Omnipaque Iohexol 350 mg/mL Injection, Solution — NDC 0407-1414-98 (Billing 00407-1414-98)
This is a package of Omnipaque Iohexol 350 mg/mL Injection, Solution from GE Healthcare, no longer marketed (first marketed Dec 2016), no longer in the FDA NDC Directory.
NDC database record
One package, one record: these facts belong to NDC 0407-1414-98 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0407 labeler · 1414 product · 98 package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 0407141498 9
- Medicaid fills, this package
- 11,082 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 000437
- GCN: 25523
- GPI-14 (Medi-Span): 94402042002040
- HICL (First Databank): 000151
- AHFS class code: 36:68.00.00
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
Clinical
- It is a contrast dye that makes X-rays and CT scans easier to read. Depending on the product, it can be used to look at the spine, blood vessels, urinary system, digestive tract, j...
- Staff will give it by injection or by mouth, depending on the scan. The label advises staying well hydrated before and after an injection. Oraltag is mixed with a drink and taken 2...
- How will I get it, and do I need to prepare?
- They vary by route. After a spinal injection, headache, back pain and nausea are common. Swallowed forms often cause diarrhea, nausea or belly pain. Injection into a vessel can cau...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Iohexol — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $0.4994 | $2,497.00 / 5000 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · Q9967 | $0.155 / Q9967 unit | — |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q4 2025
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Billing & reimbursement
Where does this data come from?
- CMS ASP NDC-HCPCS crosswalk · refreshed Sep 22, 2026
- DMEPDAC NDC-HCPCS crosswalk
- openFDA NSDE billing units · refreshed Oct 7, 2026
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00407-1414-98 You're viewing this | 10 BOTTLE, PLASTIC in 1 BOX / 500 mL in 1 BOTTLE, PLASTIC | 2004-09-03 | — | Discontinued by firm |
| 00407-1414-72 0407-1414-72 | 10 BOTTLE, PLASTIC in 1 BOX / 500 mL in 1 BOTTLE, PLASTIC | 2016-12-21 | — | Active |
| 00407-1414-82 0407-1414-82 | 10 BOTTLE, PLASTIC in 1 BOX / 50 mL in 1 BOTTLE, PLASTIC | 2006-07-21 | — | Discontinued by firm |
| 00407-1414-83 0407-1414-83 | 10 BOTTLE in 1 BOX / 125 mL in 1 BOTTLE | 2020-03-23 | — | Discontinued by firm |
| 00407-1414-84 0407-1414-84 | 10 BOTTLE, PLASTIC in 1 BOX / 100 mL in 1 BOTTLE, PLASTIC | 2006-07-21 | — | Discontinued by firm |
| 00407-1414-85 0407-1414-85 | 10 BOTTLE in 1 BOX / 125 mL in 1 BOTTLE | 2006-07-21 | — | Discontinued by firm |
| 00407-1414-86 0407-1414-86 | 10 BOTTLE, PLASTIC in 1 BOX / 150 mL in 1 BOTTLE, PLASTIC | 2006-07-21 | — | Discontinued by firm |
| 00407-1414-87 0407-1414-87 | 10 BOTTLE, PLASTIC in 1 BOX / 200 mL in 1 BOTTLE, PLASTIC | 2006-07-21 | — | Discontinued by firm |
| 00407-1414-48 0407-1414-48 | 10 BOTTLE, PLASTIC in 1 BOX / 500 mL in 1 BOTTLE, PLASTIC | 2016-12-21 | — | Discontinued by firm |
| 00407-1414-88 0407-1414-88 | 10 BOTTLE, PLASTIC in 1 BOX / 500 mL in 1 BOTTLE, PLASTIC | 2005-08-03 | — | Discontinued by firm |
| 00407-1414-76 0407-1414-76 | 10 BOTTLE, GLASS in 1 BOX / 125 mL in 1 BOTTLE, GLASS | 1985-12-26 | — | Active |
| 00407-1414-89 0407-1414-89 | 10 BOTTLE, PLASTIC in 1 BOX / 50 mL in 1 BOTTLE, PLASTIC | 1985-12-26 | — | Active |
| 00407-1414-90 0407-1414-90 | 10 BOTTLE, PLASTIC in 1 BOX / 75 mL in 1 BOTTLE, PLASTIC | 1985-12-26 | — | Active |
| 00407-1414-91 0407-1414-91 Main listing | 10 BOTTLE, PLASTIC in 1 BOX / 100 mL in 1 BOTTLE, PLASTIC | 1985-12-26 | — | Active |
| 00407-1414-93 0407-1414-93 | 10 BOTTLE, PLASTIC in 1 BOX / 150 mL in 1 BOTTLE, PLASTIC | 1985-12-26 | — | Active |
| 00407-1414-94 0407-1414-94 | 10 BOTTLE, PLASTIC in 1 BOX / 200 mL in 1 BOTTLE, PLASTIC | 1985-12-26 | — | Active |
| 00407-1414-95 0407-1414-95 | 10 BOTTLE, PLASTIC in 1 BOX / 125 mL in 1 BOTTLE, PLASTIC | 2020-03-23 | — | Discontinued by firm |
This pack accounts for about 2.2% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Omnipaque Iohexol 350 mg/mL Injection, Solution?
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Omnipaque 350 mg/mLthis 00407-1414-98 | GE | 10 bottles | — | — | Discontinued | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Iohexol inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Manufacturer & labeler
More NDCs from GE Healthcare labeler code 00407
- OMNISCAN gadodiamide 287 mg/mL Injection NDC 0407-0690-05
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- OMNIPAQUE Iohexol 240 mg/mL Injection, Solution NDC 0407-1412-10
- OMNIPAQUE Iohexol 300 mg/mL Injection, Solution NDC 0407-1413-10
- OMNIPAQUE Iohexol 9 mg/mL Solution NDC 0407-1415-09
- OMNIPAQUE Iohexol 12 mg/mL Solution NDC 0407-1416-12
- Visipaque Iodixanol 270 mg/mL Injection, Solution NDC 0407-2222-16
- Visipaque Iodixanol 320 mg/mL Injection, Solution NDC 0407-2223-16
- Optison Perflutren Protein-Type A Microspheres Human Albumin Microspheres and 10 mg/mL; .22 mg/mL Injection, Solution NDC 0407-2707-03
- CLARISCAN gadoterate meglumine 376.9 mg/mL Injection, Solution NDC 0407-2943-01
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION OF OMNIPAQUE INJECTION 140 mg IODINE/mL and 350 mg IODINE/mL Use only the OMNIPAQUE iodine concentrations and presentations recommended for intrathecal procedure [see Dosage and Administration (2.2 , 2.8) ]. Intrathecal administration of OMNIPAQUE of a wrong iodine concentration, even if inadvertent, may cause death, convulsions, seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema [see Warnings and Precautions (5.1) ].
