Label: OMNIPAQUE- iohexol injection, solution

  • NDC Code(s): 0407-1413-72, 0407-1414-72
  • Packager: GE Healthcare
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 18, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use OMNIPAQUE safely and effectively. See full prescribing information for OMNIPAQUE.

    OMNIPAQUE (iohexol) injection, for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, or body cavity use
    OMNIPAQUE (iohexol) oral solution
    Initial U.S. Approval: 1985

    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)

    RECENT MAJOR CHANGES

    Indications and Usage, CT cerebral ventriculography (1.1) - Removed10/2024
    Dosage and Administration (2.6, 2.10, 2.11)10/2024

    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)

    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)

    DOSAGE FORMS AND STRENGTHS

    • 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

    • 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 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)

    ADVERSE REACTIONS

    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.

    USE IN SPECIFIC POPULATIONS

    • Lactation: A lactating woman may pump and discard breast milk for 10 hours after OMNIPAQUE administration. (8.2)

    See 17 for PATIENT COUNSELING INFORMATION.

    Revised: 10/2024

  • Table of Contents

    FULL PRESCRIBING INFORMATION: CONTENTS*

    WARNING: RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION OF OMNIPAQUE INJECTION 140 mg IODINE/mL and 350 mg IODINE/mL

    1 INDICATIONS AND USAGE

    1.1 Intrathecal Procedures‡

    1.2 Intra-arterial Procedures‡

    1.3 Intravenous Procedures‡

    1.4 Oral or Rectal Procedures‡

    1.5 Intraarticular Procedures‡

    1.6 Body Cavity Procedures‡

    2 DOSAGE AND ADMINISTRATION

    2.1 Important Dosage and Administration Instructions

    2.2 Recommended Dosage for Intrathecal Procedures in Adults

    2.3 Recommended Dosage for Intra-arterial Procedures in Adults

    2.4 Recommended Dosage for Intravenous Procedures in Adults

    2.5 Recommended Dosage for Oral Procedures in Adults

    2.6 Recommended Dosage for Intraarticular Procedures in Adults

    2.7 Recommended Dosage for Body Cavity Procedures in Adults

    2.8 Recommended Dosage for Intrathecal, Intra-arterial, and Intravenous Procedures in Pediatric Patients

    2.9 Recommended Dosage for Oral or Rectal and Body Cavity Procedures in Pediatric Patients

    2.10 Directions for Use of the 500 mL Bottles of OMNIPAQUE Injection 300 mg Iodine/mL and 350 mg Iodine/mL as Imaging Bulk Package

    2.11 Directions for Use of the 500 mL Bottles of OMNIPAQUE Injection 300 mg Iodine/mL and 350 mg Iodine/mL as Pharmacy Bulk Package

    2.12 Directions for Use of the 150 mL Bottles of OMNIPAQUE Injection 300 mg Iodine/mL and 350 mg Iodine/mL with an Automated Contrast Injection System or Contrast Management System

    3 DOSAGE FORMS AND STRENGTHS

    4 CONTRAINDICATIONS

    5 WARNINGS AND PRECAUTIONS

    5.1 Risks Associated with Intrathecal Administration of OMNIPAQUE Injection 140 mg Iodine/mL and 350 mg Iodine/mL

    5.2 Risks Associated with Parenteral Administration of OMNIPAQUE Oral Solution

    5.3 Hypersensitivity Reactions

    5.4 Acute Kidney Injury

    5.5 Cardiovascular Adverse Reactions

    5.6 Thromboembolic Events

    5.7 Extravasation and Injection Site Reactions

    5.8 Thyroid Storm in Patients with Hyperthyroidism

    5.9 Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age

    5.10 Hypertensive Crisis in Patients with Pheochromocytoma

    5.11 Sickle Cell Crisis in Patients with Sickle Cell Disease

    5.12 Severe Cutaneous Adverse Reactions

    5.13 Interference with Laboratory Test

    5.14 Increased Risk of Seizures with Intrathecal Procedures

    6 ADVERSE REACTIONS

    6.1 Clinical Trials Experience

    6.2 Post-marketing Experience

    7 DRUG INTERACTIONS

    7.1 Drug-Drug Interactions

    7.2 Drug-Laboratory Test Interactions

    8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    8.2 Lactation

    8.4 Pediatric Use

    8.5 Geriatric Use

    8.6 Renal Impairment

    10 OVERDOSAGE

    11 DESCRIPTION

    12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    12.2 Pharmacodynamics

    12.3 Pharmacokinetics

    13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

    14 CLINICAL STUDIES

    16 HOW SUPPLIED/STORAGE AND HANDLING

    17 PATIENT COUNSELING INFORMATION

    *
    Sections or subsections omitted from the full prescribing information are not listed.
  • BOXED WARNING (What is this?)

    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)].

