Overview
Iohexol is an effective non-ionic, water-soluble contrast agent which is used in myelography, arthrography, nephroangiography, arteriography, and other radiographic procedures. Its low systemic toxicity is the combined result of low chemotoxicity and low osmolality.
Indication
Iohexol ia used in myelography, arthrography, nephroangiography, arteriography, and other radiographic procedures.
Associated Conditions
No associated conditions information available.
Research Report
A Comprehensive Monograph on Iohexol
Executive Summary
Iohexol is a second-generation, non-ionic, low-osmolality, water-soluble iodinated radiographic contrast agent that stands as a cornerstone of modern diagnostic imaging. Marketed under brand names such as Omnipaque and Oraltag, its development represented a significant advancement in patient safety compared to older, first-generation high-osmolality ionic agents. Its chemical structure, featuring a tri-iodinated benzene ring with hydrophilic, non-ionizing side chains, allows for high concentrations of iodine necessary for X-ray attenuation while maintaining an osmolality closer to that of physiological fluids, thereby reducing systemic toxicity and improving patient tolerance.[1]
The clinical utility of Iohexol is exceptionally broad, encompassing a vast array of procedures across nearly all medical specialties. Its primary applications involve enhancing visualization during X-ray and Computed Tomography (CT) examinations. It is administered via multiple routes—intravascularly, intrathecally, orally, rectally, and into body cavities—to opacify vascular structures, the central nervous system (brain and spinal cord), the urinary tract, joints, and the gastrointestinal (GI) tract.[1] This versatility has secured its place on the World Health Organization's List of Essential Medicines.[1]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/11/29 | Phase 4 | Recruiting | |||
2024/06/05 | Phase 4 | Recruiting | |||
2024/01/23 | Early Phase 1 | Recruiting | Alison Stopeck | ||
2023/08/01 | Phase 4 | Recruiting | Jung Im Jung | ||
2023/07/05 | Not Applicable | Recruiting | Erasme University Hospital | ||
2023/03/06 | Early Phase 1 | Recruiting | |||
2022/11/14 | Phase 1 | Completed | |||
2022/10/14 | Phase 1 | Withdrawn | |||
2022/09/07 | N/A | ENROLLING_BY_INVITATION | |||
2022/07/05 | N/A | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
GE Healthcare Inc. | 0407-1414 | INTRAVENOUS, INTRAVASCULAR, ORAL, RECTAL | 350 mg in 1 mL | 4/25/2023 | |
GE Healthcare Inc. | 0407-1414 | ORAL, INTRAVASCULAR, INTRAVENOUS | 350 mg in 1 mL | 2/1/2024 | |
GE Healthcare | 0407-1413 | INTRAVENOUS | 300 mg in 1 mL | 4/30/2023 | |
GE Healthcare | 0407-1414 | INTRAVENOUS | 350 mg in 1 mL | 4/25/2023 | |
GE Healthcare Inc. | 0407-1412 | INTRATHECAL, INTRAVASCULAR, INTRAVENOUS, ORAL | 240 mg in 1 mL | 2/1/2024 | |
GE Healthcare Inc. | 0407-1413 | INTRAVENOUS, INTRAVASCULAR, INTRATHECAL, ORAL, RECTAL | 300 mg in 1 mL | 5/8/2023 | |
GE Healthcare | 0407-1413 | INTRAVENOUS | 300 mg in 1 mL | 4/25/2023 | |
GE Healthcare | 0407-1414 | INTRAVENOUS | 350 mg in 1 mL | 4/30/2023 | |
GE Healthcare Inc. | 0407-1413 | INTRAVENOUS, INTRAVASCULAR, INTRATHECAL, ORAL, RECTAL | 300 mg in 1 mL | 4/25/2023 | |
Interpharma Praha, a.s. | 54702-501 | ORAL | 4.5 g in 1 1 | 1/5/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
OMNIPAQUE INJECTION 350 mg I/ml | SIN05923P | INJECTION | 350 mg/ml | 5/17/1991 | |
OMNIPAQUE INJECTION 300 mg I/ml | SIN05924P | INJECTION | 300 mg/ml | 5/17/1991 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
Omnipaque 180 5.82g/15mL injection vial | 48215 | Medicine | A | 3/9/1994 | |
Omnipaque 350 94.375g/125mL Injection Bottle | 48234 | Medicine | A | 3/15/1994 | |
Omnipaque 300 48.525g/75mL Injection Bottle | 48243 | Medicine | A | 3/15/1994 | |
Omnipaque 350 151g/200mL Injection Bottle | 48241 | Medicine | A | 3/15/1994 | |
Omnipaque 350 75.5g/100mL Injection Bottle | 48233 | Medicine | A | 3/15/1994 | |
OMNIPAQUE 240 iohexol 25.9g/50mL injection bottle | 39861 | Medicine | A | 12/10/1992 | |
Omnipaque 350 15.1g/20mL Injection Vial | 39868 | Medicine | A | 12/10/1992 | |
OMNIPAQUE 300 iohexol 323.5 g/500 mL solution for injection bottle | 348754 | Medicine | A | 11/10/2021 | |
Omnipaque 350 56.625g/75mL Injection Bottle | 48225 | Medicine | A | 3/15/1994 | |
Omnipaque 300 iohexol 32.35g/50mL Injection | 76068 | Medicine | A | 10/31/2000 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
OMNIPAQUE 240 | ge healthcare canada inc | 02172739 | Solution - Intravascular
,
Intra-Articular
,
Oral
,
Subarachnoidal
,
Rectal | 518 MG / ML | 5/26/1998 |
OMNIPAQUE 300 | ge healthcare canada inc | 02172747 | Solution - Oral
,
Subarachnoidal
,
Intravascular
,
Rectal
,
Intra-Articular | 647 MG / ML | 3/5/1998 |
OMNIPAQUE 350 | ge healthcare canada inc | 02172755 | Solution - Oral
,
Intravascular | 755 MG / ML | 3/5/1998 |
OMNIPAQUE 180 | ge healthcare canada inc | 02172720 | Solution - Subarachnoidal | 388 MG / ML | 3/8/1998 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
OMNIPAQUE 240 mg Iodo /ml SOLUCION INYECTABLE | Ge Healthcare Bio-Sciences, S.A.U. | 62017 | SOLUCIÓN INYECTABLE | Uso Hospitalario Y Centros De Diagnóstico Autorizados | Commercialized |
OMNIPAQUE 300 mg Iodo /ml SOLUCION INYECTABLE | Ge Healthcare Bio-Sciences, S.A.U. | 62018 | SOLUCIÓN INYECTABLE | Uso Hospitalario Y Centros De Diagnóstico Autorizados | Commercialized |
OMNIPAQUE 350 mg Iodo /ml SOLUCION INYECTABLE | Ge Healthcare Bio-Sciences, S.A.U. | 62019 | SOLUCIÓN INYECTABLE | Uso Hospitalario Y Centros De Diagnóstico Autorizados | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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