WARNING: RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION OF OMNIPAQUE INJECTION 140 and 350 mg IODINE/mL Use only the iodine concentrations and presentations recommended for intrathecal procedures. Intrathecal administration of a wrong iodine concentration, even if inadvertent, may cause death, convulsions, seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema. ( 2.2 , 2.8 , 5.1 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE OMNIPAQUE is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and body cavity imaging procedures in adults and pediatric patients. ( 1 )
1.1Intrathecal Procedures ‡ OMNIPAQUE is indicated for: Myelography and computerized tomography (CT) myelography (lumbar, thoracic, cervical, total columnar) in adults and pediatric patients aged 2 weeks and older CT cisternography in adults and pediatric patients aged 2 weeks and older
1.2Intra-arterial Procedures ‡ OMNIPAQUE is indicated for: Cardiac ventriculography in adults and pediatric patients Aortography including studies of aorta and its branches in adults and pediatric patients Selective coronary arteriography in adults Cerebral arteriography in adults Peripheral arteriography in adults Intra-arterial digital subtraction angiography (IA-DSA) of the head, neck, abdominal, renal, and peripheral vessels in adults Pulmonary angiography in pediatric patients
1.3Intravenous Procedures ‡ OMNIPAQUE is indicated for: Excretory urography in adults and pediatric patients CT of the head and body in adults and pediatric patients Peripheral venography (phlebography) in adults Intravenous digital subtraction angiography (IV-DSA) of the head, neck, abdominal, renal, and peripheral vessels in adults
1.4Oral or Rectal Procedures ‡ OMNIPAQUE is indicated for: Radiographic examination of the gastrointestinal (GI) tract by oral administration in adult patients and by oral or rectal administration in pediatric patients CT of the abdomen and pelvis by oral administration in adult and pediatric patients, in conjunction with intravenous administration of OMNIPAQUE
1.5 Intraarticular Procedures ‡ OMNIPAQUE is indicated for: Arthrography in adults
1.6Body Cavity Procedures ‡ OMNIPAQUE is indicated for: Endoscopic retrograde pancreatography (ERP) and cholangiopancreatography (ERCP) in adults Herniography in adults Hysterosalpingography in adults Voiding cystourethrography (VCU) in pediatric patients ‡ Specific dosage forms, concentrations, and presentations of OMNIPAQUE are recommended for each type of imaging procedure [see Dosage and Administrations (2.2 , 2.3 , 2.4 , 2.5 , 2.6 , 2.7 , 2.8 , 2.9) and Warnings and Precautions (5.1 , 5.2) ].
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION For each imaging procedure, specific dosage forms, concentrations, and presentations are recommended. Individualize the concentration and volume according to the specific dosing tables and accounting for factors such as age, body weight, and condition of the patient, and the equipment and imaging technique used. ( 2.2 , 2.3 , 2.4 , 2.5 , 2.6 , 2.7 , 2.8 , 2.9 ) See full prescribing information for complete dosing and administration information.
( 2 )
2.1Important Dosage and Administration Instructions Specific dosage forms, concentrations, and presentations of OMNIPAQUE are recommended for each type of imaging procedure [see Dosage and Administration (2.2 , 2.3 , 2.4 , 2.5 , 2.6 , 2.7 , 2.8 , 2.9) and Warnings and Precautions (5.1 , 5.2) ]. Individualize the volume, strength, and rate of administration of OMNIPAQUE injection according to the specific dosing tables [see Dosage and Administration (2.2 , 2.3 , 2.4 , 2.5 , 2.6 , 2.7 , 2.8 , 2.9) ] . Consider factors such as age, body weight, vessel size, blood flow rate within the vessel, anticipated pathology, degree and extent of opacification required, structures or area to be examined, disease processes affecting the patient, and equipment and technique to be employed.
Hydrate patients before and after administration of OMNIPAQUE injection [see Warnings and Precautions (5.4) ]. Use aseptic technique for all handling and administration of OMNIPAQUE injection. Administer OMNIPAQUE injection at either body (37°C, 98.6°F) or room temperature (20°C to 25°C, 68°F to 77°F).
Do not mix OMNIPAQUE injection with, or inject in intravenous lines containing, other drugs or total nutritional admixtures except when OMNIPAQUE injection is administered in an automated contrast injection system or contrast management system suitable for simultaneous injection of OMNIPAQUE injection and 0.9% Sodium Chloride Injection [see Dosage and Administration (2.10 , 2.11) ]. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Each container of OMNIPAQUE injection and OMNIPAQUE oral solution in single-dose containers are intended for one procedure only. Discard any unused portion.
2.2Recommended Dosage for Intrathecal Procedures in Adults The recommended doses for intrathecal procedures in adults are shown in Table 1. Administer over 1 minute to 2 minutes. If sequential or repeat examinations are required, allow at least 48 hours for clearance of the drug from the body before repeat administration; however, whenever possible, 5 days to 7 days is recommended.
If CT myelography is performed, delay imaging by several hours to reduce the degree of contrast. Table 1. Recommended Concentrations and Volumes of OMNIPAQUE Injection for Intrathecal Procedures in Adults Imaging Procedure Injection Type Concentration (mg Iodine/mL) Volume to Administer Lumbar Myelography Lumbar 180 Use single-dose containers or 500 mL Pharmacy Bulk Packages [see Dosage and Administration (2.11) ].
10 mL to 17 mL 240 7 mL to 12.5 mL Thoracic Myelography Lumbar Cervical 240 6 mL to 12.5 mL 300 6 mL to 10 mL Cervical Myelography Lumbar 240 6 mL to 12.5 mL 300 6 mL to 10 mL C1-2 180 7 mL to 10 mL 240 6 mL to 12.5 mL 300 4 mL to 10 mL Total Columnar Myelography Lumbar 240 6 mL to 12.5 mL 300 6 mL to 10 mL CT Cisternography Lumbar 180 10 mL to 17 mL 240 7 mL to 12.5 mL
2.3Recommended Dosage for Intra-arterial Procedures in Adults The recommended doses for intra-arterial procedures in adults are shown in Table 2. Table 2. Recommended Concentrations and Volumes of OMNIPAQUE Injection for Intra-arterial Procedures in Adults Imaging Procedure Concentration (mg Iodine/mL) Volume to Administer per Single Injection for Selective Injection Sites Maximum Cumulative Total Dose Cardiac Ventriculography 350 Use single-dose containers or a 500 mL Pharmacy Bulk Package [see Dosage and Administration (2.11) ].
