ILLUSOF

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.

Iohexol ia used in myelography, arthrography, nephroangiography, arteriography, and other radiographic procedures.

Organic iodine compounds block x-rays as they pass through the body, thereby allowing body structures containing iodine to be delineated in contrast to those structures that do not contain iodine.

The degree of opacity produced by these compounds is directly proportional to the total amount (concentration and volume) of the iodinated contrast agent in the path of the x-rays.

After intrathecal administration into the subarachnoid space, diffusion of iohexol in the CSF allows the visualization of the subarachnoid spaces of the head and spinal canal.

After intravascular administration, iohexol makes opaque those vessels in its path of flow, allowing visualization of the internal structures until significant hemodilution occurs.

Small amounts are absorbed through the bladder via intravesical instillation.

Following intrauterine instillation, the majority of the medium within the uterine cavity is discharged into the vagina immediately upon termination of procedure.

However, any medium retained in the uterine or peritoneal cavity is absorbed systemically within 60 minutes.

May not be absorbed for up to 24 hours if tubes are obstructed and dilated.

Iohexol is absorbed from cerebrospinal fluid (CSF) into the bloodstream and is eliminated by renal excretion.

No significant metabolism, deiodination, or biotransformation occurs.

Intrathecal half-life is 3.4 hours (mean).

Intravascular is approximately 2 hours (with normal renal function).

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Non-ionic radiocontrast agents like iohexol are cytotoxic to renal cells.

The toxic effects include apoptosis, cellular energy failure, disruption of calcium homeostasis, and disturbance of tubular cell polarity, and are thought to be linked to oxidative stress.

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.

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.

See full prescribing information for complete dosing and administration information. 2.1 Important Dosage and Administration Instructions Specific dosage forms, concentrations, and presentations of OMNIPAQUE are recommended for each type of imaging procedure.

Individualize the volume, strength, and rate of administration of OMNIPAQUE injection according to the specific dosing tables.

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.

Use aseptic technique for all handling and administration of OMNIPAQUE injection.

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.

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. 2.2 Recommended 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. 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 2.3 Recommended 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. 40 mL (Range of 30 mL to 60 mL) may be combined with selective coronary arteriography 250 mL Aortography and Selective Visceral Arteriography 300 Aorta (aortic arch, ascending aorta): 50 mL to 80 mL Abdominal aorta and its branches (celiac, mesenteric, hepatic, and splenic arteries): 30 mL to 60 mL Renal arteries: 5 mL to 15 mL 290 mL 350 250 mL Aortic root and arch study when used alone 350 50 mL (Range of 20 mL to 75 mL) 250 mL Selective Coronary Arteriography 350 5 mL (Range of 3 mL to 14 mL) 250 mL Cerebral Arteriography 300 Common carotid artery: 6 mL to 12 mL Internal carotid artery: 8 mL to 10 mL External carotid artery: 6 mL to 9 mL Vertebral artery: 6 mL to 10 mL 290 mL Peripheral Arteriography Aortofemoral Runoffs 300 30 mL to 90 mL 290 mL 350 20 mL to 70 mL 250 mL Selective Arteriogram 300 10 mL to 60 mL 290 mL 350 10 mL to 30 mL 250 mL IA-DSA (head, neck, abdominal, renal, and peripheral vessels) 140 Aorta: 20 mL to 45 mL at 8 mL/sec to 20 mL/sec Carotid artery: 5 mL to 10 mL at 3 mL/sec to 6 mL/sec Femoral artery: 9 mL to 20 mL at 3 mL/sec to 6 mL/sec Vertebral artery: 4 mL to 10 mL at 2 mL/sec to 8 mL/sec Renal arteries: 6 mL to 12 mL at 3 mL/sec to 6 mL/sec Other branches of aorta (includes subclavian, axillary, innominate, and iliac): 8 mL to 25 mL at 3 mL/sec to 10 mL/sec 250 mL 2.4 Recommended Dosage for Intravenous Procedures in Adults The recommended doses for intravenous procedures in adults are shown in Table 3.

