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Basic Drug Info
Drug Name:Conray
Manufacturer:Mallinckrodt Inc.
Other Info:

Storage– 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.



Clinical Trials:


Indications and Usage

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 1-3 seconds during the first 30-90 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.
Neoplasm of uncertain or unknown behavior of mediastinum --

Contraindications

Refer to PRECAUTIONS, General, concerning hypersensitivity.

CONRAY should not be used for myelography.

Arthrography should not be performed if infection is present in or near the joint.

Percutaneous transhepatic cholangiography is contraindicated in patients with coagulation defects and prolonged prothrombin times.

Endoscopic retrograde cholangiopancreatography is contraindicated during an acute attack of pancreatitis or during severe clinically evident cholangitis and in patients in whom endoscopy is prohibited.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Communicable Diseases -- broad class of diseases whose causative agents may be passed between individuals in many different ways.

Infection -- Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

Blood Coagulation Disorders -- Hemorrhagic and thrombotic disorders that occur as a consequence of abnormalities in blood coagulation due to a variety of factors such as COAGULATION PROTEIN DISORDERS; BLOOD PLATELET DISORDERS; BLOOD PROTEIN DISORDERS or nutritional conditions.

Pancreatitis -- INFLAMMATION of the PANCREAS. Pancreatitis is classified as acute unless there are computed tomographic or endoscopic retrograde cholangiopancreatographic findings of CHRONIC PANCREATITIS (International Symposium on Acute Pancreatitis, Atlanta, 1992). The two most common forms of acute pancreatitis are ALCOHOLIC PANCREATITIS and gallstone pancreatitis.

Cholangitis -- Inflammation of the biliary ductal system (BILE DUCTS); intrahepatic, extrahepatic, or both.

Warnings

SEVERE ADVERSE EVENTS — INADVERTENT INTRATHECAL ADMINISTRATION: Serious adverse reactions have been reported due to the inadvertent intrathecal administration of iodinated contrast media that are not indicated for intrathecal use.

These serious adverse reactions include: death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.

Special attention must be given to insure that this drug product is not administered intrathecally.Ionic iodinated contrast media inhibit blood coagulation, in vitro, more than nonionic contrast media.

Nonetheless, it is prudent to avoid prolonged contact of blood with syringes containing ionic 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.Serious or fatal reactions have been associated with the administration of iodine-containing radiopaque media.

It is of utmost importance to be completely prepared to treat any contrast medium reaction.Serious neurologic sequelae, including permanent paralysis, have been reported following cerebral arteriography, selective spinal arteriography and arteriography of vessels supplying the spinal cord.

The intravascular injection of a contrast medium should never be made following the administration of vasopressors since they strongly potentiate neurologic effects.In patients with subarachnoid hemorrhage, a rare association between contrast administration and clinical deterioration, including convulsions and death, has been reported.

Therefore, administration of intravascular iodinated ionic contrast media in these patients should be undertaken with caution.A definite risk exists in the use of intravascular contrast agents in patients who are known to have multiple myeloma.

In such instances, anuria has developed, resulting in progressive uremia, renal failure and eventually death.

Although neither the contrast agent nor dehydration has separately proved 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 to the procedure; however, partial dehydration in the preparation of these patients for the examination is not recommended, since this may predispose to precipitation of 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 40, should be considered before instituting intravascular administration of contrast agents.Administration of radiopaque materials to patients known or suspected to have 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 blood pressure should be assessed throughout the procedure, and measures for treatment of a hypertensive crisis should be available.Contrast media have been shown to promote the phenomenon of sickling in individuals who are homozygous for sickle cell disease when the material is injected intravenously or intra-arterially.Convulsions have occurred in patients with primary or metastatic cerebral lesions following the administration of iodine-containing radiopaque media for the contrast enhancement of CT brain images.In patients with advanced renal disease, iodinated contrast media should be used with caution, and only when the need for the examination dictates, since excretion of the medium may be impaired.

Patients with combined renal and hepatic disease, those with severe hypertension or congestive heart failure, and recent renal transplant recipients may present an additional risk.Renal failure has been reported in patients with liver dysfunction who were given an oral cholecystographic agent followed by an intravascular iodinated radiopaque agent, and also in patients with occult renal disease, notably diabetics and hypertensives.

In these classes of patients, there should be no fluid restriction and every attempt made to maintain normal hydration, prior to contrast medium administration, since dehydration is the single most important factor influencing further renal impairment.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 the administration of iodinated contrast agents.

Therefore, careful consideration of the potential risks should be given before performing this radiographic procedure in these patients.Caution should be exercised in performing contrast medium studies in patients with endotoxemia and/or those with elevated body temperatures.Reports of thyroid storm occurring following the intravascular use of iodinated radiopaque agents in patients with hyperthyroidism or with an autonomously functioning thyroid nodule, suggest that this additional risk be evaluated in such patients before use of this drug.

Iodine containing contrast agents may alter the results of thyroid function tests which depend on iodine estimation, e.g.

PBI and radioactive iodine uptake studies.

Such tests, if indicated, should be performed prior to the administration of this preparation.

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