Indicated for:

Respiratory Tract Infections:

• Indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes.

Otitis Media:

• Indicated for the treatment of otitis media caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis.

Skin and Skin Structure Infections:

• Indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus and Streptococcus pyogenes.

Bone Infections:

• Indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis.

Genitourinary Tract Infections:

• Indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae.

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

KEFLEX should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

Cephalexin should be administered with caution in the presence of impaired renal function (creatinine clearance < 30 mL/min, with or without dialysis). Under such conditions, careful clinical observation and laboratory studies renal function monitoring should be conducted because safe dosage may be lower than that usually recommended.

Antibiotic associated pseudomembranous colitis has been reported with virtually all broad-spectrum antibiotics (including macrolides, semisynthetic penicillins and cephalosporins). The severity of the colitis may range from mild to life threatening. It is important to consider the diagnosis in patients who develop diarrhoea or colitis in association with antibiotic use.

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including KEFLEX, and may range in severity from mild diarrhea to fatal colitis.

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced.

Allergic reactions in the form of rash, urticaria, angioedema, anaphylaxis, erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis have been reported with the use of KEFLEX.

Positive direct Coombs’ tests have been reported during treatment with the cephalosporin antibacterial drugs including cephalexin. Acute intravascular hemolysis induced by cephalexin therapy has been reported.

Cephalosporins may be associated with prolonged prothrombin time.

Administration of KEFLEX with metformin results in increased plasma metformin concentrations and decreased renal clearance of metformin.

Co-administration of probenecid with KEFLEX is not recommended.

A false-positive reaction may occur when testing for the presence of glucose in the urine using Benedict’s solution or Fehling’s solution.

Available data from published epidemiologic studies and pharmacovigilance case reports over several decades with cephalosporin use, including KEFLEX use in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Data from a published clinical lactation study reports that cephalexin is present in human milk.

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• Prophylaxis for simple hand lacerations. GoToSource

• Acne. GoToSource 

Thrombotic thrombocytopenic purpura (clotting in small blood vessels). GoToSource

Urticaria (hives). GoToSource

Hypersensitivity myocarditis. GoToSource

Tubular necrosis (kidney injury). GoToSource

Interstitial nephritis (kidney disorder in which spaces between the kidney tubules become swollen). GoToSource

Pseudomembranous colitis (inflammation of the colon). GoToSource

Stevens-johnson syndrome (severe drug reaction). GoToSource

Clostridium difficile-associated diarrhea. GoToSource

Seizures. GoToSource

Anaphylactic reactions. GoToSource

Lawsuits filed for stevens-johnson syndrome and toxic epidermal necrolysis.