Classes
DEA Class; Rx
Common Brand Names; Ceclor (DSC), Raniclor (DSC)
- Cephalosporins, 2nd Generation
Description
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.
Indications
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
Contraindications
Documented hypersensitivity
Adverse Effects
- 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
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
1.5 g/day PO capsules or oral suspension; 1 g/day PO extended-release tablets.
1.5 g/day PO capsules or oral suspension; 1 g/day PO extended-release tablets.
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.
40 mg/kg/day PO (Max: 1 g/day) for immediate release formulations; safety and efficacy of extended-release tablets have not been established.
40 mg/kg/day PO oral suspension.
Safety and efficacy have not been established.
How supplied
Cefaclor
capsule
- 250mg
- 500mg
tablet, extended-release
- 500mg