FORTAZ
Clinical safety rating: caution
Comprehensive clinical and safety monograph for FORTAZ (FORTAZ).
Inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), inhibiting peptidoglycan cross-linking, leading to cell lysis.
| Metabolism | Minimally metabolized; primarily excreted unchanged in urine via glomerular filtration. |
| Excretion | Primarily renal (80-90% unchanged) via glomerular filtration and tubular secretion; 5-10% biliary/fecal |
| Half-life | 2 hours (normal renal function); prolonged to 12-20 hours in ESRD |
| Protein binding | 10-20%, primarily to albumin |
| Volume of Distribution | 0.15-0.25 L/kg, indicating limited extravascular distribution |
| Bioavailability | IM: 90% |
| Onset of Action | IV: Immediate; IM: 15-30 minutes |
| Duration of Action | 6-8 hours (prolonged in renal impairment) |
1-2 g IV/IM every 8-12 hours; maximum 6 g/day for serious infections.
| Dosage form | INJECTABLE |
| Renal impairment | CrCl 31-50 mL/min: 1 g q12h; CrCl 16-30 mL/min: 1 g q24h; CrCl 6-15 mL/min: 500 mg q24h; CrCl ≤5 mL/min: 500 mg q48h. Hemodialysis: 1 g after each dialysis session. |
| Liver impairment | No dose adjustment required for hepatic impairment. |
| Pediatric use | Neonates ≤7 days: 50 mg/kg IV q12h; Neonates 8-28 days: 50 mg/kg IV q8h; Infants and children (1 month-12 years): 33.3-50 mg/kg IV/IM q8h, not to exceed 6 g/day. |
| Geriatric use | No dosage adjustment solely based on age; adjust based on renal function and hydration status. Caution in elderly due to potential decreased renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for FORTAZ (FORTAZ).
| Breastfeeding | Ceftazidime (FORTAZ) is excreted in breast milk in low concentrations; M/P ratio not determined. Considered compatible with breastfeeding due to poor oral bioavailability and minimal infant exposure. |
| Teratogenic Risk | No evidence of teratogenicity in animal studies; human data limited but no increased risk of major congenital anomalies reported. Caution in first trimester due to lack of extensive human data. FDA Pregnancy Category B. |
| Fetal Monitoring |
■ FDA Black Box Warning
None (no FDA black box warning).
| Serious Effects |
["Hypersensitivity to ceftazidime or any cephalosporin","History of severe immediate reaction to penicillins or other beta-lactams (cross-sensitivity)"]
| Precautions | ["Hypersensitivity reactions (including anaphylaxis) in patients with penicillin or cephalosporin allergies","Seizures, especially in elderly or renally impaired patients with high doses","Pseudomembranous colitis due to Clostridium difficile","Interference with glucose testing (false-positive urine glucose)","Renal impairment: dose adjustment required"] |
| Food/Dietary | No significant food interactions. May be taken without regard to meals. |
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| Monitor maternal renal function and CBC during prolonged therapy. Fetal monitoring includes standard third-trimester growth scans; no specific fetal toxicity monitoring required. |
| Fertility Effects | No adverse effects on fertility in animal studies; no human data indicating reproductive impairment. |
| Clinical Pearls |
| For empiric therapy in febrile neutropenia, combine with an aminoglycoside. Adjust dose in renal impairment; CrCl 10-30 mL/min: 1g q24h; CrCl <10 mL/min: 500mg q24h. Inhaled form for cystic fibrosis patients with Pseudomonas. Ensure adequate hydration to prevent crystalluria. |
| Patient Advice | Complete the full course even if you feel better. · Report any signs of allergic reaction, especially rash or difficulty breathing. · Avoid alcohol during treatment. · Take with food if gastrointestinal upset occurs. · Notify your doctor if you have kidney disease or are on dialysis. |