(Approval lapsed) Cephalexin capsules, USP 500mg (Ascend)

Treatment of the following infections when caused by susceptible strains of the designated micro-organisms.

Respiratory tract infections. Caused by S. pneumoniae and group A β-haemolytic Streptococci (penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefalexin is generally effective in the eradication of Streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefalexin in the subsequent prevention of rheumatic fever are not available at present).

Bacterial sinusitis. Caused by Streptococci, S. pneumoniae and S. aureus (methicillin sensitive only).

Otitis media. Due to S. pneumoniae, Staphylococci.

Skin and skin structure infections. Caused by Staphylococci and/or Streptococci.

Genitourinary tract infections, including acute prostatitis. Caused by E. coli, P. mirabilis, and Klebsiella sp.

The effectiveness of cefalexin in the treatment of bacterial infections of the brain and spinal column has not been established and cefalexin is not indicated in these conditions.

Note. Appropriate culture and susceptibility tests should be initiated prior to and during therapy to determine susceptibility of the causative organism to cefalexin. Renal function studies should be performed when indicated.