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. |
| Molecular Weight | 385.82 |
| 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 | Animal studies have shown no evidence of teratogenicity; however, no adequate well-controlled studies in pregnant women. Use only if clearly needed. |
| 2nd trimester | No evidence of fetal harm in animal studies; use with caution. |
| 3rd trimester | Generally considered safe; however, use near term may theoretically affect neonatal gut flora. |
Clinical note
Comprehensive clinical and safety monograph for CECLOR (CECLOR).
| Placental transfer | Cefaclor crosses the placenta; fetal serum concentrations are about 30-60% of maternal serum levels. |
| Breastfeeding | Cefaclor is excreted into human milk in small amounts; peak milk concentrations are about 0.5-1.0 mcg/mL. Considered compatible with breastfeeding, but monitor infant for diarrhea, rash, or thrush. |
■ FDA Black Box Warning
None.
| Serious Effects |
Hypersensitivity to cefaclor or any cephalosporin antibiotic
| 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. |
| Clinical Pearls |
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| Lactation Rating |
| L2 (probably compatible) |
| 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. |
| 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. |
| 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. |