  • 1 INDICATIONS AND USAGE

    1.1 Intrathecal 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

    1.2 Intra-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

    1.3 Intravenous 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

    1.4 Oral or Rectal Procedures‡

    OMNIPAQUE is indicated for:

    • Radiographic examination of the gastrointestinal (GI) tract in adults and pediatric patients
    • CT of the abdomen and pelvis in conjunction with intravenous administration of OMNIPAQUE in adults and pediatric patients

    1.5 Intraarticular Procedures‡

    OMNIPAQUE is indicated for:

    • Arthrography in adults

    1.6 Body 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)].

  • 2 DOSAGE AND ADMINISTRATION

    2.1 Important 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.

    2.2 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 ProcedureInjection TypeConcentration
    (mg Iodine/mL)    		Volume to Administer
    *
    Use single-dose containers or 500 mL Pharmacy Bulk Packages [see Dosage and Administration (2.11)].
    Lumbar MyelographyLumbar180*10 mL to 17 mL
    240*7 mL to 12.5 mL
    Thoracic MyelographyLumbar
    Cervical    		240*6 mL to 12.5 mL
    300*6 mL to 10 mL
    Cervical MyelographyLumbar240*6 mL to 12.5 mL
    300*6 mL to 10 mL
    C1-2180*7 mL to 10 mL
    240*6 mL to 12.5 mL
    300*4 mL to 10 mL
    Total Columnar MyelographyLumbar240*6 mL to 12.5 mL
    300*6 mL to 10 mL
    CT CisternographyLumbar180*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 ProcedureConcentration
    (mg Iodine/mL)    		Volume to Administer per Single Injection for Selective Injection SitesMaximum Cumulative Total Dose
    *
    Use single-dose containers or a 500 mL Pharmacy Bulk Package [see Dosage and Administration (2.11)].
    Cardiac Ventriculography350*40 mL (Range of 30 mL to 60 mL)
    may be combined with selective coronary arteriography    		250 mL
    Aortography and Selective Visceral Arteriography300*
    • 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 alone350*50 mL (Range of 20 mL to 75 mL)250 mL
    Selective Coronary Arteriography350*5 mL (Range of 3 mL to 14 mL)250 mL
    Cerebral Arteriography300*
    • 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 ArteriographyAortofemoral Runoffs300*30 mL to 90 mL290 mL
    350*20 mL to 70 mL250 mL
    Selective Arteriogram300*10 mL to 60 mL290 mL
    350*10 mL to 30 mL250 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 ProcedureConcentration
    (mg Iodine/mL)    		Volume to Administer
    *
    Use single-dose containers or 500 mL Pharmacy Bulk Packages [see Dosage and Administration (2.11)].
    †
    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 [see Dosage and Administration (2.10, 2.11, 2.12)].
    Excretory Urography300*0.6 mL/kg to 1.2 mL/kg body weight
    (maximum dose is 102 mL)
    350*
    CTHead240*120 mL to 250 mL by infusion
    300†70 mL to 150 mL by rapid injection
    350†80 mL by rapid injection
    Body300†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 AdministerAdministration Instructions
    *
    See Table 5 for dilution instructions of OMNIPAQUE injection
    †
    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 [see Dosage and Administration (2.10, 2.11, 2.12)].
    Oral Dose Using Diluted OMNIPAQUE Injection
    6 mg Iodine/mL to 12 mg Iodine/mL of Diluted 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 (see Table 5).
    Oral Dose Using OMNIPAQUE Oral Solution
    9 mg Iodine/mL or 12 mg Iodine/mL of OMNIPAQUE Oral Solution500 mL to 1,000 mLAdminister 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†100 mL to 150 mLAdminister 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, infant formula, 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 1Dilution Method 2Dilution Method 3
    Volume of OMNIPAQUE 240 mg Iodine/mL
    (mL)    		Volume of Added Liquid*
    (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)
    *
    Use water, carbonated beverage, milk, infant formula, or juice.
    6259752098017983
    9389623097026974
    12509504096035965
    15639375095043957
    18759256094052948
    21889127093060940

    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 ProcedureLocationConcentration
    (mg Iodine/mL)    		Volume to AdministerDouble Contrast/Single Contrast
    *
    Use single-dose containers or 500 mL Pharmacy Bulk Packages [see Dosage and Administration (2.11)].
    ArthrographyKnee240*5 mL to 15 mLLower 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
    Shoulder300*10 mL
    Temporomandibular300*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 ProcedureConcentration (mg Iodine/mL)Volume to AdministerRoute of Administration
    *
    Use single-dose containers or 500 mL Pharmacy Bulk Packages [see Dosage and Administration (2.11)].
    Endoscopic retrograde pancreatography (ERP) and cholangiopancreatography (ERCP)240*10 mL to 50 mLIntraductal
    Herniography240*15 mL to 20 mLIntraperitoneal
    300*
    Hysterosalpingography240*50 mLIntrauterine

    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.
    • 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 8: Recommended Concentrations and Volumes of OMNIPAQUE Injection Based on Age for Intrathecal Procedure in Pediatric Patients Aged 2 Weeks and Older
    Imaging ProcedureInjection TypeAgeConcentration
    (mg Iodine/mL)    		Volume to Administer
    *
    Use single-dose containers.
    • Myelography
      • Lumbar
      • Thoracic
      • Cervical
      • Total Columnar
    • CT cisternography
    		Lumbar2 weeks up to 3 months180*2 mL to 4 mL
    3 months up to 36 months4 mL to 8 mL
    3 years up to 7 years5 mL to 10 mL
    7 years up to 13 years5 mL to 12 mL
    13 years to 18 years6 mL to 15 mL

    Recommended Dosage for Intra-arterial Procedures in Pediatric Patients

    The recommended doses for intra-arterial procedures in pediatric patients are shown in Table 9.

