cefaclor ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antibiotics, cefalosporanic acid derivatives 525 53994-73-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • cefaclor
  • alfacet
  • ceclor
  • cephaclor
  • distaclor
  • losefar
  • cefaclor hydrate
Semisynthetic, broad-spectrum antibiotic derivative of CEPHALEXIN.
  • Molecular weight: 367.80
  • Formula: C15H14ClN3O4S
  • CLOGP: -1.64
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 3
  • TPSA: 112.73
  • ALOGS: -3.24
  • ROTB: 4

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
1 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 8.59 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 52 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 67.97 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 90 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
April 4, 1979 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
Drug hypersensitivity 632.86 29.03 297 2584 250713 50351530
Cross sensitivity reaction 466.72 29.03 83 2798 1886 50600357
Type IV hypersensitivity reaction 453.94 29.03 84 2797 2398 50599845
International normalised ratio fluctuation 342.53 29.03 65 2816 2125 50600118
Bloody discharge 216.12 29.03 40 2841 1134 50601109
Lyme disease 179.66 29.03 39 2842 2504 50599739
Rash maculo-papular 177.71 29.03 64 2817 26577 50575666
Therapeutic product effect incomplete 94.83 29.03 61 2820 91454 50510789
Oedema 85.83 29.03 52 2829 70129 50532114
Infection 83.79 29.03 73 2808 172881 50429362
Drug intolerance 60.33 29.03 68 2813 219036 50383207
Toxic epidermal necrolysis 40.46 29.03 21 2860 20971 50581272

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
Cross sensitivity reaction 99.12 29.54 19 881 1243 29572384
Type IV hypersensitivity reaction 94.22 29.54 18 882 1156 29572471
Drug hypersensitivity 44.62 29.54 27 873 68379 29505248
Complex regional pain syndrome 36.09 29.54 7 893 484 29573143

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
Cross sensitivity reaction 544.69 27.51 102 3402 3265 64491963
Type IV hypersensitivity reaction 543.04 27.51 102 3402 3320 64491908
Drug hypersensitivity 499.74 27.51 246 3258 237569 64257659
International normalised ratio fluctuation 331.90 27.51 66 3438 2895 64492333
Bloody discharge 208.77 27.51 40 3464 1437 64493791
Lyme disease 183.44 27.51 39 3465 2376 64492852
Rash maculo-papular 181.77 27.51 75 3429 46951 64448277
Oedema 109.90 27.51 66 3438 91869 64403359
Therapeutic product effect incomplete 92.91 27.51 62 3442 103420 64391808
Infection 88.48 27.51 76 3428 184804 64310424
Drug intolerance 71.61 27.51 68 3436 187924 64307304
Toxic epidermal necrolysis 42.54 27.51 26 3478 37140 64458088
Urticaria 29.33 27.51 38 3466 147279 64347949

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC J01DC04 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
OTHER BETA-LACTAM ANTIBACTERIALS
Second-generation cephalosporins
CHEBI has role CHEBI:36047 antibacterial drugs
CHEBI has role CHEBI:88188 allergenic drug
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
Infection of skin AND/OR subcutaneous tissue indication 19824006
Pneumonia due to Streptococcus indication 34020007
Streptococcal tonsillitis indication 41582007
Lower respiratory tract infection indication 50417007
Upper respiratory infection indication 54150009
Urinary tract infectious disease indication 68566005
Haemophilus influenzae pneumonia indication 70036007
Tonsillitis indication 90176007 DOID:10456
Acute Moraxella catarrhalis bronchitis indication 195722003
Acute bacterial bronchitis indication 233598009
Pneumonia indication 233604007 DOID:552
Streptococcus pyogenes infection indication 302809008
Infective otitis media indication 312218008
Pharyngitis indication 405737000 DOID:2275
Infection due to Staphylococcus aureus indication 406602003
Moraxella Catarrhalis Chronic Bronchitis indication
Haemophilus Influenzae Bronchitis indication
Haemophilus Influenzae Chronic Bronchitis indication
Streptococcus Pneumoniae Bronchitis indication
Streptococcus Pneumoniae Chronic Bronchitis indication
Pyrexia of unknown origin off-label use 7520000
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 2.02 acidic
pKa2 13.93 acidic
pKa3 7.67 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
Penicillin-binding protein 1A Enzyme WOMBAT-PK
Streptokinase A Enzyme EC50 6.33 WOMBAT-PK

External reference:

IDSource
4017534 VUID
N0000145917 NUI
D00256 KEGG_DRUG
203635 RXNORM
4017534 VANDF
C0007537 UMLSCUI
CHEBI:3478 CHEBI
CHEMBL680 ChEMBL_ID
CHEMBL1201018 ChEMBL_ID
DB00833 DRUGBANK_ID
D002433 MESH_DESCRIPTOR_UI
51039 PUBCHEM_CID
10897 IUPHAR_LIGAND_ID
69K7K19H4L UNII
4368 MMSL
862 MMSL
871 MMSL
d00081 MMSL
002726 NDDF
387270009 SNOMEDCT_US
4937008 SNOMEDCT_US
70356-03-5 SECONDARY_CAS_RN

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Cefaclor HUMAN PRESCRIPTION DRUG LABEL 1 0093-1087 TABLET, FILM COATED, EXTENDED RELEASE 500 mg ORAL ANDA 24 sections
CEFACLOR HUMAN PRESCRIPTION DRUG LABEL 1 0143-9985 CAPSULE 250 mg ORAL ANDA 20 sections
CEFACLOR HUMAN PRESCRIPTION DRUG LABEL 1 0143-9986 CAPSULE 500 mg ORAL ANDA 20 sections
Cefaclor HUMAN PRESCRIPTION DRUG LABEL 1 16571-070 SUSPENSION 125 mg ORAL ANDA 23 sections
Cefaclor HUMAN PRESCRIPTION DRUG LABEL 1 16571-071 SUSPENSION 250 mg ORAL ANDA 23 sections
Cefaclor HUMAN PRESCRIPTION DRUG LABEL 1 16571-072 SUSPENSION 375 mg ORAL ANDA 23 sections
CEFACLOR HUMAN PRESCRIPTION DRUG LABEL 1 21695-782 SUSPENSION 250 mg ORAL ANDA 21 sections
Cefaclor HUMAN PRESCRIPTION DRUG LABEL 1 23594-125 FOR SUSPENSION 125 mg ORAL ANDA 24 sections
Cefaclor HUMAN PRESCRIPTION DRUG LABEL 1 23594-250 FOR SUSPENSION 250 mg ORAL ANDA 24 sections
Cefaclor HUMAN PRESCRIPTION DRUG LABEL 1 23594-375 FOR SUSPENSION 375 mg ORAL ANDA 24 sections
Cefaclor HUMAN PRESCRIPTION DRUG LABEL 1 50090-1602 CAPSULE 500 mg ORAL ANDA 23 sections
Cefaclor HUMAN PRESCRIPTION DRUG LABEL 1 54868-3478 CAPSULE 250 mg ORAL ANDA 13 sections
Cefaclor HUMAN PRESCRIPTION DRUG LABEL 1 54868-3511 CAPSULE 500 mg ORAL ANDA 13 sections
CEFACLOR HUMAN PRESCRIPTION DRUG LABEL 1 59115-071 CAPSULE 500 mg ORAL ANDA 21 sections
CEFACLOR HUMAN PRESCRIPTION DRUG LABEL 1 59115-072 CAPSULE 250 mg ORAL ANDA 21 sections
Cefaclor HUMAN PRESCRIPTION DRUG LABEL 1 61442-171 CAPSULE 250 mg ORAL ANDA 23 sections
Cefaclor HUMAN PRESCRIPTION DRUG LABEL 1 61442-172 CAPSULE 500 mg ORAL ANDA 23 sections
Cefaclor HUMAN PRESCRIPTION DRUG LABEL 1 61442-173 SUSPENSION 125 mg ORAL ANDA 23 sections
Cefaclor HUMAN PRESCRIPTION DRUG LABEL 1 61442-174 SUSPENSION 187 mg ORAL ANDA 23 sections
Cefaclor HUMAN PRESCRIPTION DRUG LABEL 1 61442-175 SUSPENSION 250 mg ORAL ANDA 23 sections
Cefaclor HUMAN PRESCRIPTION DRUG LABEL 1 61442-176 SUSPENSION 375 mg ORAL ANDA 23 sections
Cefaclor HUMAN PRESCRIPTION DRUG LABEL 1 63629-1007 CAPSULE 250 mg ORAL ANDA 23 sections
Cefaclor HUMAN PRESCRIPTION DRUG LABEL 1 63629-1008 CAPSULE 500 mg ORAL ANDA 23 sections
Cefaclor HUMAN PRESCRIPTION DRUG LABEL 1 68289-003 CAPSULE 500 mg ORAL ANDA 23 sections
Cefaclor HUMAN PRESCRIPTION DRUG LABEL 1 68289-004 CAPSULE 250 mg ORAL ANDA 23 sections