Table 3.

Recommended Concentrations and Volumes of OMNIPAQUE Injection for Intravenous Procedures in Adults Imaging Procedure Concentration (mg Iodine/mL) Volume to Administer Excretory Urography 300 Use single-dose containers or 500 mL Pharmacy Bulk Packages. 0.6 mL/kg to 1.2 mL/kg body weight (maximum dose is 102 mL) 350 CT Head 240 120 mL to 250 mL by infusion 300 Use single-dose containers, 500 mL Imaging Bulk Packages or Pharmacy Bulk Packages, or 150 mL single-dose bottles with an automated contrast injection system or contrast management system. 70 mL to 150 mL by rapid injection 350 80 mL by rapid injection Body 300 50 mL to 200 mL by rapid injection 350 60 mL to 100 mL by rapid injection Peripheral Venography (phlebography) 240 20 mL to 150 mL per leg 300 40 mL to 100 mL per leg IV-DSA (head, neck, abdominal, renal, and peripheral vessels) 350 30 mL to 50 mL at 7.5 mL/sec to 30 mL/sec using a pressure injector Frequently three or more doses may be required; the maximum cumulative total dose is 250 mL 2.5 Recommended Dosage for Oral Procedures in Adults Recommended Dosage for Radiographic Examination of the GI Tract in Adults The recommended dose for radiographic examination of the GI tract in adults is 50 mL to 100 mL of OMNIPAQUE injection 350 mg iodine/mL administered undiluted orally.

Recommended Dosage for CT of the Abdomen and Pelvis in Conjunction with Intravenous Administration of OMINIPAQUE Injection in Adults The recommended oral dose using diluted OMNIPAQUE injection or OMNIPAQUE oral solution and concurrent intravenous doses for CT of the abdomen and pelvis in adults are shown in Table 4.

Table 4.

Recommended Concentrations and Volumes of Diluted OMNIPAQUE Injection or OMNIPAQUE Oral Solution for Oral Administration and Concurrent Intravenous OMNIPAQUE Injection for CT of the Abdomen and Pelvis in Adults Concentration (mg Iodine/mL) Volume to Administer Administration Instructions Oral Dose Using Diluted OMNIPAQUE Injection 6 mg Iodine/mL to 12 mg Iodine/mL of Diluted OMNIPAQUE Injection See Table for dilution instructions of OMNIPAQUE injection 500 mL to 1,000 mL Administer the oral dose all at once or over a period of up to 45 minutes if there is difficulty in consuming the required volume.

Use a higher iodine concentration of the diluted product if a smaller volume needs to be administered.

Solution 9 mg Iodine/mL or 12 mg Iodine/mL of OMNIPAQUE Oral Solution 500 mL to 1,000 mL Administer the oral dose all at once or over a period of up to 45 minutes if there is difficulty in consuming the required volume.

Intravenous Dose of OMNIPAQUE injection in Conjunction with Oral Administration 300 Use single-dose containers, 500 mL Imaging or Pharmacy Bulk Packages, or 150 mL single-dose bottles with an automated contrast injection system or contrast management system. 100 mL to 150 mL Administer up to 40 minutes AFTER consumption of the oral dose.

Preparation of Diluted OMNIPAQUE Injection for Oral Administration for CT of the Abdomen and Pelvis in Adults Prepare the diluted OMNIPAQUE injection in water, carbonated beverage, milk, or juice just prior to administration according to Table 5.

Discard any unused portion after the procedure.

Table 5.

Volumes of OMNIPAQUE Injection and Added Liquid to Dilute OMNIPAQUE Injection for Oral Administration for CT of the Abdomen in Adults Concentration of Diluted OMNIPAQUE injection (mg iodine/mL) Dilution Method 1 Dilution Method 2 Dilution Method 3 Volume of OMNIPAQUE 240 mg Iodine/mL (mL) Volume of Added Liquid Use water, carbonated beverage, milk, or juice. (mL) Volume of OMNIPAQUE 300 mg Iodine/mL (mL) Volume of Added Liquid (mL) Volume of OMNIPAQUE 350 mg Iodine/mL (mL) Volume of Added Liquid (mL) 6 25 975 20 980 17 983 9 38 962 30 970 26 974 12 50 950 40 960 35 965 2.6 Recommended Dosage for Intraarticular Procedures in Adults The recommended doses for intraarticular procedures in adults are shown in Table 6.

