Cephadex Anhydrous Cephalexin antibiotic 500mg 100 Tablets

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INDICATIONS & USAGE

Cephalexin capsules, USP is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:

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

• Otitis media due to Streptococcus pneumoniae, Staphylococcus aureus, Streptococcus pyogenes, Haemophilus influenzae 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, Klebsiella pneumoniae and Proteus mirabilis

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

• To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cephalexin capsules, Cephalexin capsules, USP and other antibacterial drugs, 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.

Contraindications

Cephalexin is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

DOSAGE & ADMINISTRATION

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: skin and skin structure infections, streptococcal pharyngitis 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 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 one 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 Cephalexin should be administered for at least ten days.

Before taking this medicine

Do not use this medication if you are allergic to cephalexin, or other cephalosporin antibiotics, such as:

• cefaclor (Ceclor);
• cefadroxil (Duricef);
• cefdinir (Omnicef);
• cefditoren (Spectracef);
• cefixime (Suprax);
• cefprozil (Cefzil);
• ceftazidime (Fortaz); or
• cefuroxime (Ceftin).

Before using cephalexin, tell your doctor if you are allergic to any drugs (especially penicillins), or if you have:

• kidney disease;
• liver disease;
• a stomach or intestinal disorder such as colitis;
• diabetes; or
• if you are malnourished.

If you have any of these conditions, you may need a dose adjustment or special tests to take cephalexin safely.

The oral suspension (liquid) form of cephalexin may contain sugar. This may affect you if you have diabetes.

FDA pregnancy category B. Cephalexin is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Cephalexin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.