Omnipaque Injection, Solution
FDA Label NDC 71872-7370

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medical Purchasing Solutions, Llc for the product Omnipaque (NDC 71872-7370). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding warning: risks associated with intrathecal administration of omnipaque injection 140 mg iodine/ml and 350 mg iodine/ml, 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 ‡, 2.1 important dosage and administration instructions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)].

1.1 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 by oral administration in adult patients and by oral or rectal administration in pediatric patients
  • CT of the abdomen and pelvis by oral administration in adult and pediatric patients, in conjunction with intravenous administration of OMNIPAQUE

1.5 Intraarticular Procedures ‡

OMNIPAQUE is indicated for:

  • Arthrography in adults

1.6 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)].

2.1 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
    Lumbar MyelographyLumbar180

    Use single-dose containers or 500 mL Pharmacy Bulk Packages [see Dosage and Administration (2.11)].

    		10 mL to 17 mL
    240 7 mL to 12.5 mL
    Thoracic 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
Cardiac Ventriculography350

Use single-dose containers or a 500 mL Pharmacy Bulk Package [see Dosage and Administration (2.11)].

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
Excretory Urography300

Use single-dose containers or 500 mL Pharmacy Bulk Packages [see Dosage and Administration (2.11)].

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

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)].

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

Other

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
Oral Dose Using Diluted OMNIPAQUE Injection
6 mg Iodine/mL to 12 mg Iodine/mL of Diluted OMNIPAQUE Injection

See Table 5 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 (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

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)].

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, 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

    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)
    6259752098017983
    9389623097026974
    12509504096035965

    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
      • Myelography
        • Lumbar
        • Thoracic
        • Cervical
        • Total Columnar
        • CT cisternography
      		Lumbar2 weeks up to 3 months180

      Use single-dose containers .

      		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
      Cardiac Ventriculography300

      Use single-dose containers or 500 mL Pharmacy Bulk Packages [see Dosage and Administration (2.11)].

      		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
      Excretory Urography300

      Use single-dose containers or 500 mL Pharmacy Bulk Packages [see Dosage and Administration (2.11)].

      		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

      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)].

      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
        Less than 3 months180

        Use single-dose containers or 500 mL Pharmacy Bulk Packages [see Dosage and Administration (2.11)] .

        		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
        Oral Dose Using Diluted OMNIPAQUE Injection
        9 mg Iodine/mL to 21 mg Iodine/mL of Diluted OMNIPAQUE Injection

        See Table 13 for dilution instructions of 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
        9 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

        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)].

        		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 1Dilution Method 2Dilution Method 3
          Volume of OMNIPAQUE 240 mg iodine/mL
          (mL)           		Volume of Added Liquid

          Use water, carbonated beverage, milk, infant formula, 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)
          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

            See Table 15 below for dilution instructions of OMNIPAQUE injection.


            (mg iodine/mL)             		Volume to Administer
            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 1Dilution 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

            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.

                    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%)

                    Metformin

                    In patients with renal impairment, metformin can cause lactic acidosis. Iodinated contrast agents appear to increase the risk of metformin-induced lactic acidosis, possibly as a result of worsening renal function. Stop metformin at the time of, or prior to, OMNIPAQUE administration in patients with an eGFR between 30 and 60 mL/min/1.73 m 2; in patients with a history of hepatic impairment, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure, and reinstitute metformin only after renal function is stable.

                    Radioactive Iodine

                    OMNIPAQUE may interfere with thyroid uptake of radioactive iodine (I-131 and I-123) and decrease therapeutic and diagnostic efficacy. Avoid thyroid therapy or testing for up to 6 weeks post OMNIPAQUE.

                    Protein-Bound Iodine Test

                    Iodinated contrast agents, including OMNIPAQUE, will temporarily increase protein-bound iodine in blood. Do not perform protein-bound iodine test for at least 16 days following administration of OMNIPAQUE. However, thyroid function tests that do not depend on iodine estimation, e.g., T 3resin uptake or direct thyroxine assays, are not affected.

                    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.

                    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.

                    Intrathecal Use

                    The safety and effectiveness of OMNIPAQUE have been established in pediatric patients aged 2 weeks and older for myelography and CT myelography (lumbar, thoracic, cervical, total columnar) and for CT cisternography. Use of OMNIPAQUE is supported by controlled clinical studies in adults for myelography, in addition to clinical studies in pediatric patients undergoing myelography.

                    The safety and effectiveness of OMNIPAQUE have not been established for intrathecal use in pediatric patients less than 2 weeks of age.

                    The safety and effectiveness of OMNIPAQUE for CT cerebral ventriculography have not been established in pediatric patients.

                    Intra-arterial or Intravenous Use

                    Cardiac Ventriculography, Aortography, and Pulmonary Angiography

                    The safety and effectiveness of OMNIPAQUE have been established in pediatric patients from birth to 17 years of age for cardiac ventriculography, aortography, and pulmonary angiography. Use of OMNIPAQUE is supported by controlled clinical studies in adults for cardiac ventriculography and aortography, in addition to controlled clinical studies in pediatric patients undergoing cardiac ventriculography, including aortography.