40 mL (Ra… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection and Oral Solution: Colorless to pale yellow solution available in the following presentations: Dosage Form Concentration (mg of iodine/mL) Package Size Package Type Injection 140 50 mL Single-Dose Bottle 180 10 mL Single-Dose Vial 240 10 mL and 20 mL Single-Dose Vial 50 mL and 100 mL Sigle-Dose Bottle 300 10 mL Single-Dose Vial 30 mL, 50 mL, 100 mL, 125 mL, and 150 mL Single-Dose Bottle 500 mL OMNIPAQUE injection 300 mg iodine/mL and OMNIPAQUE injection 350 mg iodine/mL in bottles of 500 mL can be used as either an Imaging Bulk Package or a Pharmacy Bulk Package [see Dosage and Administration (2.10 , 2.11) ].
Imaging or Pharmacy Bulk Package 350 50 mL, 75 mL, 100 mL, 125 mL, 150 mL, and 200 mL Single-Dose Bottle 500 mL Imaging or Pharmacy Bulk Package Oral Solution 9 500 mL Single-Dose Bottle 12 500 mL Single-Dose Bottle Injection: 140 mg iodine/mL, 180 mg iodine/mL, and 240 mg iodine/mL in single-dose vials/bottles; 300 mg iodine/mL and 350 mg iodine/mL in single-dose vials/bottles and imaging or pharmacy bulk package Oral Solution: 9 mg iodine/mL and 12 mg iodine/mL ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS OMNIPAQUE for hysterosalpingography is contraindicated during pregnancy or suspected pregnancy, menstruation or when menstruation is imminent, within 6 months after termination of pregnancy, within 30 days after conization or curettage, when signs of infection are present in any portion of the genital tract including the external genitalia, and when reproductive tract neoplasia is known or suspected because of the risk of peritoneal spread of neoplasm. Hysterosalpingography during pregnancy (or suspected pregnancy), menstruation (or when menstruation is imminent), within 6 months after termination of pregnancy, within 30 days after conization or curettage, when signs of infection are present in any portion of the genital tract, including the external genitalia, and when reproductive tract neoplasia is known or suspected.
( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Life-threatening or fatal reactions can occur. Always have emergency equipment and trained personnel available. ( 5.3 ) Acute Kidney Injury: Acute injury including renal failure can occur.
Minimize dose and maintain adequate hydration to minimize risk. ( 5.4 ) Cardiovascular Adverse Reactions: Hemodynamic disturbances including shock and cardiac arrest may occur during or after administration. ( 5.5 ) Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age: Individualize thyroid function monitoring based on risk factors such as prematurity.
( 5.9 )
5.1Risks Associated with Intrathecal Administration of OMNIPAQUE Injection 140 mg Iodine/mL and 350 mg Iodine/mL Use only the iodine concentrations and presentations recommended for intrathecal procedures [see Dosage and Administration (2.2 , 2.8) ]. Intrathecal administration of OMNIPAQUE of a wrong iodine concentration, even if inadvertent, can cause death, convulsions, seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema.
5.2Risks Associated with Parenteral Administration of OMNIPAQUE Oral Solution Adverse reactions such as hemolysis may occur if OMNIPAQUE oral solution is administered intravenously or intraarterially due to low osmolality [see Description (11) ] . OMNIPAQUE oral solution is for oral use only.
5.3Hypersensitivity Reactions OMNIPAQUE can cause life-threatening or fatal hypersensitivity reactions including anaphylaxis. Manifestations include respiratory arrest, laryngospasm, bronchospasm, angioedema, and shock. Most severe reactions develop shortly after the start of the injection (within 1 to 3 minutes), but delayed reactions can also occur.
There is an increased risk in patients with a history of a previous reaction to contrast agent and known allergic disorders (i.e., bronchial asthma, drug, or food allergies) or other hypersensitivities. Premedication with antihistamines or corticosteroids does not prevent serious life-threatening reactions but may reduce both their incidence and severity. Obtain a history of allergy, hypersensitivity, or hypersensitivity reactions to iodinated contrast agents and always have emergency resuscitation equipment and trained personnel available prior to OMNIPAQUE administration.
Monitor all patients for hypersensitivity reactions.
5.4Acute Kidney Injury Acute kidney injury, including renal failure, may occur after parenteral administration of OMNIPAQUE. Risk factors include: pre-existing renal impairment, dehydration, diabetes mellitus, congestive heart failure, advanced vascular disease, elderly age, concomitant use of nephrotoxic or diuretic medications, multiple myeloma/paraproteinaceous diseases, repetitive and/or large doses of an iodinated contrast agent. Use the lowest necessary dose of OMNIPAQUE in patients with renal impairment.
Adequately hydrate patients prior to and following parenteral administration of OMNIPAQUE. Do not use laxatives, diuretics, or preparatory dehydration prior to OMNIPAQUE administration.
5.5Cardiovascular Adverse Reactions Life-threatening or fatal cardiovascular reactions including hypotension, shock, cardiac arrest have occurred with the parenteral administration of OMNIPAQUE. Most deaths occur during injection or five to ten minutes later, with cardiovascular disease as the main aggravating factor. Cardiac decompensation, serious arrhythmias, and myocardial ischemia or infarction can occur during coronary arteriography and ventriculography.
Based on clinical literature, reported deaths from the administration of iodinated contrast agents range from 6.6 per million (0.00066%) to 1 in 10,000 (0.01%). Use the lowest necessary dose of OMNIPAQUE in patients with congestive heart failure and always have emergency resuscitation equipment and trained personnel available. Monitor all patients for severe cardiovascular reactions.
