FORTAZ IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for FORTAZ IN PLASTIC CONTAINER (FORTAZ IN PLASTIC CONTAINER).
Ceftazidime inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), specifically PBP3, thereby disrupting peptidoglycan cross-linking and leading to cell lysis. It is a third-generation cephalosporin with broad-spectrum activity against Gram-negative bacteria, including Pseudomonas aeruginosa.
| Metabolism | Ceftazidime is not significantly metabolized; it is excreted unchanged primarily by the kidneys via glomerular filtration. Minor hepatic metabolism may occur but is negligible. |
| Excretion | Primarily renal (80-90% unchanged) via glomerular filtration and tubular secretion; minor biliary/fecal (<10%) |
| Half-life | 1.8 hours in normal adults; prolonged to 3-5 hours in neonates and 10-30 hours in severe renal impairment (CrCl <10 mL/min) |
| Protein binding | Poor, approximately 10%; primarily albumin |
| Volume of Distribution | 0.13-0.22 L/kg; indicates distribution primarily into extracellular fluid |
| Bioavailability | Intravenous: 100%; intramuscular: 90-100% |
| Onset of Action | Intravenous: rapid (within 30 minutes); intramuscular: 1-2 hours |
| Duration of Action | 8-12 hours for susceptible organisms; requires dose adjustment in renal impairment to avoid accumulation |
1-2 g IV/IM every 8-12 hours; maximum 6 g/day.
| Dosage form | INJECTABLE |
| Renal impairment | CrCl 30-50 mL/min: 1-2 g every 12 hours; CrCl 10-29 mL/min: 1-2 g every 24 hours; CrCl <10 mL/min: 1 g every 48 hours. |
| Liver impairment | No dosage adjustment required for hepatic impairment. |
| Pediatric use | Infants and children: 30-50 mg/kg IV/IM every 8 hours; maximum 6 g/day. |
| Geriatric use | Adjust dose based on renal function; monitor creatinine clearance. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for FORTAZ IN PLASTIC CONTAINER (FORTAZ IN PLASTIC CONTAINER).
| Breastfeeding | Ceftazidime is excreted in human milk in low concentrations (M/P ratio approximately 0.13-0.28). Considered compatible with breastfeeding; caution in neonates with hyperbilirubinemia or G6PD deficiency. |
| Teratogenic Risk | No evidence of teratogenicity in animal studies. Human data limited: ceftazidime crosses placenta; no confirmed congenital anomalies reported. Use in pregnancy only if clearly needed. |
| Fetal Monitoring |
■ FDA Black Box Warning
None (not subject to FDA boxed warning).
| Serious Effects |
["Known hypersensitivity to ceftazidime or any other cephalosporin antibiotic.","Severe immediate hypersensitivity (anaphylaxis) to penicillins (cross-sensitivity)."]
| Precautions | ["Hypersensitivity reactions (including anaphylaxis, angioedema, bronchospasm) particularly in patients with penicillin or other beta-lactam allergy.","Clostridioides difficile-associated diarrhea (CDAD) ranging from mild diarrhea to fatal colitis.","Neurological adverse effects (seizures, encephalopathy) in patients with renal impairment who receive high doses; dose adjustment required for CrCl <50 mL/min.","Superinfection with resistant organisms during prolonged therapy.","Drug-induced hemolytic anemia (rare).","Increased INR in patients on warfarin (possible vitamin K deficiency).","Carcinogenesis, mutagenesis, impairment of fertility: none known in animal studies."] |
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| Monitor maternal renal function, signs of hypersensitivity, and gastrointestinal disturbances. No specific fetal monitoring required unless maternal infection severity dictates. |
| Fertility Effects | No known adverse effects on fertility in animal studies. Human data insufficient to assess impact on human fertility. |