Cephalexin

Product manufactured by Denton Pharma, Inc.

Application Nr Approved Date Route Status External Links
ANDA090836 2013-03-29 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

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 Streptococcuspyogenes. 1.2 Otitis Media Cephalexin Is Indicated For The Treatment Of Otitis Media Caused By Susceptible Isolates Of Streptococcuspneumoniae, Haemophilus Infl Uenz Ae, Staphylococcus Aureus, Streptococcuspyogenes, And Mo Raxella 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 Treat Ment Of Bone Infections Caused By Susceptible Isolates Of Staphylococcusaureus And Proteus Mi Rabilis. 1.5 Genitourinary Tract Infections Cephalexin Is Indicated For The Treatment Of Genitourinary Tract Infections, Including Acute Prostatitis, Caused By Susceptible Isolates Of Escheric Hia C Oli, Proteus Mirabilis, And Klebsiella Pneumonia E. 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.

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
3. D&c Yellow No. 10 D&C YELLOW NO. 10 Molecular DYE-Dye
4. Gelatin GELATIN Unresolved
5. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
6. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.

Active Ingredients ( 1 Total)

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

Comments