    Table 9. Recommended Concentrations and Volumes of OMNIPAQUE Injection per Body Weight for Intra-arterial Procedures in Pediatric Patients
    Imaging ProcedureConcentration
    (mg Iodine/mL)    		Volume per Body Weight to Administer per Single InjectionMaximum Cumulative Volume
    *
    Use single-dose containers or 500 mL Pharmacy Bulk Packages [see Dosage and Administration (2.11)].
    Cardiac Ventriculography300*1.75 mL/kg
    (Range of 1.5 mL/kg to 2 mL/kg)    		6 mL/kg up to a total volume of 290 mL
    350*1.25 mL/kg
    (Range of 1 mL/kg to 1.5 mL/kg)    		5 mL/kg up to a total volume of 250 mL
    Aortography (aortic root, aortic arch, and descending aorta)350*1 mL/kg5 mL/kg up to a total volume of 250 mL
    Pulmonary Angiography350*1 mL/kg5 mL/kg up to a total volume of 250 mL

    Recommended Dosage for Intravenous Procedures in Pediatric Patients

    The recommended doses for intravenous procedures in pediatric patients are shown in Table 10.

    Table 10. Recommended Concentrations and Volumes of OMNIPAQUE Injection per Body Weight for Intravenous Procedures in Pediatric Patients
    Imaging ProcedureConcentration
    (mg Iodine/mL)    		Volume per Body Weight to Administer
    *
    Use single-dose containers or 500 mL Pharmacy Bulk Packages [see Dosage and Administration (2.11)].
    †
    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 [see Dosage and Administration (2.10, 2.11, 2.12)].
    Excretory Urography300*0.5 mL/kg to 3 mL/kg
    (Maximum single dose: 116 mL)
    CT of the Head and Body240*1 mL/kg to 2 mL/kg (with maximum 3 mL/kg)
    (Maximum single dose: 116 mL)
    300†

    2.9 Recommended Dosage for Oral or Rectal and Body Cavity Procedures in Pediatric Patients

    Recommended Dosage for Radiographic Examination of the GI Tract in Pediatric Patients

    • The recommended doses for radiographic examination of the GI tract are shown in Table 11.
    • Administer orally or rectally.
    Table 11. Recommended Concentrations and Volumes of OMNIPAQUE Injection Based on Age for Radiographic Examination of the GI Tract in Pediatric Patients
    AgeConcentration
    (mg iodine/mL)    		Oral VolumeRectal Volume
    *
    Use single-dose containers or 500 mL Pharmacy Bulk Packages [see Dosage and Administration (2.11)].
    Less than 3 months180*5 mL to 30 mLMay be a larger volume than the volume given orally
    (up to 300 mL)
    3 months to 3 years180*, 240*, or 300*Up to 60 mL
    4 years to 10 yearsUp to 80 mL
    Greater than 10 yearsUp to 100 mL

    Recommended Dosage for CT of the Abdomen and Pelvis in Conjunction with Intravenous Administration of OMNIPAQUE in Pediatric Patients

    The recommended oral dose using diluted OMNIPAQUE injection or OMNIPAQUE oral solution and concurrent intravenous dose for CT of the abdomen and pelvis in pediatric patients are shown in Table 12.

    Table 12. 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 Pediatric Patients
    Concentration
    (mg Iodine/mL)    		Volume to AdministerAdministration InstructionsMaximum Dose by Age or Body Weight
    *
    See Table 13 for dilution instructions of OMNIPAQUE injection
    †
    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 [see Dosage and Administration (2.10, 2.11, 2.12)].
    Oral Dose Using Diluted OMNIPAQUE Injection
    9 mg Iodine/mL to 21 mg Iodine/mL of Diluted OMNIPAQUE Injection*180 mL to 750 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 (see Table 13).
    • less than 3 years old: 5 grams iodine
    • 3 years old to 18 years old: 10 grams iodine
    Oral Dose Using OMNIPAQUE Oral Solution
    6 mg Iodine/mL or 12 mg Iodine/mL of OMNIPAQUE Oral Solution180 mL to 750 mLAdminister the oral dose all at once or over a period of up to 45 minutes if there is difficulty in consuming the required volume.
    • less than 3 years old: 5 grams iodine
    • 3 years old to 18 years old: 10 grams iodine
    Intravenous Dose in Conjunction with Oral Administration
    240† or 300†2 mL/kg body weight (with a range of 1 mL/kg to 2 mL/kg)Administer up to 60 minutes AFTER consumption of the oral dose.3 mL/kg (maximum single dose: 116 mL)

    Preparation of Diluted OMNIPAQUE Injection for Oral Administration for CT of the Abdomen and Pelvis in Pediatric Patients

    • Prepare the diluted OMNIPAQUE injection in water, carbonated beverage, milk, infant formula, or juice just prior to administration according to Table 13.
    • Discard any unused portion after the procedure.
    Table 13. Volumes of OMNIPAQUE Injection and Added Liquid to Dilute OMNIPAQUE Injection for Oral Administration for CT of the Abdomen and Pelvis in Pediatric Patients
    Concentration of Diluted OMNIPAQUE injection
    (mg iodine/mL)    		Dilution Method 1 Dilution Method 2Dilution Method 3
    Volume of OMNIPAQUE 240 mg iodine/mL
    (mL)    		Volume of Added Liquid*
    (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)
    *
    Use water, carbonated beverage, milk, infant formula, or juice.
    6259752098017983
    9389623097026974
    12509504096035965
    15639375095043957
    18759256094052948
    21889127093060940