5.6Thromboembolic E… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Risks Associated with Intrathecal Administration of OMNIPAQUE Injection 140 mg Iodine/mL and 350 mg Iodine/mL [see Warnings and Precautions (5.1) ] Risks Associated with Parenteral Administration of OMNIPAQUE Oral Solution [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Acute Kidney Injury [see Warnings and Precautions (5.4) ] Cardiovascular Adverse Reactions [see Warnings and Precautions (5.5) ] Thromboembolic Events [ see Warnings and Precautions (5.6) ] Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age [see Warnings and Precautions (5.9) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.12) ] Most common adverse reactions (incidence ≥ 1%) in adult patients Intrathecal: Headaches, pain including backache, neckache, stiffness and neuralgia, nausea, vomiting, dizziness Intra-arterial or intravenous: Pain, vision abnormalities (including blurred vision and photomas), headache, taste perversion, arrhythmias including premature ventricular contractions (PVCs) and premature atrial contractions (PACs), angina/chest pain, nausea Oral: Diarrhea, nausea, vomiting, abdominal pain, flatulence, headache Body Cavity: Pain, swelling, heat sensation ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 1-800-654-0118 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Intrathecal Administration Adults Adverse reactions (≥1%) in 1,531 adult patients following intrathecal administration of OMNIPAQUE in clinical trials are presented in Table 16. Table 16.
Adverse Reactions (≥1%) in in Adult Patients Following Intrathecal Administration of OMNIPAQUE in Clinical Trials System Organ Class Adverse Reaction Incidence N=1,531 Nervous system disorders Headaches 18% Musculoskeletal and connective tissue disorders Pain including backache, neckache, stiffness, neuralgia 8% Gastrointestinal disorders Nausea 6% Vomiting 3% Nervous System disorders Dizziness 2% Other adverse reactions (<1%) were: Ear and labyrinth disorders : tinnitus, vertigo Eye disorders : photophobia General disorders and administration site conditions : sensation of heat Metabolism and nutrition disorders : loss of appetite Musculoskeletal and connective tissue disorders : feeling of heaviness Nervous system disorders : drowsiness, hypertonia, neuralgia, neurological changes, paresthesia, syncope Renal and urinary disorders : difficulty in micturition Skin and subcutaneous tissue disorders : sweating Vascular disorders : hypertension, hypotension Pediatric Patients The adverse reactions reported in pediatric patients following intrathecal administration of OMNIPAQUE were generally similar to those reported in adults.
A total of 152 pediatric patients were administered OMNIPAQUE 180 mg iodine/mL intrathecally by lumbar puncture for pediatric myelography in clinical trials. Adverse reactions (≥1%) are presented in Table 17. Table 17.
Adverse Reactions (≥1%) in Pediatric Patients Following Intrathecal Administration of OMNIPAQUE 180 mg iodine/mL by Lumbar Puncture for Myelography in Clinical Trials System Organ Class Adverse Reaction Incidence N=152 Nervous system disorders Headache 9% Gastrointestinal disorders Vomiting 6% Musculoskeletal and connective tissue disorders Backache 1.3% Other adverse reactions (<1%) were: Gastrointestinal disorders: stomachache General disorders and administration site conditions: fever Nervous system disorders : neurological changes Psychiatric disorders : visual hallucination Skin and subcutaneous tissue disorders : hives Intra-arterial or Intravenou… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS
7.1Drug-Drug Interactions Metformin In patients with renal impairment, metformin can cause lactic acidosis. Iodinated contrast agents appear to increase the risk of metformin-induced lactic acidosis, possibly as a result of worsening renal function. Stop metformin at the time of, or prior to, OMNIPAQUE administration in patients with an eGFR between 30 and 60 mL/min/1.73 m 2 ; in patients with a history of hepatic impairment, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast.
Re-evaluate eGFR 48 hours after the imaging procedure, and reinstitute metformin only after renal function is stable. Radioactive Iodine OMNIPAQUE may interfere with thyroid uptake of radioactive iodine (I-131 and I-123) and decrease therapeutic and diagnostic efficacy. Avoid thyroid therapy or testing for up to 6 weeks post OMNIPAQUE.
7.2Drug-Laboratory Test Interactions Protein-Bound Iodine Test Iodinated contrast agents, including OMNIPAQUE, will temporarily increase protein-bound iodine in blood. Do not perform protein-bound iodine test for at least 16 days following administration of OMNIPAQUE. However, thyroid function tests that do not depend on iodine estimation, e.g., T 3 resin uptake or direct thyroxine assays, are not affected.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation: A lactating woman may pump and discard breast milk for 10 hours after OMNIPAQUE administration. ( 8.2 )
8.1Pregnancy Risk Summary Hysterosalpingography is contraindicated in pregnant women due to the potential risk to the fetus from an intrauterine procedure [see Contraindications (4) ]. There are no data with iohexol use in pregnant women to inform any drug-associated risks. Iohexol crosses the placenta and reaches fetal tissues in small amounts ( see Data ) .
In animal reproduction studies, no developmental toxicity occurred with intravenous iohexol administration to rats and rabbits at doses up to 0.4 (rat) and 0.5 (rabbit) times the maximum recommended human intravenous dose ( see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Literature reports show that intravenously administered iohexol crosses the placenta and is visualized in the digestive tract of exposed infants after birth. Animal Data Iohexol was neither embryotoxic nor teratogenic in either rats or rabbits at the following dose levels tested: 1.0, 2.0, 4.0 g iodine/kg in rats, administered intravenously to 3 groups of 25 dams once daily during days 6 through 15 of pregnancy; 0.3, 1.0, 2.5 g iodine/kg in rabbits, administered intravenously to 3 groups of 18 rabbits dosed once a day during days 6 through 18 of pregnancy.
8.2Lactation Risk Summary Published literature reports that breast feeding after intravenous iohexol administration to the mother would result in the infant receiving an oral dose of approximately 0.7% of the maternal intravenous dose; however, lactation studies have not been conducted with oral, intrathecal, or intracavity administration of iohexol. There is no information on the effects of the drug on the breastfed infant or on milk production. Iodinated contrast agents are excreted unchanged in human milk in very low amounts with poor absorption from the gastrointestinal tract of a breastfed infant.
Exposure to iohexol to a breastfed infant can be minimized by temporary discontinuation of breastfeeding (see Clinical Considerations ). The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for OMNIPAQUE and any potential adverse effects on the breastfed infant from OMNIPAQUE or from the underlying maternal condition. Clinical Considerations Interruption of breastfeeding after exposure to iodinated contrast agents is not necessary because the potential exposure of the breastfed infant to iodine is small.
However, a lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk for 10 hours (approximately 5 elimination half-lives) after OMNIPAQUE administration to minimize drug exposure to a breastfed infant.
