FDA label 2ea8076f-0f08-4f03-bee9-5f293bc2d886

NOT FOR INTRATHECAL USE

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 inadvertently administered intrathecally. The possibility exists for inadvertent administration into the intrathecal space during epidural administrations. Therefore, epidural administration procedures, such as pain management catheter placement, should not be performed with use of this product. General 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. A definite risk exists in the use of intravascular contrast agents in patients who are known to have multiple myeloma. In such instances there has been anuria 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 the causative factor. The risk in myelomatous patients is not a contraindication to the procedures; however, partial dehydration in the preparation of these patients for the examination is not recommended since this may predispose to the precipitation of myeloma protein in the renal tubules. No form of therapy, including dialysis, has been successful in reversing this effect. Myeloma, which occurs most commonly in persons over age 40, should be considered before intravascular administration of a contrast agent. 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. Since iodine-containing contrast agents may alter the results of thyroid function tests, such tests, if indicated, should be performed prior to the administration of this preparation. A history of sensitivity to iodine per se or to other contrast agents is not an absolute contraindication to the use of diatrizoate meglumine, but calls for extreme caution in administration. Avoid accidental introduction of this preparation into the subarachnoid space since even small amounts may produce convulsions and possible fatal reactions. 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. Cerebral angiography should be undertaken with special caution in extreme age, poor clinical condition, advanced arteriosclerosis, severe arterial hypertension, cardiac decompensation, recent cerebral embolism, or thrombosis. Urography should be performed with extreme caution in patients with severe concomitant hepatic and renal disease.

ADVERSE REACTIONS Adverse reactions accompanying the use of iodine-containing intravascular contrast agents are usually mild and transient although severe and life-threatening reactions, including fatalities, have occurred. Because of the possibility of severe reactions to the procedure and/or the radiopaque medium, appropriate emergency facilities and well-trained personnel should be available to treat both conditions. Emergency facilities and personnel should remain available for 30 to 60 minutes following the procedure since severe delayed reactions have been known to occur. Nausea, vomiting, flushing, or a generalized feeling of warmth are the reactions seen most frequently with intravascular injection. Symptoms which may occur are chills, fever, sweating, headache, dizziness, pallor, weakness, severe retching and choking, wheezing, a rise or fall in blood pressure, facial or conjunctival petechiae, urticaria, pruritus, rash and other eruptions, edema, cramps, tremors, itching, sneezing, lacrimation, etc. Antihistaminic agents may be of benefit; rarely such reactions may be severe enough to require discontinuation of dosage. Severe reactions which may require emergency measures may take the form of a cardiovascular reaction characterized by peripheral vasodilatation with resultant hypotension and reflex tachycardia, dyspnea, agitation, confusion, and cyanosis progressing to unconsciousness. Or, the histamine-liberating effect of these compounds may induce an allergic-like reaction which may range in severity from rhinitis or angioneurotic edema to laryngeal or bronchial spasm or anaphylactoid shock. Temporary renal shutdown or other nephropathy may occur. Temporary neurologic effects of varying severity have occurred in a few instances, particularly when the medium was used for angiography in the diagnosis of cerebral pathology. Although local tissue tolerance is usually good, there have been a few reports of a burning or stinging sensation or numbness and of venospasm or venous pain, and partial collapse of the injected vein. Neutropenia or thrombophlebitis may occur. Adverse effects may sometimes occur as a consequence of the procedure for which the contrast agent is used. Adverse reactions in excretion urography have included cardiac arrest, ventricular fibrillation, anaphylaxis with severe asthmatic reaction, and flushing due to generalized vasodilation. Cerebral angiography has been known to cause temporary neurologic complications such as induction of seizures, particularly in patients with convulsive disorders; confusional states or drowsiness; transient paresis; coma; temporary disturbances in vision; or seventh nerve weakness. During peripheral arteriography , complications have occurred including hemorrhage from the puncture site, thrombosis of the vessel, and brachial plexus palsy following axillary artery injections. Complications of percutaneous transhepatic cholangiography have been estimated to occur in four to six percent of cases and have included bile leakage and biliary peritonitis, gallbladder perforation, internal bleeding, septicemia involving gram-negative organisms, and tension pneumothorax from inadvertent puncture of the diaphragm and lung. Bile leakage may be more likely in patients with complete obstruction due to carcinoma. During splenoportography, intraperitoneal extravasation of the contrast medium may cause transient diaphragmatic irritation or mild to moderate transient pain which may sometimes be referred to the shoulder, the periumbilical region, or other areas. Because of the proximity of the pleural cavity, accidental pneumothorax has been known to occur. Inadvertent injection of the medium into other nearby structures is not likely to cause untoward consequences. Arthrography may induce joint pain or increase existing pain, particularly if a large dose is used and the medium extravasates into surrounding soft tissue. Pain or discomfort is usually immediate and transient but may be delayed or of extended duration (up to 24 hours). Lipid-filled histiocytes have been found in tissue removed following arthrography. The technique of discography may be painful, particularly when disk pathology exists. Pain on injection may also be related to the volume of the dose. The nature of the disk pathology or extravasation of contrast agent may cause referred pain. When any percutaneous technique is employed the possibility of thrombosis or of other complications due to the mechanical trauma of the procedure should be borne in mind.