    Recommended Dosage for Voiding Cystourethrography in Pediatric Patients

    • Voiding cystourethrography (VCU) can be performed in conjunction with excretory urography [see Dosage and Administration (2.8)].
    • The concentration of diluted OMNIPAQUE injection may vary depending upon the patient's size and age and with the technique and equipment used.
    • Volume ranges of diluted OMNIPAQUE injection 50 mg iodine/mL and 100 mg iodine/mL are shown in Table 14.
    • Dilute OMNIPAQUE injection with Sterile Water for Injection according to Table 15, utilizing aseptic technique, just prior to use.
    • Discard any unused portion after the procedure.
    Table 14. Volume Ranges of Diluted OMNIPAQUE Injection for VCU in Pediatric Patients
    Concentration of Diluted OMNIPAQUE Injection*
    (mg iodine/mL)    		Volume to Administer
    *
    See Table 15 below for dilution instructions of OMNIPAQUE injection.
    5050 mL to 600 mL by intravesical administration
    10050 mL to 300 mL by intravesical administration
    Table 15. Volumes of OMNIPAQUE Injection and Sterile Water for Injection to Dilute OMNIPAQUE Injection for VCU in Pediatric Patients
    Concentration of Diluted OMNIPAQUE injection
    (mg iodine/mL)    		Dilution Method 1 Dilution Method 2Dilution Method 3
    Volume of OMNIPAQUE 240 mg Iodine/mL
    (mL)    		Volume of Sterile Water for Injection
    (mL)    		Volume of OMNIPAQUE 300 mg Iodine/mL
    (mL)    		Volume of Sterile Water for Injection
    (mL)    		Volume of OMNIPAQUE 350 mg Iodine/mL
    (mL)    		Volume of Sterile Water for Injection
    (mL)
    50100380100500100600
    60100300100400100483
    70100243100330100400
    80100200100275100338
    90100167100233100289
    100100140100200100250

    2.10 Directions for Use of the 500 mL Bottles of OMNIPAQUE Injection 300 mg Iodine/mL and 350 mg Iodine/mL as Imaging Bulk Package

    • OMNIPAQUE injection 300 mg iodine/mL and OMNIPAQUE injection 350 mg iodine/mL in 500 mL bottles may be used as an Imaging Bulk Package (IBP) for intravenous use [see Dosage and Administration (2.4, 2.8)].
    • When used as an IBP, check the appropriate box on the container label to indicate that the selected container is to be utilized as an Imaging Bulk Package. This container is for use only with an automated contrast injection system, contrast management system, or contrast media transfer set approved or cleared for use with this contrast agent in this IBP. See device labeling for information on devices indicated for use with this IBP and techniques to help assure safe use.
    • Use the OMNIPAQUE IBP and 0.9% Sodium Chloride Injection USP in a room designated for radiological procedures that involve administration of a contrast agent.
    • Using aseptic technique, penetrate the container closure only one time with a suitable sterile component of the automated contrast injection system, contrast management system, or contrast media transfer set cleared for use with the OMNIPAQUE IBP.
    • If 0.9% Sodium Chloride Injection USP is used with the OMNIPAQUE IBP, prepare the 0.9% Sodium Chloride Injection USP sterile port in accordance with the dosage and administration section of its approved prescribing information and affix the saline tag provided with the OMNIPAQUE IBP on the 0.9% Sodium Chloride Injection USP container.
    • Once the OMNIPAQUE IBP and 0.9% Sodium Chloride Injection containers are punctured, do not remove them from the work area during the entire period of use. Maintain the OMNIPAQUE IBP in an inverted position such that container contents are in continuous contact with the dispensing set.
    • After the container closure is punctured, if the integrity of the OMNIPAQUE IBP, the 0.9% Sodium Chloride Injection, and the delivery system cannot be assured through direct continuous supervision, discard the IBP, 0.9% Sodium Chloride Injection USP, and all associated disposables for the contrast media transfer set.
    • A maximum time from initial puncture is 8 hours. Discard any unused portion.

    2.11 Directions for Use of the 500 mL Bottles of OMNIPAQUE Injection 300 mg Iodine/mL and 350 mg Iodine/mL as Pharmacy Bulk Package

    • OMNIPAQUE injection 300 mg iodine/mL and OMNIPAQUE injection 350 mg iodine/mL in 500 mL bottles contain many single doses and may be used as a Pharmacy Bulk Package (PBP).
    • When used as a PBP, check the appropriate box on the container label to indicate that the selected container is to be utilized as a Pharmacy Bulk Package. This container is not for direct infusion; it is for use in pharmacy admixture service to dispense aliquots using a suitable dispensing set under a laminar flow hood or equivalent clean air compounding area using aseptic technique.
    • Penetrate the container closure only one time, utilizing a suitable transfer device and aseptic technique.
    • The withdrawal of container contents should be accomplished without delay. However, should this not be possible, a maximum time of 8 hours from initial closure entry is permitted to complete fluid transfer operations.
    • Do not remove the container from the aseptic area during the entire 8-hour period.
    • The temperature of the container should not exceed 37°C (98.6°F), after the closure has been entered.
    • Discard any unused portion after 8 hours from the initial closure entry.

