TAZIDIME IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TAZIDIME IN PLASTIC CONTAINER (TAZIDIME IN PLASTIC CONTAINER).
Ceftazidime inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), primarily PBP-3, leading to cell lysis and death. It is a beta-lactam antibiotic with activity against Gram-negative bacteria including Pseudomonas aeruginosa.
| Metabolism | Ceftazidime is not metabolized significantly; it is excreted unchanged primarily by the kidneys via glomerular filtration. Minimal hepatic metabolism. |
| Excretion | Primarily renal (80-90% unchanged via glomerular filtration and tubular secretion); biliary/fecal excretion accounts for <1%. |
| Half-life | Terminal elimination half-life 1.7-2.0 hours in adults with normal renal function; prolonged to 12-30 hours in end-stage renal disease. |
| Protein binding | Approximately 17% bound to plasma proteins (mainly albumin). |
| Volume of Distribution | 0.22-0.35 L/kg, indicating distribution primarily into extracellular fluid. |
| Bioavailability | IM: approximately 100% after intramuscular administration; IV: 100% (not applicable for oral absorption as ceftazidime is not available orally). |
| Onset of Action | IV: rapid, within 1-2 hours; IM: 2-4 hours. |
| Duration of Action | 6-8 hours in normal renal function; extended to 24-48 hours in severe renal impairment due to reduced clearance. |
| Molecular Weight | 546.58 |
1-2 g intravenously every 8 hours for most infections; up to 2 g every 6 hours for severe infections, particularly in neutropenic patients or those with cystic fibrosis.
| Dosage form | INJECTABLE |
| Renal impairment | CrCl >50 mL/min: no adjustment. CrCl 31-50 mL/min: 1 g every 12 hours. CrCl 16-30 mL/min: 1 g every 24 hours. CrCl 6-15 mL/min: 500 mg every 24 hours. CrCl <5 mL/min: 500 mg every 48 hours. For hemodialysis: administer 1 g after each dialysis session, then every 48 hours. |
| Liver impairment | No dose adjustment required for hepatic impairment alone, as primarily renally eliminated. |
| Pediatric use | Neonates (0-4 weeks): 30 mg/kg every 12 hours. Infants and children (1 month-12 years): 30-50 mg/kg every 8 hours, maximum 6 g/day. For severe infections (e.g., meningitis, cystic fibrosis): up to 50 mg/kg every 8 hours, maximum 6 g/day. For febrile neutropenia: 50 mg/kg every 8 hours. Administered intravenously. |
| Geriatric use | Dose based on renal function; monitor CrCl and adjust accordingly. Elderly patients often have reduced creatinine clearance; use ideal body weight for dosing. Consider lower initial doses if renal impairment present. |
| 1st trimester | Ceftazidime crosses the placenta. Human data are limited but generally reassuring; no evidence of teratogenicity. Use if clearly needed. |
| 2nd trimester | As in t1, use if clearly needed. Considered compatible with pregnancy. |
| 3rd trimester | As in t1, use if clearly needed. Considered compatible with pregnancy. |
Clinical note
Comprehensive clinical and safety monograph for TAZIDIME IN PLASTIC CONTAINER (TAZIDIME IN PLASTIC CONTAINER).
| Placental transfer | Crosses the placenta; fetal serum concentrations reach about 30% to 50% of maternal levels. |
| Breastfeeding | Ceftazidime is excreted into breast milk in small amounts. It is considered compatible with breastfeeding; however, monitor infant for potential gastrointestinal disturbances or allergic reactions. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
Hypersensitivity to ceftazidime or other cephalosporinsPrevious severe immediate hypersensitivity reaction to penicillins or other beta-lactams
| Precautions | Hypersensitivity reactions including anaphylaxis., Clostridium difficile-associated diarrhea (CDAD)., Neurological toxicity (seizures, encephalopathy) in patients with renal impairment or high doses., Prolonged use may cause overgrowth of nonsusceptible organisms., Dose adjustment required in renal impairment., Interference with glucose testing (false-positive urinary glucose). |
| Food/Dietary | No significant food interactions. However, alcohol should be avoided during therapy and for 72 hours post-treatment due to risk of disulfiram-like reaction. |
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| Lactation Rating |
| L2 (Probably Compatible) |
| Teratogenic Risk | Insufficient human data; animal studies show no teratogenicity. Avoid first trimester unless essential. |
| Fetal Monitoring | Monitor for hypersensitivity reactions, renal function, and signs of superinfection. |
| Fertility Effects | No known adverse effects on fertility. |
| Clinical Pearls | Ceftazidime (TAZIDIME) is a third-generation cephalosporin with potent activity against Pseudomonas aeruginosa. In patients with renal impairment, adjust dose based on creatinine clearance to avoid neurotoxicity. For febrile neutropenia, combine with an aminoglycoside or another antipseudomonal agent. Monitor for prolonged PT/INR in patients at risk for bleeding. Do not mix with aminoglycosides in same IV line; administer separately. In cystic fibrosis patients, higher doses may be required due to increased clearance. |
| Patient Advice | Notify your provider if you have kidney disease, a history of seizures, or an allergy to penicillins or cephalosporins. · Report any signs of severe diarrhea (watery or bloody), rash, seizures, or unusual bleeding/bruising immediately. · Complete the full course of therapy even if you feel better. · Avoid alcohol during treatment and for at least 72 hours after the last dose to prevent disulfiram-like reaction. · Inform your healthcare provider about all medications you are taking, especially anticoagulants (e.g., warfarin). |