CEFDINIR MONOHYDRATE

Details

Stereochemistry	ABSOLUTE
Molecular Formula	C14H13N5O5S2.H2O
Molecular Weight	413.429
Optical Activity	UNSPECIFIED
Defined Stereocenters	2 / 2
E/Z Centers	1
Charge	0

SHOW SMILES / InChI

Structure Search

SMILES

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

InChI

InChIKey=QWUVJQSNISEEQI-KYIYMPJCSA-N

InChI=1S/C14H13N5O5S2.H2O/c1-2-5-3-25-12-8(11(21)19(12)9(5)13(22)23)17-10(20)7(18-24)6-4-26-14(15)16-6;/h2,4,8,12,24H,1,3H2,(H2,15,16)(H,17,20)(H,22,23);1H2/b18-7-;/t8-,12-;/m1./s1

HIDE SMILES / InChI

Molecular Formula	C14H13N5O5S2
Molecular Weight	395.414
Charge	0
Count

Stereochemistry	ABSOLUTE
Additional Stereochemistry	No
Defined Stereocenters	2 / 2
E/Z Centers	1
Optical Activity	UNSPECIFIED

Molecular Formula	H2O
Molecular Weight	18.0153
Charge	0
Count

Stereochemistry	ACHIRAL
Additional Stereochemistry	No
Defined Stereocenters	0 / 0
E/Z Centers	0
Optical Activity	NONE

Description
Sources: https://www.drugs.com/pro/cefdinir.html
Curator's Comment: description was created based on several sources, including: http://www.rxlist.com/omnicef-drug.htm#I | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050739s015,050749s021lbl.pdf | https://www.ncbi.nlm.nih.gov/pubmed/3255303

Cefdinir is an extended-spectrum, semisynthetic cephalosporin, for oral administration. As with other cephalosporins, bactericidal activity of cefdinir results from inhibition of cell wall synthesis. Cefdinir is stable in the presence of some, but not all, β-lactamase enzymes. Cefdinir is indicated for the treatment of: Community-Acquired Pneumonia, Acute Exacerbations of Chronic Bronchitis, Acute Maxillary Sinusitis, Pharyngitis/Tonsillitis and Uncomplicated Skin and Skin Structure Infections. Side effects include diarrhea, vaginal infections or inflammation, nausea, headache, and abdominal pain. Concomitant administration of 300-mg cefdinir capsules with 30 mL Maalox® TC suspension reduces the rate (Cmax) and extent (AUC) of absorption by approximately 40%. As with other β-lactam antibiotics, probenecid inhibits the renal excretion of cefdinir.

CNS Activity

Originator

Approval Year

Targets

Primary Target	Pharmacology	Condition	Potency
Myeloperoxidase 6 Target ID: P05164 Gene ID: 4353.0 Gene Symbol: MPO Target Organism: Homo sapiens (Human) Sources: https://www.ncbi.nlm.nih.gov/pubmed/8133056	Inhibitor 8297
Bacterial penicillin-binding protein 233 Target ID: CHEMBL2354204 Sources: https://www.ncbi.nlm.nih.gov/pubmed/10508039 \| https://www.ncbi.nlm.nih.gov/pubmed/16801430 \| https://www.ncbi.nlm.nih.gov/pubmed/17540669	Inhibitor 8297

