Schedule H

Intravenous (IV), Intramuscular (IM)

Plain Ceftazidime:

• Powder for injection: 250 mg, 500 mg, 1 g, 2 g per vial (as ceftazidime pentahydrate)

Ceftazidime + Avibactam (Beta-lactamase Inhibitor Combination):

• Powder for injection: Ceftazidime 2 g + Avibactam 500 mg per vial

Note: Ceftazidime is available as sodium salt for injection requiring reconstitution before use.

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Hospital-Acquired Pneumonia / Ventilator-Associated Pneumonia (HAP/VAP)

Parameter Dosing Details

Starting dose 2 g IV every 8 hours

Titration Not applicable

Usual maintenance dose 2 g IV every 8 hours

Maximum dose 6 g/day (2 g every 8 hours)

Key Clinical Notes:

• Administer as IV infusion over 15–30 minutes

• Excellent Pseudomonas aeruginosa coverage — key advantage over other third-generation cephalosporins

• Consider combination with aminoglycoside for suspected MDR Pseudomonas

• Duration: 7–14 days based on clinical response

1. Complicated Urinary Tract Infections / Pyelonephritis

Parameter Dosing Details

Starting dose 1 g IV every 8–12 hours

Titration Increase to 2 g every 8 hours for severe/complicated infections

Usual maintenance dose 1–2 g IV every 8–12 hours

Maximum dose 6 g/day

Key Clinical Notes:

• Achieves excellent urinary concentrations

• Duration: 7–14 days; step-down to oral therapy once stable

• Consider culture-directed de-escalation

1. Complicated Intra-abdominal Infections

Parameter Dosing Details

Starting dose 2 g IV every 8 hours

Titration Not applicable

Usual maintenance dose 2 g IV every 8 hours

Maximum dose 6 g/day

Key Clinical Notes:

• MUST combine with metronidazole (or other anti-anaerobic agent) — ceftazidime lacks anaerobic coverage

• Duration: 4–7 days with adequate source control; longer if source control inadequate

• Surgical/interventional drainage essential for abscesses

1. Septicaemia / Bloodstream Infections

Parameter Dosing Details

Starting dose 2 g IV every 8 hours

Titration Not applicable

Usual maintenance dose 2 g IV every 8 hours

Maximum dose 6 g/day

Key Clinical Notes:

• Empiric choice when Pseudomonas suspected

• First dose should not be delayed for cultures

• Duration: Typically 7–14 days; longer for endovascular infections

• De-escalate based on culture results at 48–72 hours

1. Bacterial Meningitis (Including Pseudomonas Coverage)

Parameter Dosing Details

Starting dose 2 g IV every 8 hours

Titration Not applicable

Usual maintenance dose 2 g IV every 8 hours

Maximum dose 6 g/day

Key Clinical Notes:

• Achieves adequate CSF penetration (10–20% of serum levels; higher with meningeal inflammation)

• Use when Pseudomonas meningitis suspected (post-neurosurgical, CSF shunt infections)

• Duration: Minimum 21 days for Pseudomonas meningitis

• Often combined with aminoglycoside (intrathecal or IV)

1. Febrile Neutropenia (Empiric Therapy)

Parameter Dosing Details

Starting dose 2 g IV every 8 hours

Titration Not applicable

Usual maintenance dose 2 g IV every 8 hours

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

Same indications as adults: HAP/VAP, complicated UTI, septicaemia, meningitis, febrile neutropenia

Age-Based Dosing:

Neonates 0–7 days 25–50 mg/kg IV Every 12 hours 100 mg/kg/day

Neonates 8–28 days 50 mg/kg IV Every 8–12 hours 150 mg/kg/day

Infants 1–12 months 30–50 mg/kg IV Every 8 hours 150 mg/kg/day

Children 1–12 years 30–50 mg/kg IV Every 8 hours 6 g/day

Adolescents ≥12 years Adult dosing Every 8 hours 6 g/day

Indication-Specific Paediatric Dosing:

Indication Dose Notes

Meningitis 50 mg/kg IV every 8 hours (max 2 g/dose) Duration: 21 days for Pseudomonas; 10–14 days for other Gram-negatives

Febrile Neutropenia 50 mg/kg IV every 8 hours (max 2 g/dose) Often combined with aminoglycoside

Severe Infections 50 mg/kg IV every 8 hours (max 2 g/dose) Maximum 6 g/day

Key Clinical Notes:

• Administer as IV infusion over 15–30 minutes

• IM route may be used for less severe infections (reconstitute with lidocaine 0.5–1%)

• Adjust dose for renal impairment

Secondary Indications — Paediatric (Off-label)

Indication Dose Duration Notes

Cystic Fibrosis Pulmonary Exacerbation (OFF-LABEL) 50 mg/kg IV every 8 hours (max 2 g/dose) 10–14 days Specialist only. Based on international CF guidelines and Indian paediatric pulmonology practice.

