Ceclor (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. Ceclor (cefaclor) is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of Ceclor (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

Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ceclor (cefaclor) and other antibacterial drugs, Ceclor (cefaclor) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Ceclor (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.

B.I.D. Treatment Option - For the treatment of otitis media and pharyngitis, the total daily dosage may be divided and administered every 12 hours.

Ceclor (cefaclor) may be administered in the presence of impaired renal function. Under such a condition, the dosage usually is unchanged (see PRECAUTIONS).

In the treatment of p-hemolytic streptococcal infections, a therapeutic dosage of Ceclor (cefaclor) should be administered for at least 10 days.

Pulvules:

250 mg, purple and white (No. 3061) - (RxPak* of 15)

NDC 0002-3061-15; (100s)
NDC 0002-3061-02; (ID ^†100)
NDC 0002-3061-33

500 mg, purple and gray (No. 3062) - (RxPak of 15)

NDC 0002-3062-15

For Oral Suspension:

125 mg/5 mL, strawberry flavor (M-5057^‡) - (150-mL size) NDC 0002-5057-68
187 mg/5 mL, strawberry flavor (M-5130^‡) - (100-mL size) NDC 0002-5130-48
250 mg/5 mL, strawberry flavor (M-5058^‡) - (75-mL size) NDC 0002-5058-18; (150-mL size) NDC 0002-5058-68
375 mg/5 mL, strawberry flavor (M-5132^‡) - (100-mL size) NDC 0002-5132-48

*A11 RxPaks (prescription packages, Lilly) have safety closures.
^†ldenti-Dose® (unit dose medication, Lilly).
^‡After mixing, store in a refrigerator. Shake well before using. Keep tightly closed. The mixture may be kept for 14 days without significant loss of potency. Discard unused portion after 14 days.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]

Literature revised March 28, 2003. Manufactured by: Eli Lilly Italia, S.p.A. Sesto Florentino (Firenze), Italy for Eli Lilly and Company Indianapolis, IN 46285, USA. FDA Rev date: 3/17/2004

Last reviewed on RxList: 12/12/2007
This monograph has been modified to include the generic and brand name in many instances.