Conditions

Condition	Modality	Highest Phase	Product
Community-acquired pneumonia 47 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050739s015,050749s021lbl.pdf	Curative	Approved 8429	CEFDINIR Approved Use To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir 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. Cefdinir for oral suspension 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. Adults and Adolescents Community-Acquired Pneumonia caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains) (see CLINICAL STUDIES ). Acute Exacerbations of Chronic Bronchitis caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). Acute Maxillary Sinusitis caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). NOTE: For information on use in pediatric patients, see PRECAUTIONS, Pediatric Use and DOSAGE AND ADMINISTRATION . Pharyngitis/Tonsillitis caused by Streptococcus pyogenes (see CLINICAL STUDIES ). NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever. Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes. Pediatric Patients Acute Bacterial Otitis Media caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). Pharyngitis/Tonsillitis caused by Streptococcus pyogenes (see CLINICAL STUDIES ). NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever. Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes. Launch Date 2006
Acute exacerbations of chronic bronchitis 3 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050739s015,050749s021lbl.pdf	Curative	Approved 8429	CEFDINIR Approved Use To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir 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. Cefdinir for oral suspension 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. Adults and Adolescents Community-Acquired Pneumonia caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains) (see CLINICAL STUDIES ). Acute Exacerbations of Chronic Bronchitis caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). Acute Maxillary Sinusitis caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). NOTE: For information on use in pediatric patients, see PRECAUTIONS, Pediatric Use and DOSAGE AND ADMINISTRATION . Pharyngitis/Tonsillitis caused by Streptococcus pyogenes (see CLINICAL STUDIES ). NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever. Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes. Pediatric Patients Acute Bacterial Otitis Media caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). Pharyngitis/Tonsillitis caused by Streptococcus pyogenes (see CLINICAL STUDIES ). NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever. Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes. Launch Date 2006
Acute maxillary sinusitis 10 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050739s015,050749s021lbl.pdf	Curative	Approved 8429	CEFDINIR Approved Use To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir 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. Cefdinir for oral suspension 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. Adults and Adolescents Community-Acquired Pneumonia caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains) (see CLINICAL STUDIES ). Acute Exacerbations of Chronic Bronchitis caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). Acute Maxillary Sinusitis caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). NOTE: For information on use in pediatric patients, see PRECAUTIONS, Pediatric Use and DOSAGE AND ADMINISTRATION . Pharyngitis/Tonsillitis caused by Streptococcus pyogenes (see CLINICAL STUDIES ). NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever. Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes. Pediatric Patients Acute Bacterial Otitis Media caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). Pharyngitis/Tonsillitis caused by Streptococcus pyogenes (see CLINICAL STUDIES ). NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever. Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes. Launch Date 2006
Pharyngitis 31 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050739s015,050749s021lbl.pdf	Curative	Approved 8429	CEFDINIR Approved Use To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir 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. Cefdinir for oral suspension 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. Adults and Adolescents Community-Acquired Pneumonia caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains) (see CLINICAL STUDIES ). Acute Exacerbations of Chronic Bronchitis caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). Acute Maxillary Sinusitis caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). NOTE: For information on use in pediatric patients, see PRECAUTIONS, Pediatric Use and DOSAGE AND ADMINISTRATION . Pharyngitis/Tonsillitis caused by Streptococcus pyogenes (see CLINICAL STUDIES ). NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever. Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes. Pediatric Patients Acute Bacterial Otitis Media caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). Pharyngitis/Tonsillitis caused by Streptococcus pyogenes (see CLINICAL STUDIES ). NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever. Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes. Launch Date 2006
Tonsillitis 36 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050739s015,050749s021lbl.pdf	Curative	Approved 8429	CEFDINIR Approved Use To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir 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. Cefdinir for oral suspension 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. Adults and Adolescents Community-Acquired Pneumonia caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains) (see CLINICAL STUDIES ). Acute Exacerbations of Chronic Bronchitis caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). Acute Maxillary Sinusitis caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). NOTE: For information on use in pediatric patients, see PRECAUTIONS, Pediatric Use and DOSAGE AND ADMINISTRATION . Pharyngitis/Tonsillitis caused by Streptococcus pyogenes (see CLINICAL STUDIES ). NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever. Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes. Pediatric Patients Acute Bacterial Otitis Media caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). Pharyngitis/Tonsillitis caused by Streptococcus pyogenes (see CLINICAL STUDIES ). NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever. Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes. Launch Date 2006
Uncomplicated skin and skin-structure infections 21 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050739s015,050749s021lbl.pdf	Curative	Approved 8429	CEFDINIR Approved Use To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir 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. Cefdinir for oral suspension 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. Adults and Adolescents Community-Acquired Pneumonia caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains) (see CLINICAL STUDIES ). Acute Exacerbations of Chronic Bronchitis caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). Acute Maxillary Sinusitis caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). NOTE: For information on use in pediatric patients, see PRECAUTIONS, Pediatric Use and DOSAGE AND ADMINISTRATION . Pharyngitis/Tonsillitis caused by Streptococcus pyogenes (see CLINICAL STUDIES ). NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever. Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes. Pediatric Patients Acute Bacterial Otitis Media caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). Pharyngitis/Tonsillitis caused by Streptococcus pyogenes (see CLINICAL STUDIES ). NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever. Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes. Launch Date 2006

C_max

Value	Dose	Analyte	Population
1 μg/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/7625793	200 mg single, oral dose: 200 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFDINIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
1.55 μg/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/7625793	300 mg single, oral dose: 300 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFDINIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
2.15 μg/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/7625793	400 mg single, oral dose: 400 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFDINIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
2.35 μg/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/7625793	600 mg single, oral dose: 600 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFDINIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED

AUC

Value	Dose	Analyte	Population
4.08 μg × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/7625793	200 mg single, oral dose: 200 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFDINIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
6.53 μg × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/7625793	300 mg single, oral dose: 300 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFDINIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
8.83 μg × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/7625793	400 mg single, oral dose: 400 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFDINIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
9.84 μg × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/7625793	600 mg single, oral dose: 600 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFDINIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED

