FDA label 03b52dda-0d25-4f46-b62d-98362a39bd30

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 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. Diatrizoate meglumine should be used with extreme caution in patients with severe concomitant hepatic and renal disease, and those with severe hypertension or congestive heart failure. Since iodine-containing contrast agents may alter the results of thyroid function tests dependent on iodine estimation, 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 media is not an absolute contraindication to the use of diatrizoate meglumine, 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.

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 most frequently encountered with intravenous administration of contrast agents. Such symptoms as chills, fever, sweating, headache, dizziness, pallor, weakness, severe retching and choking, wheezing, a rise or fall in blood pressure, ventricular fibrillation, cardiac arrest, facial or conjunctival petechiae, urticaria,pruritus, rash, and other eruptions, edema, cramps, tremors, itching, sneezing, lacrimation, etc., may occur. Antihistaminic agents may be of benefit; rarely such reactions may be severe enough to require discontinuation of dosage. Pulmonary edema, spasm, seizures, hemiparesis, syncope, and impairment of vision have also occurred. Neutropenia may also 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, apnea, dyspnea, agitation, and 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. Although local tissue tolerance to diatrizoate meglumine is usually good, intravenous injection of the medium in a more concentrated formulation has produced a few instances of a burning or stingingsensation or numbness and of venospasm or venous pain, and partial collapse of the injected vein. Although not reported as resulting following lower extremity venography with diatrizoate meglumine, conditions such as thrombophlebitis, and the rare possibility of gangrene, should be considered as potential adverse reactions.