Proven Efficacy Toward Infectious Diseases
Cefaclor is indicated for the treatment of otitis media, lower respiratory infections, pharyngitis and tonsillitis, urinary tract infections, and skin and skin structure infections, caused by susceptible organisms. It is a second-generation cephalosporin antibiotic indicated for children as young as 1 month of age.
Important Safety Information
INDICATIONS AND USAGE
Cefaclor for Oral Suspension, USP, is a cephalosporin antibiotic indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms:
- Otitis media caused by Streptococcus pneumoniae, Haemophilus influenza*, staphylococci, and Streptococcus pyogenes
- Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenza*, and Streptococcus pyogenes
- Pharyngitis and Tonsillitis, caused by Streptococcus pyogenes
- Urinary tract infections, including pyelonephritis and cystitis, caused by Escherichia coli, Proteus mirabilis, Klebsiella spp., and coagulase-negative staphylococci
- Skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes
* Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains.
Cefaclor is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
WARNINGS AND PRECAUTIONS
- Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactam antibiotics such as cefaclor. Hypersensitivity reactions can occur in patients who have demonstrated some form of allergy, particularly to cefaclor, cephalosporins, penicillins, or other drugs.
- Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibiotics, including Cefaclor for Oral Suspension, and may range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients presenting with diarrhea after taking antibiotics, and can occur over 2 months after administration of antibiotics. Ongoing antibiotic use not directed against C. difficile may need to be discontinued.
- Use only in proven or strongly suspected bacterial infections of susceptible organisms. Do not use for prophylactic use.
- Prolonged use may result in overgrowth of nonsusceptible organisms. If superinfection occurs appropriate measures should be taken.
- Positive direct Coombs’ tests have been reported during treatment with cephalosporin antibiotics.
- Use with caution in patients with impaired renal function. Careful clinical and laboratory observation are warranted.
- As with other beta-lactam antibiotics, renal excretion of cefaclor is inhibited by probenecid.
- Exercise caution in patients with history of gastrointestinal disease, particularly colitis.
- Cases of serum-sickness-like reactions have been reported with the use of cefaclor, characterized by findings of erythema multiforme, rashes, and other skin manifestations accompanies by arthritis/arthralgia, with or without fever.
Most common adverse reactions to cefaclor: hypersensitivity, gastrointestinal symptoms including diarrhea, eosinophilia, genital pruritus, and moniliasis or vaginitis.
To report SUSPECTED ADVERSE REACTIONS, contact Avadel Pharmaceuticals (USA), Inc. at 1-877-622-2320 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.0915-A CEF HCP ISI