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cefdinir 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antibiotics, cefalosporanic acid derivatives | 533 | 91832-40-5 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A third-generation oral cephalosporin antibacterial agent that is used to treat bacterial infections of the respiratory tract and skin.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.60 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| 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):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| 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:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 4, 1997 | FDA |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients 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 term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients 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 term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients 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:
| Source | Code | Description |
|---|---|---|
| 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
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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 level | Dissociation constant | Type (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:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA 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:
| ID | Source |
|---|---|
| 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:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| 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 |