Clear Statement: Neonatal use requires neonatologist supervision. Safe for use from birth with appropriate dose adjustment. Monitor renal function in all neonates.

Safety Monitoring in Children:

• Renal function at baseline and during therapy

• CBC if therapy >7 days

• Monitor for diarrhoea (may indicate C. difficile)

• Injection site monitoring

CAPD 500 mg–1 g Every 24 hours May add to dialysate for peritonitis

CRRT (CVVH/CVVHDF) 1–2 g Every 12 hours Adjust based on effluent rate; consult pharmacy

• Known hypersensitivity to ceftazidime or any cephalosporin

• History of severe immediate hypersensitivity reaction (anaphylaxis) to any beta-lactam antibiotic (penicillins, carbapenems, other cephalosporins)

• Hypersensitivity to L-arginine (present in some formulations as buffer)

• History of non-severe penicillin allergy — cross-reactivity risk is low (~1–2%) but caution warranted; observe for reaction after first dose

• History of antibiotic-associated colitis or Clostridioides difficile infection

• Renal impairment — dose reduction mandatory; neurotoxicity risk with accumulation

• Seizure disorders — high doses in renal failure may lower seizure threshold

• Prolonged therapy — risk of superinfection (fungal, resistant bacteria)

• Neonates — monitor for hyperbilirubinaemia (though less concern than with ceftriaxone)

• Sodium content in formulation — consider in patients on sodium-restricted diets

Parameter Details

Risk Category Generally considered safe; crosses placenta but no evidence of teratogenicity in human studies

Preferred alternatives Ceftriaxone often preferred unless specific Pseudomonas coverage required

When may be used When clinically indicated for serious infections; benefit outweighs theoretical risk

Monitoring Monitor for maternal hypersensitivity; no specific fetal monitoring required

Parameter Details

Compatibility Compatible with breastfeeding

Preferred alternatives None required; ceftazidime acceptable during lactation

Drug levels in milk Low (concentrations in breast milk are very low)

Infant monitoring Monitor for diarrhoea, oral thrush, or diaper rash; no need to interrupt breastfeeding

Parameter Recommendation

Starting dose Standard adult dosing, but MUST assess renal function first

Titration Adjust based on eGFR (not serum creatinine alone — may underestimate renal impairment in elderly)

Special risks Neurotoxicity (confusion, encephalopathy, myoclonus, seizures) with dose accumulation in renal impairment; C. difficile colitis risk increased

Monitoring Calculate eGFR using CKD-EPI or Cockcroft-Gault; renal function every 2–3 days in ICU; daily assessment for neurotoxicity

Interacting Drug Mechanism & Effect Management

Aminoglycosides (concurrent administration) Physical incompatibility in IV line (inactivation); potential additive nephrotoxicity Do NOT mix in same IV line. Administer separately. Monitor renal function daily.

Chloramphenicol Theoretical antagonism (bacteriostatic vs bactericidal) Avoid co-administration for serious infections

Loop Diuretics (Furosemide, high-dose) Increased nephrotoxicity risk Monitor renal function closely; avoid if possible in renal impairment

Probenecid Reduces renal tubular secretion of ceftazidime Generally not clinically significant, but monitor in renal impairment; avoid if possible

Interacting Drug Effect Management

Vancomycin Potential additive nephrotoxicity Monitor renal function; common combination in practice — use with caution

Oral Anticoagulants (Warfarin) Possible INR elevation due to altered gut flora and reduced vitamin K synthesis Monitor INR closely during and after ceftazidime therapy

Typhoid vaccine (live oral) Antibiotic may reduce vaccine efficacy Complete antibiotic course before administering live vaccine

Methotrexate Possible reduced methotrexate clearance Monitor for methotrexate toxicity

• Diarrhoea

• Injection site reactions (pain, phlebitis, induration)

• Rash (maculopapular)

• Nausea, vomiting

• Elevated hepatic transaminases (usually transient)

• Eosinophilia

• Positive direct Coombs test (without haemolysis)

Adverse Effect Clinical Notes

Anaphylaxis / Severe Hypersensitivity Immediate discontinuation; emergency management with adrenaline. Cross-reactivity with other beta-lactams.

