cephalexin 500 mg
1 INDICATIONS & USAGE Cephalexin is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria: Respiratory tract infection ( 1.1 ) Otitis media ( 1.2 ) Skin and skin structure infections ( 1.3 ) Bone infections (1.4) Genitourinary tract infections ( 1.5 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, Cephalexin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.6) 1.1 Respiratory Tract Infections Cephalexin is indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes. 1.2 Otitis Media Cephalexin is indicated for the treatment of otitis media caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. 1.3 Skin and Skin Structure Infections Cephalexin is 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. 1.4 Bone Infections Cephalexin is indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis. 1.5 Genitourinary Tract Infections Cephalexin is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae. 1.6 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, Cephalexin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information is available, this information 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.
Ascend Laboratories, LLC
CAPSULE GREEN 219
219 CAPSULE GREEN
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16 HOW SUPPLIED/STORAGE AND HANDLING
CEPHALEXIN capsules, USP, are supplied as follows: The 250 mg capsules are a white to off white powder filled into size 2 capsules (dark green cap and dark green body) that are imprinted with “220” on the both cap and body in edible black ink. They are available as follows: Bottles of 20 NDC-67877-220-20 Bottles of 100 NDC-67877-220-01 Bottles of 500 NDC-67877-220-05 Bottles of 1000 NDC-67877-220-10 30 capsules (3 x 10 Unit-Dose) NDC 67877-220-84 50 capsules (5 x 10 Unit-Dose) NDC-67877-220-74 100 capsules (10 x 10 Unit-Dose) NDC-67877-220-38 The 500 mg capsules are a white to off white powder filled into size 0 capsules (light green cap and light green body) that are imprinted with “219” on the both cap and body in edible black ink. They are available as follows: Bottles of 20 NDC-67877-219-20 Bottles of 100 NDC-67877-219-01 Bottles of 500 NDC-67877-219-05 Bottles of 1000 NDC-67877-219-10 30 capsules (3 x 10 Unit-Dose) NDC 67877-219-84 50 capsules (5 x 10 Unit-Dose) NDC-67877-219-74 100 capsules (10 x 10 Unit-Dose) NDC-67877-219-38 The 333 mg capsules are a white to off white powder filled into size 1 capsules (light green cap and light green body) that are imprinted “CEP” on cap and “333” on body in edible black ink. They are available as follows: Bottles of 20 NDC-67877-254-20 Bottles of 100 NDC-67877-254-01 Bottle of 500 NDC-67877-254-05 Bottle of 1000 NDC-67877-254-10 100 capsules (10 X 10 Unit-Dose) NDC-67877-254-38 The 750 mg capsules are a white to off white powder filled into size '00 elongated' capsules (dark green cap and dark green body) that are imprinted “CEP” on cap and “750” on body in edible white ink. They are available as follows: Bottles of 20 NDC-67877-255-20 Bottles of 50 NDC-67877-255-23 Bottles of 100 NDC-67877-255-01 Bottle of 500 NDC-67877-255-05 Bottle of 1000 NDC-67877-255-10 Store at 20°C to 25°C (68°F to77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].
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