cefdinir 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antibiotics, cefalosporanic acid derivatives 533 91832-40-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • cefdinir monohydrate
  • cefdinir
  • cefdiel
  • cefnil
  • cefzon
A third-generation oral cephalosporin antibacterial agent that is used to treat bacterial infections of the respiratory tract and skin.
  • Molecular weight: 395.41
  • Formula: C14H13N5O5S2
  • CLOGP: -0.48
  • LIPINSKI: 0
  • HAC: 10
  • HDO: 4
  • TPSA: 158.21
  • ALOGS: -3.65
  • ROTB: 5
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.60 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 4 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 15 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 25.29 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 18.50 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
Dec. 4, 1997 FDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Sinusitis 98.58 15.33 120 6551 226533 63255818
Drug hypersensitivity 59.20 15.33 112 6559 310575 63171776
Pneumonia 49.06 15.33 131 6540 456636 63025715
Bronchitis 41.45 15.33 58 6613 124877 63357474
Urinary tract infection 39.15 15.33 86 6585 264598 63217753
COVID-19 33.83 15.33 50 6621 113053 63369298
Product dose omission issue 33.36 15.33 75 6596 234238 63248113
Upper respiratory tract infection 25.58 15.33 37 6634 82010 63400341
Therapy interrupted 24.34 15.33 23 6648 32432 63449919
Illness 22.90 15.33 27 6644 49032 63433319
Ear infection 21.19 15.33 23 6648 38190 63444161
Sinus disorder 17.65 15.33 17 6654 24536 63457815
Pharyngitis streptococcal 17.58 15.33 12 6659 10660 63471691
Kidney infection 16.57 15.33 16 6655 23160 63459191
Drug intolerance 16.36 15.33 6 6665 308655 63173696
Infusion site nodule 16.03 15.33 6 6665 1486 63480865
Influenza 15.65 15.33 35 6636 108687 63373664
Stevens-Johnson syndrome 15.58 15.33 16 6655 24934 63457417
Surgery 15.50 15.33 19 6652 35893 63446458
Arthropathy 15.39 15.33 3 6668 234789 63247562

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Pneumonia 53.73 17.18 112 3281 362515 34591023
Sinusitis 44.92 17.18 35 3358 41367 34912171
Drug hypersensitivity 21.01 17.18 32 3361 80497 34873041
Stevens-Johnson syndrome 20.72 17.18 16 3377 18623 34934915
Upper respiratory tract infection 18.04 17.18 19 3374 33040 34920498

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Pneumonia 79.56 15.05 189 7610 660057 79076532
Sinusitis 61.21 15.05 85 7714 195416 79541173
Drug hypersensitivity 55.04 15.05 102 7697 298814 79437775
Urinary tract infection 42.37 15.05 87 7712 274425 79462164
Bronchitis 32.46 15.05 51 7748 130593 79605996
Upper respiratory tract infection 29.02 15.05 40 7759 91128 79645461
Stevens-Johnson syndrome 27.66 15.05 26 7773 39140 79697449
Faeces discoloured 25.85 15.05 22 7777 29105 79707484
Product dose omission issue 23.51 15.05 65 7734 247472 79489117
Ear infection 22.68 15.05 22 7777 34410 79702179
Therapy interrupted 18.74 15.05 19 7780 31322 79705267
Platelet count decreased 18.36 15.05 51 7748 194613 79541976
Upper respiratory tract inflammation 16.47 15.05 8 7791 4027 79732562
Influenza 16.44 15.05 38 7761 129568 79607021
Pharyngitis streptococcal 15.92 15.05 11 7788 10703 79725886
Death 15.80 15.05 102 7697 566412 79170177
Illness 15.69 15.05 21 7778 46490 79690099
Infusion site pain 15.29 15.05 12 7787 14164 79722425

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC J01DD15 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
OTHER BETA-LACTAM ANTIBACTERIALS
Third-generation cephalosporins
FDA CS M0003827 Cephalosporins
FDA EPC N0000175488 Cephalosporin Antibacterial
CHEBI has role CHEBI:36047 antibacterial drugs
MeSH PA D000900 Anti-Bacterial Agents
MeSH PA D000890 Anti-Infective Agents

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Pneumonia due to Streptococcus indication 34020007
Streptococcal tonsillitis indication 41582007
Haemophilus influenzae pneumonia indication 70036007
Acute bacterial sinusitis indication 75498004
Acute Moraxella catarrhalis bronchitis indication 195722003
Streptococcus pyogenes infection indication 302809008
Infective otitis media indication 312218008
Infection due to Staphylococcus aureus indication 406602003
Streptococcus Pneumoniae Bronchitis indication
Haemophilus Influenzae Bronchitis indication
Moraxella Catarrhalis Pneumonia indication
Haemophilus Parainfluenzae Bronchitis indication
Haemophilus Parainfluenzae Pneumonia indication
Pyrexia of unknown origin off-label use 7520000
Acute nephropathy contraindication 58574008
Pseudomembranous enterocolitis contraindication 397683000




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 2.68 acidic
pKa2 9.97 acidic
pKa3 13.07 acidic
pKa4 3.23 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Bacterial penicillin-binding protein Enzyme INHIBITOR CHEMBL CHEMBL
Pencillin binding protein 2a; Penicillin binding protein 2'; Penicillin binding protein, PBP2; Penicillin-binding protein 2; Penicillin-binding protein 2'; Peptidase Enzyme WOMBAT-PK
Penicillin-binding protein 3 Enzyme WOMBAT-PK
Zinc finger protein mex-5 Cytosolic other EC50 4.48 CHEMBL
Cytoplasmic zinc-finger protein Unclassified EC50 4.30 CHEMBL

