CEFPODOXIME PROXETIL

Details

Stereochemistry	EPIMERIC
Molecular Formula	C21H27N5O9S2
Molecular Weight	557.597
Optical Activity	UNSPECIFIED
Defined Stereocenters	2 / 3
E/Z Centers	1
Charge	0

SHOW SMILES / InChI

Structure Search

SMILES

[H][C@]12SCC(COC)=C(N1C(=O)[C@H]2NC(=O)C(=N/OC)\C3=CSC(N)=N3)C(=O)OC(C)OC(=O)OC(C)C

InChI

InChIKey=LTINZAODLRIQIX-FBXRGJNPSA-N

InChI=1S/C21H27N5O9S2/c1-9(2)33-21(30)35-10(3)34-19(29)15-11(6-31-4)7-36-18-14(17(28)26(15)18)24-16(27)13(25-32-5)12-8-37-20(22)23-12/h8-10,14,18H,6-7H2,1-5H3,(H2,22,23)(H,24,27)/b25-13-/t10?,14-,18-/m1/s1

HIDE SMILES / InChI

Description
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065462s005lbl.pdf
Curator's Comment: description was created based on several sources, including: https://www.drugs.com/pro/cefpodoxime-proxetil.html#DOSAGE_AND_ADMINISTRATION | https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=06a35453-8356-4690-aacb-3845cdc84102 | http://www.rxlist.com/vantin-drug.htm

Cefpodoxime is an orally administered, extended spectrum, semi-synthetic antibiotic of the cephalosporin class. Cefpodoxime is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis. Cefpodoxime has activity in the presence of some beta-lactamases, both penicillinases and cephalosporinases, of Gram-negative and Gram-positive bacteria. Cefpodoxime is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions: acute otitis media; pharyngitis and/or tonsillitis; community-acquired pneumonia; acute bacterial exacerbation of chronic bronchitis; gonorrhea; uncomplicated skin and skin structure infections; acute maxillary sinusitis and uncomplicated urinary tract infections (cystitis). Common adverse reactions include diarrhea, nausea, vaginal fungal infections, vulvovaginal infections, abdominal pain, headache. Concomitant administration of high doses of antacids (sodium bicarbonate and aluminum hydroxide) or H2 blockers reduces peak plasma levels by 24% to 42% and the extent of absorption by 27% to 32%, respectively. Oral anti-cholinergics (e.g., propantheline) delay peak plasma levels (47% increase in Tmax), but do not affect the extent of absorption (AUC). Probenecid: As with other beta-lactam antibiotics, renal excretion of cefpodoxime was inhibited by probenecid and resulted in an approximately 31% increase in AUC and 20% increase in peak cefpodoxime plasma levels.

Originator

Approval Year

Targets

Primary Target	Pharmacology	Potency
Bacterial penicillin-binding protein 233 Target ID: CHEMBL2354204 Sources: https://www.ncbi.nlm.nih.gov/pubmed/2351624 \| https://www.ncbi.nlm.nih.gov/pubmed/12041787	Inhibitor 8297
Multidrug resistance-associated protein 4 14 Target ID: CHEMBL1743128 Sources: https://www.ncbi.nlm.nih.gov/pubmed/23956101	Inhibitor 8297	133.0 µM [IC50]
Canalicular multispecific organic anion transporter 1 21 Target ID: CHEMBL5748 Sources: https://www.ncbi.nlm.nih.gov/pubmed/23956101	Inhibitor 8297	133.0 µM [IC50]
Canalicular multispecific organic anion transporter 2 8 Target ID: CHEMBL5918 Sources: https://www.ncbi.nlm.nih.gov/pubmed/23956101	Inhibitor 8297	133.0 µM [IC50]
Bile salt export pump 15 Target ID: CHEMBL6020 Sources: https://www.ncbi.nlm.nih.gov/pubmed/23956101	Inhibitor 8297	81.7 µM [IC50]