    2.12 Directions for Use of the 150 mL Bottles of OMNIPAQUE Injection 300 mg Iodine/mL and 350 mg Iodine/mL with an Automated Contrast Injection System or Contrast Management System

    • OMNIPAQUE injection 300 mg iodine/mL and OMNIPAQUE injection 350 mg iodine/mL in 150 mL bottles may be used with a contrast media management system cleared for use with OMNIPAQUE injection 300 mg iodine/mL and 350 mg iodine/mL in 150 mL bottles.
    • See device labeling for information on device indications, instructions for use, and techniques to help assure safe use.
    • Using aseptic technique, penetrate the container closure only one time with a suitable sterile component of the contrast media management system cleared for use with OMNIPAQUE 300 mg iodine/mL and 350 mg iodine/mL in 150 mL bottles.
    • Once the container is punctured, do not remove the bottle from the work area during the entire period of use.
    • Maximum use time is 4 hours after initial puncture.
    • Each bottle is for one procedure only. Discard unused portion.
  • 3 DOSAGE FORMS AND STRENGTHS

    Injection and Oral Solution: Colorless to pale yellow solution available in the following presentations:

    Dosage FormConcentration
    (mg of iodine/mL)    		Package SizePackage Type
    *
    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)].
    Injection14050 mLSingle-Dose Bottle
    18010 mLSingle-Dose Vial
    24010 mL and 20 mLSingle-Dose Vial
    50 mL and 100 mLSigle-Dose Bottle
    30010 mLSingle-Dose Vial
    30 mL, 50 mL, 100 mL, 125 mL, and 150 mLSingle-Dose Bottle
    500 mL*Imaging or Pharmacy Bulk Package
    35050 mL, 75 mL, 100 mL, 125 mL, 150 mL, and 200 mLSingle-Dose Bottle
    500 mL*Imaging or Pharmacy Bulk Package
    Oral Solution9500 mLSingle-Dose Bottle
    12500 mLSingle-Dose Bottle
  • 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.

  • 5 WARNINGS AND PRECAUTIONS

    5.1 Risks 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.

    5.2 Risks 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.

    5.3 Hypersensitivity 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.

    5.4 Acute 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.

    5.5 Cardiovascular 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.

    5.6 Thromboembolic Events

    Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke can occur during angiocardiography procedures with iodinated contrast agents including OMNIPAQUE. During these procedures, increased thrombosis and activation of the complement system occurs. Risk factors for thromboembolic events include: length of procedure, catheter and syringe material, underlying disease state, and concomitant medications.

    To minimize thromboembolic events, use meticulous angiographic techniques, and minimize the length of the procedure. Avoid blood remaining in contact with syringes containing OMNIPAQUE, which increases the risk of clotting. Avoid angiocardiography in patients with homocystinuria because of the risk of inducing thrombosis and embolism.

    5.7 Extravasation and Injection Site Reactions

    Extravasation of OMNIPAQUE during intravenous or intra-arterial injection may cause tissue necrosis and/or compartment syndrome, particularly in patients with severe arterial or venous disease. Ensure intravenous or intra-arterial placement of catheters prior to injection. Monitor patients for extravasation and advise patients to seek medical care for progression of symptoms.

    5.8 Thyroid Storm in Patients with Hyperthyroidism

    Thyroid storm has occurred after the intravenous or intra-arterial use of iodinated contrast agents in patients with hyperthyroidism, or with an autonomously functioning thyroid nodule. Evaluate the risk in such patients before use of OMNIPAQUE.

    5.9 Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age

    Thyroid dysfunction characterized by hypothyroidism or transient thyroid suppression has been reported after both single exposure and multiple exposures to iodinated contrast media (ICM) in pediatric patients 0 to 3 years of age.

    Younger age, very low birth weight, prematurity, underlying medical conditions affecting thyroid function, admission to neonatal or pediatric intensive care units, and congenital cardiac conditions are associated with an increased risk of hypothyroidism after ICM exposure. Pediatric patients with congenital cardiac conditions may be at the greatest risk given that they often require high doses of contrast during invasive cardiac procedures.

    An underactive thyroid during early life may be harmful for cognitive and neurological development and may require thyroid hormone replacement therapy. After exposure to ICM, individualize thyroid function monitoring based on underlying risk factors, especially in term and preterm neonates.

    5.10 Hypertensive Crisis in Patients with Pheochromocytoma

    Hypertensive crisis has occurred after the use of iodinated contrast agents in patient with pheochromocytoma. Monitor patients when administering OMNIPAQUE intravenously or intra-arterially if pheochromocytoma or catecholamine-secreting paragangliomas are suspected. Inject the minimum amount of contrast necessary, assess the blood pressure throughout the procedure, and have measures for treatment of a hypertensive crisis readily available.

    5.11 Sickle Cell Crisis in Patients with Sickle Cell Disease

    Iodinated contrast agents when administered intravenously or intra-arterially may promote sickling in individuals who are homozygous for sickle cell disease. Hydrate patients prior to and following OMNIPAQUE administration and use OMNIPAQUE only if the necessary imaging information cannot be obtained with alternative imaging modalities.

    5.12 Severe Cutaneous Adverse Reactions

    Severe cutaneous adverse reactions (SCAR) may develop from 1 hour to several weeks after intravenous or intra-arterial contrast agent administration. These reactions include Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS). Reaction severity may increase and time to onset may decrease with repeat administration of contrast agents; prophylactic medications may not prevent or mitigate severe cutaneous adverse reactions. Avoid administering OMNIPAQUE to patients with a history of a severe cutaneous adverse reaction to OMNIPAQUE.

    5.13 Interference with Laboratory Test

    OMNIPAQUE can interfere with protein-bound iodine test [see Drug Interactions (7.2)].