8.4Pediatric Use Intrathecal Use The safety and effectiveness of OMNIPAQUE have been established in pediatric patients aged 2 weeks and older for myelography and CT myelography (lumbar, thoracic, cervical, total columnar) and for CT cisternography. Use of OMNIPAQUE is supported by controlled clinical studies in adults for myelography, in addition to clinical studies in pediatric patients undergoing myelography. The safety and effectiveness of OMNIPAQUE have not been established for intrathecal use in pediatric patients less than 2 weeks of age.
The safety and effectiveness of OMNIPAQUE for CT cerebral ventriculography have not been established in pediatric patients. Intra-arterial or Intravenous Use Cardiac Ventriculography, Aortography, and Pulmonary Angiography The safety and effectiveness of OMNIPAQUE have been established in pediatric patients from birth to 17 y… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Hysterosalpingography is contraindicated in pregnant women due to the potential risk to the fetus from an intrauterine procedure [see Contraindications (4) ]. There are no data with iohexol use in pregnant women to inform any drug-associated risks. Iohexol crosses the placenta and reaches fetal tissues in small amounts ( see Data ) .
In animal reproduction studies, no developmental toxicity occurred with intravenous iohexol administration to rats and rabbits at doses up to 0.4 (rat) and 0.5 (rabbit) times the maximum recommended human intravenous dose ( see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Literature reports show that intravenously administered iohexol crosses the placenta and is visualized in the digestive tract of exposed infants after birth. Animal Data Iohexol was neither embryotoxic nor teratogenic in either rats or rabbits at the following dose levels tested: 1.0, 2.0, 4.0 g iodine/kg in rats, administered intravenously to 3 groups of 25 dams once daily during days 6 through 15 of pregnancy; 0.3, 1.0, 2.5 g iodine/kg in rabbits, administered intravenously to 3 groups of 18 rabbits dosed once a day during days 6 through 18 of pregnancy.
🧒 Pediatric Use ▾
8.4Pediatric Use Intrathecal Use The safety and effectiveness of OMNIPAQUE have been established in pediatric patients aged 2 weeks and older for myelography and CT myelography (lumbar, thoracic, cervical, total columnar) and for CT cisternography. Use of OMNIPAQUE is supported by controlled clinical studies in adults for myelography, in addition to clinical studies in pediatric patients undergoing myelography. The safety and effectiveness of OMNIPAQUE have not been established for intrathecal use in pediatric patients less than 2 weeks of age.
The safety and effectiveness of OMNIPAQUE for CT cerebral ventriculography have not been established in pediatric patients. Intra-arterial or Intravenous Use Cardiac Ventriculography, Aortography, and Pulmonary Angiography The safety and effectiveness of OMNIPAQUE have been established in pediatric patients from birth to 17 years of age for cardiac ventriculography, aortography, and pulmonary angiography. Use of OMNIPAQUE is supported by controlled clinical studies in adults for cardiac ventriculography and aortography, in addition to controlled clinical studies in pediatric patients undergoing cardiac ventriculography, including aortography.
Excretory Urography The safety and effectiveness of OMNIPQUE have been established in pediatric patients from birth to 17 years of age for excretory urography. Use of OMNIPAQUE is supported by controlled clinical studies in adults for urography, in addition to controlled clinical studies in pediatric patients undergoing urography and clinical safety data in pediatric patients down to birth. CT of the Head and Body The safety and effectiveness of OMNIPAQUE have been established in pediatric patients from birth to 17 years of age for CT imaging of the head and body.
Use of OMNIPAQUE is supported by controlled clinical studies in adults for head and body CT, in addition to clinical studies in pediatric patients undergoing head CT and in 69 pediatric patients undergoing CT of the abdomen after oral administration of diluted OMNIPAQUE plus intravenous administration of OMNIPAQUE. Selective Coronary Arteriography, Cerebral and Peripheral Arteriography, Intra-arterial Digital Subtraction Angiography, Peripheral Venography, and Intravenous Digital Subtraction Angiography The safety and effectiveness of OMNIPAQUE have not been established in pediatric patients for selective coronary arteriography, cerebral or peripheral arteriography, intra-arterial digital subtraction angiography, peripheral venography, and intravenous digital subtraction angiography.
Oral or Rectal Use Examination of the GI Tract The safety and effectiveness of OMNIPAQUE have been established in pediatric patients, from birth to 17 years of age for examination of the GI tract. Use of OMNIPAQUE is supported by controlled studies in adults for examination of the GI tract, in addition to clinical studies in pediatric patients undergoing examination of the GI tract. CT of the Abdomen and Pelvis in Conjunction with Intravenous Use The safety and effectiveness of OMNIPAQUE for CT of the abdomen and pelvis have been established in pediatric patients from birth to 17 years of age.
Use is supported by clinical trials in adults, in addition to clinical studies in 69 pediatric patients undergoing CT of the abdomen. Intraarticular Use The safety and effectiveness of OMNIPAQUE have not been established in pediatric patients for arthrography. Body Cavity Use Voiding Cystourethrography OMNIPAQUE is indicated for use in pediatric patients from birth to 17 years of age for voiding cystourethrography (VCU).
Use for voiding cystourethrography is supported by clinical studies in 51 pediatric patients undergoing VCU. ERCP, Herniography, and Hysterosalpingography The safety and effectiveness of OMNIPAQUE have not been established in pediatric patients for ERCP, herniography, or hysterosalpingography. In general, the frequency of adverse reactions in pediatric patients was similar to that seen in adults [ s ee… [Excerpted — this section continues on DailyMed.]
🧓 Geriatric Use ▾
8.5Geriatric Use In clinical studies of OMNIPAQUE for CT of the head and body, 52 (17%) of patients were 70 and over. No overall differences in safety were observed between these patients and younger patients. Other reported clinical experience has not identified differences in safety and effectiveness between the elderly and younger patients.
Iohexol is substantially excreted by the kidney, and the risk of adverse reactions to iohexol may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
🆘 Overdosage ▾
10 OVERDOSAGE The adverse effects of overdosage in intra-arterial or intravenous administration are life-threatening and affect mainly the pulmonary and cardiovascular systems. The symptoms include: cyanosis, bradycardia, acidosis, pulmonary hemorrhage, convulsions, coma, and cardiac arrest. Treatment of an overdosage is directed toward the support of all vital functions, and prompt institution of symptomatic therapy. Iohexol can be dialyzed.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The iodine atoms in iohexol provide attenuation of X-rays in direct proportion to the concentration of iohexol. Since concentration changes over time, iohexol provides time-dependent image contrast which may assist in visualizing body structures.