                    Excretory Urography

                    The safety and effectiveness of OMNIPQUE have been established in pediatric patients from birth to 17 years of age for excretory urography. Use of OMNIPAQUE is supported by controlled clinical studies in adults for urography, in addition to controlled clinical studies in pediatric patients undergoing urography and clinical safety data in pediatric patients down to birth.

                    CT of the Head and Body

                    The safety and effectiveness of OMNIPAQUE have been established in pediatric patients from birth to 17 years of age for CT imaging of the head and body. Use of OMNIPAQUE is supported by controlled clinical studies in adults for head and body CT, in addition to clinical studies in pediatric patients undergoing head CT and in 69 pediatric patients undergoing CT of the abdomen after oral administration of diluted OMNIPAQUE plus intravenous administration of OMNIPAQUE.

                    Selective Coronary Arteriography, Cerebral and Peripheral Arteriography, Intra-arterial Digital Subtraction Angiography, Peripheral Venography, and Intravenous Digital Subtraction Angiography

                    The safety and effectiveness of OMNIPAQUE have not been established in pediatric patients for selective coronary arteriography, cerebral or peripheral arteriography, intra-arterial digital subtraction angiography, peripheral venography, and intravenous digital subtraction angiography.

                    Oral or Rectal Use

                    Examination of the GI Tract

                    The safety and effectiveness of OMNIPAQUE have been established in pediatric patients, from birth to 17 years of age for examination of the GI tract. Use of OMNIPAQUE is supported by controlled studies in adults for examination of the GI tract, in addition to clinical studies in pediatric patients undergoing examination of the GI tract.

                    CT of the Abdomen and Pelvis in Conjunction with Intravenous Use

                    The safety and effectiveness of OMNIPAQUE for CT of the abdomen and pelvis have been established in pediatric patients from birth to 17 years of age. Use is supported by clinical trials in adults, in addition to clinical studies in 69 pediatric patients undergoing CT of the abdomen.

                    Intraarticular Use

                    The safety and effectiveness of OMNIPAQUE have not been established in pediatric patients for arthrography.

                    Body Cavity Use

                    Voiding Cystourethrography

                    OMNIPAQUE is indicated for use in pediatric patients from birth to 17 years of age for voiding cystourethrography (VCU). Use for voiding cystourethrography is supported by clinical studies in 51 pediatric patients undergoing VCU.

                    ERCP, Herniography, and Hysterosalpingography

                    The safety and effectiveness of OMNIPAQUE have not been established in pediatric patients for ERCP, herniography, or hysterosalpingography.

                    In general, the frequency of adverse reactions in pediatric patients was similar to that seen in adults [s ee 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)] .

                    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.

                    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.

                    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
                    Injection14050 mLSingle-Dose Polymer BottlesBoxes of 100407-1401-52
                    18010 mLSingle-Dose Glass VialsBoxes of 100407-1411-10
                    24010 mLSingle-Dose Glass VialsBoxes of 100407-1412-10
                    20 mLSingle-Dose Glass VialsBoxes 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 VialsBoxes 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 BottlesBoxes of 100407-1413-53
                    150 mLSingle-Dose Polymer BottlesBoxes of 100407-1413-65
                    500 mL

                    OMNIPAQUE injection 300 mg iodine/mL and OMNIPAQUE injection 350 mg iodine/mL in bottles of 500 mL can be used as either an Imaging Bulk Package or a Pharmacy Bulk Package [see Dosage and Administration (2.10, 2.11)] .

                    		Imaging or Pharmacy Bulk Package Polymer BottlesBoxes 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 BottlesBoxes 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 BottlesBoxes of 100407-1414-72
                    Oral Solution9500 mLSingle-Dose Polymer BottlesBoxes of 100407-1415-09
                    12500 mLSingle-Dose Polymer BottlesBoxes 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.

                    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)].

                    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.

                    © 2026 GE HealthCare

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
    ArthrographyKnee240

    Use single-dose containers or 500 mL Pharmacy Bulk Packages [see Dosage and Administration (2.11)].

    		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
    Endoscopic retrograde pancreatography (ERP) and cholangiopancreatography (ERCP)240

    Use single-dose containers or 500 mL Pharmacy Bulk Packages [see Dosage and Administration (2.11)].

    		10 mL to 50 mLIntraductal
    Herniography240 15 mL to 20 mLIntraperitoneal
    300
    Hysterosalpingography240 50 mLIntrauterine

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
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

OMNIPAQUE injection 300 mg iodine/mL and OMNIPAQUE injection 350 mg iodine/mL in bottles of 500 mL can be used as either an Imaging Bulk Package or a Pharmacy Bulk Package [see Dosage and Administration (2.10, 2.11)].

Imaging or Pharmacy Bulk Package
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.

5.1 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.

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.

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 Cork 01)

    Chemical Structure (Omnipaque Cork 01)

    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

        By vapor-pressure osmometry.


        (mOsmol/kg water)         		Absolute Viscosity
        (cP)         		Specific Gravity
        20°C37°C37°C
        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.

12.1 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.

12.3 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.

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.

Storage And Handling

Storage and Handling

  • OMNIPAQUE Injection: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. May be stored in a contrast media warmer for up to one month, not to exceed 37°C (98.6°F).
  • OMNIPAQUE Oral Solution: Store between 0°C and 30°C (32°F to 86°F).

    • Protect from light. Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.

* Please review the disclaimer below.