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).

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

Prior to Omnipaque administration, please read the full Prescribing Information including Boxed Warning for Omnipaque. Also read the full Prescribing Information for Omnipaque Imaging Bulk Package and Omnipaque Pharmacy Bulk Package

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).


WARNINGS AND PRECAUTIONS Risks Associated With Inadvertent Intrathecal Administration: Omnipaque Injections 140 and 350 are contraindicated for intrathecal use. Inadvertent intrathecal administration can cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema. Risks Associated With Inadvertent Parenteral Administration of Omnipaque Oral Solution: Omnipaque Oral Solutions 9 and 12 are contraindicated for parenteral administration. Adverse reactions such as hemolysis may occur if administered intravascularly. Do not administer Omnipaque Oral Solutions 9 and 12 parenterally. 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 three minutes), but reactions can occur up to hours later. There is an increased risk in patients with a history of a previous reaction to contrast agents and known allergies (ie, 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. Contrast-Induced Acute Kidney Injury: Acute kidney injury, including renal failure, may occur after parenteral administration of Omnipaque. Risk factors include preexistng renal impairment, dehydration, diabetes mellitus, congestive heart failure, advanced vascular disease, elderly age, concomitant use of nephrotoxic or diuretic medications, multiple myeloma/paraproteinaceous diseases, and 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.

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).

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

Prior to Omnipaque administration, please read the full Prescribing Information including Boxed Warning for Omnipaque. Also read the full Prescribing Information for Omnipaque Imaging Bulk Package and Omnipaque Pharmacy Bulk Package

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).


WARNINGS AND PRECAUTIONS Risks Associated With Inadvertent Intrathecal Administration: Omnipaque Injections 140 and 350 are contraindicated for intrathecal use. Inadvertent intrathecal administration can cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema. Risks Associated With Inadvertent Parenteral Administration of Omnipaque Oral Solution: Omnipaque Oral Solutions 9 and 12 are contraindicated for parenteral administration. Adverse reactions such as hemolysis may occur if administered intravascularly. Do not administer Omnipaque Oral Solutions 9 and 12 parenterally. 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 three minutes), but reactions can occur up to hours later. There is an increased risk in patients with a history of a previous reaction to contrast agents and known allergies (ie, 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. Contrast-Induced Acute Kidney Injury: Acute kidney injury, including renal failure, may occur after parenteral administration of Omnipaque. Risk factors include preexistng renal impairment, dehydration, diabetes mellitus, congestive heart failure, advanced vascular disease, elderly age, concomitant use of nephrotoxic or diuretic medications, multiple myeloma/paraproteinaceous diseases, and 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.


Bring the potential benefits of Omnipaque™ (iohexol) to your practice

Omnipaque can be a solution for many of your contrast needs, providing you with:

  • Well-established safety profile and demonstrated efficacy1
  • Extensive range of environmentally friendly packaging options2
  • Various support services

Clinical Experience and Versatility

  • Introduced in 1986 - More than 30 years of clinical experience1
    - Published in thousands of trials and clinical studies
    - Approved for use in more than 100 countries1
  • The most indications of any low-osmolar contrast medium 2
    - Indication for oral administration2, in conjuction with IV, for CT of the abdomen 2
    - Indication for hysterosalpingography2
    - Intrathecal indication for myelography use2
    - Indications for the Cath Lab2

Packaging

  • +PLUSPAKTM polymer bottle for enhanced workplace safety and efficiency
    • The landmark design of +PLUSPAK streamlines processes one bottle at a time. Labels are easy to read from any angle and the built-in hanger is simple to use. Medical supply has never been more efficient.
    • GE Healthcare’s easy-to-open, metal-free, twist-off polypropylene cap avoids cuts from metal crimps. Our packaging was designed to be safer than glass.
    • Our pharmaceutical-grade polymer bottle won’t shatter when dropped, reducing the risk of injury from broken glass.

Potential Savings

  • 340B Drug Pricing Program
  • +PLUSPAK polymer bottles - Upfront price and waste disposal costs
  • Competitive industry pricing - One-source solution with GE Healthcare
  • Direct or through wholesaler

Support

  • Medical Affairs: 800 654 0118 or Professionalservices.medical@ge.com
  • Reimbursement Hotline: 800 767 6664
  • Customer Service: 800 292 8514
  • www.gehealthcare.com

References:
1. Data on file. GE Healthcare; 2011.
2. Omnipaque [prescribing information]. Marlborough, MA: GE Healthcare; 2018.

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

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

  • Taste After Taste: Delivery of Oral Omnipaque™

  • Reimbursement

Professional Resources and Disclosures

Indications and Important Safety Information

JB58735US |Sep 2018