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 |
| Molecular Weight | 546.58 |
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 | Crosses placenta; limited human data suggest low risk; considered safe when clearly needed. |
| 2nd trimester | Crosses placenta; no known teratogenicity; use if benefit outweighs risk. |
| 3rd trimester | Crosses placenta; no known adverse fetal effects; use if indicated. |
Clinical note
Comprehensive clinical and safety monograph for FORTAZ IN PLASTIC CONTAINER (FORTAZ IN PLASTIC CONTAINER).
| Placental transfer | Ceftazidime crosses the placenta; fetal serum concentrations are about 10-15% of maternal levels. |
| Breastfeeding | Ceftazidime is excreted into breast milk in low concentrations; unlikely to cause adverse effects in nursing infants; consider potential for diarrhea and sensitization. |
| Lactation Rating |
■ FDA Black Box Warning
None (not subject to FDA boxed warning).
| Serious Effects |
Hypersensitivity to ceftazidime or any other cephalosporinSevere immediate hypersensitivity reaction to penicillins (e.g., anaphylaxis)
| 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. |
| Food/Dietary | No clinically significant food interactions. Ceftazidime is administered intravenously and absorption is not affected by food. However, maintain adequate hydration during therapy to prevent crystalluria. |
Loading safety data…
| L1 (Safe) |
| 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 | 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. |
| Clinical Pearls | FORTAZ (ceftazidime) in plastic container is a fifth-generation cephalosporin with antipseudomonal activity. For empiric coverage, combine with an aminoglycoside in febrile neutropenic patients. Adjust dose in renal impairment (CrCl <50 mL/min) by extending dosing interval. Incompatible with vancomycin and aminoglycosides in same IV line; administer separately. Monitor for Clostridioides difficile diarrhea and hypersensitivity reactions, including cross-allergy in penicillin-allergic patients (~10%). |
| Patient Advice | This medication is given intravenously to treat serious bacterial infections. · Report any signs of allergic reaction: rash, itching, swelling, or difficulty breathing. · Inform your doctor if you have kidney disease or are on dialysis, as dose adjustment is needed. · Complete the full course of therapy even if you feel better. · Contact your healthcare provider if you develop severe diarrhea, especially with blood or mucus. · Do not mix ceftazidime with other medications in the same IV line without consulting a pharmacist. |