Cephalexin 500 MG Oral Capsule
INDICATIONS AND USAGE Cephalexin capsules, USP are 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. Cephalexin capsules, USP are generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin capsules, USP 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 cephalexin capsules, USP and other antibacterial drugs, cephalexin capsules, 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.
aidarex pharmaceuticals llc
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HOW SUPPLIED Cephalexin capsules, USP, are available in: The 250 mg cephalexin capsules, USP are a white to off white powder filled into size 2 capsules (opaque dark green cap and opaque white body) that are imprinted with “293” in edible black ink on cap and body. They are available as follows: Bottle of 20’s NDC 33261-149-20 Bottle of 28’s NDC 33261-149-28 Bottle of 30’s NDC 33261-149-30 Bottle of 40’s NDC 33261-149-40 Bottle of 100’s NDC 33261-149-00 The 500 mg cephalexin capsules, USP are a white to off white powder filled into size 0 capsules (opaque dark green cap and opaque light green body) that are imprinted with “294” in edible black ink on cap and body. They are available as follows: Bottle of 20’s NDC 33261-020-20 Bottle of 28’s NDC 33261-020-28 Bottle of 30’s NDC 33261-020-30 Bottle of 40’s NDC 33261-020-40 Bottle of 100’s NDC 33261-020-00 Store at 25°C (77°F); excursions permitted to 15‑30°C (59‑86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.
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