Optiray Warnings

USE THE RECOMMENDED OPTIRAY (IOVERSOL) CONCENTRATION FOR THE PARTICULAR PROCEDURE TO BE UNDERTAKEN.
GENERAL: Serious or fatal reactions have been associated with the administration of all iodine containing radiopaque media, including Optiray (ioversol). It is of utmost importance that a course of action be carefully planned in advance for immediate treatment of serious reactions, and that adequate facilities and appropriate personnel be readily available in case a severe reaction should occur.
A previous reaction to a contrast medium of different chemical structure or a history of iodine sensitivity is not an absolute contraindication to the use of Optiray. However, extreme caution should be exercised in injecting these patients and prophylactic therapy (as with corticosteroids for example) should be considered. (See General under Precautions.)
There must be a clear indication for performing procedures involving the administration of contrast agents in all patients.
Patients with a history of allergy, bronchial asthma or other allergic manifestations, combined renal and hepatic disease, the elderly, debilitated or severely ill patients, those with homocystinuria, endotoxemia, elevated body temperature, severe hypertension or congestive heart failure, other cardiovascular disease, hyperthyroidism and recent renal transplant recipients, as well as patients sensitive to iodine, present an additional risk and call for careful evaluation of the risks involved against the benefits expected.
Patients with a serum creatinine level above 3 mg/dL should not undergo excretory urography or other radiological procedures unless the benefits clearly outweigh the risks incurred.
In patients with advanced renal disease, iodinated contrast media should be used with caution and only when the examination is essential since excretion of the medium is impaired. Use of Optiray is not recommended in patients with anuria or severe oliguria.
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 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.
General anaesthesia may be indicated in some procedures; however, one should be aware of possible increased incidence of adverse reactions in such circumstances.
The administration of Optiray should be terminated if rash, abdominal pain, vomiting and breathing difficulties occur and consult the physician for the further treatment.
VASCULAR USE: Intravascularly administered iodine containing contrast media are potentially hazardous.
Non-ionic iodinated contrast media, including Optiray (ioversol), inhibit blood coagulation less than ionic contrast media. Clotting has been reported when blood remains in contact with syringes, catheters or tubes containing non-ionic contrast media. Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures with non-ionic and also with ionic contrast media. Therefore, meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimize thromboembolic events. Numerous factors, including length of procedure, number of injections, 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 keeping guidewires, catheters and all angiographic equipment free of blood, use of manifold systems and/or three way stopcocks, frequent catheter flushing with heparinized saline solutions and minimizing the length of the procedure. Non-ionic iodinated contrast media are not recommended as flush solutions. The use of plastic syringes in place of glass syringes has been reported to decrease but not eliminate the likelihood of clotting.
In patients who are known to have multiple myeloma and other paraproteinemias, because of the risk of inducing transient to fatal renal failure, extreme caution should be used. In these instances, anuria has developed resulting in progressive uremia, renal failure and eventually death. A minimal diagnostic dose should be employed and renal function, as well as extent of urinary precipitation of the myelomatous protein, should be monitored for a few days subsequent to the procedure. The patients should be normally hydrated for the examination since dehydration may predispose to precipitation of myeloma protein in the renal tubules. No form of therapy, including dialysis, has been successful in reversing the effect.
Intravascular administration of contrast media may promote sickling in individuals who are homozygous for sickle cell disease. Fluid restriction is not advised in these patients.
As with any contrast medium, including Optiray, serious neurologic sequelae, including permanent paralysis, can occur following cerebral arteriography and injection into vessels supplying the spinal cord. The injection of a contrast medium should never be made following the administration of vasopressors since they strongly potentiate neurologic effects.