Application Nr Approved Date Route Status External Links
ANDA065234 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Cephalexin Is Indicated For The Treatment Of The Following Infections When Caused By Susceptible Strains Of The Designated Microorganisms: Respiratory Tract Infections Caused By S. Pneumoniae And S. Pyogenes . (Penicillin Is The Usual Drug Of Choice In The Treatment And Prevention Of Streptococcal Infections, Including The Prophylaxis Of Rheumatic Fever. Cephalexin 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 S. Pneumoniae, H. Influenzae , Staphylococci, Streptococci, And M. Catarrhalis . Skin And Skin Structure Infections Caused By Staphylococci And/or Streptococci. Bone Infections Caused By Staphylococci And/or P. Mirabilis . Genitourinary Tract Infections, Including Acute Prostatitis, Caused By E. Coli, P. Mirabilis, And K. 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 For Oral Suspension And Other Antibacterial Drugs, Cephalexin For Oral Suspension 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.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Cephalexin CEPHALEXIN ZINC3830500

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