Conditions

Condition	Modality	Highest Phase	Product
Acute otitis media 28 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065462s005lbl.pdf	Curative	Approved 8429	CEFPODOXIME PROXETIL Approved Use 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 for Oral Suspension, USP and other antibacterial drugs, Cefpodoxime Proxetil for Oral Suspension, USP 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 2006
Pharyngitis 31 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065462s005lbl.pdf	Curative	Approved 8429	CEFPODOXIME PROXETIL Approved Use 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 for Oral Suspension, USP and other antibacterial drugs, Cefpodoxime Proxetil for Oral Suspension, USP 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 2007
Tonsillitis 36 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065462s005lbl.pdf	Curative	Approved 8429	CEFPODOXIME PROXETIL Approved Use 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 for Oral Suspension, USP and other antibacterial drugs, Cefpodoxime Proxetil for Oral Suspension, USP 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 2007
Community-acquired pneumonia 47 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065462s005lbl.pdf	Curative	Approved 8429	CEFPODOXIME PROXETIL Approved Use 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 for Oral Suspension, USP and other antibacterial drugs, Cefpodoxime Proxetil for Oral Suspension, USP 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 2007
Acute bacterial exacerbation of chronic bronchitis 31 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065462s005lbl.pdf	Curative	Approved 8429	CEFPODOXIME PROXETIL Approved Use 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 for Oral Suspension, USP and other antibacterial drugs, Cefpodoxime Proxetil for Oral Suspension, USP 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 2007
Acute, uncomplicated urethral and cervical gonorrhea 4 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065462s005lbl.pdf	Curative	Approved 8429	CEFPODOXIME PROXETIL Approved Use 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 for Oral Suspension, USP and other antibacterial drugs, Cefpodoxime Proxetil for Oral Suspension, USP 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 2007
Acute, uncomplicated ano-rectal infections in women 4 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065462s005lbl.pdf	Curative	Approved 8429	CEFPODOXIME PROXETIL Approved Use 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 for Oral Suspension, USP and other antibacterial drugs, Cefpodoxime Proxetil for Oral Suspension, USP 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 2007
Uncomplicated skin and skin-structure infections 21 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065462s005lbl.pdf	Curative	Approved 8429	CEFPODOXIME PROXETIL Approved Use 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 for Oral Suspension, USP and other antibacterial drugs, Cefpodoxime Proxetil for Oral Suspension, USP 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 2007
Acute maxillary sinusitis 10 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065462s005lbl.pdf	Curative	Approved 8429	CEFPODOXIME PROXETIL Approved Use 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 for Oral Suspension, USP and other antibacterial drugs, Cefpodoxime Proxetil for Oral Suspension, USP 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 2007
Cystitis 27 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065462s005lbl.pdf	Curative	Approved 8429	CEFPODOXIME PROXETIL Approved Use 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 for Oral Suspension, USP and other antibacterial drugs, Cefpodoxime Proxetil for Oral Suspension, USP 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 2007

C_max

Value	Dose	Analyte	Population
2.33 μg/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/2393268/	200 mg 2 times / day steady-state, oral dose: 200 mg route of administration: Oral experiment type: STEADY-STATE co-administered:	CEFPODOXIME plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
4.2 μg/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/2393268/	400 mg 2 times / day steady-state, oral dose: 400 mg route of administration: Oral experiment type: STEADY-STATE co-administered:	CEFPODOXIME plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
2.18 μg/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/2393268/	200 mg single, oral dose: 200 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFPODOXIME plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
4.16 μg/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/2393268/	400 mg single, oral dose: 400 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFPODOXIME plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN

AUC

Value	Dose	Analyte	Population
11.8 μg × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/2393268/	200 mg 2 times / day steady-state, oral dose: 200 mg route of administration: Oral experiment type: STEADY-STATE co-administered:	CEFPODOXIME plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
24 μg × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/2393268/	400 mg 2 times / day steady-state, oral dose: 400 mg route of administration: Oral experiment type: STEADY-STATE co-administered:	CEFPODOXIME plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
11.8 μg × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/2393268/	200 mg single, oral dose: 200 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFPODOXIME plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
25 μg × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/2393268/	400 mg single, oral dose: 400 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFPODOXIME plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN

T_1/2

Value	Dose	Analyte	Population
2.6 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/2393268/	200 mg 2 times / day steady-state, oral dose: 200 mg route of administration: Oral experiment type: STEADY-STATE co-administered:	CEFPODOXIME plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
2.7 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/2393268/	400 mg 2 times / day steady-state, oral dose: 400 mg route of administration: Oral experiment type: STEADY-STATE co-administered:	CEFPODOXIME plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
2.7 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/2393268/	200 mg single, oral dose: 200 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFPODOXIME plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
2.6 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/2393268/	400 mg single, oral dose: 400 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFPODOXIME plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN

Doses

Dose	Population	Adverse events
13.3 mg/kg 3 times / day multiple, oral Highest studied dose Dose: 13.3 mg/kg, 3 times / day Route: oral Route: multiple Dose: 13.3 mg/kg, 3 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/50675-S14_Vantin_medr_P2.pdf Page: 1140/0013	unhealthy, 3.4 (0.3-12.8) n = 76 Health Status: unhealthy Condition: Infection Age Group: 3.4 (0.3-12.8) Sex: M+F Population Size: 76 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/50675-S14_Vantin_medr_P2.pdf Page: 1140/0013	Disc. AE: Vomiting, Diarrhea... AEs leading to discontinuation/dose reduction: Vomiting Diarrhea Rash Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/50675-S14_Vantin_medr_P2.pdf Page: 1140/0013

AEs

AE	Significance	Dose	Population
Diarrhea	Disc. AE	13.3 mg/kg 3 times / day multiple, oral Highest studied dose Dose: 13.3 mg/kg, 3 times / day Route: oral Route: multiple Dose: 13.3 mg/kg, 3 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/50675-S14_Vantin_medr_P2.pdf Page: 1140/0013	unhealthy, 3.4 (0.3-12.8) n = 76 Health Status: unhealthy Condition: Infection Age Group: 3.4 (0.3-12.8) Sex: M+F Population Size: 76 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/50675-S14_Vantin_medr_P2.pdf Page: 1140/0013
Rash	Disc. AE	13.3 mg/kg 3 times / day multiple, oral Highest studied dose Dose: 13.3 mg/kg, 3 times / day Route: oral Route: multiple Dose: 13.3 mg/kg, 3 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/50675-S14_Vantin_medr_P2.pdf Page: 1140/0013	unhealthy, 3.4 (0.3-12.8) n = 76 Health Status: unhealthy Condition: Infection Age Group: 3.4 (0.3-12.8) Sex: M+F Population Size: 76 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/50675-S14_Vantin_medr_P2.pdf Page: 1140/0013
Vomiting	Disc. AE	13.3 mg/kg 3 times / day multiple, oral Highest studied dose Dose: 13.3 mg/kg, 3 times / day Route: oral Route: multiple Dose: 13.3 mg/kg, 3 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/50675-S14_Vantin_medr_P2.pdf Page: 1140/0013	unhealthy, 3.4 (0.3-12.8) n = 76 Health Status: unhealthy Condition: Infection Age Group: 3.4 (0.3-12.8) Sex: M+F Population Size: 76 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/50675-S14_Vantin_medr_P2.pdf Page: 1140/0013

Overview

CYP3A4	CYP2C9	CYP2D6	hERG

OverviewOther

Other Inhibitor	Other Substrate	Other Inducer
	esterase 72

Drug as victim

Target	Modality	Activity	Metabolite	Clinical evidence
esterase 72	substrate 3367 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065462s005lbl.pdf	yes

Sourcing

Vendor/Aggregator	ID	URL
ChEBI	CHEBI:3504	https://www.ebi.ac.uk/chebi/searchId.do?chebiId=CHEBI:3504
ChemicalBook	CB9511604	https://www.chemicalbook.com/ChemicalProductProperty_EN_CB9511604
MolPort	MolPort-003-845-691	https://www.molport.com/shop/molecule-link/MolPort-003-845-691
ZINC	ZINC000003830453	http://zinc15.docking.org/substances/ZINC000003830453

PubMed

Title	Date	PubMed
Investigation of molecular interaction between cefpodoxime acid and human mixtard insulin by ultrasonic and spectral methods.	2016 Sep 10	27442885
Characterization of ESBL-producing Escherichia coli recovered from companion dogs in Tai'an, China.	2017 Mar 31	28368864

Patents

Sample Use Guides

In Vivo Use Guide

The recommended dosages, durations of treatment, and applicable patient population are: Pharyngitis and/or tonsillitis 100 mg Q 12 hours (5 to 10 days) Acute community-acquired pneumonia 200 mg Q 12 hours (14 days) Acute bacterial exacerbations of chronic bronchitis 200 mg Q 12 hours (10 day) Uncomplicated gonorrhea (men and women) and rectal gonococcal infections (women) 200 mg single dose Skin and skin structure 400 mg Q 12 hours (7 to 14 days) Acute maxillary sinusitis 200 mg Q 12 hours (10 days) Uncomplicated urinary tract infection 100 mg Q 12 hours (7 days).

