Cefaclor: Potent Oral Cephalosporin for Bacterial Infections
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Cefaclor is a second-generation cephalosporin antibiotic indicated for the treatment of a wide range of bacterial infections caused by susceptible organisms. As an oral bactericidal agent, it exerts its effect by inhibiting bacterial cell wall synthesis, leading to cell lysis and death. It demonstrates activity against both Gram-positive and Gram-negative bacteria, including common respiratory and urinary pathogens. Its pharmacokinetic profile allows for convenient dosing schedules, making it a practical choice in outpatient management.
Features
- Active ingredient: Cefaclor (as cefaclor monohydrate)
- Drug class: Second-generation cephalosporin antibiotic
- Administration: Oral (capsules, tablets, oral suspension)
- Mechanism: Bactericidal; inhibits bacterial cell wall synthesis
- Spectrum: Broad-spectrum activity against Gram-positive and Gram-negative bacteria
- Formulations: 250 mg and 500 mg capsules; 125 mg/5 mL, 187 mg/5 mL, 250 mg/5 mL, and 375 mg/5 mL oral suspensions
- Bioavailability: Well-absorbed from the gastrointestinal tract
- Half-life: Approximately 0.6–0.9 hours
- Protein binding: 25%
- Excretion: Primarily renal (unchanged drug)
Benefits
- Effective against common community-acquired pathogens including Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis
- Convenient oral administration facilitates outpatient treatment and improves compliance
- Demonstrated clinical efficacy in respiratory tract infections, skin and soft tissue infections, and urinary tract infections
- Generally well-tolerated with a established safety profile in appropriate patient populations
- Flexible dosing formulations accommodate both adult and pediatric patients
- Rapid bactericidal action helps achieve prompt clinical improvement
Common use
Cefaclor is commonly prescribed for the treatment of mild to moderate infections caused by susceptible strains of microorganisms. Primary indications include pharyngitis and tonsillitis caused by Streptococcus pyogenes, otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, and Staphylococcus aureus, acute bacterial exacerbations of chronic bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis, pneumonia caused by Streptococcus pneumoniae and Haemophilus influenzae, skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes, and urinary tract infections caused by Escherichia coli, Proteus mirabilis, Klebsiella species, and coagulase-negative staphylococci. The selection of cefaclor should be based on local susceptibility patterns and clinical presentation.
Dosage and direction
Adults: The usual adult dosage is 250 mg every 8 hours. For more severe infections or those caused by less susceptible organisms, doses may be increased to 500 mg every 8 hours. The maximum daily dose should not exceed 4 grams.
Pediatric patients: The recommended daily dosage for children is 20–40 mg/kg/day in divided doses every 8 hours. For otitis media and more severe infections, 40 mg/kg/day is recommended, with a maximum daily dose of 1 gram.
Renal impairment: For patients with creatinine clearance less than 5 mL/min, the initial loading dose is 500 mg followed by 250 mg every 12 hours. For patients undergoing hemodialysis, administer 250 mg every 24 hours with an additional 250 mg dose after each dialysis session.
Administration should continue for a minimum of 48–72 hours beyond the time the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. A minimum of 10 days treatment is recommended for infections caused by Group A beta-hemolytic streptococci to prevent the occurrence of acute rheumatic fever or glomerulonephritis.
Precautions
Before prescribing cefaclor, carefully inquire about previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs. Cross-hypersensitivity may occur in up to 10% of patients with penicillin allergy. Use with caution in patients with history of gastrointestinal disease, particularly colitis. Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs during therapy, appropriate measures should be taken. Positive direct Coombs tests have been reported during treatment with cephalosporin antibiotics. In hematologic studies or in transfusion cross-matching procedures when antiglobulin tests are performed on the minor side or in Coombs testing of newborns whose mothers have received cephalosporin antibiotics before parturition, it should be recognized that a positive Coombs test may be due to the drug. Cefaclor should be administered with caution in the presence of markedly impaired renal function. Although dosage adjustments in moderate to severe renal impairment are recommended, careful clinical observation and laboratory studies should be made because safe dosage may be lower than that usually recommended.
