Source: FDA, National Drug Code (US) Revision Year: 2019
Conray is indicated for use in excretory urography, cerebral angiography, peripheral arteriography, venography, arthrography, direct cholangiography, endoscopic retrograde cholangiopancreatography, contrast enhancement of computed tomographic brain images, cranial computerized angiotomography, intravenous digital subtraction angiography and arterial digital subtraction angiography.
Conray may also be used for enhancement of computed tomographic scans performed for detection and evaluation of lesions in the liver, pancreas, kidneys, abdominal aorta, mediastinum, abdominal cavity and retroperitoneal space. Continuous or multiple scans separated by intervals of 1 to 3 seconds during the first 30 to 90 seconds post-injection of the contrast medium (dynamic CT scanning) may provide enhancement of diagnostic significance, and may be of benefit in establishing diagnoses of certain lesions in these sites with greater assurance than is possible with CT alone, and in supplying additional features of the lesions. In other cases, the contrast agent may allow visualization of lesions not seen with CT alone, or may help to define suspicious lesions seen with unenhanced CT (see CLINICAL PHARMACOLOGY). Subsets of patients in whom delayed body CT scans might be helpful have not been identified. Inconsistent results have been reported and abnormal and normal tissues may be isodense during the time frame used for delayed CT scanning. The risks of such indiscriminate use of contrast media are well known and such use is not recommended. At present, consistent results have been documented using dynamic CT techniques only.
It is advisable that Conray be at or close to body temperature when injected.
The patient should be instructed to omit the meal that precedes the examination. Appropriate premedication, which may include a barbiturate, tranquilizer or analgesic drug, may be administered prior to the examination.
A preliminary film is recommended to check the position of the patient and the x-ray exposure factors.
If a minor reaction occurs during administration, the injection should be slowed or stopped until the reaction has subsided. If a major reaction occurs, the injection should be discontinued immediately.
Under no circumstances should either corticosteroids or antihistamines be mixed in the same syringe with the contrast medium because of a potential for chemical incompatibility.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Following intravenous injection, Conray is rapidly excreted by the kidneys. Conray may be visualized in the renal parenchyma 30 seconds following bolus injection. Maximum radiographic density in the calyces and pelves occurs in most instances within 3 to 8 minutes after injection. In patients with severe renal impairment contrast visualization may be substantially delayed.
Appropriate preparation of the patient is important for optimal visualization. A low residue diet is recommended for the day preceding the examination and a laxative is given the evening before the examination, unless contraindicated.
Infants and small children should not have any fluid restrictions prior to excretory urography. Injections of Conray represent an osmotic load which, if superimposed on increased serum osmolality due to partial dehydration, may magnify hypertonic dehydration (see WARNINGS and PRECAUTIONS, General concerning preparatory dehydration).
See section on general Adverse Reactions.
Adults – The usual dose is 30 to 60 mL. Children 14 years of age and over, of average weight, may receive the adult dose. The total dose is normally injected within 30 to 90 seconds. Higher dosage may be indicated to achieve optimum results in instances where poor visualization may be anticipated (e.g., elderly patients or patients with impaired renal function). When nephrograms and/or sequential urograms are desired, the total dose should be rapidly injected, normally within 15 to 30 seconds.
The dosage for children is reduced in proportion to age and body weight. The following approximate schedule is recommended for infants and children, based on a dosage of about 0.5 mL/kg of body weight:
| Under 6 months of age | 5 mL |
| 6-12 months | 8 mL |
| 1-2 years | 10 mL |
| 2-5 years | 12 mL |
| 5-8 years | 15 mL |
| 8-12 years | 18 mL |
| 12-14 years | 20-30 mL |
Conray may be used to visualize the cerebral vasculature by any of the accepted techniques.
Cerebral angiography is normally performed with local or general anesthesia (see PRECAUTIONS, General). Premedication may be employed as indicated.
A preliminary radiograph is usually made prior to injection of the contrast agent.
In addition to the general precautions previously described, cerebral angiography should be performed with special caution in patients with advanced arteriosclerosis, severe hypertension, cardiac decompensation, senility, recent cerebral thrombosis or embolism, and migraine.
The major sources of cerebral arteriographic adverse reactions appear to be related to repeated injections of the contrast material, administration of doses higher than those recommended, the presence of occlusive atherosclerotic vascular disease and the method and technique of injection.
Adverse reactions are normally mild and transient. A feeling of warmth in the face and neck is frequently experienced. Infrequently, a more severe burning discomfort is observed.
