cefdinir 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 -1.530 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 2.296 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 1.019 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 4.266 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 50 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 28.990 % High 1
herg hERG pIC50 4.149 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 3.573 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 4.732 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 22.540 % High 1
kinase-safety-class ACVR2A,ACVR2B,ACVRL1,AKT2,AKT3,ALK,AURKA,AURKC,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,CSF1R,DDR1,DYRK1B,DYRK3,EGFR,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GRK3,GSK3A,GSK3B,HIPK2,IKBKB,ITK,JAK1,JAK2,KDR,KIT,MAP2K6,MAP3K14,MAP3K2,MAP3K21,MAP3K3,MAP3K7,MAP4K1,MAP4K3,MAPK1,MAPK10,MAPK12,MAPK7,MAPK9,MAPKAPK2,MAPKAPK5,MARK4,MELK,MTOR,NTRK1,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CA,PIK3CB,PIK3CD,PIK3CG,PIM1,PIM2,PIM3,PRKAA1,PRKCD,PRKDC,SGK1,SIK2,SIK3,STK10,STK33,SYK,TEK,TGFBR1,TTK,UHMK1,ULK1,ULK2 82
kinase-selectivity-class ACVR2A,ACVR2B,AURKC,AXL,BMX,BRAF,CDK16,CDK4,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FGFR1,GRK2,GSK3A,IKBKB,JAK2,MAP2K3,MAP2K4,MAP2K6,MAP3K14,MAP3K2,MAPK12,MAPK7,MAPK8,PIK3CB,PIM3,PRKAA1,PRKDC,STK33,SYK,TEK,TGFBR1,TTK,UHMK1 37
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 1.648 High 1
mh-clint Mouse hepatocyte intrinsic clearance 8.414 High 1
mppb Mouse plasma protein binding (% unbound) 38.960 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 1.076 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 26.010 % High 1
rh-clint Rat hepatocyte intrinsic clearance 2.673 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 91.940 % High 1
rppb Rat plasma protein binding (% unbound) 12.080 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 889.201 uM High 1

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 84.93 15.06 126 7838 342962 90277521
Pneumonia 57.25 15.06 153 7811 637906 89982577
Drug hypersensitivity 55.20 15.06 124 7840 463485 90156998
Urinary tract infection 52.17 15.06 95 7869 305537 90314946
Product dose omission issue 41.55 15.06 84 7880 291603 90328880
Vanishing bile duct syndrome 38.78 15.06 11 7953 1361 90619122
Bronchitis 37.48 15.06 56 7908 152871 90467612
Therapy interrupted 26.40 15.06 27 7937 50081 90570402
COVID-19 23.26 15.06 48 7916 168795 90451688
Illness 22.96 15.06 32 7932 81937 90538546
Arthropathy 22.12 15.06 3 7961 366239 90254244
Surgery 19.78 15.06 22 7942 44865 90575618
Cough 19.60 15.06 74 7890 368888 90251595
Upper respiratory tract infection 19.49 15.06 38 7926 128280 90492203
Ear infection 19.18 15.06 27 7937 69748 90550735
Sinus disorder 18.94 15.06 19 7945 34428 90586055
Platelet count decreased 18.93 15.06 39 7925 136930 90483553
Drug intolerance 18.65 15.06 8 7956 447583 90172900
Influenza 18.49 15.06 39 7925 139225 90481258
Diarrhoea 16.73 15.06 140 7824 939050 89681433
Product storage error 16.67 15.06 14 7950 20227 90600256
Glossodynia 16.49 15.06 4 7960 321775 90298708
Infusion site nodule 16.23 15.06 6 7958 1717 90618766
Stevens-Johnson syndrome 15.78 15.06 16 7948 29360 90591123
Multiple allergies 15.73 15.06 12 7952 15134 90605349
Pharyngitis streptococcal 15.26 15.06 11 7953 12731 90607752
Wound 15.08 15.06 4 7960 302976 90317507

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 50.33 17.76 122 4146 422027 42195040
Sinusitis 46.00 17.76 38 4230 47254 42569813
Product storage error 25.12 17.76 15 4253 11125 42605942
Ear infection 23.20 17.76 15 4253 12789 42604278
Stevens-Johnson syndrome 19.85 17.76 17 4251 22161 42594906
Drug hypersensitivity 19.04 17.76 35 4233 99354 42517713
Upper respiratory tract infection 18.57 17.76 22 4246 42151 42574916

