CECLOR CD
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CECLOR CD (CECLOR CD).
Cefaclor, a second-generation cephalosporin, inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), thereby disrupting peptidoglycan cross-linking.
| Metabolism | Cefaclor is not extensively metabolized; approximately 60-85% of the dose is excreted unchanged in the urine within 8 hours. Minor hepatic metabolism may occur. |
| Excretion | Renal: ~80% unchanged; biliary/fecal: ~20% |
| Half-life | Terminal elimination half-life: ~0.6-0.9 hours (prolonged in renal impairment) |
| Protein binding | 25-50% bound to plasma proteins (mainly albumin) |
| Volume of Distribution | 0.24-0.4 L/kg (distributes mainly into extracellular fluid) |
| Bioavailability | Oral (extended-release): ~50% (compared to immediate-release) |
| Onset of Action | Oral: ~30-60 minutes |
| Duration of Action | 6-8 hours (dose-dependent, extended-release formulation maintains levels for 12 hours) |
250-500 mg orally every 8 hours; extended-release form (CECLOR CD) 375-750 mg orally every 12 hours.
| Dosage form | TABLET, EXTENDED RELEASE |
| Renal impairment | CrCl 10-50 mL/min: administer 50% of dose or same dose every 12-24 hours; CrCl <10 mL/min: administer 25% of dose or same dose every 24-48 hours. |
| Liver impairment | No specific adjustment recommended; use with caution in severe hepatic impairment. |
| Pediatric use | 20-40 mg/kg/day orally in 2-3 divided doses; maximum 1 g/day. Extended-release form not recommended for children <16 years. |
| Geriatric use | Use lowest effective dose; monitor renal function; no specific dose adjustment except based on renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CECLOR CD (CECLOR CD).
| Breastfeeding | Cefaclor is excreted into human breast milk in small quantities (M/P ratio approximately 0.06-0.3). It is considered compatible with breastfeeding due to low oral bioavailability in infants; however, observe for potential diarrhea or allergic reaction in the nursing infant. Use with caution. |
| Teratogenic Risk | Cefaclor (CECLOR CD) is classified as FDA Pregnancy Category B. Animal studies have not demonstrated fetal risk, and there are no adequate well-controlled studies in pregnant women. However, as with all antibiotics, use only if clearly needed. First trimester: No known teratogenic effects; risk cannot be ruled out. Second and third trimesters: Considered safe; no known fetal adverse effects from maternal use. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Hypersensitivity to cefaclor or any other cephalosporin antibiotic.","Hypersensitivity to penicillins (cross-sensitivity possible).","Previous immediate-type reaction (e.g., anaphylaxis) to any beta-lactam agent."]
| Precautions | ["Serious hypersensitivity reactions (including anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported.","Clostridioides difficile-associated diarrhea (CDAD) may occur.","Potential for nephrotoxicity in patients with renal impairment; dose adjustment recommended.","Prolonged use may result in superinfection with non-susceptible organisms.","Caution in patients with a history of penicillin allergy due to cross-sensitivity."] |
| Food/Dietary | Take with food to enhance absorption and reduce gastrointestinal discomfort. Avoid alcohol during therapy and for 72 hours after completion due to possible disulfiram-like reaction (flushing, headache, nausea). |
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| Fetal Monitoring | Monitor for signs of maternal allergic reaction or gastrointestinal disturbance. No specific fetal monitoring required. Standard antenatal assessment is sufficient. |
| Fertility Effects | No known adverse effects on fertility in animal studies. No human data suggest impairment of fertility. |
| Clinical Pearls | CECLOR CD (cefaclor extended-release) is a second-generation cephalosporin with activity against gram-positive cocci (except MRSA) and some gram-negatives like Haemophilus influenzae and Moraxella catarrhalis. Unlike immediate-release, CD formulation allows once-daily dosing. Monitor renal function in elderly; dose adjustment needed if CrCl < 30 mL/min. Serum sickness-like reactions (erythema multiforme, arthralgia) are rare but distinctive to cefaclor. False-positive urine glucose test with Clinitest, not with glucose oxidase methods. |
| Patient Advice | Take once daily with food to increase absorption and reduce GI upset. · Do not crush or chew the extended-release tablet; swallow whole. · Complete the full course even if you feel better to prevent resistance. · Report any rash, joint pain, or unusual bruising to your doctor immediately. · Avoid alcohol during treatment and for 72 hours after last dose to prevent disulfiram-like reaction. · This medication may cause diarrhea; contact your doctor if watery or bloody stools occur. · Inform your doctor if you have kidney disease, as dose adjustment may be needed. · Antacids containing magnesium or aluminum can decrease absorption; separate by at least 2 hours. |