Cephalexin Cephalexin 500 MG Oral Capsule
1 INDICATIONS AND 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 capsules, and cephalexin for oral suspension and other antibacterial drugs, cephalexin capsules, and cephalexin for oral suspension 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 capsules, and cephalexin for oral suspension and other antibacterial drugs, cephalexin capsules, and cephalexin for oral suspension 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.
Teva Pharmaceuticals USA Inc
CAPSULE ORANGE Teva 3147
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16 HOW SUPPLIED/STORAGE AND HANDLING
CEPHALEXIN capsules USP 250 mg: Swedish orange body and gray cap imprinted “TEVA” on the cap and “3145” on the body, in bottles of 100 (NDC 0093-3145-01) and 500 (NDC 0093-3145-05). 500 mg: Swedish orange body and Swedish orange cap imprinted “TEVA” on the cap and “3147” on the body, in bottles of 100 (NDC 0093-3147-01) and 500 (NDC 0093-3147-05). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.
CEPHALEXIN for Oral Suspension * USP (a cherry mixed fruit flavored formula) 125 mg/5 mL: bottles of 100 mL (NDC 0093-4175-73) and 200 mL (NDC 0093-4175-74). 250 mg/5 mL: bottles of 100 mL (NDC 0093-4177-73) and 200 mL (NDC 0093-4177-74). Directions for mixing are included on the label. Store dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Shake well before using. Keep tightly closed. * After mixing, store in refrigerator. May be kept for 14 days without significant loss of potency.
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