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 85.79 15.29 219 9642 876495 109702943
Urinary tract infection 54.06 15.29 101 9760 326181 110253257
Sinusitis 46.85 15.29 90 9771 296598 110282840
Vanishing bile duct syndrome 44.88 15.29 15 9846 3153 110576285
Drug hypersensitivity 44.77 15.29 114 9747 453976 110125462
Product dose omission issue 38.37 15.29 87 9774 321695 110257743
Bronchitis 30.30 15.29 52 9809 156980 110422458
Faeces discoloured 28.74 15.29 24 9837 33924 110545514
Ear infection 27.71 15.29 31 9830 62701 110516737
Stevens-Johnson syndrome 27.56 15.29 27 9834 46874 110532564
Pharyngitis streptococcal 26.86 15.29 16 9845 13261 110566177
Upper respiratory tract infection 26.01 15.29 44 9817 131284 110448154
Product storage error 24.07 15.29 18 9843 21710 110557728
Platelet count decreased 21.77 15.29 57 9804 230386 110349052
Illness 21.07 15.29 31 9830 82140 110497298
Cholestatic liver injury 20.65 15.29 11 9850 7365 110572073
Infusion site dermatitis 19.14 15.29 3 9858 18 110579420
Therapy interrupted 17.65 15.29 22 9839 49800 110529638
Death 17.31 15.29 114 9747 698755 109880683
Influenza 17.18 15.29 43 9818 169058 110410380
Cough 17.17 15.29 84 9777 461557 110117881
Upper respiratory tract inflammation 16.57 15.29 8 9853 4363 110575075
Therapy cessation 16.20 15.29 20 9841 44837 110534601
Drug intolerance 16.20 15.29 8 9853 406504 110172934
Diarrhoea 15.37 15.29 162 9699 1139343 109440095

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 drug
MeSH PA D000097902 beta Lactam Antibiotics
MeSH PA D000097911 Third Generation Cephalosporins
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000900 Anti-Bacterial Agents

Related Drugs by ATC class:

J01DD Third-generation cephalosporins 17 drugs
cefcapenecefditoren pivoxilcefetametcefiximecefmenoximecefodizimecefoperazonecefotaximecefpiramidecefpodoxime proxetilcefsulodinceftazidime show all 17 →

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 Cytosolic other 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
CI0FAO63WC INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Cefdinir HUMAN PRESCRIPTION DRUG LABEL 1 0093-3160 CAPSULE 300 mg ORAL ANDA 27 sections
Cefdinir HUMAN PRESCRIPTION DRUG LABEL 1 0093-4136 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 0781-2176 CAPSULE 300 mg ORAL ANDA 26 sections
Cefdinir Human Prescription Drug Label 1 0904-7563 CAPSULE 300 mg ORAL ANDA 24 sections
Cefdinir HUMAN PRESCRIPTION DRUG LABEL 1 10544-194 CAPSULE 300 mg ORAL ANDA 26 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 42291-043 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 50090-2719 CAPSULE 300 mg ORAL ANDA 26 sections
Cefdinir Human Prescription Drug Label 1 50090-2735 POWDER, FOR SUSPENSION 250 mg ORAL ANDA 25 sections
Cefdinir HUMAN PRESCRIPTION DRUG LABEL 1 50090-3723 POWDER, FOR SUSPENSION 250 mg ORAL ANDA 13 sections
Cefdinir HUMAN PRESCRIPTION DRUG LABEL 1 50090-3724 POWDER, FOR SUSPENSION 250 mg ORAL ANDA 13 sections
Cefdinir HUMAN PRESCRIPTION DRUG LABEL 1 50090-4258 POWDER, FOR SUSPENSION 125 mg ORAL ANDA 29 sections
Cefdinir Human Prescription Drug Label 1 50090-5583 POWDER, FOR SUSPENSION 250 mg ORAL ANDA 25 sections
cefdinir Human Prescription Drug Label 1 50090-5811 POWDER, FOR SUSPENSION 250 mg ORAL ANDA 24 sections
Cefdinir Human Prescription Drug Label 1 50090-6041 CAPSULE 300 mg ORAL ANDA 24 sections
Cefdinir Human Prescription Drug Label 1 50090-6042 CAPSULE 300 mg ORAL ANDA 24 sections