CEFPROZIL

Description
Sources: http://www.sandoz.ca/cs/groups/public/@sge_ca/documents/document/n_prod_1324519.pdf
Curator's Comment: description was created based on several sources, including: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050664s026,050665s026lbl.pdf | https://www.drugs.com/pro/cefprozil.html | https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a547cc0a-6af0-49c7-a5ea-c41684cc36ae | http://www.wikidoc.org/index.php/Cefprozil

Cefprozil is a 2nd generation cephalosporin that is FDA approved for the treatment of mild to moderate infections of upper respiratory tract, lower respiratory tract, and uncomplicated skin and skin-structure infections. Cefprozil, like the penicillins, is a beta-lactam antibiotic. By binding to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, it inhibits the third and last stage of bacterial cell wall synthesis. Common adverse reactions include diarrhea, nausea, vomiting, dizziness, abdominal pain and vaginitis. Nephrotoxicity has been reported following concomitant administration of aminoglycoside antibiotics and cephalosporin antibiotics. Concomitant administration of probenecid doubled the AUC for cefprozil.

CNS Activity

Originator

Approval Year

Targets

Primary Target	Pharmacology	Condition	Potency
Penicillin-binding protein 2B 10 Target ID: P0A3M6 Gene ID: 933948.0 Gene Symbol: penA Target Organism: Streptococcus pneumoniae (strain ATCC BAA-255 / R6) Sources: https://www.ncbi.nlm.nih.gov/pubmed/11959556	Inhibitor 8504
Penicillin-binding protein 1A 45 Target ID: Q8DR59 Gene ID: 934791.0 Gene Symbol: pbpA Target Organism: Streptococcus pneumoniae (strain ATCC BAA-255 / R6) Sources: https://www.ncbi.nlm.nih.gov/pubmed/11959556	Inhibitor 8504
Penicillin-binding protein 2X 5 Target ID: P59676 Gene ID: 934744.0 Gene Symbol: pbpX Target Organism: Streptococcus pneumoniae (strain ATCC BAA-255 / R6) Sources: https://www.ncbi.nlm.nih.gov/pubmed/11959556	Inhibitor 8504