Serious neurological reactions that have been associated with cerebral angiography and not listed under the general Adverse Reactions include stroke, amnesia and respiratory difficulties.
Cardiovascular reactions that may occur with some frequency are bradycardia and decrease in systemic blood pressure. The blood pressure change is transient and usually requires no treatment.
The usual dosage employed varies with the site and method of injection and the age, condition and weight of the patient. In adults, carotid and vertebral angiography, by either the percutaneous needle or catheter methods, is usually performed with a single rapid injection of 6 to 10 mL. Additional injections are made as indicated. Retrograde brachial cerebral angiography, in adults, is usually performed with a single rapid injection of 35 to 50 mL into the right brachial artery. Other dosages may be employed depending upon the vessel injected and the procedure followed. The dose for children is reduced in approximate proportion to age and body weight.
Conray may be injected to visualize the arterial and venous peripheral circulation. Arteriograms of the upper and lower extremities may be obtained by any of the established techniques. Most frequently, a percutaneous injection is made into the brachial artery in the arm or the femoral artery in the leg. Venograms are obtained by injection into an appropriate vein in the upper and lower extremity.
The procedure is normally performed with local or general anesthesia (see PRECAUTIONS, General). Premedication may be employed as indicated.
A preliminary radiograph is usually made prior to the injection of the contrast agent.
In addition to the general precautions previously described, moderate decreases in blood pressure occur frequently with intra-arterial (brachial) injections. This change is usually transient and requires no treatment; however, the blood pressure should be monitored for approximately ten minutes following injection. Special care is required when venography is performed in patients with suspected thrombosis, phlebitis, severe ischemic disease, local infection or a totally obstructed venous system. In the presence of venous stasis, vein irrigation with normal saline should be considered following the procedure. Venography is optimally performed with a more dilute solution such as Conray 43 (Iothalamate Meglumine Injection USP 43%).
Extreme caution during injection of the contrast agent is necessary to avoid extravasation and fluoroscopy is recommended. This is especially important in patients with severe arterial or venous disease.
In addition to the general adverse reactions previously described, hemorrhage and thrombosis have occurred at the puncture site of the percutaneous injection. Brachial plexus injury has been reported following axillary artery injection. Thrombophlebitis, syncope and very rare cases of gangrene have been reported following venography.
Peripheral Arteriography: In adults a single rapid injection of 20 to 40 mL is normally sufficient to visualize the entire extremity. The dose for children is reduced in proportion to body weight. Venography: The usual dose for adults is a single rapid injection of 20 to 40 mL. The dose for children is reduced in proportion to body weight. Following the procedure, the venous system should be flushed with either 5% dextrose in water (D5W) or normal saline (Sodium Chloride Injection USP) or the contrast medium should be removed by leg massage and/or leg elevation.
In addition to the general precautions previously described, strict aseptic technique is required to prevent the introduction of infection. Fluoroscopic control should be used to ensure proper introduction of the needle into the synovial space and prevent extracapsular injection. Aspiration of excessive synovial fluid will reduce the pain on injection and prevent the rapid dilution of the contrast agent. It is important that undue pressure not be exerted during the injection.
In addition to the general adverse reactions previously described arthrography may induce joint pain or discomfort which is usually mild and transient but occasionally may be severe and persist for 24 to 48 hours following the procedure. Effusion requiring aspiration may occur in patients with rheumatoid arthritis.
Arthrography is usually performed under local anesthesia. The amount of contrast agent required is solely dependent on the size of the joint to be injected and the technique employed.
The following dosage schedule for normal adult joints should serve only as a guide since joints may require more or less contrast medium for optimal visualization. Dosage should be reduced for children in proportion to body weight.
| Knee, hip | 5-15 mL |
| Shoulder, ankle | 5-10 mL |
| Other | 1-4 mL |
Passive or active manipulation is used to disperse the medium throughout the joint space.
The lower volumes of contrast medium are usually employed for double contrast examinations. Following the injection of the contrast medium 50 to 100 cc of either filtered room air or carbon dioxide is introduced for examination of the knee and lesser volumes for other joints. The concomitant use of epinephrine 1:1000 will reduce the rate of contrast medium absorption as well as the production of synovial fluids and consequent dilution of the medium.
In addition to the general precautions previously described, in the presence of acute pancreatitis, direct cholangiography, if necessary, should be employed with caution, injecting no more than 5 to 10 mL without undue pressure. Percutaneous transhepatic cholangiography should only be attempted when compatible blood for potential transfusions is in readiness and emergency surgical facilities are available. The patient should be carefully monitored for at least 24 hours to ensure prompt detection of bile leakage and hemorrhage. Appropriate premedication of the patient is recommended and drugs which are cholespastic, such as morphine, should be avoided. Respiratory movements should be controlled during introduction of the needle.
