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Overview
Iohexol is a contrast media that is FDA approved for the diagnosis of intrathecal administration in adults including myelography (lumbar, thoracic, cervical, total columnar) and in contrast enhancement for computerized tomography (myelography, cisternography, ventriculography. Common adverse reactions include Headaches, Pain, Nausea and Vomiting, Dizziness.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
OMNIPAQUE 300 is indicated for intrathecal administration in adults including myelography (lumbar, thoracic, cervical, total columnar) and in contrast enhancement for computerized tomography (myelography, cisternography, ventriculography).
The volume and concentration of OMNIPAQUE 300 to be administered will depend on the degree and extent of contrast required in the area(s) under examination and on the equipment and technique employed.
OMNIPAQUE 300 at a concentration of 300 mgI/mL is recommended for the examination of the lumbar, thoracic, and cervical regions in adults by lumbar or direct cervical injection and is slightly hypertonic to CSF.
A total dose of 3060 mg iodine or a concentration of 300 mgI/mL should not be exceeded in adults in a single myelographic examination. This is based on clinical trial evaluation to date. As in all diagnostic procedures, the minimum volume and dose to produce adequate visualization should be used. Most procedures do not require either maximum dose or concentration.
Anesthesia is not necessary. Premedication sedatives or tranquilizers are usually not needed (see PRECAUTIONS). Patients should be well hydrated prior to and following contrast administration.
Seizure-prone patients should be maintained on anticonvulsant medication.
Many radiopaque contrast agents are incompatible in vitro with some antihistamines and many other drugs; therefore, concurrent drugs should not be physically admixed with contrast agents.
Rate of Injection
To avoid excessive mixing with CSF and consequent dilution of contrast, injection should be made slowly over 1 to 2 minutes.
Depending on the estimated volume of contrast medium which may be required for the procedure a small amount of CSF may be removed to minimize distention of the subarachnoid spaces.
The lumbar or cervical puncture needle may be removed immediately following injection since it is not necessary to remove OMNIPAQUE after injection into the subarachnoid space.
Adults
The usual recommended total doses for use in lumbar, thoracic, cervical, and total columnar myelography in adults are 1.2 gI to 3.0 gI as follows:
Refer to DIRECTIONS FOR PROPER USE OF OMNIPAQUE PHARMACY BULK PACKAGE section for instructions.
Parenteral products should be inspected visually for particulate matter or discoloration prior to administration. If particulate matter or discoloration is present, do not use.
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. An interval of at least 48 hours should be allowed before repeat examination; however, whenever possible, 5 to 7 days is recommended.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Iohexol in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Iohexol in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Iohexol in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Iohexol in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Iohexol in pediatric patients.
Contraindications
OMNIPAQUE should not be administered to patients with a known hypersensitivity to iohexol.
Warnings
Nonionic iodinated contrast media inhibit blood coagulation, in vitro, less than ionic contrast media. Clotting has been reported when blood remains in contact with syringes containing nonionic contrast media.
Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures with both ionic and nonionic contrast media. Therefore, meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimize thromboembolic events. Numerous factors, including length of procedure, catheter and syringe material, underlying disease state, and concomitant medications may contribute to the development of thromboembolic events. For these reasons, meticulous angiographic techniques are recommended including close attention to guidewire and catheter manipulation, use of manifold systems and/or three-way stopcocks, frequent catheter flushing with heparinized saline solutions and minimizing the length of the procedure. The use of plastic syringes in place of glass syringes has been reported to decrease but not eliminate the likelihood of in vitro clotting.
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.
Radiopaque contrast agents are potentially hazardous in patients with multiple myeloma or other paraproteinemia, particularly in those with therapeutically resistant anuria. Although neither the contrast agent nor dehydration has separately proven to be the cause of anuria in myeloma, it has been speculated that the combination of both may be causative factors. The risk in myelomatous patients is not a contraindication; however, special precautions are necessary. Partial dehydration in the preparation of these patients prior to injection is not recommended since this may predispose the patient to precipitation of the myeloma protein in the renal tubules. No form of therapy, including dialysis, has been successful in reversing the effect. Myeloma, which occurs most commonly in persons over age 40, should be considered before instituting intravascular administration of contrast agents.
Ionic contrast media, when injected intravenously or intra-arterially, may promote sickling in individuals who are homozygous for sickle cell disease.
