ANSPOR
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ANSPOR (ANSPOR).
Cephalexin is a first-generation cephalosporin antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to cell lysis and death.
| Metabolism | Cephalexin is not extensively metabolized; it is primarily excreted unchanged in the urine. Minor hepatic metabolism may occur. |
| Excretion | Primarily renal (90–95%) as unchanged drug via glomerular filtration and tubular secretion; biliary excretion negligible (<1%) |
| Half-life | 1.5–2 hours in adults with normal renal function; prolonged to 20–30 hours in severe renal impairment (CrCl <10 mL/min) |
| Protein binding | 10–20% bound to serum albumin |
| Volume of Distribution | 0.13–0.22 L/kg; indicates distribution primarily into extracellular fluid |
| Bioavailability | Oral: 75–90% (well absorbed); IM: 100% |
| Onset of Action | Oral: 30–60 minutes; IM: 15–30 minutes |
| Duration of Action | 6–8 hours for susceptible organisms; requires twice-daily dosing due to short half-life |
250-500 mg orally every 6 hours for 10-14 days; maximum 4 g/day.
| Dosage form | FOR SUSPENSION |
| Renal impairment | CrCl 10-50 mL/min: 250 mg every 12-24 hours. CrCl <10 mL/min: 250 mg every 24-48 hours. |
| Liver impairment | No specific adjustment recommended; monitor for adverse effects in severe impairment. |
| Pediatric use | 12.5-25 mg/kg orally every 6 hours; maximum 50 mg/kg/day. |
| Geriatric use | Start at lower end of dosing range; monitor renal function and adjust based on CrCl. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ANSPOR (ANSPOR).
| Breastfeeding | Cefradine is excreted into human breast milk in low concentrations. M/P ratio is approximately 0.12–0.20. Considered compatible with breastfeeding by the American Academy of Pediatrics; however, monitor infant for potential diarrhea or allergic reaction. |
| Teratogenic Risk | Cefradine (ANSPOR) is classified as FDA Pregnancy Category B. Animal studies have not demonstrated fetal risk, and adequate well-controlled studies in pregnant women are lacking. No evidence of teratogenicity; however, caution is advised. First trimester: no known risk; second and third trimesters: no known fetal adverse effects. |
■ FDA Black Box Warning
No FDA boxed warning exists for cephalexin.
| Serious Effects |
["Known hypersensitivity to cephalosporins or penicillins (cross-sensitivity).","Previous immediate hypersensitivity reaction to penicillins."]
| Precautions | ["Hypersensitivity reactions including anaphylaxis.","Clostridioides difficile-associated diarrhea (CDAD).","Dosage adjustment required in renal impairment.","Seizures with high doses or renal failure.","Potential for superinfection with prolonged use."] |
| Food/Dietary | Iron-fortified infant formula and iron supplements may reduce absorption; take at least 2 hours apart. No other significant food interactions. Avoid alcohol. |
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| Fetal Monitoring | No specific monitoring required beyond routine maternal care. Monitor for signs of hypersensitivity or superinfection in mother. No fetal monitoring indicated. |
| Fertility Effects | No reported adverse effects on fertility in animal studies or human data. No known impact on spermatogenesis or oogenesis. |
| Clinical Pearls |
| ANSPOR (cefdinir) is a third-generation oral cephalosporin with activity against Gram-positive and Gram-negative bacteria. It is stable in the presence of some beta-lactamases. Dose adjustment required for CrCl <30 mL/min. Avoid use in patients with immediate hypersensitivity to penicillins due to cross-reactivity (approx 10%). Administer with iron supplements or iron-fortified infant formula at least 2 hours apart to reduce chelation. Suspension should be refrigerated and discarded after 10 days. |
| Patient Advice | Take exactly as prescribed, even if you feel better. · Complete the full course of therapy. · If using suspension, shake well before each dose. Refrigerate and discard after 10 days. · Avoid alcohol while taking this medication. · Notify your doctor if you experience diarrhea, rash, or signs of allergic reaction. · Take iron supplements or iron-fortified infant formula at least 2 hours apart from ANSPOR. |