Adverse reactions may often be attributed to injection pressure or excessive volume of the medium resulting in overdistention of the ducts and producing local pain.
Some of the medium may enter the pancreatic duct which may result in pancreatic irritation. Occasionally, nausea, vomiting, fever, and tachycardia have been observed. Pancholangitis resulting in liver abscess or septicemia has been reported.
In percutaneous transhepatic cholangiography, some discomfort is common, but severe pain is unusual. Complications of the procedure are often serious and have been reported in 4 to 6 percent of patients. These reactions have included bile leakage and biliary peritonitis, gall bladder perforation, internal bleeding (sometimes massive), blood-bile fistula resulting in septicemia involving gram-negative organisms, and tension pneumothorax from inadvertent puncture of the diaphragm or lung. Bile leakage is more likely to occur in patients with obstructions that cause unrelieved high biliary pressure.
It is advisable that Conray be at or close to body temperature when injected. The injection is made slowly without undue pressure, taking the necessary precautions to avoid the introduction of bubbles.
Operative: The usual dose is 10 mL but as much as 25 mL may be needed depending upon the caliber of the ducts. If desired, the contrast agent may be diluted 1:1 with Sodium Chloride Injection USP using strict aseptic procedures. Following surgical exploration of the ductal system, repeat studies may be performed before closure of the abdomen, using the same dose as before.
Postoperative: Postoperatively, the ductal system may be examined by injection of the contrast agent through an in-place T-tube. These delayed cholangiograms are usually made from the fifth to the tenth postoperative day prior to removal of the T-tube. The usual dose is the same as for operative cholangiography.
Percutaneous Transhepatic Cholangiography: This procedure is recommended for carefully selected patients for the differential diagnosis of jaundice due to extrahepatic biliary obstruction or parenchymal disease. The procedure is only employed where oral or intravenous cholangiography and other procedures have failed to provide the necessary information. In obstructed cases, percutaneous transhepatic cholangiography is used to determine the cause and site of obstruction to help plan surgery. The technique may also be of value in avoiding laparotomy in poor risk jaundice patients since failure to enter a duct suggests hepatocellular disease. Careful attention to technique is essential for the success and safety of the procedure. The procedure is usually performed under local anesthesia following analgesic premedication.
Depending upon the caliber of the biliary tree, a dose of 20 to 40 mL is generally sufficient to opacify the entire ductal system. If desired, the contrast agent may be diluted 1:1 with Sodium Chloride injection USP using strict aseptic procedures.
As the needle is advanced or withdrawn, a bile duct may be located by frequent aspiration for bile or mucus. Before the dose is administered, as much bile as possible is aspirated. The injection may be repeated for exposures in different planes and repositioning of the patient, if necessary, should be done with care. If a duct is not readily located by aspiration, successive small doses of 1 to 2 mL of the medium are injected into the liver as the needle is gradually withdrawn, until a duct is visualized by x-ray.
If no duct can be located after 3 or 4 attempts, the procedure should be terminated. Inability to enter a duct by a person experienced in the technique is generally considered to be strongly suggestive of hepatocellular disease.
Endoscopic retrograde cholangiopancreatography (ERCP) is indicated in carefully selected patients with known or suspected pancreatic or biliary tract disease when other diagnostic procedures have failed to provide the necessary diagnostic information. Prior to the development of ERCP, x-ray examination of the pancreatic ducts could only be obtained at laparotomy.
Endoscopic retrograde cholangiopancreatography should only be performed by personnel skilled and experienced with the procedure, and careful attention to technique is essential for the success and safety of the procedure. Fluoroscopy is mandatory during injection to prevent over distention of the duct systems.
Adverse reactions that have occurred which are attributable to either the procedure or to Conray, include nausea, vomiting, fever, severe abdominal pain, duodenal wall intravasation, septicemia, pancreatitis and perforation of the common bile duct associated with pathology.
The procedure is usually performed following pharyngeal anesthesia and analgesic or sedative premedication. Duodenal motility may be controlled in patients with active duodenal peristalsis with an appropriate antiperistaltic agent.
The contrast medium should be injected slowly under fluoroscopic control employing the minimal dose that is adequate to visualize the common bile duct, the pancreatic duct, or both duct systems. The dosage will vary greatly depending on the pathological findings and can range from 10 to 100 mL for visualization of the common bile duct; and from 2 to 10 mL for visualization of the pancreatic duct.