Conditions

Condition	Modality	Highest Phase	Product
Uncomplicated urinary tract infections 7 Sources: http://www.sandoz.ca/cs/groups/public/@sge_ca/documents/document/n_prod_1324519.pdf	Curative	Approved 8583	CEFPROZIL Approved Use 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 ß-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including ß-lactamase-producing strains). (See CLINICAL STUDIES.) NOTE: In the treatment of otitis media due to ß-lactamase producing organisms, cefprozil had bacteriologic eradication rates somewhat lower than those observed with a product containing a specific ß-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 ß-lactamase inhibitors. Acute Sinusitis: Caused by Streptococcus pneumoniae, Haemophilus influenzae (including ß-lactamase producing strains), and Moraxella (Branhamella) catarrhalis (including ß-lactamase-producing strains). Lower Respiratory Tract: Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial Exacerbation of Chronic Bronchitis: Caused by Streptococcus pneumoniae, Haemophilus influenzae (including ß-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including ß-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. Launch Date 2005
Uncomplicated skin and skin-structure infections 21 Sources: http://www.sandoz.ca/cs/groups/public/@sge_ca/documents/document/n_prod_1324519.pdf	Curative	Approved 8583	CEFPROZIL Approved Use 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 ß-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including ß-lactamase-producing strains). (See CLINICAL STUDIES.) NOTE: In the treatment of otitis media due to ß-lactamase producing organisms, cefprozil had bacteriologic eradication rates somewhat lower than those observed with a product containing a specific ß-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 ß-lactamase inhibitors. Acute Sinusitis: Caused by Streptococcus pneumoniae, Haemophilus influenzae (including ß-lactamase producing strains), and Moraxella (Branhamella) catarrhalis (including ß-lactamase-producing strains). Lower Respiratory Tract: Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial Exacerbation of Chronic Bronchitis: Caused by Streptococcus pneumoniae, Haemophilus influenzae (including ß-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including ß-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. Launch Date 2005
Acute sinusitis 2 Sources: http://www.sandoz.ca/cs/groups/public/@sge_ca/documents/document/n_prod_1324519.pdf	Curative	Approved 8583	CEFPROZIL Approved Use 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 ß-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including ß-lactamase-producing strains). (See CLINICAL STUDIES.) NOTE: In the treatment of otitis media due to ß-lactamase producing organisms, cefprozil had bacteriologic eradication rates somewhat lower than those observed with a product containing a specific ß-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 ß-lactamase inhibitors. Acute Sinusitis: Caused by Streptococcus pneumoniae, Haemophilus influenzae (including ß-lactamase producing strains), and Moraxella (Branhamella) catarrhalis (including ß-lactamase-producing strains). Lower Respiratory Tract: Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial Exacerbation of Chronic Bronchitis: Caused by Streptococcus pneumoniae, Haemophilus influenzae (including ß-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including ß-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. Launch Date 2005
Otitis media 42 Sources: http://www.sandoz.ca/cs/groups/public/@sge_ca/documents/document/n_prod_1324519.pdf	Curative	Approved 8583	CEFPROZIL Approved Use 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 ß-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including ß-lactamase-producing strains). (See CLINICAL STUDIES.) NOTE: In the treatment of otitis media due to ß-lactamase producing organisms, cefprozil had bacteriologic eradication rates somewhat lower than those observed with a product containing a specific ß-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 ß-lactamase inhibitors. Acute Sinusitis: Caused by Streptococcus pneumoniae, Haemophilus influenzae (including ß-lactamase producing strains), and Moraxella (Branhamella) catarrhalis (including ß-lactamase-producing strains). Lower Respiratory Tract: Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial Exacerbation of Chronic Bronchitis: Caused by Streptococcus pneumoniae, Haemophilus influenzae (including ß-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including ß-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. Launch Date 2005
Pharyngitis 31 Sources: http://www.sandoz.ca/cs/groups/public/@sge_ca/documents/document/n_prod_1324519.pdf	Curative	Approved 8583	CEFPROZIL Approved Use 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 ß-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including ß-lactamase-producing strains). (See CLINICAL STUDIES.) NOTE: In the treatment of otitis media due to ß-lactamase producing organisms, cefprozil had bacteriologic eradication rates somewhat lower than those observed with a product containing a specific ß-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 ß-lactamase inhibitors. Acute Sinusitis: Caused by Streptococcus pneumoniae, Haemophilus influenzae (including ß-lactamase producing strains), and Moraxella (Branhamella) catarrhalis (including ß-lactamase-producing strains). Lower Respiratory Tract: Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial Exacerbation of Chronic Bronchitis: Caused by Streptococcus pneumoniae, Haemophilus influenzae (including ß-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including ß-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. Launch Date 2005
Tonsillitis 36 Sources: http://www.sandoz.ca/cs/groups/public/@sge_ca/documents/document/n_prod_1324519.pdf	Curative	Approved 8583	CEFPROZIL Approved Use 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 ß-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including ß-lactamase-producing strains). (See CLINICAL STUDIES.) NOTE: In the treatment of otitis media due to ß-lactamase producing organisms, cefprozil had bacteriologic eradication rates somewhat lower than those observed with a product containing a specific ß-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 ß-lactamase inhibitors. Acute Sinusitis: Caused by Streptococcus pneumoniae, Haemophilus influenzae (including ß-lactamase producing strains), and Moraxella (Branhamella) catarrhalis (including ß-lactamase-producing strains). Lower Respiratory Tract: Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial Exacerbation of Chronic Bronchitis: Caused by Streptococcus pneumoniae, Haemophilus influenzae (including ß-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including ß-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. Launch Date 2005

