Important Safety Information For: IOPAMIDOL INJECTION
WARNING: RISKS ASSOCIATED WITH INTRATHECAL USE
Intrathecal administration, even if inadvertent, can cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. Iopamidol Injection, USP is for intra-arterial or intravenous use only.
Iopamidol injection can cause life-threatening or fatal hypersensitivity reactions including anaphylaxis. Manifestations include respiratory arrest, laryngospasm, bronchospasm, angioedema, and shock. Most severe reactions develop shortly after the start of injection (e.g., within 1 to 3 minutes), but delayed reactions can also occur. Obtain a history of allergy, hypersensitivity, or hypersensitivity reactions to iodinated contrast agents and always have emergency resuscitation equipment and trained personnel available prior to iopamidol injection administration. Monitor all patients for hypersensitivity reactions.
Acute kidney injury, including renal failure, may occur after iopamidol injection administration. Use the lowest necessary dose of iopamidol injection in patients with renal impairment. Adequately hydrate patients prior to and following iopamidol injection administration. Do not use laxatives, diuretics, or preparatory dehydration prior to iopamidol injection administration.
Iopamidol injection increases the circulatory osmotic load and may induce acute or delayed hemodynamic disturbances in patients with congestive heart failure, severely impaired renal function, combined renal and hepatic disease, and combined renal and cardiac disease, particularly when repetitive or large doses are administered. Fatal cardiovascular reactions have occurred mostly within 10 minutes of iopamidol injection; the main feature was cardiac arrest with cardiovascular disease as the main underlying factor. Monitor all patients for severe cardiovascular reactions.
Serious, in some cases fatal, thromboembolic events, including myocardial infarction and stroke, can occur during angiographic procedures. During these procedures, increased thrombosis and activation of the complement system occurs. To minimize thromboembolic events, use meticulous angiographic techniques and minimize the length of the procedure. Avoid blood remaining in contact with syringes containing iodinated contrast agents, which increases risk of clotting. Avoid angiocardiography in patients with homocystinuria because of the risk of inducing thrombosis and embolism.
Extravasation can occur with iopamidol injection administration, particularly in patients with severe arterial or venous disease. Inflammation, blistering, skin necrosis, and compartment syndrome have been reported following extravasation. In addition, injection site reactions such as pain and swelling at the injection site can also occur. Ensure intravascular placement of catheters prior to injection. Monitor patients for extravasation and advise patients to seek medical care for progression of symptoms.
Thyroid storm has occurred after the intravascular use of iodinated agents in patients with hyperthyroidism or with an autonomously functioning thyroid nodule. Evaluate the risk in such patients before use of iopamidol injection.
The most frequent adverse reactions are: hot flashes, angina pectoris, flushing, bradycardia, hypotension, and hives.
Please see the package insert for Iopamidol Injection, USP for full prescribing information.