T_1/2

Value	Dose	Analyte	Population
1.43 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/7625793	200 mg single, oral dose: 200 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFDINIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
1.46 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/7625793	300 mg single, oral dose: 300 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFDINIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
1.43 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/7625793	400 mg single, oral dose: 400 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFDINIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
1.5 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/7625793	600 mg single, oral dose: 600 mg route of administration: Oral experiment type: SINGLE co-administered:	CEFDINIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED

F_unbound

Value	Dose	Co-administered	Analyte	Population
39% EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/7625793	200 mg single, oral dose: 200 mg route of administration: Oral experiment type: SINGLE co-administered:		CEFDINIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED

Doses

Dose	Population	Adverse events
600 mg 1 times / day multiple, oral Recommended Dose: 600 mg, 1 times / day Route: oral Route: multiple Dose: 600 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s013,050749s017lbl.pdf Page: p.13	unhealthy n = 5093 Health Status: unhealthy Condition: Bacterial infections Population Size: 5093 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s013,050749s017lbl.pdf Page: p.13	Disc. AE: Diarrhea, Nausea... AEs leading to discontinuation/dose reduction: Diarrhea Nausea Rash (0.4%) Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s013,050749s017lbl.pdf Page: p.13
600 mg 1 times / day multiple, oral Recommended Dose: 600 mg, 1 times / day Route: oral Route: multiple Dose: 600 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s013,050749s017lbl.pdf Page: p.9	unhealthy Health Status: unhealthy Condition: Bacterial infections Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s013,050749s017lbl.pdf Page: p.9	Disc. AE: Allergic reaction, Hypersensitivity reaction... AEs leading to discontinuation/dose reduction: Allergic reaction Hypersensitivity reaction (serious) Pseudomembranous colitis Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s013,050749s017lbl.pdf Page: p.9

AEs

AE	Significance	Dose	Population
Rash	0.4% Disc. AE	600 mg 1 times / day multiple, oral Recommended Dose: 600 mg, 1 times / day Route: oral Route: multiple Dose: 600 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s013,050749s017lbl.pdf Page: p.13	unhealthy n = 5093 Health Status: unhealthy Condition: Bacterial infections Population Size: 5093 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s013,050749s017lbl.pdf Page: p.13
Diarrhea	Disc. AE	600 mg 1 times / day multiple, oral Recommended Dose: 600 mg, 1 times / day Route: oral Route: multiple Dose: 600 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s013,050749s017lbl.pdf Page: p.13	unhealthy n = 5093 Health Status: unhealthy Condition: Bacterial infections Population Size: 5093 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s013,050749s017lbl.pdf Page: p.13
Nausea	Disc. AE	600 mg 1 times / day multiple, oral Recommended Dose: 600 mg, 1 times / day Route: oral Route: multiple Dose: 600 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s013,050749s017lbl.pdf Page: p.13	unhealthy n = 5093 Health Status: unhealthy Condition: Bacterial infections Population Size: 5093 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s013,050749s017lbl.pdf Page: p.13
Allergic reaction	Disc. AE	600 mg 1 times / day multiple, oral Recommended Dose: 600 mg, 1 times / day Route: oral Route: multiple Dose: 600 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s013,050749s017lbl.pdf Page: p.9	unhealthy Health Status: unhealthy Condition: Bacterial infections Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s013,050749s017lbl.pdf Page: p.9
Pseudomembranous colitis	Disc. AE	600 mg 1 times / day multiple, oral Recommended Dose: 600 mg, 1 times / day Route: oral Route: multiple Dose: 600 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s013,050749s017lbl.pdf Page: p.9	unhealthy Health Status: unhealthy Condition: Bacterial infections Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s013,050749s017lbl.pdf Page: p.9
Hypersensitivity reaction	serious Disc. AE	600 mg 1 times / day multiple, oral Recommended Dose: 600 mg, 1 times / day Route: oral Route: multiple Dose: 600 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s013,050749s017lbl.pdf Page: p.9	unhealthy Health Status: unhealthy Condition: Bacterial infections Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s013,050749s017lbl.pdf Page: p.9

Overview

CYP3A4	CYP2C9	CYP2D6	hERG

OverviewOther

Other Inhibitor	Other Substrate	Other Inducer
OCTN2 66 PEPT1 20 PEPT2 10 OAT1 599 OAT3 642 CYP2B6 810 CYP 111	OAT3 339 CYP 270	CYP 76

