epidemiology note: Many Indian CRE isolates co-produce NDM metallo-beta-lactamase; for NDM + OXA-48 co-producers, Ceftazidime-Avibactam must be co-administered with Aztreonam (synergy therapy); requires strict renal CrCl dose adjustment.
- Review all concomitant CNS depressants, QTc-prolonging agents, nephrotoxins, or CYP450 modulators prior to dispensing.
10. Clinical Monitoring, Patient Counselling & Storage
Clinical & Laboratory Monitoring: Verify molecular carbapenemase genotype (Xpert Carba-R: KPC/OXA-48 vs NDM) before initiation; infuse over 2 hours every 8 hours.
Pharmacist Patient Counselling Points:
- Verify molecular carbapenemase genotype (Xpert Carba-R: KPC/OXA-48 vs NDM) before initiation; infuse over 2 hours every 8 hours.
- Must be used strictly under direct medical supervision; never share prescription medicines or alter the prescribed dose.
Storage, Stability & Dispensing Safeguards: Verify molecular carbapenemase genotype (Xpert Carba-R: KPC/OXA-48 vs NDM) before initiation; infuse over 2 hours every 8 hours.
11. Visual Pharmacology & Mechanism Diagram (svg-v339-01-adme-12-step-journey)
12. Authoritative References, Regulatory Sources & Editorial Disclaimer
Primary Compendial & Guideline Reference: Drugs and Cosmetics Act, 1940 & Rules, 1945 (Schedule H / H1 / X); NDPS Act, 1985 & Essential Narcotic Drugs (END) Notification; Indian Pharmacopoeia (IP) & National Formulary of India (NFI).
Official Verification Portals: CDSCO — Drugs & Cosmetics Act and Rules (Schedules H, H1, X) • Department of Revenue — Narcotic Drugs and Psychotropic Substances (NDPS) Act • Indian Pharmacopoeia Commission (IPC) — National Formulary of India
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.