Application Nr Approved Date Route Status External Links
ANDA065409 2007-06-08 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Cefpodoxime Proxetil Is Indicated For The Treatment Of Patients With Mild To Moderate Infections Caused By Susceptible Strains Of The Designated Microorganisms In The Conditions Listed Below. Recommended Dosages, Durations Of Therapy, And Applicable Patient Populations Vary Among These Infections. Please See Dosage And Administration For Specific Recommendations. Acute Otitis Media Caused By Streptococcus Pneumoniae (excluding Penicillin-Resistant Strains), Streptococcus Pyogenes, Haemophilus Influenzae (including Beta-Lactamase-Producing Strains), Or Moraxella (branhamella) Catarrhalis (including Beta-Lactamase Producing Strains). Pharyngitis And/or Tonsillitis Caused By Streptococcus Pyogenes. Note: Only Penicillin By The Intramuscular Route Of Administration Has Been Shown To Be Effective In The Prophylaxis Of Rheumatic Fever. Cefpodoxime Proxetil Is Generally Effective In The Eradication Of Streptococci From The Oropharynx. However, Data Establishing The Efficacy Of Cefpodoxime Proxetil For The Prophylaxis Of Subsequent Rheumatic Fever Are Not Available. Community-Acquired Pneumonia Caused By S. Pneumoniae Or H. Influenzae (including Beta-Lactamase-Producing Strains). Acute Bacterial Exacerbation Of Chronic Bronchitis Caused By S. Pneumoniae, H. Influenzae (non-Beta-Lactamase-Producing Strains Only), Or M. Catarrhalis. Data Are Insufficient At This Time To Establish Efficacy In Patients With Acute Bacterial Exacerbations Of Chronic Bronchitis Caused By Beta-Lactamase-Producing Strains Of H. Influenzae. Acute, Uncomplicated Urethral And Cervical Gonorrhea Caused By Neisseria Gonorrhoeae (including Penicillinase-Producing Strains). Acute, Uncomplicated Ano-Rectal Infections In Women Due To Neisseria Gonorrhoeae (including Penicillinase-Producing Strains). Note: The Efficacy Of Cefpodoxime In Treating Male Patients With Rectal Infections Caused By N. Gonorrhoeae Has Not Been Established. Data Do Not Support The Use Of Cefpodoxime Proxetil In The Treatment Of Pharyngeal Infections Due To N. Gonorrhoeae In Men Or Women. Uncomplicated Skin And Skin Structure Infections Caused By Staphylococcus Aureus (including Penicillinase-Producing Strains) Or Streptococcus Pyogenes. Abscesses Should Be Surgically Drained As Clinically Indicated. Note: In Clinical Trials, Successful Treatment Of Uncomplicated Skin And Skin Structure Infections Was Dose-Related. The Effective Therapeutic Dose For Skin Infections Was Higher Than Those Used In Other Recommended Indications. (see Dosage And Administration .) Acute Maxillary Sinusitis Caused By Haemophilus Influenzae (including Beta-Lactamase-Producing Strains), Streptococcus Pneumoniae, And Moraxella Catarrhalis. Uncomplicated Urinary Tract Infections (cystitis) Caused By Escherichia Coli, Klebsiella Pneumoniae, Proteus Mirabilis, Or Staphylococcus Saprophyticus. Note: In Considering The Use Of Cefpodoxime Proxetil In The Treatment Of Cystitis, Cefpodoxime Proxetil’s Lower Bacterial Eradication Rates Should Be Weighed Against The Increased Eradication Rates And Different Safety Profiles Of Some Other Classes Of Approved Agents. (see Clinical Studies Section.) Appropriate Specimens For Bacteriological Examination Should Be Obtained In Order To Isolate And Identify Causative Organisms And To Determine Their Susceptibility To Cefpodoxime. Therapy May Be Instituted While Awaiting The Results Of These Studies. Once These Results Become Available, Antimicrobial Therapy Should Be Adjusted Accordingly. To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Cefpodoxime Proxetil And Other Antibacterial Drugs, Cefpodoxime Proxetil 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 (9 Total)

Name Structure Kind Function Status
1. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
2. Starch, Corn STARCH, CORN Unresolved
3. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
4. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular
5. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
6. Anhydrous Citric Acid ANHYDROUS CITRIC ACID Molecular
7. Sodium Citrate, Unspecified Form SODIUM CITRATE, UNSPECIFIED FORM Molecular
8. Sodium Benzoate SODIUM BENZOATE Molecular
9. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Cefpodoxime Proxetil CEFPODOXIME PROXETIL ZINC4468725

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