Administration of radiopaque materials to patients known or suspected of having pheochromocytoma should be performed with extreme caution. If, in the opinion of the physician, the possible benefits of such procedures outweigh the considered risks, the procedures may be performed; however, the amount of radiopaque medium 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 following the use of iodinated, ionic radiopaque contrast media in patients with hyperthyroidism or with an autonomously functioning thyroid nodule suggest that this additional risk be evaluated in such patients before use of any contrast medium.
Urography should be performed with caution in patients with severely impaired renal function and patients with combined renal and hepatic disease.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Iohexol in the drug label.
Postmarketing Experience
Adverse reactions following the use of OMNIPAQUE 300 and OMNIPAQUE 350 are usually of mild to moderate severity. However, serious, life-threatening and fatal reactions, mostly of cardiovascular origin, have been associated with the administration of iodine-containing contrast media, including OMNIPAQUE. * The injection of contrast media is frequently associated with the sensation of warmth and pain, especially in peripheral angiography; pain and warmth are less frequent and less severe with OMNIPAQUE than with many contrast media.
Cardiovascular System
Arrhythmias including PVCs and PACs (2%), angina/chest pain (1%), and hypotension (0.7%). Others including cardiac failure, asystole, bradycardia, tachycardia, and vasovagal reaction were reported with an individual incidence of 0.3% or less. In controlled clinical trials involving 1485 patients, one fatality occurred. A cause and effect relationship between this death and iohexol has not been established.
Nervous System
Vertigo (including dizziness and lightheadedness) (0.5%), pain (3%), vision abnormalities (including blurred vision and photomas) (2%), headache (2%), and taste perversion (1%). Others including anxiety, fever, motor and speech dysfunction, convulsion, paresthesia, somnolence, stiff neck, hemiparesis, syncope, shivering, transient ischemic attack, cerebral infarction, and nystagmus were reported, with an individual incidence of 0.3% or less.
Respiratory System
Dyspnea, rhinitis, coughing, and laryngitis, with an individual incidence of 0.2% or less.
Gastrointestinal System
Nausea (2%) and vomiting (0.7%). Others including diarrhea, dyspepsia, cramp, and dry mouth were reported, with an individual incidence of less than 0.1%.
Skin and Appendages
Urticaria (0.3%), purpura (0.1%), abscess (0.1%), and pruritus (0.1%).
Individual adverse reactions which occurred to a significantly greater extent for a specific procedure are listed under that indication.
Pediatrics
In controlled clinical trials involving 391 patients for pediatric angiocardiography, urography, and contrast enhanced computed tomographic head imaging, adverse reactions following the use of OMNIPAQUE 300 and OMNIPAQUE 350 were generally less frequent than with adults.
Pain (0.8%), fever (0.5%), taste abnormality (0.5%), and convulsion (0.3%).
Respiratory System
Congestion (0.3%) and apnea (0.3%).
Gastrointestinal System
Nausea (1%), hypoglycemia (0.3%), and vomiting (2%).
Skin and Appendages
Rash (0.3%).
General Adverse Reactions to Contrast Media
Physicians should remain alert for the occurrence of adverse effects in addition to those discussed above.
The following reactions have been reported after administration of other intravascular iodinated contrast media, and rarely with iohexol. Reactions due to technique: hematomas and ecchymoses. Hemodynamic reactions: vein cramp and thrombophlebitis following intravenous injection. Cardiovascular reactions: rare cases of cardiac arrhythmias, reflex tachycardia, chest pain, cyanosis, hypertension, hypotension, peripheral vasodilatation, shock, and cardiac arrest. Renal reactions: occasionally, transient proteinuria, and rarely, oliguria or anuria. Allergic reactions: asthmatic attacks, nasal and conjunctival symptoms, dermal reactions such as urticaria with or without pruritus, as well as pleomorphic rashes, sneezing and lacrimation and, rarely, anaphylactic reactions. Rare fatalities have occurred, due to this or unknown causes. Signs and symptoms related to the respiratory system: pulmonary or laryngeal edema, bronchospasm, dyspnea; or to the nervous system: restlessness, tremors, convulsions. Other reactions: flushing, pain, warmth, metallic taste, nausea, vomiting, anxiety, headache, confusion, pallor, weakness, sweating, localized areas of edema, especially facial cramps, neutropenia, and dizziness. Rarely, immediate or delayed rigors can occur, sometimes accompanied by hyperpyrexia.
Infrequently, "iodism" (salivary gland swelling) from organic iodinated compounds appears two days after exposure and subsides by the sixth day.
