Overview
Cefprozil is a cephalosporin antibiotic that is commonly employed to treat a variety of bacterial infections, including those of the ear and skin, bronchitis, and others.
Indication
For the treatment of the following infections (respiratory, skin, soft tissue, UTI, ENT) caused by; S. pneumoniae, H. influenzae, staphylococci, S. pyogenes (group A beta-hemolytic streptococci), E. coli, P. mirabilis, Klebsiella sp, coagulase-negative staph
Associated Conditions
- Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB)
- Bacterial Infections
- Community Acquired Pneumonia (CAP)
- Streptococcal Pharyngitis
- Tonsillitis streptococcal
- Urinary Tract Infection
- Bacterial otitis media
- Uncomplicated skin and subcutaneous tissue bacterial infections
Research Report
Cefprozil (DB01150): A Comprehensive Pharmacological and Clinical Monograph
Section 1: Drug Identification and Chemical Profile
Cefprozil is a semi-synthetic, orally administered, second-generation cephalosporin antibiotic. As a member of the β-lactam class of antibacterial agents, it has played a significant role in the management of common community-acquired bacterial infections since its introduction. This section provides a detailed overview of its chemical identity, nomenclature, and physicochemical properties, which form the basis of its pharmacological activity and clinical utility.
1.1 Nomenclature and Identifiers
The precise identification of a pharmaceutical agent is fundamental for clinical practice, research, and regulatory affairs. Cefprozil is identified by a standardized set of names and registry numbers that ensure unambiguous communication across different disciplines and databases.
- Systematic (IUPAC) Name: The definitive chemical name for Cefprozil is (6R,7R)−7−amino]−8−oxo−3−prop−1−enyl−5−thia−1−azabicyclo[4.2.0]oct−2−ene−2−carboxylicacid.[1] This nomenclature precisely defines the molecule's core cephem structure, the stereochemistry at its chiral centers (critical for its interaction with bacterial enzymes), and the specific side chains that determine its spectrum of activity and pharmacokinetic properties.
- Registry Numbers and Database Identifiers: Cefprozil is cataloged in major chemical and pharmacological databases under unique identifiers. The Chemical Abstracts Service (CAS) Number is 92665-29-7, which serves as a universal identifier for the substance.[1] Its DrugBank accession number is DB01150, linking it to a comprehensive database of drug data.[1] A consolidated list of key identifiers is presented in Table 1.
- Synonyms and Trade Names: In research and early development, Cefprozil was known by the code BMY-28100.[2] A common synonym is Cefproxil.[1] Following its regulatory approval, it was market
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
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2024/07/10 | Phase 4 | Recruiting | |||
2020/06/04 | Phase 1 | Completed | |||
2009/04/15 | Phase 1 | Completed | |||
2009/04/15 | Phase 1 | Completed | |||
2009/04/15 | Phase 1 | Completed | |||
2009/04/15 | Phase 1 | Completed | |||
2009/02/10 | Phase 1 | Completed | |||
2009/02/10 | Phase 1 | Completed | |||
2009/02/03 | Phase 1 | Completed | |||
2009/02/03 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
RedPharm Drug Inc. | 67296-0590 | ORAL | 500 mg in 1 1 | 7/7/2011 | |
A-S Medication Solutions | 50090-1188 | ORAL | 500 mg in 1 1 | 8/9/2018 | |
Rising Health, LLC | 57237-034 | ORAL | 125 mg in 5 mL | 10/26/2022 | |
Physicians Total Care, Inc. | 54868-5757 | ORAL | 250 mg in 5 mL | 12/8/2010 | |
Teva Pharmaceuticals USA, Inc. | 0093-1077 | ORAL | 250 mg in 1 1 | 8/31/2018 | |
Aurobindo Pharma Limited | 65862-099 | ORAL | 125 mg in 5 mL | 12/31/2021 | |
Aurobindo Pharma Limited | 65862-068 | ORAL | 250 mg in 1 1 | 12/23/2021 | |
Rising Health, LLC | 57237-035 | ORAL | 250 mg in 5 mL | 10/26/2022 | |
Wockhardt USA LLC. | 64679-713 | ORAL | 500 mg in 1 1 | 11/26/2019 | |
A-S Medication Solutions | 50090-1739 | ORAL | 500 mg in 1 1 | 9/24/2019 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
SANDOZ CEFPROZIL | 02302187 | Tablet - Oral | 500 MG | 1/24/2008 | |
APO-CEFPROZIL | 02293951 | Powder For Suspension - Oral | 250 MG / 5 ML | 4/20/2007 | |
NU-CEFPROZIL | nu-pharm inc | 02336340 | Powder For Suspension - Oral | 125 MG / 5 ML | N/A |
CEFZIL TABLETS - 250MG | bristol-myers squibb canada | 02163659 | Tablet - Oral | 250 MG | 12/31/1995 |
CEFZIL POWDER FOR ORAL SUSPENSION-125MG/5ML | bristol-myers squibb canada | 02163675 | Powder For Suspension - Oral | 125 MG / 5 ML | 12/31/1995 |
NU-CEFPROZIL | nu-pharm inc | 02336111 | Tablet - Oral | 500 MG | N/A |
APO-CEFPROZIL | 02293943 | Powder For Suspension - Oral | 125 MG / 5 ML | 4/20/2007 | |
CEFZIL POWDER FOR ORAL SUSPENSION-250 MG/ 5 ML | bristol-myers squibb canada | 02163683 | Powder For Suspension - Oral | 250 MG / 5 ML | 12/31/1995 |
NU-CEFPROZIL | nu-pharm inc | 02336359 | Powder For Suspension - Oral | 250 MG / 5 ML | N/A |
NU-CEFPROZIL | nu-pharm inc | 02336103 | Tablet - Oral | 250 MG | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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