Route of Administration: Oral

In Vitro Use Guide

The in-vitro activity of cefpodoxime was studied in 529 clinical isolates and compared with the activity of other oral beta-lactams. Amongst the Enterobacteriaceae cefpodoxime was very active (MIC90 less than or equal to 1 mg/l--other than genera commonly possessing chromosomal beta-lactamases). Against these strains cefpodoxime was comparable in activity to cefixime and about eight-fold more active than cefuroxime and 8-16-fold more active than cefaclor and cephalexin. Staphylococcus aureus strains were moderately susceptible (MIC90 4 mg/l) to cefpodoxime.

Name

Type

Language

CEFPODOXIME PROXETIL

Official Name

English

NSC-759161

Code

English

Cefpodoxime proxetil [WHO-DD]

Common Name

English

(6R,7R)-7-(((2Z)-2-(2-AMINO-4-THIAZOLYL)-2-(METHOXYIMINO)ACETYL)AMINO)-3-(METHOXYMETHYL)-8-OXO-5-THIA-1-AZABICYCLO(4.2.0)OCT-2-ENE-2-CARBOXYLIC ACID 1-(((1-METHYLETHOXY)CARBONYL)OXY)ETHYL ESTER

Systematic Name

English

CEFPODOXIME 1-(ISOPROPOXYCARBONYLOXY)ETHYL ESTER

Systematic Name

English

CEFPODOXIME 1-(ISOPROPOXYCARBONYLOXY)ETHYL ESTER [MI]

Systematic Name

English

CEFPODOXIME PROXETIL [USP MONOGRAPH]

Common Name

English

VANTIN

Brand Name

English

CEFPODOXIME PROXETIL [USP IMPURITY]

Common Name

English

CEFPODOXIME PROXETIL [ORANGE BOOK]

Common Name

English

CEFPODOXIME PROXETIL [VANDF]

Common Name

English

(RS)-1-((ISOPROPOXYCARBONYL)OXY)ETHYL (+)-(6R,7R)-7-(2-(2-AMINO-4-THIAZOLYL)-2-((Z)-METHOXYIMINO)ACETAMIDO)-3-(METHOXYMETHYL)-8-OXO-5-THIA-1-AZABICYCLO(4.2.0)OCT-2-ENE-2-CARBOXYLATE

Systematic Name

English

ORELOX

Brand Name

English

CEFPODOXIME PROXETIL [EP MONOGRAPH]

Common Name

English

CEFPODOXIME (AS PROXETIL)

Common Name

English

CEFPODOXIME PROXETIL [MART.]

Common Name

English

CEFPODOXIME PROXETIL [GREEN BOOK]

Common Name

English

5-THIA-1-AZABICYCLO(4.2.0)OCT-2-ENE-2-CARBOXYLIC ACID, 7-(((2-AMINO-4-THIAZOLYL)(METHOXYIMINO)ACETYL)AMINO)-3-(METHOXYMETHYL)-8-OXO-, 1-(((1-METHYLETHOXY)CARBONYL)OXY)ETHYL ESTER, (6R-(6.ALPHA.,7.BETA.(Z)))-

Systematic Name

English

U-76252

Code

English

CEFPODOXIME PROXETIL [USP-RS]

Common Name

English

CEFODOX

Brand Name

English

CEFPODOXIME PROXETIL [USAN]

Common Name

English

(±)-1-HYDROXYETHYL (+)-(6R,7R)-7-(2-(2-AMINO-4-THIAZOLYL)GLYOXYLAMIDO)-3-(METHOXYMETHYL)-8-OXO-5-THIA-1-AZABICYCLO(4.2.0)OCT-2-ENE-2-CARBOXYLATE, 7 (SUP 2)-(Z)-(O-METHYLOXIME), ISOPROPYL CARBONATE (ESTER)

Systematic Name

English

CS-807

Code

English

SIMPLICEF

Brand Name

English

CEFPODOXIME PROXETIL [JAN]

Common Name

English

BANAN

Brand Name

English

OTREON

Brand Name

English

PODOMEXEF

Brand Name

English

Classification Tree Code System Code

NCI_THESAURUS

C357