Clostridioides difficile-Associated Diarrhoea (CDAD) Can occur during or weeks after therapy. Discontinue if severe; confirm with stool testing; treat with oral vancomycin or fidaxomicin.

Neurotoxicity (encephalopathy, myoclonus, seizures) Risk factors: renal impairment, high doses, elderly. Discontinue; usually reversible with drug clearance.

Stevens-Johnson Syndrome / TEN Rare; discontinue immediately; dermatology and supportive care required.

Haematological Effects (neutropenia, thrombocytopenia, agranulocytosis) With prolonged therapy (>14 days). Monitor CBC weekly in prolonged use. Reversible on discontinuation.

Interstitial Nephritis Rare; presents with fever, rash, eosinophilia, rising creatinine. Discontinue.

Haemolytic Anaemia (Coombs-positive) Rare; discontinue if clinically significant haemolysis.

During treatment Renal function every 2–3 days (ICU) or twice weekly (ward); daily assessment for diarrhoea, rash, neurotoxicity

Prolonged therapy (>7–10 days) CBC weekly (monitor for neutropenia); LFTs weekly; assess for superinfection

Culture-directed Review cultures at 48–72 hours for de-escalation opportunity

Plain Ceftazidime:

• Fortum® (GSK)

• Orzid® (Sun Pharma)

• Ceftaz® (Ranbaxy/Sun)

• Tazidime® (various)

• Intacef® (Intas)

• Zidime® (Abbott)

• Taxim-AZ® (Alkem)

• Wincef® (various)

• Mahacef-Plus® (Mankind) — verify formulation

Ceftazidime + Avibactam:

• Zavicefta® (Pfizer)

• Ceftavidime® (various generics)

Note: Ceftazidime is listed in NLEM 2022 (1 g injection). Prices may be lower in Jan Aushadhi / government supply. Not currently under NPPA price ceiling.

1. Anti-pseudomonal cephalosporin of choice — Ceftazidime has excellent Pseudomonas aeruginosa activity, distinguishing it from other third-generation cephalosporins (ceftriaxone, cefotaxime which lack reliable Pseudomonas coverage).

1. Poor Gram-positive coverage — Ceftazidime has LIMITED activity against Staphylococci and Streptococci compared to ceftriaxone. Do NOT use as monotherapy when significant Gram-positive coverage needed; add vancomycin if MRSA or resistant Gram-positives suspected.

1. No anaerobic activity — Always combine with metronidazole for intra-abdominal infections or suspected anaerobic involvement.

1. Renal dose adjustment is critical — Ceftazidime accumulation in renal failure causes neurotoxicity (encephalopathy, seizures, myoclonus). Always calculate eGFR and adjust dose accordingly.

1. Extended infusion for critically ill — In severe infections or when higher MICs suspected, consider extended infusion (3–4 hour infusion) to optimise time above MIC. Consult ID or clinical pharmacist.

1. Ceftazidime-Avibactam for resistance — When dealing with ESBL, AmpC, or KPC-producing organisms resistant to plain ceftazidime, ceftazidime-avibactam restores activity. Reserve for confirmed resistant organisms.

cephalosporin; anti-pseudomonal; Pseudomonas; HAP; VAP; meningitis; febrile-neutropenia; renal-dose-adjust; neurotoxicity-risk; Schedule-H; NLEM-India; Ceftazidime

RxIndia v1.0 — 06 Jun 2025

• CDSCO Drug Database

• Indian Pharmacopoeia 2022

• National Formulary of India (NFI) 2021

• National List of Essential Medicines (NLEM) 2022

• API Textbook of Medicine (11th Edition)

• ICMR Treatment Guidelines for Antimicrobial Use in Common Syndromes (2019)

• AIIMS Antibiotic Policy (2023)

• PGIMER Chandigarh Antimicrobial Guidelines

• IAP Antimicrobial Dosing Guidelines for Paediatrics

• Harrison's Principles of Internal Medicine (21st Edition)

• Goodman & Gilman's The Pharmacological Basis of Therapeutics (14th Edition)

• Product package inserts (Fortum®)