iopamidol Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
iodine-containing contrast media 1464 60166-93-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • iopamidol
  • iopamiron
A non-ionic, water-soluble contrast agent which is used in myelography, arthrography, nephroangiography, arteriography, and other radiological procedures.
  • Molecular weight: 777.09
  • Formula: C17H22I3N3O8
  • CLOGP: -2.24
  • LIPINSKI: 3
  • HAC: 11
  • HDO: 8
  • TPSA: 188.45
  • ALOGS: -2.99
  • ROTB: 10

  • Status: OFP

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

Drug dosage:

None

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 96 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 1530.44 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 0.28 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.90 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 1 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 2.10 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Dec. 31, 1985 FDA BRACCO

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
Contrast media reaction 209.66 33.52 37 2172 968 46682885
Anaphylactic reaction 130.45 33.52 59 2150 53053 46630800
Anaphylactic shock 125.72 33.52 44 2165 20230 46663623
Maternal exposure during pregnancy 96.44 33.52 60 2149 102489 46581364
Urticaria 84.02 33.52 58 2151 117834 46566019
Contrast encephalopathy 80.67 33.52 11 2198 45 46683808
No adverse event 80.67 33.52 37 2172 34194 46649659
Extravasation 65.35 33.52 16 2193 2099 46681754
Hypersensitivity 61.04 33.52 53 2156 150268 46533585
Throat tightness 50.75 33.52 23 2186 20616 46663237
Wrong product administered 49.85 33.52 16 2193 5614 46678239
Anaphylactoid reaction 48.37 33.52 14 2195 3477 46680376
Dyspnoea 43.82 33.52 83 2126 515465 46168388
Sneezing 40.43 33.52 17 2192 12724 46671129
Contrast media allergy 37.77 33.52 10 2199 1789 46682064

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
Anaphylactic shock 270.35 25.56 81 2255 13912 29936230
Contrast media reaction 235.43 25.56 43 2293 816 29949326
Anaphylactic reaction 128.53 25.56 56 2280 27926 29922216
Contrast media allergy 85.79 25.56 16 2320 340 29949802
Contrast encephalopathy 78.08 25.56 11 2325 32 29950110
Urticaria 77.86 25.56 50 2286 54556 29895586
Hepatic artery stenosis 71.16 25.56 12 2324 139 29950003
Pruritus 44.12 25.56 50 2286 118154 29831988
No adverse event 40.71 25.56 22 2314 17397 29932745
Extravasation 36.97 25.56 11 2325 1817 29948325
Cardio-respiratory arrest 35.63 25.56 32 2304 57274 29892868
Anaphylactoid reaction 30.91 25.56 10 2326 2176 29947966
Blood pressure decreased 30.66 25.56 27 2309 47048 29903094
Hypersensitivity 29.36 25.56 28 2308 54000 29896142
Vomiting 27.76 25.56 56 2280 219762 29730380

Pharmacologic Action:

SourceCodeDescription
ATC V08AB04 VARIOUS
CONTRAST MEDIA
X-RAY CONTRAST MEDIA, IODINATED
Watersoluble, nephrotropic, low osmolar X-ray contrast media
FDA MoA N0000010258 X-Ray Contrast Activity
MeSH PA D003287 Contrast Media
MeSH PA D064907 Diagnostic Uses of Chemicals
FDA EPC N0000180185 Radiographic Contrast Agent
CHEBI has role CHEBI:35703 xenobiotic
CHEBI has role CHEBI:37338 radioopaque media
CHEBI has role CHEBI:78298 environmental contaminants

Drug Use (View source of the data)

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 10.76 acidic
pKa2 11.36 acidic
pKa3 12.12 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

IDSource
4017756 VUID
N0000146122 NUI
D01797 KEGG_DRUG
4017756 VANDF
C0022026 UMLSCUI
CHEBI:31711 CHEBI
CHEMBL1200932 ChEMBL_ID
DB08947 DRUGBANK_ID
D007479 MESH_DESCRIPTOR_UI
4399 INN_ID
JR13W81H44 UNII
65492 PUBCHEM_CID
5966 RXNORM
4905 MMSL
d01461 MMSL
000672 NDDF
109219007 SNOMEDCT_US
395754005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
ISOVUE200 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1314 INJECTION, SOLUTION 408 mg INTRAVASCULAR NDA 23 sections
ISOVUE300 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1315 INJECTION, SOLUTION 612 mg INTRAVASCULAR NDA 24 sections
ISOVUE300 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1315 INJECTION, SOLUTION 612 mg INTRAVASCULAR NDA 24 sections
ISOVUE300 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1315 INJECTION, SOLUTION 612 mg INTRAVASCULAR NDA 24 sections
ISOVUE370 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1316 INJECTION, SOLUTION 755 mg INTRAVASCULAR NDA 24 sections
ISOVUE370 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1316 INJECTION, SOLUTION 755 mg INTRAVASCULAR NDA 24 sections
ISOVUE370 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1316 INJECTION, SOLUTION 755 mg INTRAVASCULAR NDA 24 sections
ISOVUE250 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1317 INJECTION, SOLUTION 510 mg INTRAVASCULAR NDA 24 sections
ISOVUE250 HUMAN PRESCRIPTION DRUG LABEL 1 0270-1317 INJECTION, SOLUTION 510 mg INTRAVASCULAR NDA 24 sections
ISOVUE-M HUMAN PRESCRIPTION DRUG LABEL 1 0270-1411 INJECTION, SOLUTION 408 mg INTRATHECAL NDA 22 sections
ISOVUE-M HUMAN PRESCRIPTION DRUG LABEL 1 0270-1412 INJECTION, SOLUTION 612 mg INTRATHECAL NDA 22 sections
ISOVUE-M 200 HUMAN PRESCRIPTION DRUG LABEL 1 52584-411 INJECTION, SOLUTION 408 mg INTRATHECAL NDA 11 sections