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Keflex

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Keflex

Keflex

INDICATIONS

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

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

Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis

Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes

Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis

Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella 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 (cephalexin) and other antibacterial drugs, Keflex (cephalexin) 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 (cephalexin) is administered orally.

Adults — The adult dosage ranges from 1 to 4 g daily in divided doses. The 333 mg and 750 mg strengths should be administered such that the daily dose is within 1 to 4 grams per day. 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 (cephalexin) 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 β-hemolytic streptococcal infections, a therapeutic dosage of Keflex (cephalexin) should be administered for at least 10 days.

HOW SUPPLIED

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

The 250 mg capsules are a white powder filled into size 2 capsules (opaque white and opaque dark green) that are imprinted with Keflex (cephalexin) 250 mg on the white body in edible black ink. They are available as follows:

Bottles of 20 NDC 11042-112-97
Bottles of 100 NDC 11042-112-96

The 333 mg capsules are a white powder filled into size 1 capsules (opaque light green and opaque light green) that are imprinted Keflex (cephalexin) 333 mg on the light green body in edible black ink. They are available as follows:

Bottles of 50 NDC 11042-114-40

The 500 mg capsules are a white powder filled into size 0 capsules (opaque light green and opaque dark green) that are imprinted with Keflex (cephalexin) 500 mg on the light green body in edible black ink. They are available as follows:

Bottles of 20NDC 11042-113-97
Bottles of 100 NDC 11042-113-96

The 750 mg capsules are a white powder filled into elongated size 00 capsules (opaque dark green and opaque dark green) that are imprinted Keflex (cephalexin) 750 mg on the dark green body in edible white ink. They are available as follows:

Bottles of 50 NDC 11042-115-40

Display box of 10 cartons each containing 1 blister card of 1 capsule as a sample package (Not For ReSale) NDC 11042-115-01

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

Literature revised October 26, 2006. Manufactured by: CEPH International Corporation, Carolina, PR 00985 for MIDDLEBROOK PHARMACEUTICALS, INC., Germantown, Maryland 20876, USA. Revision Date: 06/07. FDA revision date: 9/16/2008

Last reviewed on RxList: 11/8/2010
This monograph has been modified to include the generic and brand name in many instances.

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