Contraindications
Cefaclor is contraindicated in patients with known hypersensitivity to cephalosporin antibiotics or any component of the formulation. Do not administer to patients who have experienced anaphylactic reactions to penicillins due to the possibility of cross-sensitivity. Avoid use in patients with history of severe immediate hypersensitivity reactions to other beta-lactam antibiotics. Contraindicated in patients with previous cephalosporin-associated hemolytic anemia. Not recommended for patients with known phenylketonuria when using formulations containing aspartame.
Possible side effect
The most common adverse reactions associated with cefaclor therapy include gastrointestinal disturbances (occurring in approximately 2.5% of patients) such as diarrhea, nausea, vomiting, and abdominal pain. Hypersensitivity reactions (approximately 1.5% of patients) may manifest as rash, urticaria, pruritus, and serum sickness-like reactions. Serum sickness-like reactions have been reported more frequently in children than in adults and are characterized by arthralgia, arthritis, fever, rash, and lymphadenopathy. Other reported adverse effects include transient elevations in liver enzymes, eosinophilia, vaginitis, dizziness, fatigue, headache, and reversible interstitial nephritis. Rare but serious adverse reactions include pseudomembranous colitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, anaphylaxis, hemolytic anemia, thrombocytopenia, and neutropenia. Hematologic abnormalities including leukopenia and reversible neutropenia may occur particularly with prolonged administration.
Drug interaction
Probenecid may decrease renal tubular secretion of cefaclor, resulting in increased and prolonged blood levels. Concurrent administration with nephrotoxic drugs (aminoglycosides, potent diuretics) may increase the risk of nephrotoxicity. Cefaclor may enhance the anticoagulant effect of warfarin and other oral anticoagulants, requiring close monitoring of prothrombin time. The presence of cefaclor may cause false-positive reactions for glucose in the urine with Benedict’s or Fehling’s solution and with Clinitest tablets. Concomitant use with bacteriostatic antibiotics may interfere with its bactericidal action. Aluminum and magnesium-containing antacids may reduce the absorption rate of cefaclor, though the extent of absorption is not significantly affected.
Missed dose
If a dose is missed, it should be taken as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue with the regular dosing schedule. Do not double the dose to make up for a missed dose. Maintaining consistent blood levels is important for therapeutic efficacy, so patients should be instructed to take the medication at evenly spaced intervals. Setting reminders or using pill organizers can help improve adherence to the prescribed regimen.
Overdose
Symptoms of cefaclor overdose may include nausea, vomiting, epigastric distress, diarrhea, and convulsions. Serum levels of cefaclor can be reduced by hemodialysis. In cases of suspected overdose, gastric lavage may be indicated if performed soon after ingestion. General supportive measures should be instituted with careful monitoring of renal function. Hemodialysis may be helpful in removing cefaclor from the body, particularly in patients with renal impairment. There is no specific antidote for cefaclor overdose. Treatment should be symptomatic and supportive, with particular attention to maintaining hydration and electrolyte balance. Seizure activity should be managed with appropriate anticonvulsant therapy.
Storage
Store capsules and tablets at controlled room temperature (20–25°C or 68–77°F) in a tight, light-resistant container. Keep oral suspension in the refrigerator (2–8°C or 36–46°F) after reconstitution; discard unused portion after 14 days. Do not freeze the oral suspension. Keep all medications out of reach of children and pets. Protect from moisture and excessive heat. Do not use beyond the expiration date printed on the packaging. Keep in the original container with the lid tightly closed to protect from light and moisture.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. The content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read here. The prescribing information contained herein may not include all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective, or appropriate for any given patient.
Reviews
Clinical studies have demonstrated cefaclor’s efficacy in treating various bacterial infections. In multicenter trials involving patients with respiratory tract infections, clinical cure rates ranged from 85–95% depending on the specific infection and pathogen. For acute otitis media in pediatric patients, success rates of 80–90% have been reported against common pathogens. Studies in skin and soft tissue infections show comparable efficacy to other oral cephalosporins with clinical improvement typically observed within 48–72 hours of initiation. The drug is generally well-tolerated, with most adverse effects being mild and self-limiting. However, the incidence of serum sickness-like reactions, particularly in pediatric populations, has been noted in post-marketing surveillance. Resistance patterns have evolved over time, with increasing prevalence of beta-lactamase producing strains necessitating careful consideration of local susceptibility data before prescribing.