OMNICEF
Clinical safety rating: caution
Comprehensive clinical and safety monograph for OMNICEF (OMNICEF).
Cephalosporin antibiotic; inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), disrupting peptidoglycan cross-linking.
| Metabolism | Not extensively metabolized; primarily eliminated renally as unchanged drug. |
| Excretion | Renal excretion as unchanged drug: 80-90% (primarily via glomerular filtration and tubular secretion); biliary/fecal: 10-20% (minor). |
| Half-life | 1.7 hours (range 1.2–2.3 h) in healthy adults; prolonged to 3.2–6.6 h in renal impairment (CrCl <30 mL/min); no significant change in hepatic impairment. |
| Protein binding | 60–70% bound to plasma proteins (primarily albumin). |
| Volume of Distribution | 0.35 L/kg (approx. 25 L in 70 kg adult); indicates distribution primarily into extracellular fluid. |
| Bioavailability | Oral: 16–21% (absolute); due to limited absorption and first-pass metabolism; food does not affect extent of absorption, but may delay peak concentration. |
| Onset of Action | Oral: peak plasma concentration at 2–4 hours; clinical effect typically within 24–48 hours for susceptible infections. |
| Duration of Action | Recommended dosing every 12 hours (cefdinir) for 5–10 days; antibacterial activity persists for about 12 hours post-dose. |
| Action Class | Cephalosporins: 3 generation |
| Brand Substitutes | Cefotax 250mg Injection, Sifotaxim 250mg Injection, Gencef 250mg Injection, Tox 250mg Injection, Tax O Bid 250mg Injection, Cefotax 125mg Injection, Ceftax 125mg Injection, Cotax 125mg Injection, Fefa 125mg Injection, Vintax 125mg Injection |
300 mg orally twice daily for 10 days; or 600 mg orally once daily for 10 days (for community-acquired pneumonia, acute exacerbations of chronic bronchitis, sinusitis, pharyngitis/tonsillitis, uncomplicated skin infections).
| Dosage form | CAPSULE |
| Renal impairment | For CrCl 30-49 mL/min: 300 mg orally once daily. For CrCl <30 mL/min: 300 mg orally every 48 hours. |
| Liver impairment | No adjustment required for mild to moderate hepatic impairment (Child-Pugh A and B). Not studied in severe hepatic impairment (Child-Pugh C). |
| Pediatric use | For patients 6 months to 12 years: 7 mg/kg orally twice daily for 10 days (maximum 600 mg/day). For acute otitis media, pharyngitis/tonsillitis, and sinusitis. |
| Geriatric use | No specific dose adjustment; use caution due to age-related renal decline. Adjust dose based on renal function as per renal adjustment guidelines. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for OMNICEF (OMNICEF).
| Breastfeeding | Excreted in breast milk in low amounts. M/P ratio unknown. Consider risk-benefit; monitor infant for diarrhea, rash, and fungal infections. |
| Teratogenic Risk | Pregnancy Category B. No evidence of teratogenicity in animal studies, but adequate human studies are lacking. Caution in first trimester; avoid unnecessary use. |
| Fetal Monitoring | Monitor maternal renal function and signs of hypersensitivity. Fetal assessment for adverse effects is not routinely required unless prolonged use. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Known hypersensitivity to cefdinir or other cephalosporins","Hypersensitivity to penicillins (cross-sensitivity)"]
| Precautions | ["Hypersensitivity reactions including anaphylaxis","Clostridioides difficile-associated diarrhea (CDAD)","Seizures with high doses or renal impairment","Renal impairment requires dose adjustment","Potential for cross-allergenicity with penicillins"] |
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| Fertility Effects | No known effects on human fertility based on animal studies. |