Generic
Cefaclor
51 brands available in the market
At a glance
Cefaclor is a second-generation cephalosporin antibiotic used in the treatment of various bacterial infections. It kills bacteria by inhibiting bacterial cell wall synthesis.
Description
Cefaclor is a second-generation cephalosporin antibiotic which has stability against β-lactamase inactivation and possesses a broad spectrum of activity. It is active in vitro against the following organisms: Alpha and beta hemolytic Streptococci, Staphylococci (including coagulase-positive, coagulase-negative, and penicillinase-producing strains), Streptococcus pneumoniae, Streptococcus pyogenes, Branhamella catarrhalis, Escherichia coli, Proteus mirabilis, Klebsiella species, and Haemophilus influenzae (including ampicillin-resistant strains).
Cefaclor is indicated for respiratory tract infections (pneumonia, bronchitis), otitis media, pharyngitis and tonsillitis, urinary tract infections (pyelonephritis, cystitis), and skin and skin structure infections. For β-hemolytic Streptococcal infections, therapy should be administered for at least 10 days.
Indications
- Respiratory tract infections (pneumonia, bronchitis)
- Otitis media
- Pharyngitis and tonsillitis
- Urinary tract infections (pyelonephritis, cystitis)
- Skin and skin structure infections
Therapeutic class
Second generation cephalosporins
Pharmacological class
Cephalosporin Antibiotic
Pharmacology
Cefaclor is a second-generation cephalosporin antibiotic which has stability against β-lactamase inactivation and possesses a broad spectrum of activity. It inhibits the final transpeptidation step of peptidoglycan synthesis in the bacterial cell wall, inhibiting biosynthesis and arresting cell wall assembly, resulting in bacterial cell death.
Mechanism of action
Cefaclor binds to penicillin-binding proteins (PBPs) and inhibits the final transpeptidation step of peptidoglycan synthesis in the bacterial cell wall, inhibiting cell wall assembly and causing bacterial cell death.
Dosage
Adults: 250-500 mg every 8 hours (oral). Severe infections: up to 4 g/day. β-hemolytic Streptococcal infections: at least 10 days of therapy.
Children (>1 month): 20 mg/kg/day in divided doses every 8 hours. Severe infections (e.g., otitis media): 40 mg/kg/day (max 1 g/day).
Pediatric dosing table:
1 month-1 year (9 kg): Suspension ½ tsp tid; Pediatric drops 0.625 ml tid
1-5 years (9-18 kg): Suspension 1 tsp tid; Pediatric drops 1.25 ml tid
Over 5 years: Suspension 2 tsp tid
Renal impairment: CrCl 10-50 mL/min: Half to full dose; CrCl <10 mL/min: Half dose.
Hemodialysis: Predialysis loading dose: 250 mg-1 g; Interdialytic maintenance: 250-500 mg every 6 hours.
Elderly: No differences in responses observed compared to younger patients.
Infants <1 month: Safety and efficacy not established.
Administration
May be taken with or without food, preferably at a fixed time each day. Swallow tablets whole; do not chew, crush, or break. Shake suspension well before use. After reconstitution, suspension can be used for 7 days at room temperature and 14 days in the refrigerator.
Missed dose
If you miss a dose, take it as soon as you remember. Skip the missed dose if it is almost time for your next dose. Do not double the dose.
Side effects
Common side effects: Rash, vomiting, allergic reaction, nausea, injection site reaction, increased liver enzymes, diarrhea.
Gastrointestinal: Diarrhea, nausea, vomiting.
Rare: Transient hepatitis, cholestatic jaundice, fever, abdominal pain, superinfection, renal dysfunction, toxic nephropathy, hemorrhage, elevated LDH, pancytopenia.
Side effects are usually mild and transient.
Precautions & warnings
- Prescribing in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit and increases the risk of drug-resistant bacteria.
- Prolonged use may result in overgrowth of nonsusceptible organisms; if superinfection occurs, take appropriate measures.
- Use with caution in penicillin-sensitive patients (risk of cross-allergy).
- Use with caution in patients with history of gastrointestinal disease, particularly colitis.
- If rash, itching, swelling of face/mouth, or difficulty breathing occurs, discontinue and inform your doctor.
- If diarrhea does not stop or if blood is found in stools, inform your doctor.
- Avoid alcohol consumption (may increase side effects).
Contraindications
- Known allergy to cephalosporin group of antibiotics
Drug interactions
- Aminoglycosides: May enhance nephrotoxic effect.
- Warfarin: May increase prothrombin time; monitor prothrombin time regularly and adjust dose.
- Probenecid: Inhibits renal excretion of cefaclor.
- BCG, typhoid vaccine, sodium picosulfate: May diminish therapeutic effect.
- Benedict's or Fehling's solution urine glucose tests: May cause false-positive reaction.
Food interactions
Alcohol consumption is unsafe (may cause unpleasant side effects like nausea, vomiting, sweating, anxiety, and palpitations).
Use in pregnancy
Generally considered safe during pregnancy (Category B). Animal studies have shown low or no adverse effects; limited human studies available. Use during pregnancy only if clearly needed.
Pregnancy Category: B — always consult a doctor before taking during pregnancy.
Use in lactation
Safe during breastfeeding (if prescribed). Cefaclor is excreted in breast milk in small amounts and is not harmful to the baby. Avoid prolonged use (risk of rash and diarrhea).
Pediatric use
Safety and efficacy in infants less than 1 month of age have not been established. Children >1 month: 20-40 mg/kg/day (divided doses), max 1 g/day.
Geriatric use
No differences in responses observed between elderly and younger patients; however, greater sensitivity in some older individuals cannot be ruled out.
Renal / hepatic impairment
Hepatic impairment: Limited information; caution required.
Overdose effects
Overdose symptoms: Nausea, vomiting, epigastric distress, diarrhea. Treatment: Supportive and symptomatic.
Storage conditions
Store at room temperature, protected from light. After reconstitution, suspension can be used for 7 days at room temperature and 14 days in the refrigerator (2-8°C). Keep the bottle tightly closed.
Chemical structure
Cefaclor Monohydrate (Second Generation Cephalosporin)