    5.14 Increased Risk of Seizures with Intrathecal Procedures

    Focal and generalized motor seizures have been reported after intrathecal use of iodinated contrast agents. In several of the cases, higher than recommended doses were administered.

    Use of medications that may lower the seizure threshold (phenothiazine derivatives, including those used for their antihistaminic properties; tricyclic antidepressants; MAO inhibitors; CNS stimulants; analeptics; antipsychotic agents) should be carefully evaluated. Consider discontinuing these agents at least 48 hours before and for at least 24 hours following intrathecal administration of OMNIPAQUE.

  • 6 ADVERSE REACTIONS

    The following clinically significant adverse reactions are described elsewhere in the labeling:

    6.1 Clinical 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 ClassAdverse ReactionIncidence
    N=1,531
    Nervous system disordersHeadaches18%
    Musculoskeletal and connective tissue disordersPain including backache, neckache, stiffness, neuralgia8%
    Gastrointestinal disordersNausea6%
    Vomiting3%
    Nervous System disordersDizziness2%

    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 ClassAdverse ReactionIncidence
    N=152
    Nervous system disordersHeadache9%
    Gastrointestinal disordersVomiting6%
    Musculoskeletal and connective tissue disordersBackache1.3%

    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 Intravenous Administration

    Adults

    Adverse reactions (≥1%) in 1,485 adult patients following intra-arterial or intravenous administration of OMNIPAQUE in clinical trials are presented in Table 18.

    Table 18. Adverse Reactions (≥1%) in Adult Patients Following Intra-arterial or Intravenous Administration of OMNIPAQUE in Clinical Trials
    System Organ ClassAdverse ReactionIncidence
    (N=1,485)
    Cardiac disordersArrhythmias including PVCs and PACs2%
    Nervous system disordersPain3%
    Vision abnormalities including blurred vision and photomas2%
    Taste perversion1%
    Gastrointestinal disordersNausea2%

    Other adverse reactions (<1%) were:

    Cardiac disorders: hypotension, cardiac failure, asystole, bradycardia, tachycardia, vasovagal reaction

    Respiratory, thoracic and mediastinal disorders: dyspnea, rhinitis, coughing, laryngitis

    Gastrointestinal disorders: vomiting, diarrhea, dyspepsia, cramp, dry mouth

    General disorders and administration site conditions: fever, shivering

    Nervous system disorders: cerebral infarction, convulsion, hemiparesis, motor and speech dysfunction, nystagmus, paresthesia, somnolence, transient ischemic attack, vertigo including dizziness and lightheadedness

    Musculoskeletal and connective tissue disorders: still neck

    Skin and subcutaneous tissue disorders: urticaria, abscess, pruritus, purpura

    Psychiatric disorders: anxiety, syncope

    Pediatric Patients

    Adverse reactions reported in pediatric patients following intra-arterial or intravenous administration of OMNIPAQUE were generally similar in quality and frequency to those reported in adults. A total of 391 pediatric patients in clinical trials were administered OMNIPAQUE 240 mg iodine/mL, 300 mg iodine/mL, or 350 mg iodine/mL by intra-arterial or intravenous injection for pediatric cardiac ventriculography, excretory urography, and CT head imaging.

    Adverse reactions (≥1%) were vomiting (2%) and nausea (1%).

    Other adverse reactions (<1%) were:

    Cardiac disorders: Ventricular tachycardia, 2:1 heart block, hypertension, anemia

    General disorders and administration site conditions: Pain, fever

    Nervous system disorders: Convulsion, taste abnormality

    Respiratory, thoracic and mediastinal disorders: Congestion, apnea

    Endocrine disorders: Hypoglycemia

    Skin and subcutaneous tissue disorders: Rash

    Oral or Rectal Administration for Examination of the Gastrointestinal Tract

    Adults

    A total of 54 adult patients were administered undiluted OMNIPAQUE 350 mg iodine/mL by oral route for radiographic examination of the gastrointestinal tract in clinical trials. Adverse reactions (≥1%) are presented in Table 19.

    Table 19. Adverse Reactions (≥1%) in Adult Patients Following Oral Administration of Undiluted OMNIPAQUE 350 mg Iodine/mL in Clinical Trials
    System Organ ClassAdverse ReactionIncidence
    N=54
    Gastrointestinal disordersDiarrhea42%
    Nausea15%
    Vomiting11%
    Abdominal Pain7%
    Flatulence2%
    Nervous system disordersHeadache2%

    Pediatrics Patients

    A total of 58 pediatric patients were administered OMNIPAQUE by oral or rectal administration in clinical trials. Adverse reactions (≥1%) are presented in Table 20.

    Table 20. Adverse Reactions (≥1%) in Pediatric Patients Following Oral or Rectal Administration of OMNIPAQUE in Clinical Trials
    System Organ ClassAdverse ReactionIncidence
    N=58
    Gastrointestinal disordersDiarrhea36%
    Vomiting9%
    Nausea5%
    Abdominal pain2%
    General disorders and administration site conditionsFever5%
    Skin and subcutaneous tissue disordersUrticaria2%
    Vascular disordersHypotension2%

    Oral Administration for CT of the Abdomen in Conjunction with Intravenous Administration

    Adults

    A total of 44 adult patients received diluted OMNIPAQUE (4-9 mg iodine/mL) by oral route in conjunction with intravenously injected OMNIPAQUE 300 mg iodine/mL for CT examination of the abdomen in clinical trials. Adverse reactions (≥1%) were limited to a single report of vomiting (2.3%).

