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 645.37 29.13 322 3269 310365 63175066
Cross sensitivity reaction 459.27 29.13 83 3508 2079 63483352
Type IV hypersensitivity reaction 441.25 29.13 84 3507 2814 63482617
International normalised ratio fluctuation 416.08 29.13 78 3513 2400 63483031
Bloody discharge 306.22 29.13 56 3535 1495 63483936
Lyme disease 255.91 29.13 55 3536 3394 63482037
Rash maculo-papular 166.75 29.13 64 3527 31832 63453599
Therapeutic product effect incomplete 107.44 29.13 74 3517 124982 63360449
Infection 90.45 29.13 86 3505 229087 63256344
Oedema 70.44 29.13 52 3539 97570 63387861
Drug intolerance 62.89 29.13 82 3509 308579 63176852
Iron deficiency 62.18 29.13 21 3570 7209 63478222
Muscle tension dysphonia 43.97 29.13 8 3583 206 63485225
Platelet count increased 43.96 29.13 21 3570 17690 63467741
Dysphemia 40.65 29.13 12 3579 2663 63482768
Toxic epidermal necrolysis 36.87 29.13 21 3570 25313 63460118
Clostridium difficile infection 36.18 29.13 22 3569 29900 63455531
Urticaria 33.56 29.13 44 3547 165758 63319673
Vomiting 32.03 29.13 86 3505 559531 62925900
Vaccination complication 30.39 29.13 8 3583 1169 63484262
Immunisation reaction 30.01 29.13 7 3584 623 63484808
Oral pruritus 29.31 29.13 9 3582 2282 63483149

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 98.32 28.60 19 982 1378 34954552
Type IV hypersensitivity reaction 91.70 28.60 18 983 1416 34954514
Drug hypersensitivity 47.09 28.60 29 972 80500 34875430
Complex regional pain syndrome 35.51 28.60 7 994 560 34955370
Medical device implantation 28.92 28.60 6 995 620 34955310

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 537.28 27.62 102 4114 3610 79736562
Type IV hypersensitivity reaction 527.63 27.62 102 4114 3979 79736193
Drug hypersensitivity 517.07 27.62 269 3947 298647 79441525
International normalised ratio fluctuation 401.44 27.62 79 4137 3375 79736797
Bloody discharge 297.05 27.62 56 4160 1897 79738275
Lyme disease 261.14 27.62 55 4161 3295 79736877
Rash maculo-papular 170.89 27.62 75 4141 56003 79684169
Therapeutic product effect incomplete 105.84 27.62 75 4141 141570 79598602
Infection 97.21 27.62 89 4127 241623 79498549
Oedema 95.56 27.62 66 4150 119514 79620658
Drug intolerance 75.90 27.62 81 4135 264038 79476134
Iron deficiency 52.00 27.62 20 4196 10634 79729538
Vomiting 41.18 27.62 101 4115 665727 79074445
Platelet count increased 40.61 27.62 21 4195 22385 79717787
Urticaria 39.88 27.62 49 4167 185152 79555020
Toxic epidermal necrolysis 38.84 27.62 26 4190 44555 79695617
Muscle tension dysphonia 32.90 27.62 6 4210 168 79740004

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
C0007537 UMLSCUI
CHEBI:3478 CHEBI
8XI PDB_CHEM_ID
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
387270009 SNOMEDCT_US
4937008 SNOMEDCT_US
4017534 VANDF
70356-03-5 SECONDARY_CAS_RN
002726 NDDF

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 23594-125 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 23594-250 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 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
Cefaclor HUMAN PRESCRIPTION DRUG LABEL 1 81948-6250 SUSPENSION 250 mg ORAL ANDA 22 sections