12.2Pharmacodynamics Intrathecal Administration The initial concentration and volume of the contrast medium, in conjunction with patient manipulation and the volume of cerebrospinal fluid (CSF) into which the contrast medium is placed, will determine the extent of the contrast that can be achieved. Following intrathecal injection in conventional radiography, OMNIPAQUE 180 mg iodine/mL, 240 mg iodine/mL, and 300 mg iodine/mL will continue to provide contrast for at least 30 minutes. Slow diffusion of iohexol takes place throughout the CSF with subsequent absorption into the bloodstream.
At approximately 1 hour following injection, contrast will no longer be sufficient for conventional myelography. After administration into the lumbar subarachnoid space, computerized tomography shows the presence of contrast medium in the thoracic region in about 1 hour, in the cervical region in about 2 hours, and in the basal cisterns in 3 to 4 hours. Intravenous or Intra-arterial Administration Following intravenous or intra-arterial administration of OMNIPAQUE, the degree of contrast enhancement is directly related to the iodine concentration of an administered dose; peak iodine blood concentrations occur immediately (15 seconds to 120 seconds) following rapid intravenous injection.
The time to maximum contrast enhancement can vary, depending on the organ, from the time that peak blood iodine concentrations are reached to one hour after intravenous bolus administration. When a delay between peak blood iodine concentrations and peak contrast is present, it suggests that radiographic contrast enhancement is at least in part dependent on the accumulation of iodine containing agent within the lesion and outside the blood pool. Oral Administration Orally administered OMNIPAQUE produces visualization of the gastrointestinal tract.
Less than 1% of orally administered iohexol is recovered in the urine, suggesting minimal amounts are absorbed from the normal gastrointestinal tract. This amount may increase in the presence of bowel perforation or bowel obstruction. Intraarticular Administration Visualization of the joint spaces can be accomplished by direct injection of contrast medium.
For intraarticular cavities, the injected iohexol is absorbed into the surrounding tissue and subsequently absorbed into systemic circulation. Body Cavity Administration For most body cavities, the injected iohexol is absorbed into the surrounding tissue and subsequently absorbed into systemic circulation. Examinations of the uterus (hysterosalpingography) and bladder (voiding cystourethrography) involve the almost immediate drainage of contrast medium from the cavity upon conclusion of the radiographic procedure.
12.3Pharmacokinetics Following the intravenous administration of iohexol (between 500 mg iodine/kg to 1,500 mg iodine/kg) to 16 adult subjects, apparent first-order terminal elimination half-life was 12.6 hours and total body clearance was 131 (98 to 165) mL/min. Clearance was not dose dependent. Absorption As evidenced by the amount recovered in urine, <1% of orally administered iohexol is absorbed from the normal gastrointestinal tract.
This amount may increase in the presence of bowel perforation or bowel obstruction. Distribution In 16 adult subjects (receiving between 500 mg iodine/kg to 1,500 mg iodine/kg intravenous iohexol) the plasma volume of distribution was165 (108 to 219) mL/kg. In five adult patients receiving 16 mL to 18 mL of OMNIPAQUE (180 mg iodine/mL) by lumbar intrathecal injection the plasma volume of distribution was 559 (350 to 849) mL/kg.
Elimination Metabolism No significant metabolism, deiodination or biotransformation occurs. Excretion Fol… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action The iodine atoms in iohexol provide attenuation of X-rays in direct proportion to the concentration of iohexol. Since concentration changes over time, iohexol provides time-dependent image contrast which may assist in visualizing body structures.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied OMNIPAQUE (iohexol) injection and OMNIPAQUE (iohexol) oral solution are colorless to pale yellow solutions available in the following presentations: Dosage Form Concentration (mg iodine/mL) Package Size Package Type & Material Sale Unit NDC Injection 140 50 mL Single-Dose Polymer Bottles Boxes of 10 0407-1401-52 180 10 mL Single-Dose Glass Vials Boxes of 10 0407-1411-10 240 10 mL Single-Dose Glass Vials Boxes of 10 0407-1412-10 20 mL Single-Dose Glass Vials Boxes of 10 0407-1412-20 50 mL Single-Dose Polymer Bottles Boxes of 10 0407-1412-30 100 mL Single-Dose Polymer Bottles Boxes of 10 0407-1412-33 300 10 mL Single-Dose Glass Vials Boxes of 10 0407-1413-10 30 mL Single-Dose Polymer Bottles Boxes of 10 0407-1413-59 50 mL Single-Dose Polymer Bottles Boxes of 10 0407-1413-61 100 mL Single-Dose Polymer Bottles Boxes of 10 0407-1413-63 125 mL Single-Dose Glass Bottles Boxes of 10 0407-1413-53 150 mL Single-Dose Polymer Bottles Boxes of 10 0407-1413-65 500 mL OMNIPAQUE injection 300 mg iodine/mL and OMNIPAQUE injection 350 mg iodine/mL in bottles of 500 mL can be used as either an Imaging Bulk Package or a Pharmacy Bulk Package [see Dosage and Administration (2.10 , 2.11) ] .
Imaging or Pharmacy Bulk Package Polymer Bottles Boxes of 10 0407-1413-72 350 50 mL Single-Dose Polymer Bottles Boxes of 10 0407-1414-89 75 mL Single-Dose Polymer Bottles Boxes of 10 0407-1414-90 100 mL Single-Dose Polymer Bottles Boxes of 10 0407-1414-91 125 mL Single-Dose Glass Bottles Boxes of 10 0407-1414-76 150 mL Single-Dose Polymer Bottles Boxes of 10 0407-1414-93 200 mL Single-Dose Polymer Bottles Boxes of 10 0407-1414-94 500 mL Imaging or Pharmacy Bulk Package Polymer Bottles Boxes of 10 0407-1414-72 Oral Solution 9 500 mL Single-Dose Polymer Bottles Boxes of 10 0407-1415-09 12 500 mL Single-Dose Polymer Bottles Boxes of 10 0407-1416-12 The container closure system components (bottle, vial, stopper, and cap) of OMNIPAQUE injection and OMNIPAQUE oral solution are not made with natural rubber latex.
Storage and Handling OMNIPAQUE Injection: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. May be stored in a contrast media warmer for up to one month, not to exceed 37°C (98.6°F). OMNIPAQUE Oral Solution: Store between 0°C and 30°C (32°F to 86°F).
Protect from light. Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.
