FDA label c3a18c6d-c51b-4bfe-a022-2d1b9be2a0b0

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 inadvertentlyadministered 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, but calls for extreme caution in administration. 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. The inherent risks of angiocardiography in cyanotic infants and patients with chronic pulmonary emphysema must be weighed against the necessity for performing this procedure. In pediatric angiocardiography , a dose of 10 to 20 mL may be particularly hazardous in infants weighing less than 7 kg. This risk is probably significantly increased if these infants have preexisting right heart“strain,” right heart failure, and effectively decreased or obliterated pulmonary vascular beds. Urography and nephrotomography should be performed with extreme caution in patients with severe concomitant hepatic and renal disease. Selective visceral arteriography should be performed with extreme caution in patients with severe generalized atherosclerosis, specifically with plaques or aneurysms at the level of the iliac or femoral arteries. Selective coronary arteriography should be performed only in selected patients and those in whom the expected benefits outweigh the procedural risk.

ADVERSE REACTIONS Mild, moderate, and sometimes severe adverse reactions may occur associated with the procedure and/or the contrast media. Reactions known to occur with parenteral administration of iodinated ionic contrast media (see the listing below) are possible with a nonionic agent. Approximately 95 percent of adverse reactions accompanying the use of other water-soluble intravascularly administered contrast agents are mild to moderate in degree. However, severe and life-threatening reactions and fatalities, mostly of cardiovascular origin, have occurred. Reported incidences of death from the administration of other iodinated contrast media range from 6.6 per 1 million (0.00066 percent) to 1 in 10,000 patients (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. 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. 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. 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. Adverse reactions 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 vasodilatation. Reactions following higher doses for nephrotomography are usually mild and transitory and do not appear to occur more frequently or severely than those induced by doses for excretion urography. Nausea, vomiting, flushing, or a generalized feeling of warmth are the reactions seen most frequently. In aortography , the risks of procedures include injury to the aorta and neighboring organs, pleural puncture, renal damage including infarction and acute tubular necrosis with oliguria and anuria, accidental selective filling of the right renal artery during the translumbar procedure in the presence of preexistent renal disease, retroperitoneal hemorrhage from the translumbar approach, spinal cord injury and pathology associated with syndrome of transverse myelitis, generalized petechiae, and death following hypotension, arrhythmia, and anaphylactoid reactions. Adverse reactions in pediatric angiocardiography have included arrhythmia and death. During peripheral arteriography , complications have occurred including hemorrhage from the puncture site, thrombosis of the vessel, and brachial plexus palsy following axillary artery injections. During selective coronary arteriography and selective coronary arteriography combined with left ventriculography , most patients will have transient ECG changes. Transient arrhythmias may occur infrequently. Ventricular fibrillation may result from manipulation of the catheter during the procedure or administration of the medium. Other reactions may include hypotension, chest pain, and myocardial infarction. Transient elevation of CPK (creatine phosphokinase) has occurred in approximately 30 percent of the patients tested. Fatalities have been reported. Complications due to the procedure include hemorrhage, thrombosis, pseudoaneurysms at the puncture site, and dislodgment of arteriosclerotic plaques. Dissection of the coronary vessels and transient sinus arrest have occurred rarely. Adverse reactions in selective renal arteriography include nausea, vomiting, hypotension and hypertension. Post-arteriographic changes in laboratory studies include transient elevations in BUN, serum creatinine and glucose. Complications due to the procedure during selective visceral arteriography include hematomas, thrombosis, pseudoaneurysms at injection site, and dislodgment of arteriosclerotic plaques. Other reactions may include urticaria, hypotension, hypertension, and insignificant changes in renal function and liver chemistry tests.