TAZIDIME
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TAZIDIME (TAZIDIME).
Ceftazidime inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), inhibiting transpeptidase activity, and disrupting peptidoglycan cross-linking.
| Metabolism | Ceftazidime is not significantly metabolized; it is primarily excreted unchanged in the urine via glomerular filtration. |
| Excretion | Primarily renal (80-90% unchanged via glomerular filtration), biliary/fecal <5%. |
| Half-life | 1.9 hours (range 1.5-2.8 hours); prolonged in renal impairment (up to 20 hours in ESRD). |
| Protein binding | Approximately 17% (primarily albumin). |
| Volume of Distribution | 0.21-0.30 L/kg; indicates distribution primarily in extracellular fluid. |
| Bioavailability | IM: 100% (fully absorbed). |
| Onset of Action | IV: Immediate (peak serum concentration at end of infusion); IM: 30-60 minutes. |
| Duration of Action | 6-8 hours in normal renal function; extended to 24 hours or more in severe renal impairment. |
| Molecular Weight | 546.58 |
1 to 2 g IV/IM every 8 hours; maximum 6 g/day.
| 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. |
| Liver impairment | No adjustment required for hepatic impairment; dose based on renal function. |
| Pediatric use | Neonates (0-4 weeks): 30 mg/kg IV q12h (≤7 days) or q8h (>7 days); Infants/children (1 month-12 years): 30-50 mg/kg IV/IM q8h (max 6 g/day). |
| Geriatric use | Initiate with lower dose range; adjust based on renal function per creatinine clearance. |
| 1st trimester | Ceftazidime crosses the placenta. Human data on use in first trimester are limited but no teratogenicity reported. Use only if clearly needed. |
| 2nd trimester | Ceftazidime crosses the placenta. Animal studies show no fetal harm. Use during pregnancy only if potential benefit justifies risk. |
| 3rd trimester | Ceftazidime crosses the placenta. Considered safe for maternal infections; no known neonatal adverse effects. |
Clinical note
Comprehensive clinical and safety monograph for TAZIDIME (TAZIDIME).
| Placental transfer | Ceftazidime crosses the placenta readily, with fetal serum concentrations reaching approximately 30-50% of maternal levels. |
| Breastfeeding | Ceftazidime is excreted into breast milk in low concentrations (approximately 0.3-1.2% of maternal dose). It is unlikely to cause adverse effects in nursing infants. Compatible with breastfeeding. |
■ FDA Black Box Warning
None.
| Serious Effects |
Known hypersensitivity to ceftazidime or any cephalosporin antibioticSevere immediate hypersensitivity (e.g., anaphylaxis) to penicillins
| Precautions | Hypersensitivity reactions, including anaphylaxis, may occur, Clostridioides difficile-associated diarrhea (CDAD) reported, Neurologic toxicity (seizures, encephalopathy) especially in patients with renal impairment, Development of drug-resistant bacteria, Hemolytic anemia (positive Coombs test), Renal function impairment requires dose adjustment, Potentially prothrombin activity reduction and bleeding risk (rare) |
| Food/Dietary | No significant food interactions. Can be taken with or without food. Avoid alcohol during treatment due to potential disulfiram-like reaction (though rare with cephalosporins). |
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| Lactation Rating | L2 |
| Teratogenic Risk | Teratogenic effects not observed in animal studies; inadequate human data. Renal effects (oligohydramnios) possible if used in late pregnancy. Risk Category B (FDA). Caution in second and third trimester due to potential fetal renal impairment. |
| Fetal Monitoring | Monitor maternal renal function (serum creatinine, BUN) and fluid/electrolyte balance. Assess fetal well-being if prolonged therapy in pregnancy; ultrasound for amniotic fluid volume if risk of oligohydramnios. Watch for signs of Clostridioides difficile infection. |
| Fertility Effects | No adverse effects on fertility reported in animal studies. No human data available regarding impact on male or female fertility. |
| Clinical Pearls | Monitor renal function and adjust dose accordingly; ceftazidime is primarily renally excreted. For pseudomonal infections, consider combination therapy with an aminoglycoside. Ceftazidime has poor activity against Gram-positive organisms and anaerobes; not reliable for MRSA or Bacteroides fragilis. In cystic fibrosis patients, higher doses may be required due to altered pharmacokinetics. Rapid IV administration can cause seizures; infuse over 15-30 minutes. |
| Patient Advice | Take this medication exactly as prescribed at evenly spaced intervals. · Do not skip doses; complete the full course even if you feel better. · If you miss a dose, take it as soon as possible unless it is almost time for the next dose; do not double the dose. · Report any signs of allergic reaction: rash, itching, swelling, or difficulty breathing. · Notify your healthcare provider if you experience diarrhea, especially if watery or bloody. · This medication may cause dizziness; avoid driving if affected. · Avoid alcohol while on this medication to reduce risk of side effects. |