📦 Storage and Handling ▾
Storage and Handling OMNIPAQUE Injection: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. May be stored in a contrast media warmer for up to one month, not to exceed 37°C (98.6°F). OMNIPAQUE Oral Solution: Store between 0°C and 30°C (32°F to 86°F).
Protect from light. Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.
📋 Description ▾
11 DESCRIPTION Iohexol is a nonionic radiographic contrast agent available as: OMNIPAQUE (iohexol) injection for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and body cavity use OMNIPAQUE (iohexol) oral solution for oral use The chemical name of iohexol is Bis(2,3-dihydroxypropyl)-5-[ N -(2,3-dihydroxypropyl)-acetamido]-2,4,6- triiodoisophthalamide with a molecular weight of 821.14 (iodine content 46.36%). Iohexol has the following structural formula: OMNIPAQUE injection is a sterile, pyrogen-free, colorless to pale yellow solution available in five concentrations of iodine: OMNIPAQUE 140 mg iodine/mL: Each mL contains 302 mg iohexol (providing 140 mg organically bound iodine) and the following inactive ingredients: 0.1 mg edetate calcium disodium and 1.21 mg tromethamine.
OMNIPAQUE 180 mg iodine/mL: Each mL contains 388 mg iohexol (providing 180 mg organically bound iodine) and the following inactive ingredients: 0.1 mg edetate calcium disodium and 1.21 mg tromethamine. OMNIPAQUE 240 mg iodine/mL: Each mL contains 518 mg iohexol (providing 240 mg organically bound iodine) and the following inactive ingredients: 0.1 mg edetate calcium disodium and 1.21 mg tromethamine. OMNIPAQUE 300 mg iodine/mL: Each mL contains 647 mg iohexol (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.1 mg edetate calcium disodium and 1.21 mg tromethamine.
OMNIPAQUE 350 mg iodine/mL: Each mL contains 755 mg iohexol (providing 350 mg organically bound iodine) and the following inactive ingredients: 0.1 mg edetate calcium disodium and 1.21 mg tromethamine. OMNIPAQUE oral solution is a sterile, pyrogen-free, colorless to pale yellow solution available in two concentrations of iodine: OMNIPAQUE oral solution 9 mg iodine/mL: Each mL contains 19 mg iohexol (providing 9 mg organically bound iodine) and the following inactive ingredients: 0.1 mg edetate calcium disodium and 1.21 mg tromethamine.
OMNIPAQUE oral solution 12 mg iodine/mL: Each mL contains 26 mg iohexol (providing 12 mg organically bound iodine) and the following inactive ingredients: 0.1 mg edetate calcium disodium and 1.21 mg tromethamine. The pH is adjusted between 6.8 and 7.7 with hydrochloric acid or sodium hydroxide. OMNIPAQUE injection and OMNIPAQUE oral solution contain no preservatives and no ingredient made from a gluten-containing grain (wheat, barley, or rye).
OMNIPAQUE injection and OMNIPAQUE oral solution have the following physical properties: Table 21. Physicochemical Properties of OMNIPAQUE Dosage Form Concentration (mg iodine/mL) Osmolality By vapor-pressure osmometry. (mOsmol/kg water) Absolute Viscosity (cP) Specific Gravity 20°C 37°C 37°C Injection 140 322 2.3 1.5 1.164 180 408 3.1 2.0 1.209 240 520 5.8 3.4 1.280 300 672 11.8 6.3 1.349 350 844 20.4 10.4 1.406 Oral solution 9 38 1.1 0.8 1.011 12 45 1.1 0.8 1.014 OMNIPAQUE injection has osmolalities from approximately 1.1 to 3 times that of plasma (285 mOsmol/kg water) or cerebrospinal fluid (301 mOsmol/kg water) as shown in the above table and are hypertonic.
OMNIPAQUE oral solution is hypotonic. Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Hypersensitivity Reactions Advise the patient concerning the risk of hypersensitivity reactions that can occur both during and after OMNIPAQUE administration. Advise the patient to report any signs or symptoms of hypersensitivity reactions during the procedure and to seek immediate medical attention for any signs or symptoms experienced after discharge [see Warnings and Precautions (5.3) ]. Advise patients to inform their physician if they develop a rash after receiving OMNIPAQUE [see Warnings and Precautions (5.12) ].
Acute Kidney Injury Advise the patient concerning appropriate hydration to decrease the risk of contrast-induced acute kidney injury [see Warnings and Precautions (5.4) ] . Extravasation If extravasation occurs during injection, advise patients to seek medical care for progression of symptoms [see Warnings and Precautions (5.7) ]. Lactation Advise a lactating woman that interruption of breastfeeding is not necessary.
However, to avoid any exposure, a lactating woman may consider pumping and discarding breast milk for 10 hours after OMNIPAQUE administration [see Use in Specific Populations (8.2) ]. Thyroid Dysfunction Advise parents/caregivers about the risk of developing thyroid dysfunction after OMNIPAQUE administration. Advise parents/caregivers about when to seek medical care for their child to monitor for thyroid function [see Warnings and Precautions (5.9) ].
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Following the intravenous administration of iohexol (between 500 mg iodine/kg to 1,500 mg iodine/kg) to 16 adult subjects, apparent first-order terminal elimination half-life was 12.6 hours and total body clearance was 131 (98 to 165) mL/min. Clearance was not dose dependent. Absorption As evidenced by the amount recovered in urine, <1% of orally administered iohexol is absorbed from the normal gastrointestinal tract.
This amount may increase in the presence of bowel perforation or bowel obstruction. Distribution In 16 adult subjects (receiving between 500 mg iodine/kg to 1,500 mg iodine/kg intravenous iohexol) the plasma volume of distribution was165 (108 to 219) mL/kg. In five adult patients receiving 16 mL to 18 mL of OMNIPAQUE (180 mg iodine/mL) by lumbar intrathecal injection the plasma volume of distribution was 559 (350 to 849) mL/kg.
Elimination Metabolism No significant metabolism, deiodination or biotransformation occurs. Excretion Following intravenous, intra-arterial or intrathecal administration, iohexol is excreted unchanged by glomerular filtration. Approximately 90% of the intravenously injected iohexol dose is excreted within the first 24 hours.