Use passive or active manipulation to disperse the medium throughout the joint space.

Table 6.

Recommended Concentrations and Volumes of OMNIPAQUE Injection for Intraarticular Procedures in Adults Imaging Procedure Location Concentration (mg Iodine/mL) Volume to Administer Double Contrast/Single Contrast Arthrography Knee 240 Use single-dose containers or 500 mL Pharmacy Bulk Packages. 5 mL to 15 mL Lower volumes recommended for double-contrast examinations; higher volumes recommended for single-contrast examinations. 300 5 mL to 15 mL 350 5 mL to 10 mL Shoulder 300 10 mL Temporomandibular 300 0.5 mL to 1 mL 2.7 Recommended Dosage for Body Cavity Procedures in Adults The recommended doses for body cavity procedures in adults are shown in Table 7.

Volume to administer may vary depending on individual anatomy and/or disease state.

Table 7.

Recommended Concentrations and Volumes of OMNIPAQUE Injection for Body Cavity Procedures in Adults Imaging Procedure Concentration (mg Iodine/mL) Volume to Administer Route of Administration Endoscopic retrograde pancreatography (ERP) and cholangiopancreatography (ERCP) 240 Use single-dose containers or 500 mL Pharmacy Bulk Packages. 10 mL to 50 mL Intraductal Herniography 240 15 mL to 20 mL Intraperitoneal 300 Hysterosalpingography 240 50 mL Intrauterine 2.8 Recommended Dosage for Intrathecal, Intra-arterial, and Intravenous Procedures in Pediatric Patients Recommended Dosage for Intrathecal Procedures in Pediatric Patients Aged 2 Weeks and Older Recommended doses based on age for intrathecal procedures in pediatric patients aged 2 weeks and older are shown in Table 8.

Table 8: Recommended Concentrations and Volumes of OMNIPAQUE Injection Based on Age for Intrathecal Procedure in Pediatric Patients Aged 2 Weeks and Older Imaging Procedure Injection Type Age Concentration (mg Iodine/mL) Volume to Administer Myelography Lumbar Thoracic Cervical Total Columnar CT cisternography Lumbar 2 weeks up to 3 months 180 Use single-dos.

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.

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.

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) .

May be stored in a contrast media warmer for up to one month, not to exceed 37°C (98.6°F).

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.

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) .

May be stored in a contrast media warmer for up to one month, not to exceed 37°C (98.6°F).

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.

Hysterosalpingography is contraindicated in pregnant women due to the potential risk to the fetus from an intrauterine procedure.

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.

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.

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 to 4% and to 20%, respectively.

Literature reports show that intravenously administered iohexol crosses the placenta and is visualized in the digestive tract of exposed infants after birth.

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 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 of pregnancy.

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.

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.

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.

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.

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.

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.

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.

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 Adverse Reactions.

Pediatric patients at higher risk of experiencing adverse events during contrast-medium administration may include those having asthma, a sensitivity to medication and/or allergens, congestive heart failure, a serum creatinine greater than 1.5 mg/dL or those less than 12 months of age.

Thyroid function tests indicative of thyroid dysfunction, characterized by hypothyroidism or transient thyroid suppression have been reported following iodinated contrast media administration in pediatric patients, including term and preterm neonates.

Some patients were treated for hypothyroidism.

After exposure to iodinated contrast media, individualize thyroid function monitoring in pediatric patients to 3 years of age based on underlying risk factors, especially in term and preterm neonates.

In clinical studies of OMNIPAQUE for

CT of the head and body, 52 (17%) of patients were 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.