    Pediatric Patients

    A total of 69 pediatric patients received diluted OMNIPAQUE (9-29 mg iodine/mL) by oral route in conjunction with intravenously administered OMNIPAQUE 240 mg iodine/mL or OMNIPAQUE 300 mg iodine/mL for CT examination of the abdomen in clinical trials. Adverse reactions (≥1%) were limited to a single report of vomiting (1.4%).

    Intraarticular Administration

    Arthrography in Adults

    A total of 285 adult patients received OMNIPAQUE 240 mg iodine/mL, 300 mg iodine/mL, or 350 mg iodine/mL for various body cavity examinations in clinical trials. The most frequent adverse reactions (≥1%) were administration site pain (26%) and swelling (22%) in arthrography. Patients also experienced heat (7%).

    Body Cavity Use

    VCU in Pediatric Patients

    No new adverse reactions associated with the use of OMNIPAQUE for VCU procedures were reported in 51 pediatric patients studied.

    6.2 Post-marketing Experience

    The following adverse reactions have been identified during post-approval use of OMNIPAQUE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

    General

    Immune system disorders: Hypersensitivity reactions, anaphylactic or anaphylactoid reactions, anaphylactic or anaphylactoid shock including life-threatening or fatal anaphylaxis

    General disorders and administration site conditions: Pyrexia, chills, pain and discomfort, asthenia, administration site conditions including extravasation

    Intrathecal Administration

    Nervous system disorders: Meningism, aseptic meningitis, seizures or status epilepticus, disorientation, coma, depressed or loss of consciousness, transient contrast-induced toxic encephalopathy (including amnesia, hallucination, paralysis, paresis, speech disorder, aphasia, dysarthria), restlessness, tremors, hypoesthesia

    Musculoskeletal and connective tissue disorders: Pain, muscle spasms or spasticity

    Psychiatric disorders: Confusional state, agitation, anxiety

    Eye disorders: Transient visual impairment including cortical blindness

    Renal and urinary disorders: Acute kidney injury

    Intra-arterial or Intravenous Administration

    Cardiac disorders: Severe cardiac complications (including cardiac arrest, cardiopulmonary arrest), shock, peripheral vasodilatation, palpitations, vasospasm including spasm of coronary arteries, myocardial infarction, syncope, cyanosis, pallor, flushing, chest pain

    Vascular disorders: Vasospasm and thrombophlebitis following intravenous injection

    Blood and lymphatic system disorders: Neutropenia

    Nervous system disorders: Disorientation, coma, depressed or loss of consciousness, transient contrast-induced toxic encephalopathy (including amnesia, hallucination, paralysis, paresis, speech disorder, aphasia, dysarthria), restlessness, tremors, hypoesthesia

    Psychiatric disorders: Confusional state, agitation

    Eye disorders: Eye irritation or itchiness, periorbital edema, ocular or conjunctival hyperemia, lacrimation

    Renal and urinary disorders: Acute kidney injury, toxic nephropathy (CIN), transient proteinuria, oliguria or anuria, increased serum creatinine

    Gastrointestinal disorders: Abdominal pain, pancreatitis aggravated, salivary gland enlargement

    Endocrine disorders: Hyperthyroidism, hypothyroidism

    Respiratory, thoracic and mediastinal disorders: Respiratory distress, respiratory failure, pulmonary edema, bronchospasm, laryngospasm, throat irritation, throat tightness, laryngeal edema, wheezing, chest discomfort, asthmatic attack

    Skin and subcutaneous tissue disorders: Contrast media reactions range from mild (e.g., pleomorphic rashes, drug eruption, erythema and skin discoloration, blisters, hyperhidrosis, angioedema, localized areas of edema) to severe (e.g., Stevens-Johnson syndrome and toxic epidermal necrolysis [SJS/TEN], bullous or exfoliative dermatitis, acute generalized exanthematous pustulosis [AGEP] and drug reaction with eosinophilia and systemic symptoms [DRESS])

    Oral Administration

    Gastrointestinal disorders: Dysphagia, abdominal pain

    Body Cavity Administration

    Gastrointestinal disorders: Pancreatitis

    Musculoskeletal and connective tissue disorders: Arthritis (arthrography)

    Hysterosalpingography: Injection of OMNIPAQUE for hysterosalpingography is associated with immediate, transient pain. Monitor injection pressure and volume instilled to minimize pain and to avoid disruptive distention of the uterus and fallopian tubes. Fluoroscopic monitoring is recommended.

    Nervous system disorders: Pain (49%), somnolence and fever each with an individual incidence of 3%

    Gastrointestinal disorders: Nausea (3%)

  • 7 DRUG INTERACTIONS

    7.1 Drug-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 m2; 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.

    7.2 Drug-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., T3 resin uptake or direct thyroxine assays, are not affected.

  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    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.

    8.2 Lactation

    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.

    8.4 Pediatric 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 [see Adverse Reactions (6.1)]. 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 0 to 3 years of age based on underlying risk factors, especially in term and preterm neonates [see Warnings and Precautions (5.9) and Adverse Reactions (6.2)].

    8.5 Geriatric 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.

    8.6 Renal Impairment

    The clearance of iohexol decreases with increasing degree of renal impairment and results in delayed opacification of the urinary system. In addition, preexisting renal impairment increases the risk for acute kidney injury [see Warnings and Precautions (5.4)]. Iohexol can be removed by dialysis.

