Generic: IOHEXOL
Radiographic Contrast Agent [EPC]
1 INDICATIONS AND USAGE OMNIPAQUE is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and body cavity imaging procedures in adults and pediatric patients. ( 1 ) 1.1 Intrathecal Procedures โก 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...
1 INDICATIONS AND USAGE OMNIPAQUE is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and body cavity imaging procedures in adults and pediatric patients. ( 1 ) 1.1 Intrathecal Procedures โก 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 โก 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 โก 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 โก OMNIPAQUE is indicated for: Radiographic examination of the gastrointestinal (GI) tract in adults and pediatric patients CT of the abdomen and pelvis in conjunction with intravenous administration of OMNIPAQUE in adults and pediatric patients 1.5 Intraarticular Procedures โก OMNIPAQUE is indicated for: Arthrography in adults 1.6 Body Cavity Procedures โก 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 โก 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) ].
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Life-threatening or fatal reactions can occur. Always have emergency equipment and trained personnel available. ( 5.3 ) Acute Kidney Injury: Acute injury including renal failure can occur. Minimize dose and maintain adequate hydration to minimize risk. ( 5.4 ) Cardiovascular Adverse Reactions: Hemodynamic disturbances including shock and cardiac arrest may occur during or after administration. ( 5.5 ) Thyroid Dysfunction in Pediatric Patient...
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Life-threatening or fatal reactions can occur. Always have emergency equipment and trained personnel available. ( 5.3 ) Acute Kidney Injury: Acute injury including renal failure can occur. Minimize dose and maintain adequate hydration to minimize risk. ( 5.4 ) Cardiovascular Adverse Reactions: Hemodynamic disturbances including shock and cardiac arrest may occur during or after administration. ( 5.5 ) Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age: Individualize thyroid function monitoring based on risk factors such as prematurity. ( 5.9 ) 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: 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) ] ...
6 ADVERSE REACTIONS 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 โฅ 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 (โฅ1%) in 1,531 adult patients following intrathecal administration of OMNIPAQUE in clinical trials are presented in Table 16. Table 16. Adverse Reactions (โฅ1%) 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 (โฅ1%) are presented in Table 17. Table 17. Adverse Reactions (โฅ1%) 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 (โฅ1%) 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 (โฅ1%) 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 (โฅ1%) 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 (โฅ1%) are presented in Table 19. Table 19. Adverse Reactions (โฅ1%) 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 (โฅ1%) are presented in Table 20. Table 20. Adverse Reactions (โฅ1%) 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 (โฅ1%) 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 (โฅ1%) 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 (โฅ1%) were administration site pain (26%) and swelling (22%) in arthrography. Patients also experienced heat (7%). Body Cavity Use VCU in Pediatric Patients No new adverse reactions associated with the use of OMNIPAQUE for VCU procedures were reported in 51 pediatric patients studied. 6.2 Post-marketing Experience The following adverse reactions have been identified during post-approval use of OMNIPAQUE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. General Immune system disorders: Hypersensitivity reactions, anaphylactic or anaphylactoid reactions, anaphylactic or anaphylactoid shock including life-threatening or fatal anaphylaxis General disorders and administration site conditions: Pyrexia, chills, pain and discomfort, asthenia, administration site conditions including extravasation Intrathecal Administration Nervous system disorders: Meningism, aseptic meningitis, seizures or status epilepticus, disorientation, coma, depressed or loss of consciousness, transient contrast-induced toxic encephalopathy (including amnesia, hallucination, paralysis, paresis, speech disorder, aphasia, dysarthria), restlessness, tremors, hypoesthesia Musculoskeletal and connective tissue disorders : Pain, muscle spasms or spasticity Psychiatric disorders: Confusional state, agitation, anxiety Eye disorders: Transient visual impairment including cortical blindness Renal and urinary disorders: Acute kidney injury Intra-arterial or Intravenous Administration Cardiac disorders: Severe cardiac complications (including cardiac arrest, cardiopulmonary arrest), shock, peripheral vasodilatation, palpitations, vasospasm including spasm of coronary arteries, myocardial infarction, syncope, cyanosis, pallor, flushing, chest pain Vascular disorders: Vasospasm and thrombophlebitis following intravenous injection Blood and lymphatic system disorders: Neutropenia Nervous system disorders: Disorientation, coma, depressed or loss of consciousness, transient contrast-induced toxic encephalopathy (including amnesia, hallucination, paralysis, paresis, speech disorder, aphasia, dysarthria), restlessness, tremors, hypoesthesia Psychiatric disorders: Confusional state, agitation Eye disorders: Eye irritation or itchiness, periorbital edema, ocular or conjunctival hyperemia, lacrimation Renal and urinary disorders: Acute kidney injury, toxic nephropathy (CIN), transient proteinuria, oliguria or anuria, increased serum creatinine Gastrointestinal disorders: Abdominal pain, pancreatitis aggravated, salivary gland enlargement Endocrine disorders: Hyperthyroidism, hypothyroidism Respiratory, thoracic and mediastinal disorders: Respiratory distress, respiratory failure, pulmonary edema, bronchospasm, laryngospasm, throat irritation, throat tightness, laryngeal edema, wheezing, chest discomfort, asthmatic attack Skin and subcutaneous tissue disorders: Contrast media reactions range from mild (e.g., pleomorphic rashes, drug eruption, erythema and skin discoloration, blisters, hyperhidrosis, angioedema, localized areas of edema) to severe (e.g., Stevens-Johnson syndrome and toxic epidermal necrolysis [SJS/TEN], bullous or exfoliative dermatitis, acute generalized exanthematous pustulosis [AGEP] and drug reaction with eosinophilia and systemic symptoms [DRESS]) Oral Administration Gastrointestinal disorders: Dysphagia, abdominal pain Body Cavity Administration Gastrointestinal disorders: Pancreatitis Musculoskeletal and connective tissue disorders: Arthritis (arthrography) Hysterosalpingography : Injection of OMNIPAQUE for hysterosalpingography is associated with immediate, transient pain. Monitor injection pressure and volume instilled to minimize pain and to avoid disruptive distention of the uterus and fallopian tubes. Fluoroscopic monitoring is recommended. Nervous system disorders : Pain (49%), somnolence and fever each with an individual incidence of 3% Gastrointestinal disorders : Nausea (3%)
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