C_max

Value	Dose	Analyte	Population
3534.7 ng/mL CLINICAL TRIAL 10.1007/s12325-020-01593-7	125 mg single, oral dose: 125 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFPROZIL plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
2438.8 ng/mL CLINICAL TRIAL 10.1007/s12325-020-01593-7	125 mg single, oral dose: 125 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFPROZIL plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FED
2429.8 ng/mL CLINICAL TRIAL 10.1007/s12325-020-01593-7	125 mg single, oral dose: 125 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFPROZIL plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FED
3873 ng/mL CLINICAL TRIAL 10.1007/s12325-020-01593-7	125 mg single, oral dose: 125 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFPROZIL plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
12.3 mg/L REVIEW https://doi.org/10.1093/clinids/14.Supplement_2.S184	1000 mg single, oral dose: 1000 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFPROZIL plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
30.4 mg/L REVIEW https://doi.org/10.1093/clinids/14.Supplement_2.S184	1000 mg single, oral dose: 1000 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFPROZIL plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
15.8 mg/L REVIEW https://doi.org/10.1093/clinids/14.Supplement_2.S184	1000 mg single, oral dose: 1000 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFPROZIL plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
5.7 mg/L REVIEW https://link.springer.com/article/10.2165/00003495-199345020-00008	250 mg single, oral dose: 250 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFPROZIL plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
11.16 μg/mL CLINICAL TRIAL https://doi.org/10.1128/AAC.34.11.2152	15 mg/kg single, oral dose: 15 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	CEFPROZIL plasma	Homo sapiens population: HEALTHY age: CHILD sex: UNKNOWN food status: FED
15.93 μg/mL CLINICAL TRIAL https://doi.org/10.1128/AAC.34.11.2152	30 mg/kg single, oral dose: 30 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	CEFPROZIL plasma	Homo sapiens population: HEALTHY age: CHILD sex: UNKNOWN food status: FED

AUC

Value	Dose	Analyte	Population
9379.22 ng × h/mL CLINICAL TRIAL 10.1007/s12325-020-01593-7	125 mg single, oral dose: 125 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFPROZIL plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
9470.52 ng × h/mL CLINICAL TRIAL 10.1007/s12325-020-01593-7	125 mg single, oral dose: 125 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFPROZIL plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FED
9547.96 ng × h/mL CLINICAL TRIAL 10.1007/s12325-020-01593-7	125 mg single, oral dose: 125 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFPROZIL plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FED
10177.93 ng × h/mL CLINICAL TRIAL 10.1007/s12325-020-01593-7	125 mg single, oral dose: 125 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFPROZIL plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
63 mg × h/L REVIEW https://doi.org/10.1093/clinids/14.Supplement_2.S184	1000 mg single, oral dose: 1000 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFPROZIL plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
260 mg × h/L REVIEW https://doi.org/10.1093/clinids/14.Supplement_2.S184	1000 mg single, oral dose: 1000 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFPROZIL plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
71 mg × h/L REVIEW https://doi.org/10.1093/clinids/14.Supplement_2.S184	1000 mg single, oral dose: 1000 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFPROZIL plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
28.05 μg × h/mL CLINICAL TRIAL https://doi.org/10.1128/AAC.34.11.2152	15 mg/kg single, oral dose: 15 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	CEFPROZIL plasma	Homo sapiens population: HEALTHY age: CHILD sex: UNKNOWN food status: FED
44.13 μg × h/mL CLINICAL TRIAL https://doi.org/10.1128/AAC.34.11.2152	30 mg/kg single, oral dose: 30 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	CEFPROZIL plasma	Homo sapiens population: HEALTHY age: CHILD sex: UNKNOWN food status: FED

T_1/2

Value	Dose	Analyte	Population
1.37 h CLINICAL TRIAL 10.1007/s12325-020-01593-7	125 mg single, oral dose: 125 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFPROZIL plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
1.36 h CLINICAL TRIAL 10.1007/s12325-020-01593-7	125 mg single, oral dose: 125 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFPROZIL plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FED
1.63 h REVIEW https://doi.org/10.1093/clinids/14.Supplement_2.S184	1000 mg single, oral dose: 1000 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFPROZIL plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
5.2 h REVIEW https://doi.org/10.1093/clinids/14.Supplement_2.S184	1000 mg single, oral dose: 1000 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFPROZIL plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
2.2 h REVIEW https://doi.org/10.1093/clinids/14.Supplement_2.S184	1000 mg single, oral dose: 1000 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFPROZIL plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
1.77 h CLINICAL TRIAL https://doi.org/10.1128/AAC.34.11.2152	15 mg/kg single, oral dose: 15 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	CEFPROZIL plasma	Homo sapiens population: HEALTHY age: CHILD sex: UNKNOWN food status: FED
2.14 h CLINICAL TRIAL https://doi.org/10.1128/AAC.34.11.2152	30 mg/kg single, oral dose: 30 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	CEFPROZIL plasma	Homo sapiens population: HEALTHY age: CHILD sex: UNKNOWN food status: FED

