IMPORTANT SAFETY INFORMATION
Cefaclor for Oral Suspension 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. If an allergic reaction occurs, discontinue use of Cefaclor for Oral Suspension. Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures as clinically indicated.
- Exercise caution in penicillin-sensitive patients as cross-hypersensitivity with beta-lactam antibiotics has been observed in up to 10% of patients with penicillin allergy.
- 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 cautiously in patients who have demonstrated some form of allergy, particularly to drugs.
- 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.
The most frequently occurring adverse reactions related to cefaclor therapy include: gastrointestinal symptoms, including diarrhea (2.5%); hypersensitivity reactions including morbilliform eruptions (1.5%); and serum-sickness-like reactions (≤0.5%).
Increase in anticoagulant effect may occur when cefaclor is used concomitantly with oral anticoagulants.
USE IN PEDIATRIC PATIENTS:
Safety and effectiveness of cefaclor has not been established in pediatric patients less than 1 month of age.
INDICATIONS FOR USE:
Cefaclor for Oral Suspension is indicated for the treatment of otitis media, lower respiratory tract infections, pharyngitis and tonsillitis, urinary tract infections, and skin and skin structure infections caused by susceptible strains of the designated microorganisms:
- Otitis Media due to Streptococcus pneumoniae, Haemophilus influenzae*, staphylococci, and Streptococcus pyogenes
- Lower respiratory tract infections, including pneumonia, due to Streptococcus pneumoniae, Haemophilus influenzae*, and Streptococcus pyogenes
- Pharyngitis and Tonsillitis due to Streptococcus pyogenes
- Urinary tract infections, including pyelonephritis and cystitis, due to Escherichia coli, Proteus mirabilis, Klebsiella spp., and coagulase-negative staphylococci
- Skin and skin structure infections due to Staphylococcus aureus and Streptococcus pyogenes
β-lactamase-negative, ampicillin-resistant strains (BLNAR) of Haemophilus influenzae
should be considered resistant to Cefaclor.
Before prescribing Cefaclor for Oral Suspension, please read the Full Prescribing Information.
To report suspected adverse reactions, please contact FSC at 1-866-764-7822 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch