Ceftazidime
FORTAZ
What it isPBP-inhibiting third-generation cephalosporin; pseudomonal and other serious Gram-negative infections.
Why this oneIt is the classic third-generation cephalosporin that covers Pseudomonas, unlike ceftriaxone.
What limits itWeak Gram-positive activity and AmpC selection create gaps; renal impairment raises neurotoxicity risk.
FDA-approved for
- Pseudomonas infections (1985)
- bacterial infections (1985)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Usual recommended dosage (general) | Adults | 1 g IV or IM q8–12h | 1 g IV or IM q8–12h | 6 g/day |
| Uncomplicated urinary tract infection | Adults | 250 mg IV or IM q12h | 250 mg IV or IM q12h | 500 mg/day |
| Complicated urinary tract infection | Adults | 500 mg IV or IM q8–12h | 500 mg IV or IM q8–12h | 1.5 g/day |
| Bone and joint infections | Adults | 2 g IV q12h | 2 g IV q12h | 4 g/day |
| Uncomplicated pneumonia; mild skin and skin-structure infections | Adults | 500 mg–1 g IV or IM q8h | 500 mg–1 g IV or IM q8h | 3 g/day |
| Serious gynecologic and intra-abdominal infections | Adults | 2 g IV q8h | 2 g IV q8h | 6 g/day |
| Meningitis | Adults | 2 g IV q8h | 2 g IV q8h | 6 g/day |
| Very severe life-threatening infections, especially in immunocompromised patients | Adults | 2 g IV q8h | 2 g IV q8h | 6 g/day |
| Pseudomonas lung infection in cystic fibrosis, normal renal function | Cystic fibrosis patients | 30–50 mg/kg IV q8h | 30–50 mg/kg IV q8h | 6 g/day |
| Bacterial infection | Neonates 0–4 weeks | 30 mg/kg IV q12h | 30 mg/kg IV q12h | 60 mg/kg/day |
| Bacterial infection | Infants and children 1 month–12 y | 30–50 mg/kg IV q8h | 30–50 mg/kg IV q8h — reserve the higher dose for immunocompromised patients or those with cystic fibrosis or meningitis | 6 g/day |
Renal GFR <50 mL/min: reduce dose. Loading dose 1 g if renal insufficiency suspected, then by CrCl (mL/min): 50–31 → 1 g q12h; 30–16 → 1 g q24h; 15–6 → 500 mg q24h; <5 → 500 mg q48h. If the indication-based dose is lower than the renal-adjusted dose, use the lower. Severe infection normally requiring 6 g/day: increase the unit dose by 50% or shorten the interval. Hemodialysis: 1 g load, then 1 g after each dialysis session. Peritoneal dialysis/CAPD: 1 g load, then 500 mg q24h, or add 250 mg per 2 L dialysis fluid. Pediatrics: adjust CrCl for BSA or lean body mass and reduce dosing frequency.
Hepatic No adjustment needed
Generally continue therapy for 2 days after signs and symptoms of infection have disappeared; complicated infections may require longer.
Instructions
- Give IV or by deep IM injection into a large muscle mass (upper outer quadrant of gluteus maximus or lateral thigh); avoid intra-arterial administration.
- IM: reconstitute with Sterile Water for Injection, Bacteriostatic Water for Injection, or 0.5% or 1% lidocaine HCl injection (1 g vial + 3 mL diluent ≈ 280 mg/mL).
- Direct intermittent IV: reconstitute with Sterile Water for Injection (1 g vial + 10 mL ≈ 100 mg/mL; 2 g vial + 10 mL ≈ 170 mg/mL) and inject slowly into the vein over 3–5 minutes, or give through the tubing of a running compatible IV set.
- IV route is preferred for bacterial septicemia, meningitis, peritonitis, other severe or life-threatening infections, and poor-risk patients.
- Vials are supplied under reduced pressure and release carbon dioxide on dissolution — follow the insert's Instructions for Constitution. Discard the unused portion.
- Do not add to aminoglycoside solutions (potential interaction); if concurrent therapy is indicated, administer each drug separately.
Contraindications
- Known hypersensitivity to the cephalosporin class of antibacterial drugs
Cautions
- Cross-hypersensitivity with cephalosporins/beta-lactams — anaphylaxis, angioedema and severe allergic reactions (including cardiopulmonary arrest) reported rarely.
- Severe cutaneous reactions — toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme.
- Pseudomembranous colitis (C. difficile) — onset may occur during or after treatment.
- Neurotoxicity in renal impairment on unadjusted dosing — seizures, encephalopathy, coma, asterixis, neuromuscular excitability, myoclonia; adjust dose for renal function.
- Renal impairment and transient rises in BUN/serum creatinine reported.
- Overgrowth of non-susceptible organisms — candidiasis, oral thrush, vaginitis.
Adverse reactions
- Local: phlebitis and inflammation at the injection site (<2%); injection-site pain.
- Hypersensitivity (2%): pruritus, rash, fever; immediate rash/pruritus in ~1 in 285.
- Gastrointestinal (<2%): diarrhea, nausea, vomiting, abdominal pain.
- CNS (<1%): headache, dizziness, paresthesia; seizures reported.
- Other (<1%): candidiasis including oral thrush, vaginitis.
- Laboratory (transient): eosinophilia, positive Coombs test without hemolysis, thrombocytosis, elevated AST/ALT/LDH/GGT/alkaline phosphatase, raised BUN/creatinine.
- Rare: hemolytic anemia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, lymphocytosis; hyperbilirubinemia, jaundice, renal impairment.
Pregnancy Animal reproduction studies (up to 40× human dose) showed no impaired fertility or fetal harm; no adequate well-controlled studies in pregnant women — use during pregnancy only if clearly needed.
Lactation Undefined
NO BOXED WARNINGS
Principal riskWeak Gram-positive cover; it selects AmpC derepression
Cost, est. cash$20–$1,500/dose or month
Generic entry1985
Classes and tags
Clinical profile
Legacy pregnancy categoryB
Defining liabilityAllergy, gastrointestinal effects and agent-specific renal, hepatic, hematologic or interaction risks.
Mechanism of action: Ceftazidime ballicule
