Uses
Acute Otitis Media (AOM)
Treatment of AOM caused by Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, or S. pyogenes (group A β-hemolytic streptococci). (See Haemophilus influenzae Infections under Cautions.)
Pharyngitis and Tonsillitis
Treatment of pharyngitis and tonsillitis caused by S. pyogenes (group A β-hemolytic streptococci). Generally effective in eradicating S. pyogenes from the nasopharynx, but efficacy in prevention of subsequent rheumatic fever has not been established to date.
CDC, AAP, IDSA, AHA, and others recommend oral penicillin V or IM penicillin G benzathine as treatments of choice; oral cephalosporins and oral macrolides considered alternatives. Amoxicillin sometimes used instead of penicillin V, especially for young children.
Respiratory Tract Infections
Treatment of lower respiratory tract infections, including pneumonia, caused by susceptible H. influenzae, S. pneumoniae, or S. pyogenes (group A β-hemolytic streptococci). (See Haemophilus influenzae Infections under Cautions.)
Treatment of mild to moderate acute bacterial exacerbations of chronic bronchitis caused by susceptible H. influenzae (β-lactamase negative strains only), Moraxella catarrhalis (including β-lactamase producing strains), or S. pneumoniae. (See Haemophilus influenzae Infections under Cautions.)
Treatment of secondary bacterial infections of acute bronchitis caused by susceptible H. influenzae (β-lactamase negative strains only) or M. catarrhalis (including β-lactamase producing strains). (See Haemophilus influenzae Infections under Cautions.)
Skin and Skin Structure Infections
Uncomplicated skin and skin structure infections caused by susceptible Staphylococcus aureus (oxacillin-susceptible strains only) or S. pyogenes.
Urinary Tract Infections (UTIs)
Treatment of UTIs (including pyelonephritis and cystitis) caused by susceptible Escherichia coli, Proteus mirabilis, Klebsiella, or coagulase-negative staphylococci.
Dosage and Administration
Administration
Oral Administration
Administer orally.
Conventional capsules or oral suspension: Administer without regard to meals.
Extended-release tablets: Administer with meals or within 1 hour of eating. Should not be cut, crushed, or chewed.
Dosage
Available as cefaclor monohydrate; dosage expressed in terms of anhydrous cefaclor.
Pediatric Patients
General Pediatric Dosage
Oral
Children ≥1 month of age: AAP recommends 20–40 mg/kg daily in 2 or 3 equally divided doses for treatment of mild or moderate infections. AAP states the drug is inappropriate for treatment of severe infections.
Acute Otitis Media (AOM)
Oral
Children ≥1 month of age: 40 mg/kg daily in divided doses every 8 or 12 hours (as capsules or oral suspension).
Pharyngitis and Tonsillitis
Oral
Children ≥1 month of age: 20 mg/kg daily in divided doses every 8 or 12 hours for 10 days (as capsules or oral suspension). For more severe infections or those caused by less-susceptible organisms, 40 mg/kg daily in divided doses every 8 hours (as capsules or oral suspension).
Respiratory Tract Infections
Oral
Children ≥1 month of age: 20 mg/kg daily in divided doses every 8 hours (as capsules or oral suspension) for lower respiratory tract infections. For more severe infections or those caused by less-susceptible organisms, 40 mg/kg daily in divided doses every 8 hours (as capsules or oral suspension).
Skin and Skin Structure Infections
Oral
Children ≥1 month of age: 20 mg/kg daily in divided doses every 8 hours (as capsules or oral suspension). For more severe infections or those caused by less susceptible organisms, 40 mg/kg daily in divided doses every 8 hours (as capsules or oral suspension).
Urinary Tract Infections (UTIs)
Oral
Children ≥1 month of age: 20 mg/kg daily in divided doses every 8 hours (as capsules or oral suspension). For more severe infections or those caused by less susceptible organisms, 40 mg/kg daily in divided doses every 8 hours (as capsules or oral suspension).
Adults
Acute Otitis Media (AOM)
Oral
250 mg every 8 hours (as capsules or oral suspension). For more severe infections or those caused by less susceptible organisms, 500 mg every 8 hours (as capsules or oral suspension).
Pharyngitis and Tonsillitis
Oral
250 mg every 8 hours (as capsules or oral suspension). For more severe infections or those caused by less susceptible organisms, 500 mg every 8 hours (as capsules or oral suspension).
375 mg every 12 hours for 10 days (as extended-release tablets).
Respiratory Tract Infections
Lower Respiratory Tract Infections
Oral
250 mg every 8 hours (as capsules or oral suspension). For more severe infections (e.g., pneumonia) or those caused by less susceptible organisms, 500 mg every 8 hours (as capsules or oral suspension).
Acute Bacterial Exacerbations of Chronic Bronchitis
Oral
500 mg every 12 hours for 7 days (as extended-release tablets).
Secondary Bacterial Infections of Acute Bronchitis
Oral
500 mg every 12 hours for 7 days (as extended-release tablets).
Skin and Skin Structure Infections
Oral
250 mg every 8 hours (as capsules or oral suspension). For more severe infections or those caused by less susceptible organisms, 500 mg every 8 hours (as capsules or oral suspension).
375 mg every 12 hours for 7–10 days (as extended-release tablets).
Urinary Tract Infections (UTIs)
Oral
250 mg every 8 hours (as capsules or suspension). For more severe infections or those caused by less susceptible organisms, 500 mg every 8 hours (as capsules or oral suspension).
Prescribing Limits
Pediatric Patients
Maximum 1 g daily.
Special Populations
Dosage in Renal Impairment
No dosage adjustments required.
Close clinical observation and appropriate laboratory tests recommended in those with moderate or severe renal impairment. Use with caution in patients with markedly impaired renal function.
Geriatric Patients
No age-related dosage adjustments required.
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