Following intravenous or intraarterial administration, peak urine concentration occurs in the first hour after injection.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Intrathecal Administration The initial concentration and volume of the contrast medium, in conjunction with patient manipulation and the volume of cerebrospinal fluid (CSF) into which the contrast medium is placed, will determine the extent of the contrast that can be achieved. Following intrathecal injection in conventional radiography, OMNIPAQUE 180 mg iodine/mL, 240 mg iodine/mL, and 300 mg iodine/mL will continue to provide contrast for at least 30 minutes. Slow diffusion of iohexol takes place throughout the CSF with subsequent absorption into the bloodstream.
At approximately 1 hour following injection, contrast will no longer be sufficient for conventional myelography. After administration into the lumbar subarachnoid space, computerized tomography shows the presence of contrast medium in the thoracic region in about 1 hour, in the cervical region in about 2 hours, and in the basal cisterns in 3 to 4 hours. Intravenous or Intra-arterial Administration Following intravenous or intra-arterial administration of OMNIPAQUE, the degree of contrast enhancement is directly related to the iodine concentration of an administered dose; peak iodine blood concentrations occur immediately (15 seconds to 120 seconds) following rapid intravenous injection.
The time to maximum contrast enhancement can vary, depending on the organ, from the time that peak blood iodine concentrations are reached to one hour after intravenous bolus administration. When a delay between peak blood iodine concentrations and peak contrast is present, it suggests that radiographic contrast enhancement is at least in part dependent on the accumulation of iodine containing agent within the lesion and outside the blood pool. Oral Administration Orally administered OMNIPAQUE produces visualization of the gastrointestinal tract.
Less than 1% of orally administered iohexol is recovered in the urine, suggesting minimal amounts are absorbed from the normal gastrointestinal tract. This amount may increase in the presence of bowel perforation or bowel obstruction. Intraarticular Administration Visualization of the joint spaces can be accomplished by direct injection of contrast medium.
For intraarticular cavities, the injected iohexol is absorbed into the surrounding tissue and subsequently absorbed into systemic circulation. Body Cavity Administration For most body cavities, the injected iohexol is absorbed into the surrounding tissue and subsequently absorbed into systemic circulation. Examinations of the uterus (hysterosalpingography) and bladder (voiding cystourethrography) involve the almost immediate drainage of contrast medium from the cavity upon conclusion of the radiographic procedure.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES The safety and effectiveness of OMNIPAQUE for CT of the head were evaluated in three clinical studies. Each study also used an ionic high-osmolar iodinated contrast agent as a comparator. A total of 280 patients were randomized to administration of either OMNIPAQUE (n=142) or the comparator (n=138).
OMNIPAQUE patients had a mean age of 52 years (range 16 to 85), 41% were women, and were administered a mean of 692 mg iodine/kg (range 337 to 1,250 mg iodine/kg) by intravenous injection with OMNIPAQUE 240 mg iodine/mL (1 study) or 300 mg iodine/mL (2 studies). Efficacy was determined from investigator ratings of quality of contrast enhancement (none, poor, good, or excellent; only scans rated as good or excellent were considered diagnostic). The percentage of OMNIPAQUE-enhanced scans rated as good or excellent was 100% in the two studies using OMNIPAQUE 300 mg iodine/mL, and 79% in the third study using OMNIPAQUE 240 mg iodine/mL.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed with iohexol to evaluate carcinogenic potential. Iohexol was not genotoxic in a series of studies, including the Ames test, the mouse lymphoma TK locus forward mutation assay, and a mouse micronucleus assay. Iohexol did not impair the fertility of male or female rats when repeatedly administered at intravenous dosages up to 4 g iodine/kg.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed with iohexol to evaluate carcinogenic potential. Iohexol was not genotoxic in a series of studies, including the Ames test, the mouse lymphoma TK locus forward mutation assay, and a mouse micronucleus assay. Iohexol did not impair the fertility of male or female rats when repeatedly administered at intravenous dosages up to 4 g iodine/kg.
📄 Recent Major Changes ▾
Indications and Usage, Oral or Rectal Procedures ( 1.4 ) 4/2026
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 300 mg Bottle Box Label GE Healthcare Y-538I Contains 10 x 500 mL Bottles NDC 0407-1413-72 OMNIPAQUE™ (iohexol) Injection 300 mg Iodine/mL This container can be used either as: IMAGING BULK PACKAGE For Intravenous Use Only or PHARMACY BULK PACKAGE Not for Direct Infusion For Intrathecal, Intra-arterial, Intravenous, Oral, Rectal, Intraarticular, or Body Cavity Use Rx ONLY See prescribing information for dosage and administration. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
May be stored in a contrast media warmer for up to one month, not to exceed 37°C (98.6°F). Protect from light. Do not freeze.
Discard unused OMNIPAQUE 8 hours after initial puncture. Each mL contains 647 mg of iohexol (300 mg organically bound iodine), 0.1 mg edetate calcium disodium, and 1.21 mg tromethamine. The pH is adjusted between 6.8 and 7.7 with hydrochloric acid or sodium hydroxide.
No preservative added. +PLUSPAK™ (polymer bottle) Distributed by GE Healthcare Inc., Marlborough, MA 01752 U.S.A. For inquiries call 1-800-654-0118 Exp.: DD MMM YYYY Lot: 12345678 0000000 USA PRINCIPAL DISPLAY PANEL - 300 mg Bottle Box Label
PRINCIPAL DISPLAY PANEL - 350 mg Bottle Box Label GE Healthcare Y-548I Contains 10 x 500 mL Bottles NDC 0407-1414-72 OMNIPAQUE™ (iohexol) Injection 350 mg Iodine/mL This container can be used either as: IMAGING BULK PACKAGE For Intravenous Use Only or PHARMACY BULK PACKAGE Not for Direct Infusion For Intra-arterial, Intravenous, Oral, Intraarticular, or Body Cavity Use NOT FOR INTRATHECAL USE Rx ONLY See prescribing information for dosage and administration. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
May be stored in a contrast media warmer for up to one month, not to exceed 37°C (98.6°F). Protect from light. Do not freeze.
Discard unused OMNIPAQUE 8 hours after initial puncture. Each mL contains 755 mg of iohexol (350 mg organically bound iodine), 0.1 mg edetate calcium disodium, and 1.21 mg tromethamine. The pH is adjusted between 6.8 and 7.7 with hydrochloric acid or sodium hydroxide.
No preservative added. +PLUSPAK™ (polymer bottle) Distributed by GE Healthcare Inc., Marlborough, MA 01752 U.S.A. For inquiries call 1-800-654-0118 Exp.: Lot: 1211016 USA PRINCIPAL DISPLAY PANEL - 350 mg Bottle Box Label
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