Application Nr Approved Date Route Status External Links
ANDA065208 2005-12-06 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Cefprozil 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: Upper Respiratory Tract 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. Cefprozil Is Generally Effective In The Eradication Of Streptococcus Pyogenes From The Nasopharynx; However, Substantial Data Establishing The Efficacy Of Cefprozil In The Subsequent Prevention Of Rheumatic Fever Are Not Available At Present. Otitis Media Caused By Streptococcus Pneumoniae, Haemophilus Influenzae (including Β-Lactamase-Producing Strains), And Moraxella (branhamella) Catarrhalis (including Β-Lactamase-Producing Strains) (see Clinical Studies ). Note: In The Treatment Of Otitis Media Due To Β-Lactamase Producing Organisms, Cefprozil Had Bacteriologic Eradication Rates Somewhat Lower Than Those Observed With A Product Containing A Specific Β-Lactamase Inhibitor. In Considering The Use Of Cefprozil, Lower Overall Eradication Rates Should Be Balanced Against The Susceptibility Patterns Of The Common Microbes In A Given Geographic Area And The Increased Potential For Toxicity With Products Containing Β-Lactamase Inhibitors. Acute Sinusitis Caused By Streptococcus Pneumoniae, Haemophilus Influenza (including Β-Lactamase-Producing Strains), And Moraxella (branhamella) Catarrhalis (including Β-Lactamase-Producing Strains). Lower Respiratory Tract Acute Bacterial Exacerbation Of Chronic Bronchitis Caused By Streptococcus Pneumoniae, Haemophilus Influenzae (including Β-Lactamase-Producing Strains), And Moraxella (branhamella) Catarrhalis (including Β-Lactamase-Producing Strains). Skin And Skin Structure Uncomplicated Skin And Skin-Structure Infections Caused By Staphylococcus Aureus (including Penicillinase-Producing Strains) And Streptococcus Pyogenes. Abscesses Usually Require Surgical Drainage. To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Cefprozil Tablets And Other Antibacterial Drugs, Cefprozil 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.

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Hypromelloses HYPROMELLOSES Unresolved
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. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
4. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
5. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Cefprozil CEFPROZIL ZINC4474443

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