Important Risk Information About Omnipaque for Oral Administration
Oral Use is associated with mild transient, transient diarrhea, especially following high concentrations and volumes that may result in hypovolemia. Plasma fluid loss may be sufficient to cause a shock-like state that, if untreated, could be dangerous, especially in elderly, cachectic patients of any age and infants and small children.
General Reactions to Contrast Media: Serious, life-threatening and fatal reactions, mostly of cardiovascular origin, have been associated with the administration of all iodine-containing contrast media. Aseptic meningitis syndrome, profound mental disturbances, persistent transitory weakness in the leg or ocular muscles, and transitory peripheral neuropathies has been reported. In general, the reactions, which are known to occur upon parenteral administration of iodinated contrast agents, are possible with any nonionic agent.
The incidence of adverse reactions in patients with a history of allergy is twice that of the general population.
Patients with a history of previous reactions to a contrast medium are three times more susceptible than other patients.
Most adverse reactions to injectable contrast media appear within 1 to 3 minutes after the start of injection, but delayed reactions may occur.
The injection of contrast media is frequently associated with the sensation of warmth and pain.
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Please refer to the Full Prescribing Information prior to administering Omnipaque
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Important Risk Information about Omnipaque
INDICATIONS - Oral/Body Cavity Use: Adults: Omnipaque 350 is indicated for arthrography and oral pass-thru examination of the gastrointestinal (GI) tract. Omnipaque 300 is indicated for arthrography and hysterosalpingography. Omnipaque 240 is indicated for arthrography, endoscopic retrograde pancreatography and cholangiopancreatography, herniography, and hysterosalpingography. Children: Omnipaque 300 is indicated for examination of the GI tract.
Omnipaque 240 is indicated for examination of the GI tract. Omnipaque 180 is indicated for examination of the GI tract. Omnipaque diluted to concentrations from 50 mgI/mL to 100 mgI/mL is indicated for voiding cystourethrography. Oral/IV Use: Oral Omnipaque diluted to concentrations from 9 mgI/mL to 21 mgI/mL (pediatric) or 6 mg/mL to 9 mg/mL (adult) administered orally in conjunction with Omnipaque 240 (pediatric) and 300 (pediatric and adult)
administered intravenously is indicated for use in contrast enhanced computed tomography of the abdomen.
CONTRAINDICATIONS - Omnipaque should not be administered to patients with a known hypersensitivity to iohexol.
WARNINGS: Oral/Intravascular Use: Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures
with both ionic and nonionic contrast media. Omnipaque should be used with extreme care in patients with severe functional disturbances of the liver and kidneys, severe
thyrotoxicosis, or myelomatosis. Diabetics with a serum creatinine level above 3 mg/dL should not be examined unless the possible benefits of the examination clearly outweigh
the additional risk. Omnipaque is not recommended for use in patients with anuria. Contrast media are potentially hazardous in patients with multiple myeloma or other paraproteinemia.
Ionic contrast media, when injected intravenously or intra-arterially, may promote sickling in individuals who are homozygous for sickle cell disease. Administration of contrast
to patients known or suspected of having pheochromocytoma should be performed with extreme caution and the dose injected should be kept to an absolute minimum. The patient's
blood pressure should be assessed throughout the procedure and measures for the treatment of hypertensive crisis should be readily available. Reports of thyroid storm have been
reported following the use of iodinated, ionic contrast media in patients with hyperthyroidism or with an autonomously functioning thyroid nodule. Urography should be performed
with caution in patients with severely impaired renal function and patients with combined renal and hepatic disease.
PRECAUTIONS-General: Patients should be well hydrated prior to and following administration of any contrast medium. The possibility of a reaction, including serious, life-threatening, fatal, anaphylactoid, cardiovascular or central nervous system reactions, should always be considered. The possibility of an idiosyncratic reaction in susceptible patients should always be considered.
The susceptible population includes, but is not limited to, patients with a history of a previous reaction to contrast media, patients with a known sensitivity to iodine per se, and patients with a known clinical hypersensitivity: bronchial asthma, hay fever, and food allergies. After parenteral administration of a contrast agent, competent personnel and emergency facilities should be available for at least 30 to 60 minutes since severe delayed reactions have occurred.
Renal Impairment: Use in patients with hepatorenal insufficiency only if the possibility of benefit clearly outweighs the additional risk. Diabetics: Acute renal
failure has been reported in diabetic patients with diabetic nephropathy and in susceptible non-diabetic patients (often elderly with pre-existing renal disease) following
excretory urography. Congestive Heart Failure (CHF): The potential transitory increase in the circulatory osmotic load in patients with CHF requires caution during
injection. These patients should be observed for several hours following the procedure to detect delayed hemodynamic disturbances. General anesthesia may be indicated
in the performance of some procedures in selected adult patients; however, a higher incidence of adverse reactions has been reported in these patients. Angiography should
be avoided whenever possible in patients with homocystinuria, because of the risk of inducing thrombosis and embolism. Selective coronary arteriography should be performed only
in those patients in whom the expected benefits outweigh the potential risk. Repeat Procedures: If in the clinical judgment of the physician sequential or repeat
examinations are required, a suitable interval of time between administrations should be observed to allow for normal clearance of the drug from the body. Nursing Mothers:
It is not known to what extent iohexol is excreted in human milk. However, many injectable contrast agents are excreted unchanged in human milk. Although it has not been established
that serious adverse reactions occur in nursing infants, caution should be exercised when intravascular contrast media are administered to nursing women. Bottle feedings may be
substituted for breast feedings for 24 hours following administration of Omnipaque. Pediatric Use: Pediatric patients at higher risk of experiencing adverse events during
contrast medium administration may include those having asthma, 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.
ADVERSE REACTIONS - Oral Use is associated with mild, transient diarrhea, especially following high concentrations and volumes, which may result in hypovolemia. Plasma
fluid loss may be sufficient to cause a shock-like state that, if untreated, could be dangerous, especially in elderly, cachectic patients of any age and infants and small children.
General Reactions to Contrast Media: Serious, life-threatening and fatal reactions, mostly of cardiovascular origin, have been associated with the administration of all
iodine-containing contrast media. Aseptic meningitis syndrome has been reported rarely. Profound mental disturbances have been reported rarely, usually consisting of various forms
and degrees of aphasia, mental confusion, or disorientation. The onset is usually at 8 to 10 hours and lasts for about 24 hours, without after effects. Rarely, persistent though
transitory weakness in the leg or ocular muscles has been reported. Peripheral neuropathies have been rare and transitory. In general, the reactions, which are known to occur upon
parenteral administration of iodinated contrast agents, are possible with any nonionic agent. The reported incidence of adverse reactions to contrast media in patients with a
history of allergy is twice that of the general population. Patients with a history of previous reactions to a contrast medium are three times more susceptible than other patients.
Most adverse reactions to injectable contrast media appear within 1 to 3 minutes after the start of injection, but delayed reactions may occur. The injection of contrast media is
frequently associated with the sensation of warmth and pain, especially in peripheral angiography.
Prior to Omnipaque administration, please read the Full Prescribing Information.
References: 1. Omnipaque™ Prescribing Information. 2. 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. 3. Jobling C, Halligan S, Bartram C. The use of non-ionic water-soluble contrast agents for small bowel follow-through examination. Eur Radiol. 1999;9:706-710.