Keflex (Cephalexin) - Indications and Dosage

INDICATIONS AND USAGE

Keflex is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:

Respiratory tract infections caused by S. pneumoniae and S. pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Keflex is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of Keflex in the subsequent prevention of rheumatic fever are not available at present.)

Otitis media due to S. pneumoniae, H. influenzae, staphylococci, streptococci, and M. catarrhalis

Skin and skin structure infections caused by staphylococci and/or streptococci

Bone infections caused by staphylococci and/or P. mirabilis

Genitourinary tract infections, including acute prostatitis, caused by E. coli, P. mirabilis, and K. pneumoniae

Note --Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Keflex and other antibacterial drugs, Keflex 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.

DOSAGE AND ADMINISTRATION

Keflex is administered orally.

Adults --The adult dosage ranges from 1 to 4 g daily in divided doses. The usual adult dose is 250 mg every 6 hours. For the following infections, a dosage of 500 mg may be administered every 12 hours: streptococcal pharyngitis, skin and skin structure infections, and uncomplicated cystitis in patients over 15 years of age. Cystitis therapy should be continued for 7 to 14 days. For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of Keflex greater than 4 g are required, parenteral cephalosporins, in appropriate doses, should be considered.

Pediatric Patients --The usual recommended daily dosage for pediatric patients is 25 to 50 mg/kg in divided doses. For streptococcal pharyngitis in patients over 1 year of age and for skin and skin structure infections, the total daily dose may be divided and administered every 12 hours.

In severe infections, the dosage may be doubled.

In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100 mg/kg/day in 4 divided doses is required.

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

HOW SUPPLIED

Keflex® (Cephalexin Capsules, USP), are available in:

The 250 mg Pulvules® are a white powder filled into size 2 Posilok® Caps (opaque white and opaque dark green) that are imprinted with "Dista" and identity code "H69" on the green cap, and Keflex 250 mg on the white body in edible black ink. They are available as follows:

Bottles of 20 NDC 0777-0869-20 (PU402)

Bottles of 100 NDC 0777-0869-02 (PU402)

The 500 mg Pulvules are a white powder filled into an elongated, size 0 Posilok Caps (opaque light green and opaque dark green) that are imprinted with "Dista" and identity code "H71" on the dark green cap, and Keflex 500 mg on the light green body in edible black ink. They are available as follows:

Bottles of 20 NDC 0777-0871-20 (PU403)

Bottles of 100 NDC 0777-0871-02 (PU403)

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