TAZICEF
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TAZICEF (TAZICEF).
Ceftazidime is a third-generation cephalosporin that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), specifically PBP-3, leading to cell lysis and death.
| Metabolism | Ceftazidime is primarily eliminated unchanged by the kidneys via glomerular filtration; minimal hepatic metabolism. |
| Excretion | Primarily renal (80-90% unchanged via glomerular filtration and tubular secretion); biliary/fecal <10%. |
| Half-life | 2 hours (prolonged to 4-12 hours in renal impairment; anuria: 20-30 hours). |
| Protein binding | 10-17% (primarily albumin). |
| Volume of Distribution | 0.23-0.36 L/kg (indicates distribution primarily in extracellular fluid; increased in inflammation). |
| Bioavailability | IM: 90-100%. |
| Onset of Action | IM: 1-2 hours; IV: immediate (within minutes). |
| Duration of Action | 6-8 hours (dose-dependent; prolonged in renal failure). |
2 g intravenously every 8 hours for serious infections; 1 g intravenously every 8 hours for uncomplicated infections.
| Dosage form | INJECTABLE |
| Renal impairment | CrCl 31-50 mL/min: 1 g every 12 hours; CrCl 16-30 mL/min: 1 g every 24 hours; CrCl <15 mL/min: 500 mg every 24 hours; hemodialysis: 1 g after dialysis on dialysis days. |
| Liver impairment | No specific dose adjustment required for hepatic impairment; use standard dosing. |
| Pediatric use | Neonates (0-4 weeks): 30 mg/kg every 12 hours; Infants and children >1 month: 30-50 mg/kg every 8 hours; maximum 6 g/day. |
| Geriatric use | No specific dose adjustment for age; adjust dose based on renal function according to CrCl. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TAZICEF (TAZICEF).
| Breastfeeding | Ceftazidime is excreted into human milk in low concentrations. The milk-to-plasma ratio is approximately 0.05-0.1. It is considered compatible with breastfeeding due to poor oral bioavailability and negligible absorption by the infant. However, caution is advised in nursing mothers, especially if the infant is premature or has renal impairment. |
| Teratogenic Risk | Ceftazidime (TAZICEF) is classified as FDA Pregnancy Category B. Animal studies have not demonstrated fetal risk, and there are no adequate well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed. During the first trimester, theoretical risk exists but no evidence of teratogenicity. In the second and third trimesters, no known fetal adverse effects have been reported. Use is generally considered safe. |
■ FDA Black Box Warning
Ceftazidime is contraindicated in patients with a history of immediate hypersensitivity reaction (e.g., anaphylaxis) to ceftazidime or any other beta-lactam antibiotic.
| Serious Effects |
["Hypersensitivity to ceftazidime or any component of the formulation.","Hypersensitivity to other cephalosporins or severe hypersensitivity (e.g., anaphylaxis) to penicillins or other beta-lactams."]
| Precautions | ["Hypersensitivity reactions including anaphylaxis; cross-sensitivity with other beta-lactams.","Clostridioides difficile-associated diarrhea (CDAD) may occur.","Neurological adverse effects (e.g., seizures) especially in patients with renal impairment or high doses.","Hemolytic anemia (immune-mediated) has been reported.","Superinfection with non-susceptible organisms, including fungi.","Alteration in coagulation parameters (prolonged PT/INR) in patients with renal impairment or malnourished states.","Renal function monitoring required, especially in elderly and those with pre-existing renal impairment."] |
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| Fetal Monitoring | Monitor for maternal signs of hypersensitivity, superinfection, and diarrhea (Clostridioides difficile). In the fetus, no specific monitoring is required, but assess for potential changes in fetal gut flora if used near term. No dose-related ototoxicity or nephrotoxicity specific to pregnancy. |
| Fertility Effects | No evidence of impaired fertility in animal studies. Human data are lacking; no known adverse effects on fertility or reproductive capacity. |