F_unbound

Value	Dose	Co-administered	Analyte	Population
55% REVIEW https://link.springer.com/article/10.2165/00003495-199345020-00008	250 mg single, oral dose: 250 mg route of administration: Oral experiment type: SINGLE co-administered:		CEFPROZIL plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN

Doses

Dose	Population	Adverse events
500 mg 3 times / day multiple, oral Higher than recommended Dose: 500 mg, 3 times / day Route: oral Route: multiple Dose: 500 mg, 3 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/7889959/	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Food Status: UNKNOWN Sources: https://pubmed.ncbi.nlm.nih.gov/7889959/	Disc. AE: Nausea... AEs leading to discontinuation/dose reduction: Nausea (0.9%) Sources: https://pubmed.ncbi.nlm.nih.gov/7889959/
1000 mg 3 times / day multiple, oral Highest studied dose Dose: 1000 mg, 3 times / day Route: oral Route: multiple Dose: 1000 mg, 3 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/2393281/	healthy, ADULT Health Status: healthy Age Group: ADULT Sex: M Food Status: FASTED Sources: https://pubmed.ncbi.nlm.nih.gov/2393281/	Sources: https://pubmed.ncbi.nlm.nih.gov/2393281/
500 mg 2 times / day multiple, oral Recommended Dose: 500 mg, 2 times / day Route: oral Route: multiple Dose: 500 mg, 2 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/11686426/	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Food Status: UNKNOWN Sources: https://pubmed.ncbi.nlm.nih.gov/11686426/	Disc. AE: Nausea, Hot flashes... Other AEs: Migraine... AEs leading to discontinuation/dose reduction: Nausea (0.67%) Hot flashes (0.67%) Other AEs: Migraine (0.67%) Sources: https://pubmed.ncbi.nlm.nih.gov/11686426/
500 mg 2 times / day multiple, oral Recommended Dose: 500 mg, 2 times / day Route: oral Route: multiple Dose: 500 mg, 2 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/7889959/	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Food Status: UNKNOWN Sources: https://pubmed.ncbi.nlm.nih.gov/7889959/	Disc. AE: Gastrointestinal disorder... AEs leading to discontinuation/dose reduction: Gastrointestinal disorder (2.2%) Sources: https://pubmed.ncbi.nlm.nih.gov/7889959/
500 mg 2 times / day multiple, oral Recommended Dose: 500 mg, 2 times / day Route: oral Route: multiple Dose: 500 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050664s024,050665s024lbl.pdf	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Food Status: UNKNOWN Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050664s024,050665s024lbl.pdf	Disc. AE: Allergy, Diarrhea, Clostridium difficile... AEs leading to discontinuation/dose reduction: Allergy Diarrhea, Clostridium difficile Hypersensitivity reaction Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050664s024,050665s024lbl.pdf