Drug as perpetrator

Target	Modality	Activity
CYP 147	inducer 1573 Sources: https://pubmed.ncbi.nlm.nih.gov/28057172/ Page: -	no
CYP 147	inhibitor 3277 Sources: https://pubmed.ncbi.nlm.nih.gov/28057172/ Page: -	no
CYP2B6 1001	inhibitor 3277 Sources: https://pubmed.ncbi.nlm.nih.gov/17101742/ Page: -	no
PEPT1 22	inhibitor 3277 Sources: https://pubmed.ncbi.nlm.nih.gov/9374833/ Page: -	weak [Ki 11900 uM]
PEPT2 12	inhibitor 3277 Sources: https://pubmed.ncbi.nlm.nih.gov/9374833/ Page: -	weak [Ki 20100 uM]
OAT3 644	inhibitor 3277 Sources: https://pubmed.ncbi.nlm.nih.gov/22841915/ Page: -	yes [IC50 271.5 uM]
OAT1 603	inhibitor 3277 Sources: https://pubmed.ncbi.nlm.nih.gov/22841915/ Page: -	yes [IC50 692 uM]
OCTN2 71	inhibitor 3277 Sources: https://pubmed.ncbi.nlm.nih.gov/10636865/ Page: -	yes

Drug as victim

Target	Modality	Activity	Metabolite	Clinical evidence
CYP 270	substrate 3367 Sources: https://pubmed.ncbi.nlm.nih.gov/15212560/ Page: -	no
OAT3 339	substrate 3367 Sources: https://pubmed.ncbi.nlm.nih.gov/21103968/ Page: -	yes

Sourcing

Vendor/Aggregator	ID	URL
ChEBI	CHEBI:3485	https://www.ebi.ac.uk/chebi/searchId.do?chebiId=CHEBI:3485
ChemicalBook	CB7483101	https://www.chemicalbook.com/ChemicalProductProperty_EN_CB7483101
MolPort	MolPort-002-885-812	https://www.molport.com/shop/molecule-link/MolPort-002-885-812
Selleck Chemicals	Cefdinir(Omnicef)	http://www.selleckchem.com/products/Cefdinir(Omnicef).html
ZINC	ZINC000003927198	http://zinc15.docking.org/substances/ZINC000003927198

PubMed

Title	Date	PubMed
Prediction of genotoxicity of chemical compounds by statistical learning methods.	2005 Jun	15962942
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

The total daily dose for all infections is 600 mg. Once-daily dosing for 10 days is as effective as BID dosing. Usual Adult Dose for Pneumonia: 300 mg orally every 12 hours for 10 to 14 days Acute exacerbations of chronic bronchitis: 300 mg orally every 12 hours for 5 to 10 days or 600 mg orally every 24 hours for 10 days Acute maxillary sinusitis: 300 mg orally every 12 hours or 600 mg orally every 24 hours for 10 days

Route of Administration: Oral

In Vitro Use Guide

Cefdinir had a much higher MIC90 against genotypic penicillin-resistant Streptococcus pneumoniae (gPRSP) than cefditoren and cefcapene (8 mg/L cefdinir vs. 1 mg/L cefditoren and cefcapene).

Substance Class	Chemical Created by `admin` on `Sat Dec 16 06:54:37 GMT 2023` Edited by `admin` on `Sat Dec 16 06:54:37 GMT 2023`
Record UNII	6E7SN358SE
Record Status	`Validated (UNII)`
Record Version

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Name

Type

Language

CEFDINIR MONOHYDRATE

Common Name

English

(6R,7R)-7-(((2Z)-(2-AMINO-4-THIAZOLYL)(HYDROXYIMINO)ACETYL) AMINO)-3-ETHENYL-8-OXO-5-THIA-1-AZABICYCLO(4.2.0)OCT-2-ENE-2-CARBOXYLIC ACID MONOHYDRATE

Systematic Name

English

5-THIA-1-AZABICYCLO(4.2.0)OCT-2-ENE-2-CARBOXYLIC ACID, 7-(((2Z)-2-(2-AMINO-4-THIAZOLYL)-2-(HYDROXYIMINO)ACETYL)AMINO)-3-ETHENYL-8-OXO-, HYDRATE (1:1), (6R,7R)-

Systematic Name

English

Cefdinir monohydrate [WHO-DD]

Common Name

English

5-THIA-1-AZABICYCLO(4.2.0)OCT-2-ENE-2-CARBOXYLIC ACID, 7-(((2Z)-(2-AMINO-4-THIAZOLYL)(HYDROXYIMINO)ACETYL)AMINO)-3-ETHENYL-8-OXO-, MONOHYDRATE, (6R,7R)-

Systematic Name

English

Code System Code Type Description

FDA UNII

6E7SN358SE