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. |
| Molecular Weight | 395.41 |
| 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 | Avoid unless clearly needed; limited human data but animal studies show no teratogenic effects. |
| 2nd trimester | Use only if benefit outweighs risk; generally considered compatible with caution. |
| 3rd trimester | Use only if clearly needed; may theoretically affect neonatal gut flora. |
Clinical note
Comprehensive clinical and safety monograph for OMNICEF (OMNICEF).
| Placental transfer | Cefdinir crosses the placenta in small amounts; levels in fetal serum are approximately 10-20% of maternal serum concentrations. |
| Breastfeeding | Cefdinir is excreted into breast milk in low concentrations (≤0.3% of maternal dose). It is unlikely to cause adverse effects in the breastfed infant, but may theoretically alter infant gut flora. Use with caution, especially in infants with preexisting gastrointestinal issues. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
Hypersensitivity to cefdinir or any cephalosporinPrevious immediate hypersensitivity reaction 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 |
| Food/Dietary | Absorption is not significantly affected by food, but high-fat meals may slightly decrease the rate of absorption; however, overall exposure is similar. To minimize GI upset, it can be taken with a light meal. Avoid taking with iron-fortified infant formula or iron supplements within 2 hours. There is no specific interaction with alcohol, but alcohol may increase the risk of adverse effects (e.g., GI irritation). |
Loading safety data…
| Lactation Rating | L2 (Probably Compatible) |
| 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. |
| Fertility Effects | No known effects on human fertility based on animal studies. |
| Clinical Pearls | Omnicef (cefdinir) is a third-generation oral cephalosporin with good activity against Streptococcus pyogenes, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and many Enterobacteriaceae. It is FDA-approved for acute bacterial otitis media, pharyngitis/tonsillitis, acute maxillary sinusitis, community-acquired pneumonia, acute exacerbations of chronic bronchitis, uncomplicated skin and soft tissue infections, and acute uncomplicated cystitis in women. Dosage adjustment is required for patients with creatinine clearance <30 mL/min (decrease to 300 mg once daily for adult indications). The suspension is sugar-free and can be used in diabetic patients. Absorption may be enhanced by acidic gastric pH; consider co-administration with acidic beverages if GI intolerance occurs. Avoid concomitant iron supplements or iron-fortified infant formula within 2 hours of dosing due to decreased absorption. |
| Patient Advice | Take OMNICEF exactly as prescribed, with or without food, but if it causes stomach upset, take with food. · Complete the full course of therapy even if you feel better; stopping early may lead to antibiotic resistance. · Shake the oral suspension well before each use and use a proper measuring device. · If you are taking iron supplements or using iron-fortified infant formula, separate by at least 2 hours from OMNICEF dose. · Notify your doctor if you develop severe diarrhea, watery or bloody stools, rash, or signs of an allergic reaction (hives, difficulty breathing, swelling). · This medication may cause diarrhea; do not treat with anti-diarrheal medicines without consulting your doctor. · Store capsules at room temperature; oral suspension may be refrigerated for up to 14 days (do not freeze). |