Omnipaque™ (iohexol)

Indications and Use – Omnipaque™ (iohexol)

Intrathecal Administration Adults: Omnipaque 180, 240, and 300 • Myelography (lumbar, thoracic, cervical, total columnar) • Computed tomography (CT) (myelography, cisternography, ventriculography) Pediatrics: Omnipaque 180 • Myelography (lumbar, thoracic, cervical, total columnar) • CT (myelography, cisternography) Intravascular Administration Adults: Omnipaque 140 • Intra-arterial digital subtraction angiography of the head, neck, abdominal, renal and peripheral vessels. Omnipaque 240 • CT head imaging • Peripheral venography (phlebography). Omnipaque 300 • Aortography including studies of the aortic arch, abdominal aorta and its branches • CT head and body imaging • Cerebral arteriography • Peripheral venography (phlebography) • Peripheral arteriography • Excretory urography. Omnipaque 350 • Angiocardiography (ventriculography, selective coronary arteriography) • Aortography, including studies of the aortic root, aortic arch, ascending aorta, abdominal aorta and its branches • CT head and body imaging • Intravenous digital subtraction angiography of the head, neck, abdominal, renal and peripheral vessels • Peripheral arteriography • Excretory urography. Pediatrics: Omnipaque 240 • CT head and body imaging. Omnipaque 300 • Angiocardiography (ventriculography) • Excretory urography • CT head and body imaging. Omnipaque 350 • Angiocardiography (ventriculography, pulmonary arteriography, venography, and studies of the collateral arteries) • Aortography, including the aortic root, aortic arch, ascending and descending aorta. Oral or Rectal Administration Adults: Omnipaque 350 • Oral radiographic examination of the gastrointestinal tract. Pediatrics: Omnipaque 180, 240, and 300 • Oral and rectal radiographic examination of the gastrointestinal tract. Oral administration in conjunction with intravenous administration: Diluted Omnipaque Injection Adults: Omnipaque 240, 300, and 350 diluted and administered orally in conjunction with Omnipaque 300 administered intravenously • CT of the abdomen. Pediatrics: Omnipaque 240, 300, and 350 diluted and administered orally in conjunction with Omnipaque 240 or Omnipaque 300 administered intravenously • CT of the abdomen. Omnipaque Oral Solution Adults: Omnipaque Oral Solutions 9 and 12 administered orally in conjunction with Omnipaque 300 administered intravenously • CT of the abdomen. Pediatrics: Omnipaque Oral Solutions 9 and 12 administered orally in conjunction with Omnipaque 240 or Omnipaque 300 administered intravenously • CT of the abdomen. Intra-articular Administration Adults: Omnipaque 240, 300, and 350 • Arthrography. Body Cavity Administration Adults: Omnipaque 240 • Endoscopic retrograde pancreatography (ERP) and endoscopic retrograde cholangiopancreatography (ERCP) • Herniography • Hysterosalpingography. Omnipaque 300 • Hysterosalpingography. Pediatrics: Omnipaque 240, 300, and 350 diluted • Voiding cystourethrography (VCU).

IMPORTANT SAFETY INFORMATION


WARNING: RISKS WITH INADVERTENT

INTRATHECAL ADMINISTRATION OF

Omnipaque Injections 140 and 350 mgI/mL


See full Prescribing Information for complete Boxed Warning.


Omnipaque Injections 140 and 350 are contraindicated for intrathecal use. Inadvertent intrathecal administration may cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema (4, 5.1).


See Indications and additional Important Safety Information, including Boxed Warning, about Omnipaque at the bottom of this page. Please also read the full Prescribing Information.

  • Taste After Taste: Omnipaque Oral Solution in Conjunction with IV

    See Indications and Important Safety Information, including Boxed Warning, about Omnipaque at the bottom of this page. Please also read the full Prescribing Information.

    Omnipaque Oral Solution: Prediluted solution available in two iodine concentrations approved for oral use in conjunction with Omnipaque Injection administered intravenously for computed tomography of the abdomen.

    • Ready-to-drink formulation
    • Consistent and accurate dose
    • Easy to administer for staff and patients
    • Neutral taste/palatability*

    * 149 patients ingested Omnipaque Injection diluted to 9 mgI/mL. Patients rated the taste on average at 0.86 ± 1.09. (Scores ranged from -2: dislike very much to +2: like very much.)1  In another study, 25 patients were given 100 mL of Omnipaque 350 prior to radiographic examination of the GI tract. The majority of patients (18) rated Omnipaque as tasting neutral (12) or good (6).2

    References:
    1. McNamara MM, Lockhart ME, Fineberg NS, Berland LL. Oral contrast media for body CT: comparison of diatrizoate sodium and iohexol for patient acceptance and bowel opacification. J Roentgenol. 2010;195:1137- 1141.
    2. Stordahl A, Laerum F, Gjølberg T, Enge I. Water-soluble contrast media in radiography of small bowel obstruction. Comparison of ionic and non-ionic contrast media. Acta Radiol. 1988;29:53-56.

  • Procedure After Procedure: How +PLUSPAK™ polymer bottle helps you and your department

    See Indications and Important Safety Information, including Boxed Warning, about Omnipaque at the bottom of this page. Please also read the full Prescribing Information.

    +PLUSPAK is GE Healthcare’s innovative polymer packaging for contrast media solutions. It was designed with workplace safety, efficiency, and convenience in mind.
    Contact us to find out more about product availability for +PLUSPAK.

    +PLUSPAK packaging reduces risk of sharps injuries and enhances workplace safety.