In general, the reactions which are known to occur upon parenteral administration of iodinated contrast agents are possible with any nonionic agent. Approximately 95 percent of adverse reactions accompanying the use of water-soluble intravascularly administered contrast agents are mild to moderate in degree. However, severe, life-threatening anaphylactoid reactions, mostly of cardiovascular origin, have occurred. Reported incidences of death range from 6.6 per 1 million (0.00066 percent) to 1 in 10,000 (0.01 percent). Most deaths occur during injection or 5 to 10 minutes later; the main feature being cardiac arrest with cardiovascular disease as the main aggravating factor. Isolated reports of hypotensive collapse and shock are found in the literature. The incidence of shock is estimated to be 1 out of 20,000 (0.005 percent) patients.
Adverse reactions to injectable contrast media fall into two categories: chemotoxic reactions and idiosyncratic reactions.
Chemotoxic reactions result from the physicochemical properties of the contrast media, the dose, and speed of injection. All hemodynamic disturbances and injuries to organs or vessels perfused by the contrast medium are included in this category.
Idiosyncratic reactions include all other reactions. They occur more frequently in patients 20 to 40 years old. Idiosyncratic reactions may or may not be dependent on the amount of dose injected, the speed of injection, and the radiographic procedure. Idiosyncratic reactions are subdivided into minor, intermediate, and severe. The minor reactions are self-limited and of short duration; the severe reactions are life-threatening and treatment is urgent and mandatory.
The reported incidence of adverse reactions to contrast media in patients with a history of allergy are 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. However, sensitivity to contrast media does not appear to increase with repeated examinations.
Most adverse reactions to injectable contrast media appear within 1 to 3 minutes after the start of injection, but delayed reactions may occur.
Regardless of the contrast agent employed, the overall estimated incidence of serious adverse reactions is higher with angiocardiography than with other procedures. Cardiac decompensation, serious arrhythmias, angina pectoris, or myocardial ischemia or infarction may occur during angiocardiography and left ventriculography. Electrocardiographic and hemodynamic abnormalities occur less frequently with OMNIPAQUE than with diatrizoate meglumine and diatrizoate sodium injection.
Body Cavities
In controlled clinical trials involving 285 adult patients for various body cavity examinations using OMNIPAQUE 300 and 350, the following adverse reactions were reported.
The most frequent reactions, pain and swelling, were almost exclusively reported after arthrography and were generally related to the procedure rather than the contrast medium. Gastrointestinal reactions were almost exclusively reported after oral pass-thru examinations.
No adverse reactions associated with the use of OMNIPAQUE for VCU procedures were reported in 51 pediatric patients studied.
Reproduction studies performed in rats and rabbits at dosages up to 4.0 gI/kg and 2.5 gI/kg, respectively [2.3 and 1.4 times the maximum recommended dose for a 50 kg human, or approximately 0.4 (rat) and 0.5 (rabbit) times the maximum recommended dose for a 50 kg human following normalization of the data to body surface area estimates] have not revealed evidence of impaired fertility or harm to the fetus due to OMNIPAQUE. Adequate and well-controlled studies in pregnant women have not been conducted. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Iohexol in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Iohexol during labor and delivery.
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, 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.
Geriatic Use
There is no FDA guidance on the use of Iohexol with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Iohexol with respect to specific gender populations.
Race
There is no FDA guidance on the use of Iohexol with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Iohexol in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Iohexol in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Iohexol in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Iohexol in patients who are immunocompromised.
Administration and Monitoring
Administration
Intrathecal
Intravascular
Oral
Monitoring
During administration of large doses of OMNIPAQUE 350, continuous monitoring of vital signs is desirable.
IV Compatibility
There is limited information regarding IV Compatibility of Iohexol in the drug label.
Overdosage
Overdosage may occur. The adverse effects of overdosage are life-threatening and affect mainly the pulmonary and cardiovascular systems. The symptoms included: cyanosis, bradycardia, acidosis, pulmonary hemorrhage, convulsions, coma, and cardiac arrest. Treatment of an overdosage is directed toward the support of all vital functions, and prompt institution of symptomatic therapy.
The intravenous LD50 values of OMNIPAQUE (in grams of iodine per kilogram body weight) are 24.2 in mice and 15.0 in rats.
Pharmacology
There is limited information regarding Iohexol Pharmacology in the drug label.
Mechanism of Action
Following intravascular injection, iohexol is distributed in the extracellular fluid compartment and is excreted unchanged by glomerular filtration. It will opacify those vessels in the path of flow of the contrast medium permitting radiographic visualization of the internal structures until significant hemodilution occurs.