Following the procedure, the patient should be kept under close observation for 24 hours.
Conray may be useful to enhance the demonstration of the presence and extent of certain malignancies such as: gliomas including malignant gliomas, glioblastomas, astrocytomas, oligodendrogliomas and gangliomas; ependymomas; medulloblastomas; meningiomas; neuromas; pinealomas; pituitary adenomas; craniopharyngiomas; germinomas; and metastatic lesions.
The usefulness of contrast enhancement for the investigation of the retrobulbar space and in cases of low grade or infiltrative glioma has not been demonstrated.
In cases where lesions have calcified, there is less likelihood of enhancement. Following therapy, tumors may show decreased or no enhancement.
The use of Conray may be beneficial in the image enhancement of non-neoplastic lesions. General infarctions of recent onset may be better visualized with the contrast enhancement, while some infarctions are obscured if contrast media are used. The use of iodinated contrast media results in contrast enhancement in about 60% of cerebral infarctions studied from one to four weeks from the onset of symptoms.
Sites of active infection may also be enhanced following contrast medium administration.
Arteriovenous malformations and aneurysms will show contrast enhancement. In the case of these vascular lesions, the enhancement is probably dependent on the iodine content of the circulating blood pool.
The opacification of the inferior vermis following contrast medium administration has resulted in false positive diagnoses in a number of normal studies.
No special patient preparation is required for contrast enhancement of CT brain scanning. However, it is advisable to ensure that patients are well hydrated prior to examination.
The usual dosage in adults and children is 2 mL/kg (1 mL/lb) by intravenous administration, not to exceed a total dose of 150 mL. In most cases, scanning may be performed immediately after completion of administration; however, when fast scanning equipment (less than 1 minute) is used, consideration should be given to waiting approximately 5 minutes to allow for maximum contrast enhancement.
Conray may be administered for cranial computerized angiotomography when necessary to visualize the cerebral vessels to detect cerebrovascular lesions and to evaluate the anatomical relationship between the cerebral blood vessels and other parenchymal or space occupying lesions.
Conray may be administered by intravenous bolus injection, or by bolus injection followed by rapid infusion.
For bolus injection, the usual dose in adults and children is 0.5 to 1.0 mL/kg at an injection rate of 2 mL/second with scanning begun immediately after administration. This dose may be repeated as necessary. The total dose per procedure should not exceed 200 mL, and in children the total dose is reduced in approximate proportion to age and body weight.
In adults, when the combination bolus and infusion technique is used, a 50 mL bolus injection followed by a rapid infusion of 150 mL may be given or a 100 mL bolus injection followed by a rapid infusion of 100 mL may be used. Scanning is begun immediately after the bolus administration. In children, the dose is reduced in approximate proportion to age and body weight.
Conray may be administered when necessary to visualize vessels and organs in patients undergoing CT of the chest, abdomen and pelvis.
No special patient preparation is required for contrast enhancement in body CT. In patients undergoing abdominal or pelvic examination, opacification of the bowel may be valuable in scan interpretation.
In addition to the general precautions previously described, it is advisable to ensure that patients are adequately hydrated prior to examination. Patient motion, including respiration, can markedly affect image quality, therefore, patient cooperation is essential. The use of an intravascular contrast medium can obscure tumors in patients undergoing CT evaluation of the liver resulting in a false negative diagnosis. Dynamic CT scanning is the procedure of choice for malignant tumor enhancement (see CLINICAL PHARMACOLOGY).
Conray may be administered by bolus injection, by rapid infusion or by a combination of both.
For vascular opacification, a bolus injection of 25 to 50 mL may be used, repeated as necessary. When prolonged arterial or venous phase enhancement is required and for the enhancement of specific lesions, a rapid infusion of 150 mL may be used. In some instances, a 100 to 150 mL infusion may be employed to define the area of interest followed by bolus injections of 20 to 50 mL to clarify selected scans.
Intravenous digital subtraction angiography (IV DSA) is a radiographic modality which allows dynamic imaging of the arterial system following intravenous injection of iodinated x-ray contrast media through the use of image intensification, enhancement of the iodine signal and digital processing of the image data. Temporal subtraction of the images obtained during the “first arterial pass” of the injected contrast medium injection yield images which are devoid of bone and soft tissue.
Areas that have been most frequently examined by intravenous DSA are the heart, including coronary by-pass grafts; the pulmonary arteries; the arteries of the brachiocephalic circulation; the aortic arch; the abdominal aorta and its major branches including the celiac, mesenterics and renal arteries; the iliac arteries; and the arteries of the extremities.
