cefdinir ๐Ÿถ 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 ยตM/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 83.47 15.69 97 5345 170461 50429221
Drug hypersensitivity 66.57 15.69 106 5336 250904 50348778
Pneumonia 45.68 15.69 115 5327 378286 50221396
Urinary tract infection 32.24 15.69 73 5369 223947 50375735
Therapy interrupted 31.19 15.69 22 5420 20130 50579552
Product dose omission issue 26.53 15.69 60 5382 183778 50415904
Bronchitis 24.80 15.69 42 5400 104117 50495565
No adverse event 17.87 15.69 20 5422 33558 50566124
Surgery 16.09 15.69 18 5424 30187 50569495

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 48.04 18.22 103 2946 320069 29251409
Sinusitis 31.48 18.22 27 3022 34323 29537155
Drug hypersensitivity 22.05 18.22 31 3018 68375 29503103
Upper respiratory tract infection 18.23 18.22 18 3031 27331 29544147

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 72.61 15.87 169 6403 559407 63932753
Drug hypersensitivity 62.18 15.87 97 6475 237718 64254442
Sinusitis 43.01 15.87 63 6509 145865 64346295
Urinary tract infection 33.22 15.87 73 6499 231523 64260637
Faeces discoloured 25.34 15.87 21 6551 25708 64466452
Stevens-Johnson syndrome 23.89 15.87 23 6549 34226 64457934
Therapy interrupted 21.09 15.87 17 6555 20019 64472141
Product dose omission issue 21.01 15.87 55 6517 194692 64297468
Bronchitis 19.97 15.87 38 6534 108705 64383455
Upper respiratory tract infection 18.00 15.87 29 6543 72756 64419404
Upper respiratory tract inflammation 16.65 15.87 8 6564 3774 64488386

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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ 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
4021100 VANDF
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
007588 NDDF
108677001 SNOMEDCT_US
370366006 SNOMEDCT_US

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 0093-4137 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 16714-392 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 43063-964 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 50090-1027 POWDER, FOR SUSPENSION 250 mg ORAL ANDA 25 sections
Cefdinir HUMAN PRESCRIPTION DRUG LABEL 1 50090-1029 CAPSULE 300 mg ORAL ANDA 27 sections
Cefdinir Human Prescription Drug Label 1 50090-1031 CAPSULE 300 mg ORAL ANDA 25 sections
Cefdinir HUMAN PRESCRIPTION DRUG LABEL 1 50090-1033 CAPSULE 300 mg ORAL ANDA 25 sections
Cefdinir HUMAN PRESCRIPTION DRUG LABEL 1 50090-1034 CAPSULE 300 mg ORAL ANDA 24 sections
Cefdinir Human Prescription Drug Label 1 50090-2636 CAPSULE 300 mg ORAL ANDA 26 sections
Cefdinir Human Prescription Drug Label 1 50090-2719 CAPSULE 300 mg ORAL ANDA 26 sections