Approximately 90% or more of the injected dose is excreted within the first 24 hours, with the peak urine concentrations occurring in the first hour after administration. Plasma and urine iohexol levels indicate that the iohexol body clearance is due primarily to renal clearance. An increase in the dose from 500 mgI/kg to 1500 mgI/kg does not significantly alter the clearance of the drug. The following pharmacokinetic values were observed following the intravenous administration of iohexol (between 500 mgI/kg to 1500 mgI/kg) to 16 adult human subjects: renal clearance—120 (86-162) mL/min; total body clearance—131 (98-165) mL/min; and volume of distribution—165 (108-219) mL/kg.
Renal accumulation is sufficiently rapid that the period of maximal opacification of the renal passages may begin as early as 1 minute after intravenous injection. Urograms become apparent in about 1 to 3 minutes with optimal contrast occurring between 5 to 15 minutes. In nephropathic conditions, particularly when excretory capacity has been altered, the rate of excretion may vary unpredictably, and opacification may be delayed after injection. Severe renal impairment may result in a lack of diagnostic opacification of the collecting system and, depending on the degree of renal impairment, prolonged plasma iohexol levels may be anticipated. In these patients, as well as in infants with immature kidneys, the route of excretion through the gallbladder and into the small intestine may increase.
Iohexol displays a low affinity for serum or plasma proteins and is poorly bound to serum albumin. No significant metabolism, deiodination or biotransformation occurs.
OMNIPAQUE probably crosses the placental barrier in humans by simple diffusion. It is not known to what extent iohexol is excreted in human milk.
Animal studies indicate that iohexol does not cross an intact blood-brain barrier to any significant extent following intravascular administration.
OMNIPAQUE enhances computed tomographic imaging through augmentation of radiographic efficiency. The degree of density enhancement is directly related to the iodine content in an administered dose; peak iodine blood levels occur immediately following rapid intravenous injection. Blood levels fall rapidly within 5 to 10 minutes and the vascular compartment half-life is approximately 20 minutes. This can be accounted for by the dilution in the vascular and extravascular fluid compartments which causes an initial sharp fall in plasma concentration. Equilibration with the extracellular compartments is reached in about ten minutes; thereafter, the fall becomes exponential.
The pharmacokinetics of iohexol in both normal and abnormal tissue have been shown to be variable. Contrast enhancement appears to be greatest immediately after bolus administration (15 seconds to 120 seconds). Thus, greatest enhancement may be detected by a series of consecutive two-to-three second scans performed within 30 to 90 seconds after injection (ie, dynamic computed tomographic imaging). Utilization of a continuous scanning technique (ie, dynamic CT scanning) may improve enhancement and diagnostic assessment of tumor and other lesions such as abscess, occasionally revealing unsuspected or more extensive disease. For example, a cyst may be distinguished from a vascularized solid lesion when precontrast and enhanced scans are compared; the nonperfused mass shows unchanged x-ray absorption (CT number). A vascularized lesion is characterized by an increase in CT number in the few minutes after a bolus of intravascular contrast agent; it may be malignant, benign, or normal tissue, but would probably not be a cyst, hematoma, or other nonvascular lesion.
Because unenhanced scanning may provide adequate diagnostic information in the individual patient, the decision to employ contrast enhancement, which may be associated with risk and increased radiation exposure, should be based upon a careful evaluation of clinical, other radiological, and unenhanced CT findings.
CT SCANNING OF THE HEAD
In contrast enhanced computed tomographic head imaging, OMNIPAQUE does not accumulate in normal brain tissue due to the presence of the normal blood-brain barrier. The increase in x-ray absorption in normal brain is due to the presence of contrast agent within the blood pool. A break in the blood-brain barrier such as occurs in malignant tumors of the brain allows for the accumulation of contrast medium within the interstitial tissue of the tumor. Adjacent normal brain tissue does not contain the contrast medium.
Maximum contrast enhancement in tissue frequently occurs after peak blood iodine levels are reached. A delay in maximum contrast enhancement can occur. Diagnostic contrast enhanced images of the brain have been obtained up to 1 hour after intravenous bolus administration. This delay suggests that radiographic contrast enhancement is at least in part dependent on the accumulation of iodine containing medium within the lesion and outside the blood pool, although the mechanism by which this occurs is not clear. The radiographic enhancement of nontumoral lesions, such as arteriovenous malformations and aneurysms, is probably dependent on the iodine content of the circulating blood pool.
