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Cefaclor

    DEA Class; Rx

    Common Brand Names; Ceclor (DSC), Raniclor (DSC)

    • Cephalosporins, 2nd Generation

    Oral second-generation cephalosporin used primarily to treat otitis media, sinusitis, and upper respiratory tract infection caused by H. influenzae that are resistant to ampicillin or amoxicillin.

    Indicated for Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae, and Streptococcus pyogenes

    Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, and Streptococcus pyogenes

    Skin and skin structure infections cause by Staphylococcus aureus and Streptococcus pyogenes

    Urinary tract infections, including pyelonephritis and cystitis, caused by Escherichia coli, Proteus mirabilis, Klebsiella spp, and coagulase-negative staphylococci

    Acute bacterial exacerbations of chronic bronchitis or secondary bacterial infections of acute bronchitis due to Haemophilus influenzae (excluding beta-lactamase-negative, ampicillin-resistant strains), Moraxella catarrhalis, or Streptococcus pneumoniae

    Pharyngitis and tonsillitis due to Streptococcus pyogenes

    Documented hypersensitivity

    • Diarrhea (3%)
    • Increased transaminases (3%)
    • Eosinophilia (2%)
    • Moniliasis (2%)
    • Vaginitis (2%)
    • Rash (maculopapular, erythematous, or morbiliform) (1-2%)
    • Stevens-Johnson syndrome
    • Pseudomembranous colitis
    • Nausea
    • Vomiting
    • Anemia
    • Neutropenia
    • Jaundice

    Prescribing drug in absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to patient and increases risk of development of drug-resistant bacteria

    Superinfection (overgrowth by non-susceptible organisms) should always be considered a possibility in patient being treated with broad spectrum antimicrobial; careful observation of patient is essential; take appropriate measures if superinfection occurs during therapy

    Reduce dosage by 1/2 if creatinine clearance is 10-30 mL/min, and by 3/4 if <10 mL/min (high doses may cause CNS toxicity); bacterial or fungal overgrowth of non-susceptible organisms may occur with prolonged or repeated therapy

    No adequate and well-controlled studies in pregnant women

    Because animal reproduction studies are not always predictive of human response, cefaclor should be used during pregnancy only if necessary

    Effect on nursing infants is unknown; exercise caution when cefaclor is administered to a nursing woman

    Adults

    1.5 g/day PO capsules or oral suspension; 1 g/day PO extended-release tablets.

    Geriatric

    1.5 g/day PO capsules or oral suspension; 1 g/day PO extended-release tablets.

    Adolescents

    16 years and older: 40 mg/kg/day PO (Max: 1 g/day) for immediate release formulations; 1 g/day PO extended-release tablets.
    13 to 15 years: 40 mg/kg/day PO (Max: 1 g/day) for immediate release formulations; safety and efficacy of extended-release tablets have not been established.

    Children

    40 mg/kg/day PO (Max: 1 g/day) for immediate release formulations; safety and efficacy of extended-release tablets have not been established.

    Infants

    40 mg/kg/day PO oral suspension.

    Neonates

    Safety and efficacy have not been established.

    Cefaclor

    capsule

    • 250mg
    • 500mg

    tablet, extended-release

    • 500mg