Application Nr Approved Date Route Status External Links
ANDA065359 2008-02-15 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Cefuroxime Axetil Tablets And Other Antibacterial Drugs, Cefuroxime Axetil Tablets 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. Note: Cefuroxime Axetil Tablets And Cefuroxime Axetil For Oral Suspension Are Not Bioequivalent And Are Not Substitutable On A Milligram-Per-Milligram Basis (see Clinical Pharmacology) Cefuroxime Axetil Tablets Cefuroxime Axetil Tablets Are Indicated For The Treatment Of Patients With Mild To Moderate Infections Caused By Susceptible Strains Of The Designated Microorganisms In The Conditions Listed Below: 1. Pharyngitis/tonsillitis Caused By Streptococcus Pyogenes. Note: The Usual Drug Of Choice In The Treatment And Prevention Of Streptococcal Infections, Including The Prophylaxis Of Rheumatic Fever, Is Penicillin Given By The Intramuscular Route. Cefuroxime Axetil Tablets Are Generally Effective In The Eradication Of Streptococci From The Nasopharynx; However, Substantial Data Establishing The Efficacy Of Cefuroxime In The Subsequent Prevention Of Rheumatic Fever Are Not Available. Please Also Note That In All Clinical Trials, All Isolates Had To Be Sensitive To Both Penicillin And Cefuroxime. There Are No Data From Adequate And Well-Controlled Trials To Demonstrate The Effectiveness Of Cefuroxime In The Treatment Of Penicillin-Resistant Strains Of Streptococcus Pyogenes. 2. Acute Bacterial Otitis Media Caused By Streptococcus Pneumoniae, Haemophilus Influenzae (including Beta-Lactamase-Producing Strains), Moraxella Catarrhalis (including Beta-Lactamase-Producing Strains), Or Streptococcus Pyogenes. 3. Acute Bacterial Maxillary Sinusitis Caused By Streptococcus Pneumoniae Or Haemophilus Influenzae (non-Beta-Lactamase-Producing Strains Only). (see Clinical Studies Section.) Note: In View Of The Insufficient Numbers Of Isolates Of Beta-Lactamase-Producing Strains Of Haemophilus Influenzae And Moraxella Catarrhalis That Were Obtained From Clinical Trials With Cefuroxime Axetil Tablets For Patients With Acute Bacterial Maxillary Sinusitis, It Was Not Possible To Adequately Evaluate The Effectiveness Of Cefuroxime Axetil Tablets For Sinus Infections Known, Suspected, Or Considered Potentially To Be Caused By Beta-Lactamase-Producing Haemophilus Influenzae Or Moraxella Catarrhalis. 4. Acute Bacterial Exacerbations Of Chronic Bronchitis And Secondary Bacterial Infections Of Acute Bronchitis Caused By Streptococcus Pneumoniae, Haemophilus Influenzae (beta-Lactamase Negative Strains), Or Haemophilus Parainfluenzae (beta-Lactamase Negative Strains). (see Dosage And Administration Section And Clinical Studies Section.) 5. Uncomplicated Skin And Skin-Structure Infections Caused By Staphylococcus Aureus (including Beta-Lactamase-Producing Strains) Or Streptococcus Pyogenes. 6. Uncomplicated Urinary Tract Infections Caused By Escherichia Coli Or Klebsiella Pneumoniae. 7. Uncomplicated Gonorrhea, Urethral And Endocervical, Caused By Penicillinase-Producing And Non-Penicillinase-Producing Strains Of Neisseria Gonorrhoeae And Uncomplicated Gonorrhea, Rectal, In Females, Caused By Non-Penicillinase-Producing Strains Of Neisseria Gonorrhoeae. 8. Early Lyme Disease (erythema Migrans) Caused By Borrelia Burgdorferi.

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
2. 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.
3. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
4. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Cefuroxime Axetil

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