External reference:

IDSource
4021100 VUID
N0000148556 NUI
D00917 KEGG_DRUG
213978-34-8 SECONDARY_CAS_RN
1306064 RXNORM
C0060405 UMLSCUI
CHEBI:3485 CHEBI
CHEMBL927 ChEMBL_ID
D000077525 MESH_DESCRIPTOR_UI
DB00535 DRUGBANK_ID
6915944 PUBCHEM_CID
12023 IUPHAR_LIGAND_ID
6408 INN_ID
CI0FAO63WC UNII
109762 MMSL
4372 MMSL
d04256 MMSL
108677001 SNOMEDCT_US
370366006 SNOMEDCT_US
4021100 VANDF
007588 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Cefdinir HUMAN PRESCRIPTION DRUG LABEL 1 0093-3160 CAPSULE 300 mg ORAL ANDA 27 sections
Cefdinir HUMAN PRESCRIPTION DRUG LABEL 1 0093-3160 CAPSULE 300 mg ORAL ANDA 27 sections
Cefdinir HUMAN PRESCRIPTION DRUG LABEL 1 0093-4136 POWDER, FOR SUSPENSION 125 mg ORAL ANDA 28 sections
Cefdinir HUMAN PRESCRIPTION DRUG LABEL 1 0093-4136 POWDER, FOR SUSPENSION 125 mg ORAL ANDA 28 sections
Cefdinir HUMAN PRESCRIPTION DRUG LABEL 1 0093-4136 POWDER, FOR SUSPENSION 125 mg ORAL ANDA 28 sections
Cefdinir HUMAN PRESCRIPTION DRUG LABEL 1 0093-4137 POWDER, FOR SUSPENSION 250 mg ORAL ANDA 28 sections
Cefdinir HUMAN PRESCRIPTION DRUG LABEL 1 0093-4137 POWDER, FOR SUSPENSION 250 mg ORAL ANDA 28 sections
Cefdinir HUMAN PRESCRIPTION DRUG LABEL 1 0093-4137 POWDER, FOR SUSPENSION 250 mg ORAL ANDA 28 sections
Cefdinir HUMAN PRESCRIPTION DRUG LABEL 1 0781-2176 CAPSULE 300 mg ORAL ANDA 26 sections
Cefdinir HUMAN PRESCRIPTION DRUG LABEL 1 0781-6077 POWDER, FOR SUSPENSION 125 mg ORAL ANDA 27 sections
Cefdinir HUMAN PRESCRIPTION DRUG LABEL 1 0781-6078 POWDER, FOR SUSPENSION 250 mg ORAL ANDA 27 sections
Cefdinir HUMAN PRESCRIPTION DRUG LABEL 1 10544-194 CAPSULE 300 mg ORAL ANDA 26 sections
Cefdinir Human Prescription Drug Label 1 16714-391 CAPSULE 300 mg ORAL ANDA 25 sections
Cefdinir Human Prescription Drug Label 1 16714-391 CAPSULE 300 mg ORAL ANDA 25 sections
Cefdinir Human Prescription Drug Label 1 16714-391 CAPSULE 300 mg ORAL ANDA 25 sections
Cefdinir Human Prescription Drug Label 1 16714-392 POWDER, FOR SUSPENSION 125 mg ORAL ANDA 25 sections
Cefdinir Human Prescription Drug Label 1 16714-393 POWDER, FOR SUSPENSION 250 mg ORAL ANDA 25 sections
Cefdinir HUMAN PRESCRIPTION DRUG LABEL 1 17856-1150 CAPSULE 300 mg ORAL ANDA 24 sections
Cefdinir HUMAN PRESCRIPTION DRUG LABEL 1 21695-620 CAPSULE 300 mg ORAL ANDA 27 sections
Cefdinir HUMAN PRESCRIPTION DRUG LABEL 1 21695-622 POWDER, FOR SUSPENSION 250 mg ORAL ANDA 27 sections
Cefdinir HUMAN PRESCRIPTION DRUG LABEL 1 33261-905 POWDER, FOR SUSPENSION 250 mg ORAL ANDA 13 sections
Cefdinir HUMAN PRESCRIPTION DRUG LABEL 1 42254-127 POWDER, FOR SUSPENSION 250 mg ORAL ANDA 12 sections
Cefdinir HUMAN PRESCRIPTION DRUG LABEL 1 42254-177 CAPSULE 300 mg ORAL ANDA 27 sections
Cefdinir HUMAN PRESCRIPTION DRUG LABEL 1 43063-959 CAPSULE 300 mg ORAL ANDA 25 sections
Cefdinir HUMAN PRESCRIPTION DRUG LABEL 1 43063-959 CAPSULE 300 mg ORAL ANDA 25 sections
Cefdinir HUMAN PRESCRIPTION DRUG LABEL 1 43063-959 CAPSULE 300 mg ORAL ANDA 25 sections
Cefdinir HUMAN PRESCRIPTION DRUG LABEL 1 43063-959 CAPSULE 300 mg ORAL ANDA 25 sections
Cefdinir HUMAN PRESCRIPTION DRUG LABEL 1 43063-964 CAPSULE 300 mg ORAL ANDA 25 sections
Cefdinir HUMAN PRESCRIPTION DRUG LABEL 1 43063-964 CAPSULE 300 mg ORAL ANDA 25 sections
Cefdinir HUMAN PRESCRIPTION DRUG LABEL 1 43063-964 CAPSULE 300 mg ORAL ANDA 25 sections