Iohexol

OMNIPAQUE is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and body cavity imaging procedures in adults and pediatric patients. ( 1 )

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) ].

Injection and Oral Solution: Colorless to pale yellow solution available in the following presentations: Dosage Form Concentration (mg of iodine/mL) Package Size Package Type Injection 140 50 mL Single-Dose Bottle 180 10 mL Single-Dose Vial 240 10 mL and 20 mL Single-Dose Vial 50 mL and 100 mL Sigle-Dose Bottle 300 10 mL Single-Dose Vial 30 mL, 50 mL, 100 mL, 125 mL, and 150 mL Single-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 350 50 mL, 75 mL, 100 mL, 125 mL, 150 mL, and 200 mL Single-Dose Bottle 500 mL Imaging or Pharmacy Bulk Package Oral Solution 9 500 mL Single-Dose Bottle 12 500 mL Single-Dose Bottle Injection: 140 mg iodine/mL, 180 mg iodine/mL, and 240 mg iodine/mL in single-dose vials/bottles; 300 mg iodine/mL and 350 mg iodine/mL in single-dose vials/bottles and imaging or pharmacy bulk package Oral Solution: 9 mg iodine/mL and 12 mg iodine/mL ( 3 )

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. Hysterosalpingography during pregnancy (or suspected pregnancy), menstruation (or when menstruation is imminent), within 6 months after termination of pregnancy, within 30 days after conization or curettage, when signs of infection are present in any portion of the genital tract, including the external genitalia, and when reproductive tract neoplasia is known or suspected. ( 4 )

Hypersensitivity Reactions: Life-threatening or fatal reactions can occur. Always have emergency equipment and trained personnel available. ( 5.3 ) Acute Kidney Injury: Acute injury including renal failure can occur. Minimize dose and maintain adequate hydration to minimize risk. ( 5.4 ) Cardiovascular Adverse Reactions: Hemodynamic disturbances including shock and cardiac arrest may occur during or after administration. ( 5.5 ) Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age: Individualize thyroid function monitoring based on risk factors such as prematurity. ( 5.9 )

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). […]

The following clinically significant adverse reactions are described elsewhere in the labeling: Risks Associated with Intrathecal Administration of OMNIPAQUE Injection 140 mg Iodine/mL and 350 mg Iodine/mL [see Warnings and Precautions (5.1) ] Risks Associated with Parenteral Administration of OMNIPAQUE Oral Solution [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Acute Kidney Injury [see Warnings and Precautions (5.4) ] Cardiovascular Adverse Reactions [see Warnings and Precautions (5.5) ] Thromboembolic Events [ see Warnings and Precautions (5.6) ] Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age [see Warnings and Precautions (5.9) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.12) ] Most common adverse reactions (incidence ≥ 1%) in adult patients Intrathecal: Headaches, pain including backache, neckache, stiffness and neuralgia, nausea, vomiting, dizziness Intra-arterial or intravenous: Pain, vision abnormalities (including blurred vision and photomas), headache, taste perversion, arrhythmias including premature ventricular contractions (PVCs) and premature atrial contractions (PACs), angina/chest pain, nausea Oral: Diarrhea, nausea, vomiting, abdominal pain, flatulence, headache Body Cavity: Pain, swelling, heat sensation ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 1-800-654-0118 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Intrathecal Administration Adults Adverse reactions (≥1%) in 1,531 adult patients following intrathecal administration of OMNIPAQUE in clinical trials are presented in Table 16. Table 16. Adverse Reactions (≥1%) in in Adult Patients Following Intrathecal Administration of OMNIPAQUE in Clinical Trials System Organ Class Adverse Reaction Incidence N=1,531 Nervous system disorders Headaches 18% Musculoskeletal and connective tissue disorders Pain including backache, neckache, stiffness, neuralgia 8% Gastrointestinal disorders Nausea 6% Vomiting 3% Nervous System disorders Dizziness 2% 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 Class Adverse Reaction Incidence N=152 Nervous system disorders Headache 9% Gastrointestinal disorders Vomiting 6% Musculoskeletal and connective tissue disorders Backache 1.3% 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 Class Adverse Reaction Incidence (N=1,485) Cardiac disorders Arrhythmias including PVCs and PACs 2% Nervous system disorders Pain 3% Vision abnormalities including blurred vision and photomas 2% Taste perversion 1% Gastrointestinal disorders Nausea 2% 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 Class Adverse Reaction Incidence N=54 Gastrointestinal disorders Diarrhea 42% Nausea 15% Vomiting 11% Abdominal Pain 7% Flatulence 2% Nervous system disorders Headache 2% 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 Class Adverse Reaction Incidence N=58 Gastrointestinal disorders Diarrhea 36% Vomiting 9% Nausea 5% Abdominal pain 2% General disorders and administration site conditions Fever 5% Skin and subcutaneous tissue disorders Urticaria 2% Vascular disorders Hypotension 2% 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%). […]

7.1 Drug-Drug Interactions Metformin In patients with renal impairment, metformin can cause lactic acidosis. Iodinated contrast agents appear to increase the risk of metformin-induced lactic acidosis, possibly as a result of worsening renal function. Stop metformin at the time of, or prior to, OMNIPAQUE administration in patients with an eGFR between 30 and 60 mL/min/1.73 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.

