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) |
| Molecular Weight | 546.58 |
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 | Limited human data; animal studies show no evidence of fetal harm. Use only if clearly needed. |
| 2nd trimester | No known teratogenic risk; safe for use if indicated. |
| 3rd trimester | Safe; no reported adverse fetal effects. |
Clinical note
Comprehensive clinical and safety monograph for FORTAZ (FORTAZ).
| Placental transfer | Ceftazidime crosses the placenta; fetal concentrations reach approximately 10-25% of maternal serum levels. |
| Breastfeeding | Excreted into breast milk in low concentrations; unlikely to cause adverse effects in the infant. Compatible with breastfeeding. |
| Lactation Rating |
■ FDA Black Box Warning
None (no FDA black box warning).
| Serious Effects |
Hypersensitivity to ceftazidime or other cephalosporinsSevere immediate hypersensitivity to penicillins
| 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. |
| Clinical Pearls |
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| 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 | 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. |
| 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. |