FDA label fd2adc8c-f631-de56-74fc-c8f39c074703

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 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 iodipamide meglumine, but calls for extreme caution in administration.

ADVERSE REACTIONS Local reactions at the site of injection are not observed, unless excessive amounts are extravasated during injection. After too rapid administration, mild transient symptoms such as restlessness, sensations of warmth, sneezing, perspiration, salivation, flushing, pressure in the upper abdomen, dizziness, nausea, vomiting, chills, fever, headache, pallor and tremors may occur. These symptoms disappear when the injection has been completed. Rarely, swollen eyelids, laryngospasm, respiratory difficulties, hypotension, cardiac reactions and cyanosis have been reported. Hypersensitivity reactions may occur. In rare instances, despite the most careful sensitivity testing, anaphylactoid reactions may occur. Renal function tests may be altered and renal failure may occur. Endocrine: Thyroid function tests indicative of hypothyroidism or transient thyroid suppression have been uncommonly reported following iodinated contrast media administration to adult and pediatric patients, including infants. Some patients were treated for hypothyroidism.