AEs

AE	Significance	Dose	Population
Nausea	0.9% Disc. AE	500 mg 3 times / day multiple, oral Higher than recommended Dose: 500 mg, 3 times / day Route: oral Route: multiple Dose: 500 mg, 3 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/7889959/	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Food Status: UNKNOWN Sources: https://pubmed.ncbi.nlm.nih.gov/7889959/
Migraine	0.67%	500 mg 2 times / day multiple, oral Recommended Dose: 500 mg, 2 times / day Route: oral Route: multiple Dose: 500 mg, 2 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/11686426/	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Food Status: UNKNOWN Sources: https://pubmed.ncbi.nlm.nih.gov/11686426/
Hot flashes	0.67% Disc. AE	500 mg 2 times / day multiple, oral Recommended Dose: 500 mg, 2 times / day Route: oral Route: multiple Dose: 500 mg, 2 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/11686426/	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Food Status: UNKNOWN Sources: https://pubmed.ncbi.nlm.nih.gov/11686426/
Nausea	0.67% Disc. AE	500 mg 2 times / day multiple, oral Recommended Dose: 500 mg, 2 times / day Route: oral Route: multiple Dose: 500 mg, 2 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/11686426/	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Food Status: UNKNOWN Sources: https://pubmed.ncbi.nlm.nih.gov/11686426/
Gastrointestinal disorder	2.2% Disc. AE	500 mg 2 times / day multiple, oral Recommended Dose: 500 mg, 2 times / day Route: oral Route: multiple Dose: 500 mg, 2 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/7889959/	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Food Status: UNKNOWN Sources: https://pubmed.ncbi.nlm.nih.gov/7889959/
Allergy	Disc. AE	500 mg 2 times / day multiple, oral Recommended Dose: 500 mg, 2 times / day Route: oral Route: multiple Dose: 500 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050664s024,050665s024lbl.pdf	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Food Status: UNKNOWN Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050664s024,050665s024lbl.pdf
Diarrhea, Clostridium difficile	Disc. AE	500 mg 2 times / day multiple, oral Recommended Dose: 500 mg, 2 times / day Route: oral Route: multiple Dose: 500 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050664s024,050665s024lbl.pdf	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Food Status: UNKNOWN Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050664s024,050665s024lbl.pdf
Hypersensitivity reaction	Disc. AE	500 mg 2 times / day multiple, oral Recommended Dose: 500 mg, 2 times / day Route: oral Route: multiple Dose: 500 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050664s024,050665s024lbl.pdf	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Food Status: UNKNOWN Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050664s024,050665s024lbl.pdf

PubMed

Title	Date	PubMed
Prediction of genotoxicity of chemical compounds by statistical learning methods.	2005 Jun	15962942
Fatal cephalosporin-induced acute hypersensitivity myocarditis.	2006 Nov-Dec	17111287
Systems pharmacological analysis of drugs inducing stevens-johnson syndrome and toxic epidermal necrolysis.	2015 May 18	25811541

Patents

Sample Use Guides

In Vivo Use Guide

Upper respiratory tract (pharyngitis/tonsillitis): 500 mg q24h; Acute sinusitis: 250 mg or 500 mg q12h; Skin & skin structure: 250 mg q12h or 500 mg q24h; Uncomplicated urinary tract: 500 mg q24h.

Route of Administration: Oral

In Vitro Use Guide

The geometric mean value of MIC (and MIC range) in micrograms per milliliter for four penicillin-susceptible pneumococcal strains was: 0.15 (0.06 to 0.5).

Substance Class	Mixture Created by `admin` on `Mon Mar 31 18:03:49 GMT 2025` Edited by `admin` on `Mon Mar 31 18:03:49 GMT 2025`
Record UNII	4W0459ZA4V
Record Status	`Validated (UNII)`
Record Version

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Name

Type

Language

CEFPROZIL MONOHYDRATE

Preferred Name

English

CEFPROZIL

Official Name

English

CEFPROZIL [VANDF]

Common Name

English

NSC-759099

Code

English

5-THIA-1-AZABICYCLO(4.2.0)OCT-2-ENE-2-CARBOXYLIC ACID, 7-((AMINO(4-HYDROXYPHENYL)ACETYL)AMINO)-8-OXO-3-(1-PROPENYL)-, MONOHYDRATE, (6R-(6.ALPHA.,7.BETA.(R*)))-

Common Name

English

Cefprozil monohydrate [WHO-DD]

Common Name

English

CEFPROZIL MONOHYDRATE [EP MONOGRAPH]

Common Name

English

CEFPROZIL [USAN]

Common Name

English

CEFPROZIL MONOHYDRATE [MI]

Common Name

English

CEFPROZIL [USP MONOGRAPH]

Common Name

English

CEFPROZIL [USP-RS]

Common Name

English

CEFPROZIL [ORANGE BOOK]

Common Name

English

BMY-28100-03-800

Code

English

5-THIA-1-AZABICYCLO(4.2.0)OCT-2-ENE-2-CARBOXYLIC ACID, 7-(((2R)-2-AMINO-2-(4-HYDROXYPHENYL)ACETYL)AMINO)-8-OXO-3-(1-PROPEN-1-YL)-, HYDRATE (1:1), (6R,7R)-

Common Name

English

Classification Tree Code System Code

NCI_THESAURUS

C357