    Injuries associated with glass bottles make up an estimated 16% of sharps injuries in healthcare settings. Other sharp items, such as the edges of metal bottle seals, cause an additional 15% of injuries1

    • No more broken glass bottles
    • Our pharmaceutical-grade polymer bottle won’t shatter when dropped, reducing the risk of injury from broken glass

    • No more ring-pull injuries
    • GE Healthcare’s easy-to-open, metal-free, twist-off polypropylene cap avoids cuts from metal crimps. Our packaging is designed to be just plain safer than glass

    Reference:
    1. Marshall G. Radiography 2008;14:128-34.

  • Taste After Taste: Delivery of Oral Omnipaque™

    See Indications and Important Safety Information, including Boxed Warning, about Omnipaque at the bottom of this page. Please also read the full Prescribing Information.

    Omnipaque for Oral Use, in conjunction with IV Omnipaque, for CT of the abdomen

    SEE VIDEO: Opacification of the gastrointestinal tract using Omnipaque: A clinical case study

    Neutral taste for your patients*

    • A majority of patients rated Omnipaque as tasting neutral (12) or good (6)1
    • Omnipaque received a better taste preference score than did MD-Gastroview® (diatrizoate meglumine and diatrizoate sodium solution USP) (P<0.001)2
    Omnipaque taste preference chart

    Omnipaque for Oral Use

    Omnipaque - A nonionic, low-osmolar contrast medium indicated for oral use in both adults and children3

    • Omnipaque is an oral contrast medium with a neutral taste that even children may drink4
    • A majority of patients rated Omnipaque as tasting neutral (12) or good (6)1
    • In a study of pediatric patients by Smevik and Westvik, 98% of children drank the entire dose5
    • Patients in an abdominal computerized tomography study drank the entire prescribed amount and said they would do so again, if necessary6
    • Omnipaque 350 mgI/ml was used in radiographic follow-through examination of the small bowel

    *149 patients ingested Omnipaque injection diluted to 9 mg I/mL.1 Patients rated the taste on average at 0.86 ± 1.09. (Scores ranged from -2: dislike very much to +2: like very much.)2 In another study, 25 patients were given 100 mL of Omnipaque 350 prior to radiographic examination of the GI tract. A majority of patients rated Omnipaque as tasting neutral (12) or good (6).1

    Important Safety Information About Omnipaque

    CONTRAINDICATIONS: Omnipaque 140 and Omnipaque 350 are contraindicated for intrathecal use. Omnipaque Oral Solutions 9 and 12 are contraindicated for parenteral administration.

     

    Visualization

    Omnipaque is an oral contrast medium that offers gastrointestinal visualization1,6

    • Omnipaque had a statistically significant, higher small-bowel density than GastrografinTM at one hour (P=0.007) and four hours (P=0.04) after ingestion1
    • Provides good visualization of the intestines and is approved for gastrointestinal use in infants and children7

    Graph courtesy of Stordahl et al, 1998 - Acta Radial

    References:
    1. Stordahl A, Laerum F, Gjølberg T, Enge T. Water-soluble contrast media in radiography of small bowel obstruction: comparison of ionic and non-ionic contrast media. Acta Radiol. 1988;29:53-56.
    2. McNamara MM, Lockhart ME, Fineberg NS, Berland LL. Oral contrast media for body CT: comparison of diatrizoate sodium and iohexol for patient acceptance and bowel opacification. Am J Roentgenol. 2010;195:1137-1141.
    3. Omnipaque [prescribing information]. Marlborough, MA: GE Healthcare; 2018. 
    4. Smevik B, Stake G. Omnipaque as a contrast medium for bowel opacification in abdominal CT in infants and children. In: Kaufmann HJ, ed. Contrast Media in Child Radiology. Basel, Switzerland: Karger; 1986:79-80.
    5. Smevik B, Westvik J. Iohexol for contrast enhancement of bowel in pediatric abdominal CT. Acta Radiol. 1990;31:601-604.
    6. Lönnemark M, Magnusson A. Oral contrast media in CT of the abdomen: iohexol of different concentrations as a gastrointestinal contrast medium. Acta Radiol. 1995;36: 396-398.
    7. Stake G, Smevik B. Iohexol as contrast medium for the gastrointestinal tract in childhood. In: Kaufmann HJ, ed. Contrast Media in Child Radiology. Basel, Switzerland: Karger; 1986:107-109.

  • Reimbursement

    See Indications and Important Safety Information, including Boxed Warning, about Omnipaque at the bottom of this page. Please also read the full Prescribing Information.

    GE Healthcare Medical Diagnostics Reimbursement

    GE Healthcare advocates for timely patient access to medically appropriate, high-quality imaging services, provided by knowledgeable and skilled providers of care. We recognize the significant impact that reimbursement policies can have on you and your practice, and we strive to provide accurate and reliable information to help you navigate the reimbursement process. 

    Coding and Payment Information

    Through the Hospital Outpatient Prospective Payment System (HOPPS), Medicare currently "packages" payment for contrast media agents into the payment for the associated procedure.

    Contrast media is separately payable in physician offices and freestanding imaging centers. Payment is based on the average sales price (ASP) + 6%. ASP rates are adjusted quarterly and are based on the prior quarter's ASP data. The rates can be viewed on the Centers for Medicare & Medicaid Services (CMS) website at:

    https://www.cms.gov/McrPartBDrugAvgSalesPrice/

    Physicians performing diagnostic imaging procedures using contrast media should report the appropriate HCPCS code for the product along with the appropriate CPT® code(s) for the procedure(s). Physicians should select codes based on the iodine concentration used in the procedure. The mL of contrast volume reported should be consistent with the mL of contrast given to complete the imaging study. The applicable codes for Omnipaque are noted in the above chart.

Professional Resources and Disclosures

Indications and Important Safety Information

JB58735US |Sep 2018