No special patient preparation is required for intravenous digital subtraction angiography. However, it is advisable to ensure that patients are well hydrated prior to examination.
In addition to the general precautions previously described, the risks associated with IV DSA are those usually attendant with catheter procedures and include intramural injections, vessel dissection and tissue extravasation. Small test injections of contrast medium made under fluoroscopic observation to ensure the catheter tip is properly positioned, and in the case of peripheral placement that the vein is of adequate size, will reduce this potential.
Patient motion, including respiration and swallowing, can result in marked image degradation yielding non-diagnostic studies. Therefore, patient cooperation is essential.
See section on general Adverse Reactions.
Conray may be injected either centrally, into the superior or inferior vena cava, or peripherally into an appropriate arm vein. For central injections, catheters may be introduced at the antecubital fossa into either the basilic or cephalic vein or at the leg into the femoral vein and advanced to the distal segment of the corresponding vena cava. For peripheral injections, the catheter is introduced at the antecubital fossa into the appropriate size arm vein. In order to reduce the potential for extravasation during peripheral injection, a catheter of approximately 20 cm in length should be employed.
Depending on the area to be imaged, the usual dose range is 20 to 40 mL. Injections may be repeated as necessary.
Central catheter injections are usually made with a power injector with an injection rate of between 10 and 30 mL/second. When making peripheral injections, rates of 12 to 20 mL/second should be used, depending on the size of the vein. Also, since contrast medium may remain in the arm vein for an extended period following injection, it may be advisable to flush the vein, immediately following injection with an appropriate volume (20 to 25 mL) of 5% Dextrose in water or normal saline.
Arterial digital subtraction angiography provides images similar in quality to conventional film-screen systems. The advantages of arterial DSA when compared to standard film angiography include: the use of less contrast medium; the use of lower concentrations for some procedures; a decreased need for selective arterial catheterization reducing the possibility of dislodging atheromatous plaques or significantly reducing the blood flow in the artery; and a shortened examination time. The limitations of arterial DSA include: reduced spatial resolution; limited field size; and the inability to conduct simultaneous biplane examinations.
No special patient preparation is required for arterial DSA. However, it is advisable to ensure that patients are well hydrated prior to examination.
In addition to the general precautions described, the risks associated with arterial DSA are those usually attendant with catheter procedures. Following the procedure, gentle pressure hemostasis is required, followed by observation and immobilization of the limb for several hours to prevent hemorrhage from the site of arterial puncture.
The following dosage schedule for adults should serve only as a guide since the volume administered, the concentration selected and the flow rate will be determined by the resolution of the equipment being used. As a general rule, the volume used and the flow rates for arterial DSA are 50% or less than that used for conventional film arteriography. Diagnostic studies have been obtained using Conray undiluted (28.2% iodine), diluted 1:1 (14.1% iodine), and diluted 1:2 (9.4% iodine). Sodium Chloride Injection USP or Water for Injection USP may be used for dilution.
The following doses, equivalent in iodine content to undiluted Conray, have been used.
| Carotid or vertebral arteries: | 3-8 mL |
| Aortic Arch: | 15-25 mL |
| Subclavian and brachial arteries: | 5-15 mL |
| Major branches of the aorta: | 5-20 mL |
| Lumbar aorta (bifurcation): | 10-25 mL |
Overdosage may occur. The adverse effects of overdosage are life-threatening and affect mainly the pulmonary and cardiovascular system. The symptoms may include cyanosis, bradycardia, acidosis, pulmonary hemorrhage, convulsions, coma and cardiac arrest. Treatment of an overdose is directed toward the support of all vital functions and prompt institution of symptomatic therapy.
Iothalamate salts are dialyzable.
The intravenous LD50 value of various concentrations of Iothalamate Meglumine (in grams of iodine/kilogram body weight) varied from 5.7 to 8.9 g/kg in mice and 9.8 to 11.2 g/kg in rats. The LD50 values decrease as the rate of injection increases.
Store below 30°C (86°F). Exposing this product to very cold temperatures may result in crystallization of the salt. If this occurs, the container should be brought to room temperature. Shake vigorously to assure complete dissolution of any crystals. The speed of dissolution may be increased by heating with circulating warm air. Before use, examine the product to assure that all solids are redissolved, and that the container and closure have not been damaged.
This preparation is sensitive to light and must be protected from strong daylight or direct exposure to the sun.
As with all contrast media, glass containers should be inspected prior to use to ensure that breakage or other damage has not occurred during shipping and handling. All containers should be inspected for closure integrity. Damaged containers should not be used.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
