CECLOR
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CECLOR (CECLOR).
Cefaclor, a second-generation cephalosporin, inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to cell lysis and death. It exhibits bactericidal activity against susceptible organisms.
| Metabolism | Cefaclor undergoes minimal hepatic metabolism; the majority is excreted unchanged in the urine via glomerular filtration and tubular secretion. |
| Excretion | Primarily renal: 80-90% of unchanged drug excreted by glomerular filtration and tubular secretion within 8 hours. Biliary excretion accounts for <5%; fecal elimination negligible. |
| Half-life | Terminal elimination half-life: 0.6-0.9 hours in adults with normal renal function. Prolonged to 2-3 hours in end-stage renal disease. Half-life does not increase significantly with hepatic impairment. |
| Protein binding | Approximately 25% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Volume of distribution: 0.2-0.4 L/kg, indicating distribution primarily into extracellular fluid. Penetrates well into middle ear fluid, bronchial secretions, and pleural fluid. |
| Bioavailability | Oral bioavailability: 80-95% for the immediate-release formulation. Food slightly delays absorption but does not reduce extent. Suspension has comparable bioavailability to capsules. |
| Onset of Action | Oral: Onset of antibacterial effect occurs within 30-60 minutes after administration, corresponding to peak serum concentrations at 0.5-1 hour. |
| Duration of Action | Duration of antibacterial activity is approximately 6-8 hours, supporting twice-daily dosing. Sustained-release formulations (CECLOR CD) provide 12-hour coverage. |
| Action Class | Cephalosporins: 2nd generation |
| Brand Substitutes | Uniclor 500mg Capsule, Distaclor 500mg Capsule |
250 mg orally every 8 hours; for severe infections, 500 mg orally every 8 hours.
| Dosage form | CAPSULE |
| Renal impairment | CrCl 10-50 mL/min: administer 50% of usual dose at usual interval; CrCl <10 mL/min: administer 50% of usual dose every 12-18 hours. |
| Liver impairment | No specific recommendations for dose adjustment in hepatic impairment; use with caution and monitor for adverse effects. |
| Pediatric use | 20-40 mg/kg/day orally divided every 8 hours; maximum 1 g/day. |
| Geriatric use | No specific dose adjustment required; monitor renal function and adjust dose if creatinine clearance <50 mL/min. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CECLOR (CECLOR).
| Breastfeeding | Cefaclor is excreted into human breast milk in low concentrations (M/P ratio approximately 0.02–0.05). It is generally considered compatible with breastfeeding, but caution is advised due to potential for alteration of infant gut flora and risk of hypersensitivity. Observe infant for diarrhea or rash. |
| Teratogenic Risk | Cefaclor (Ceclor) 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. First trimester: No evidence of teratogenicity. Second and third trimesters: No known fetal risks; considered safe for use when clinically indicated. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Known hypersensitivity to cefaclor, any cephalosporin, or any component of the formulation","Severe immediate hypersensitivity reaction to penicillins (cross-sensitivity)"]
| Precautions | ["Hypersensitivity reactions (including anaphylaxis) cross-reactive with penicillins","Clostridioides difficile-associated diarrhea (CDAD)","Seizures in patients with renal impairment or high doses","Superinfection with prolonged use","Potential for false-positive Coombs test"] |
| Food/Dietary | Take without regard to meals; food may decrease gastrointestinal upset. Avoid alcohol during therapy. |
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| Fetal Monitoring | Monitor maternal renal function and for signs of hypersensitivity reactions. No specific fetal monitoring required; routine prenatal care adequate. |
| Fertility Effects | No known adverse effects on fertility. Animal studies have not shown impaired fertility. |
| Clinical Pearls |
| CECLOR (cefaclor) is a second-generation cephalosporin with activity against Haemophilus influenzae, including some beta-lactamase-producing strains. It is less effective against Streptococcus pneumoniae compared to amoxicillin. Monitor for hypersensitivity reactions, especially in penicillin-allergic patients. Use with caution in renal impairment; adjust dose for CrCl <50 mL/min. May cause false-positive urinary glucose tests with Clinitest tablets. |
| Patient Advice | Take this medication exactly as prescribed, usually every 8 hours. · Complete the full course even if you feel better to prevent resistance. · If you have a penicillin allergy, inform your doctor before taking this medication. · Diarrhea is common; contact your doctor if it becomes severe or contains blood. · Store at room temperature, away from moisture and heat. · Shake oral suspension well before each use. |