Cefaclor

Cefaclor is indicated for the treatment of the following infections due to susceptible micro-organisms: • Respiratory tract infections, including pneumonia, bronchitis, exacerbations of chronic bronchitis, pharyngitis and tonsillitis, and as part of the management of sinusitis.

• Otitis media. • Skin and soft tissue infections. • Urinary tract infections, including pyelonephritis and cystitis. • Cefaclor has been found to be effective in both acute and chronic urinary tract infections. • Cefaclor is generally effective in the eradication of streptococci from the nasopharynx, but data establishing efficacy in the subsequent prevention of either rheumatic fever or bacterial endocarditis are not available.

INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefaclor extended-release tablets USP and other antibacterial drugs, cefaclor extended-release tablets USP 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.

The safety and effectiveness of cefaclor extended-release tablets in treating some of the indications and pathogens for which other formulations of cefaclor are approved have NOT been established. When administered at the recommended dosages and durations of therapy, cefaclor extended-release tablets are indicated for the treatment of patients with the following mild to moderate infections when caused by susceptible strains of the designated organisms.