In patients where the blood-brain barrier is known or suspected to be disrupted, the use of any radiographic contrast medium must be assessed on an individual risk to benefit basis. However, compared to ionic media, nonionic media are less toxic to the central nervous system.
CT SCANNING OF THE BODY
In contrast enhanced computed tomographic body imaging (nonneural tissue), OMNIPAQUE diffuses rapidly from the vascular into the extravascular space. Increase in x-ray absorption is related to blood flow, concentration of the contrast medium, and extraction of the contrast medium by interstitial tissue of tumors since no barrier exists. Contrast enhancement is thus due to the relative differences in extravascular diffusion between normal and abnormal tissue, quite different from that in the brain.
Examinations of the uterus (hysterosalpingography) and bladder (voiding cystourethrography) involve the almost immediate drainage of contrast medium from the cavity upon conclusion of the radiographic procedure.
Orally administered iohexol is very poorly absorbed from the normal gastrointestinal tract. Only 0.1 to 0.5 percent of the oral dose was excreted by the kidneys. This amount may increase in the presence of bowel perforation or bowel obstruction. Iohexol is well tolerated and readily absorbed if leakage into the peritoneal cavity occurs.
Visualization of the joint spaces, uterus, fallopian tubes, peritoneal herniations, pancreatic and bile ducts, and bladder can be accomplished by direct injection of contrast medium into the region to be studied. The use of appropriate iodine concentrations assures diagnostic density.
Orally administered OMNIPAQUE produces good visualization of the gastrointestinal tract. OMNIPAQUE is particularly useful when barium sulfate is contraindicated as in patients with suspected bowel perforation or those where aspiration of contrast medium is a possibility.
Structure
File:Iohexol01.pngThis image is provided by the National Library of Medicine.
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Iohexol in the drug label.
Pharmacokinetics
Iohexol is absorbed from cerebrospinal fluid (CSF) into the bloodstream and is eliminated by renal excretion. No significant metabolism, deiodination, or biotransformation occurs.
The initial concentration and volume of the medium, in conjunction with appropriate patient manipulation and the volume of CSF into which the medium is placed, will determine the extent of the diagnostic contrast that can be achieved.
Following intrathecal injection in conventional radiography, OMNIPAQUE 300 will continue to provide good diagnostic contrast for at least 30 minutes. Slow diffusion of iohexol takes place throughout the CSF with subsequent absorption into the bloodstream. Once in the systemic circulation, iohexol displays little tendency to bind to serum or plasma proteins. At approximately 1 hour following injection, contrast of diagnostic quality will no longer be available for conventional myelography. If computerized tomographic (CT) myelography is to follow, consideration should be given to a delay of several hours to allow the degree of contrast to decrease.
After administration into the lumbar subarachnoid space, computerized tomography shows the presence of contrast medium in the thoracic region in about 1 hour, in the cervical region in about 2 hours, and in the basal cisterns in 3 to 4 hours.
In patients with renal impairment, depending on the degree of impairment, prolonged plasma iohexol levels may be anticipated due to decreased renal elimination.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Iohexol in the drug label.
Clinical Studies
There is limited information regarding Iohexol Clinical Studies in the drug label.
How Supplied
OMNIPAQUE 300
500 mL in +PLUSPAK™ (polymer bottle), boxes of 10 Pharmacy Bulk Packages
(NDC 0407-1413-68)
OMNIPAQUE 350
500 mL in +PLUSPAK™ (polymer bottle), boxes of 10 Pharmacy Bulk Packages
(NDC 0407-1414-98)
FEDERAL GOVERNMENT CODES
OMNIPAQUE 300
500 mL in +PLUSPAK™ (polymer bottle), boxes of 10 Pharmacy Bulk Packages
(NDC 0407-1413-94)
OMNIPAQUE 350
500 mL in +PLUSPAK™ (polymer bottle), boxes of 10 Pharmacy Bulk Packages
(NDC 0407-1414-25)
Protect polymer bottles of OMNIPAQUE from strong daylight and direct exposure to sunlight. Do not freeze. OMNIPAQUE should be stored at controlled room temperature, 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F)
Storage
OMNIPAQUE Injection in all presentations may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).
SPECIAL HANDLING AND STORAGE FOR POLYMER BOTTLES ONLY: DO NOT USE IF TAMPER-EVIDENT RING IS BROKEN OR MISSING.
Images
Drug Images
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