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

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

8.1 Pregnancy Risk Summary Hysterosalpingography is contraindicated in pregnant women due to the potential risk to the fetus from an intrauterine procedure [see Contraindications (4) ]. There are no data with iohexol use in pregnant women to inform any drug-associated risks. Iohexol crosses the placenta and reaches fetal tissues in small amounts ( see Data ) . In animal reproduction studies, no developmental toxicity occurred with intravenous iohexol administration to rats and rabbits at doses up to 0.4 (rat) and 0.5 (rabbit) times the maximum recommended human intravenous dose ( see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Literature reports show that intravenously administered iohexol crosses the placenta and is visualized in the digestive tract of exposed infants after birth. Animal Data Iohexol was neither embryotoxic nor teratogenic in either rats or rabbits at the following dose levels tested: 1.0, 2.0, 4.0 g iodine/kg in rats, administered intravenously to 3 groups of 25 dams once daily during days 6 through 15 of pregnancy; 0.3, 1.0, 2.5 g iodine/kg in rabbits, administered intravenously to 3 groups of 18 rabbits dosed once a day during days 6 through 18 of pregnancy.

8.2 Lactation Risk Summary Published literature reports that breast feeding after intravenous iohexol administration to the mother would result in the infant receiving an oral dose of approximately 0.7% of the maternal intravenous dose; however, lactation studies have not been conducted with oral, intrathecal, or intracavity administration of iohexol. There is no information on the effects of the drug on the breastfed infant or on milk production. Iodinated contrast agents are excreted unchanged in human milk in very low amounts with poor absorption from the gastrointestinal tract of a breastfed infant. Exposure to iohexol to a breastfed infant can be minimized by temporary discontinuation of breastfeeding (see Clinical Considerations ). The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for OMNIPAQUE and any potential adverse effects on the breastfed infant from OMNIPAQUE or from the underlying maternal condition. Clinical Considerations Interruption of breastfeeding after exposure to iodinated contrast agents is not necessary because the potential exposure of the breastfed infant to iodine is small. However, a lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk for 10 hours (approximately 5 elimination half-lives) after OMNIPAQUE administration to minimize drug exposure to a breastfed infant.

8.4 Pediatric Use Intrathecal Use The safety and effectiveness of OMNIPAQUE have been established in pediatric patients aged 2 weeks and older for myelography and CT myelography (lumbar, thoracic, cervical, total columnar) and for CT cisternography. Use of OMNIPAQUE is supported by controlled clinical studies in adults for myelography, in addition to clinical studies in pediatric patients undergoing myelography. The safety and effectiveness of OMNIPAQUE have not been established for intrathecal use in pediatric patients less than 2 weeks of age. The safety and effectiveness of OMNIPAQUE for CT cerebral ventriculography have not been established in pediatric patients. Intra-arterial or Intravenous Use Cardiac Ventriculography, Aortography, and Pulmonary Angiography The safety and effectiveness of OMNIPAQUE have been established in pediatric patients from birth to 17 years of age for cardiac ventriculography, aortography, and pulmonary angiography. Use of OMNIPAQUE is supported by controlled clinical studies in adults for cardiac ventriculography and aortography, in addition to controlled clinical studies in pediatric patients undergoing cardiac ventriculography, including aortography. Excretory Urography The safety and effectiveness of OMNIPQUE have been established in pediatric patients from birth to 17 years of age for excretory urography. Use of OMNIPAQUE is supported by controlled clinical studies in adults for urography, in addition to controlled clinical studies in pediatric patients undergoing urography and clinical safety data in pediatric patients down to birth. CT of the Head and Body The safety and effectiveness of OMNIPAQUE have been established in pediatric patients from birth to 17 years of age for CT imaging of the head and body. Use of OMNIPAQUE is supported by controlled clinical studies in adults for head and body CT, in addition to clinical studies in pediatric patients undergoing head CT and in 69 pediatric patients undergoing CT of the abdomen after oral administration of diluted OMNIPAQUE plus intravenous administration of OMNIPAQUE. Selective Coronary Arteriography, Cerebral and Peripheral Arteriography, Intra-arterial Digital Subtraction Angiography, Peripheral Venography, and Intravenous Digital Subtraction Angiography The safety and effectiveness of OMNIPAQUE have not been established in pediatric patients for selective coronary arteriography, cerebral or peripheral arteriography, intra-arterial digital subtraction angiography, peripheral venography, and intravenous digital subtraction angiography. Oral or Rectal Use Examination of the GI Tract The safety and effectiveness of OMNIPAQUE have been established in pediatric patients, from birth to 17 years of age for examination of the GI tract. Use of OMNIPAQUE is supported by controlled studies in adults for examination of the GI tract, in addition to clinical studies in pediatric patients undergoing examination of the GI tract. CT of the Abdomen and Pelvis in Conjunction with Intravenous Use The safety and effectiveness of OMNIPAQUE for CT of the abdomen and pelvis have been established in pediatric patients from birth to 17 years of age. Use is supported by clinical trials in adults, in addition to clinical studies in 69 pediatric patients undergoing CT of the abdomen. Intraarticular Use The safety and effectiveness of OMNIPAQUE have not been established in pediatric patients for arthrography. Body Cavity Use Voiding Cystourethrography OMNIPAQUE is indicated for use in pediatric patients from birth to 17 years of age for voiding cystourethrography (VCU). Use for voiding cystourethrography is supported by clinical studies in 51 pediatric patients undergoing VCU. ERCP, Herniography, and Hysterosalpingography The safety and effectiveness of OMNIPAQUE have not been established in pediatric patients for ERCP, herniography, or hysterosalpingography. In general, the frequency of adverse reactions in pediatric patients was similar to that seen in adults [ 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) ] . […]

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.