Nonionic iodinated contrast media inhibit blood coagulation, in vitro, less than ionic contrast media. Clotting has been reported when blood remains in contact with syringes containing nonionic 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.

As with all injectable contrast agents, the possibility of severe reactions should be borne in mind,
regardless of the patient’s pre-existing medical history.

For use in patients with severely impaired renal function; use in patients with multiple myeloma or other paraproteinemia, particularly in those with therapeutically resistant anuria; promotion of sickling in
individuals who are homozygous for sickle cell disease; use in patients with known or suspected pheochromocytoma; and reports of thyroid storm following the use of iodinated radiopaque diagnostic
agents in patients with hyperthyroidism or with an autonomously functioning thyroid nodule.

Caution in hydrating patients with underlying conditions that may be worsened by fluid overload;
predisposition of diabetic nephropathy to acute renal impairment which may precipitate lactic acidosis in patients taking biguanides; aggravation of the symptoms of myasthenia gravis; dangers of preparatory dehydration which may contribute to acute renal failure in patients with advanced vascular disease,
diabetic patients, and in susceptible nondiabetic patients (often elderly with preexisting renal disease);
serious, life-threatening, fatal, anaphylactoid or cardiovascular reactions, and potential transitory increase
in the circulatory osmotic load in patients with congestive heart failure.

These serious adverse reactions include: death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, actue 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.

IMPORTANT SAFETY INFORMATION:

ISOVUE^® (iopamidol injection) IS NOT FOR INTRATHECAL USE. Iopamidol injection is available as
ISOVUE-M^® for intrathecal administration.

Nonionic iodinated contrast media inhibit blood coagulation, in vitro, less than ionic contrast media. Clotting has been reported when blood remains in contact with syringes containing nonionic 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.

Caution must be exercised in patients with severely impaired renal function, those with combined renal and hepatic disease, or anuria, particularly when larger or repeat doses are administered. Radiopaque diagnostic contrast agents are potentially hazardous in patients with multiple myeloma or other paraproteinemia, particularly in those with therapeutically resistant anuria. Caution should be exercised in hydrating patients with underlying conditions that may be worsened by fluid overload, such as congestive heart failure. Diabetic nephropathy may predispose to acute renal impairment following intravascular contrast media administration. Acute renal impairment following contrast media administration may precipitate lactic acidosis in patients who are taking biguanides. Preparatory dehydration is dangerous and may contribute to acute renal failure in patients with advanced vascular disease, diabetic patients, and in susceptible nondiabetic patients (often elderly with preexisting renal disease). Patients should be well hydrated prior to and following iopamidol administration.

The possibility of a reaction, including serious, life-threatening, fatal, anaphylactoid or cardiovascular reactions, should always be considered. Patients at increased risk include those with a history of a previous reaction to a contrast medium, patients with a known sensitivity to iodine per se, and patients with a known clinical hypersensitivity (bronchial asthma, hay fever, and food allergies).

Click here for Additional Safety Information

ADDITIONAL SAFETY INFORMATION