  • 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.

  • 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:

    Chemical Structure

    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 FormConcentration
    (mg iodine/mL)    		Osmolality*
    (mOsmol/kg water)    		Absolute Viscosity
    (cP)    		Specific Gravity
    20°C37°C37°C
    *
    By vapor-pressure osmometry.
    Injection1403222.31.51.164
    1804083.12.01.209
    2405205.83.41.280
    30067211.86.31.349
    35084420.410.41.406
    Oral solution9381.10.81.011
    12451.10.81.014

    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.

  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism 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.

    12.2 Pharmacodynamics

    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.

    12.3 Pharmacokinetics

    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.

  • 13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, 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.

  • 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.

  • 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 FormConcentration (mg iodine/mL)Package SizePackage Type & MaterialSale UnitNDC
    *
    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)].
    Injection14050 mLSingle-Dose Polymer BottlesBoxes of 100407-1401-52
    18010 mLSingle-Dose
    Glass Vials    		Boxes of 100407-1411-10
    24010 mLSingle-Dose
    Glass Vials    		Boxes of 100407-1412-10
    20 mLSingle-Dose
    Glass Vials    		Boxes of 100407-1412-20
    50 mLSingle-Dose Polymer BottlesBoxes of 100407-1412-30
    100 mLSingle-Dose Polymer BottlesBoxes of 100407-1412-33
    30010 mLSingle-Dose
    Glass Vials    		Boxes of 100407-1413-10
    30 mLSingle-Dose Polymer BottlesBoxes of 100407-1413-59
    50 mLSingle-Dose Polymer BottlesBoxes of 100407-1413-61
    100 mLSingle-Dose Polymer BottlesBoxes of 100407-1413-63
    125 mLSingle-Dose
    Glass Bottles    		Boxes of 100407-1413-53
    150 mLSingle-Dose Polymer BottlesBoxes of 100407-1413-65
    500 mL*Imaging or Pharmacy Bulk Package
    Polymer Bottles    		Boxes of 100407-1413-72
    35050 mLSingle-Dose Polymer BottlesBoxes of 100407-1414-89
    75 mLSingle-Dose Polymer BottlesBoxes of 100407-1414-90
    100 mLSingle-Dose Polymer BottlesBoxes of 100407-1414-91
    125 mLSingle-Dose
    Glass Bottles    		Boxes of 100407-1414-76
    150 mLSingle-Dose Polymer BottlesBoxes of 100407-1414-93
    200 mLSingle-Dose Polymer BottlesBoxes of 100407-1414-94
    500 mL*Imaging or Pharmacy Bulk Package
    Polymer Bottles    		Boxes of 100407-1414-72
    Oral Solution9500 mLSingle-Dose
    Polymer Bottles    		Boxes of 100407-1415-09
    12500 mLSingle-Dose
    Polymer Bottles    		Boxes of 100407-1416-12

    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.

  • 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)].

  • SPL UNCLASSIFIED SECTION

    Distributed by GE Healthcare Inc., Marlborough, MA 01752 U.S.A.

    OMNIPAQUE is a trademark of GE HealthCare or one of its subsidiaries.
    GE is a trademark of General Electric Company used under trademark license.

    © 2024 GE HealthCare

  • 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, Rectal,
    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.: DD MMM YYYY
    Lot: 12345678

    0000000 USA

    PRINCIPAL DISPLAY PANEL - 350 mg Bottle Box Label
  • INGREDIENTS AND APPEARANCE
    OMNIPAQUE 
    iohexol injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0407-1413
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Iohexol (UNII: 4419T9MX03) (Iohexol - UNII:4419T9MX03) Iodine300 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    tromethamine (UNII: 023C2WHX2V) 1.21 mg  in 1 mL
    edetate calcium disodium (UNII: 25IH6R4SGF) 0.1 mg  in 1 mL
    hydrochloric acid (UNII: QTT17582CB)  
    sodium hydroxide (UNII: 55X04QC32I)  
    Product Characteristics
    ColorYELLOW (colorless to pale yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0407-1413-7210 in 1 BOX12/21/2016
    1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02060812/21/2016
    OMNIPAQUE 
    iohexol injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0407-1414
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Iohexol (UNII: 4419T9MX03) (Iohexol - UNII:4419T9MX03) Iodine350 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    tromethamine (UNII: 023C2WHX2V) 1.21 mg  in 1 mL
    edetate calcium disodium (UNII: 25IH6R4SGF) 0.1 mg  in 1 mL
    hydrochloric acid (UNII: QTT17582CB)  
    sodium hydroxide (UNII: 55X04QC32I)  
    Product Characteristics
    ColorYELLOW (colorless to pale yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0407-1414-7210 in 1 BOX12/21/2016
    1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02060812/21/2016
    Labeler - GE Healthcare (053046579)
    Establishment
    NameAddressID/FEIBusiness Operations
    GE Healthcare Ireland Limited988006565MANUFACTURE(0407-1413, 0407-1414)
    Establishment
    NameAddressID/FEIBusiness Operations
    GE Healthcare Lindesnes518890970API MANUFACTURE(0407-1413, 0407-1414)
    Establishment
    NameAddressID/FEIBusiness Operations
    GE Healthcare Shanghai Co., Ltd.545292716MANUFACTURE(0407-1413, 0407-1414)
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