• Composition
Each capsule contains
Cefaclor (in form of cefaclor hydrate) ··········· 250mg
• Indications
Cefaclor is indicated in the treatment of the following infections when caused by susceptible
strains of the designated microorganisms:
Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, Staphylococci,
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.
Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae,
Haemophilus influenzae, 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.
Pharyngitis and Tonsillitis, caused by Streptococcus pyogenes
Note: Penicillin is the usual drug of choice in the treatment and prevention of streptococcal
infections, including the prophylaxis of rheumatic fever. Cefaclor is generally effective in the
eradication of streptococci from the nasopharynx; however, substantial data establishing the
efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present.
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
• Dosage and Administration
Cefaclor is administered orally.
Adults - The usual adult dosage is 250 mg every 8 hours. For more severe infections (such as
pneumonia) or those caused by less susceptible organisms, doses may be doubled.
Pediatric patients - The usual recommended daily dosage for pediatric patients is 20
mg/kg/day in divided doses every 8 hours. In more serious infections, otitis media, and
infections caused by less susceptible organisms, 40 mg/kg/day are recommended, with a
maximum dosage of 1 g/day.
Cefaclor may be administered in the presence of impaired renal function. Under such a
condition, the dosage usually is unchanged. In the treatment of p-hemolytic streptococcal
infections, a therapeutic dosage of cefaclor should be administered for at least 10 days.

Labor and Delivery

The effect of cefaclor on labor and delivery is unknown.
Nursing Mothers
Small amounts of cefaclor have been detected in mother's milk following administration of single
500-mg doses. Average levels were 0.18, 0.20, 0.21, and 0.16 μg/mL at 2, 3, 4, and 5
hours respectively. Trace amounts were detected at 1 hour. The effect on nursing infants is not
known. Caution should be exercised when cefaclor is administered to a nursing woman.
Pediatric Use
Safety and effectiveness of this product for use in infants less than 1 month of age have not
been established
 • Contraindication
Cefaclor is contraindicated in patients with known allergy to the cephalosporin group of
antibiotics.

Manufactured by:
ILDONG PHARMACEUTICAL CO., LTD.
International name- Cefaclor hydrate 250mg