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

Stem definitionDrug idCAS RN
antibiotics, cefalosporanic acid derivatives 562 97519-39-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • ceftibuten
  • ceftibuten dihydrate
  • cedax
A cephalosporin antibacterial agent that is used in the treatment of infections, including urinary-tract and respiratory-tract infections.
  • Molecular weight: 410.42
  • Formula: C15H14N4O6S2
  • CLOGP: -1.21
  • LIPINSKI: 0
  • HAC: 10
  • HDO: 4
  • TPSA: 162.92
  • ALOGS: -3.77
  • ROTB: 6

  • Status: OFM

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

Drug dosage:

DoseUnitRoute
0.40 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 4 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.08 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 71 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 13.92 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 82.50 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
Dec. 20, 1995 FDA PERNIX THERAP

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC J01DD14 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
Acute otitis media indication 3110003
Haemophilus Influenzae Acute Otitis Media indication 19021002
Streptococcal tonsillitis indication 41582007
Tonsillitis indication 90176007 DOID:10456
Acute bacterial bronchitis indication 233598009
Streptococcus pyogenes infection indication 302809008
Infective otitis media indication 312218008
Moraxella Catarrhalis Acute Otitis Media indication 703469002
Moraxella Catarrhalis Chronic Bronchitis indication
Streptococcus Pneumoniae Chronic Bronchitis indication
Haemophilus Influenzae Chronic Bronchitis indication
Colitis contraindication 64226004 DOID:0060180
Impaired renal function disorder contraindication 197663003
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 2.57 acidic
pKa2 3.25 acidic
pKa3 13.9 acidic
pKa4 3.85 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 Enzyme WOMBAT-PK
Penicillin-binding protein 3 Enzyme WOMBAT-PK

External reference:

IDSource
4020946 VUID
N0000148426 NUI
D00922 KEGG_DRUG
118081-34-8 SECONDARY_CAS_RN
1297879 RXNORM
C0055014 UMLSCUI
CHEBI:3510 CHEBI
CHEMBL1605 ChEMBL_ID
D000077722 MESH_DESCRIPTOR_UI
DB01415 DRUGBANK_ID
5282242 PUBCHEM_CID
12029 IUPHAR_LIGAND_ID
6335 INN_ID
IW71N46B4Y UNII
207361 MMSL
4385 MMSL
5363 MMSL
d03874 MMSL
005181 NDDF
007869 NDDF
387535008 SNOMEDCT_US
96051004 SNOMEDCT_US
4020946 VANDF
4020947 VANDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Cedax HUMAN PRESCRIPTION DRUG LABEL 1 59630-820 CAPSULE 400 mg ORAL NDA 28 sections
Cedax HUMAN PRESCRIPTION DRUG LABEL 1 59630-821 SUSPENSION 18 mg ORAL NDA 28 sections