PRECAUTIONS
General
Diagnostic procedures which involve the use of iodinated intravascular contrast agents should be carried out under the direction of personnel skilled and experienced in the particular procedure to be performed. A fully equipped emergency cart, or equivalent supplies and equipment, and personnel competent in recognizing and treating adverse reactions of all types should always be available. Since severe delayed reactions have been known to occur, emergency facilities and competent personnel should be available for at least 30 to 60 minutes after administration.
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 pre-existing renal disease). Patients should be well hydrated prior to and following the administration of OPTIRAY.
The possibility of a reaction, including serious, life-threatening, fatal, anaphylactoid or cardiovascular reactions, should always be considered (See Adverse Reactions). Increased risk is associated with a history of previous reaction to a contrast medium, a known sensitivity to iodine and known allergies (i.e., bronchial asthma, hay fever and food allergies) or hypersensitivities.
The occurrence of severe idiosyncratic reactions has prompted the use of several pretesting methods. However, pretesting cannot be relied upon to predict severe reactions and may itself be hazardous to the patient. It is suggested that a thorough medical history with emphasis on allergy and hypersensitivity, prior to the injection of any contrast medium, may be more accurate than pretesting in predicting potential adverse reactions. A positive history of allergies or hypersensitivity does not arbitrarily contraindicate the use of a contrast agent when a diagnostic procedure is thought essential, but caution should be exercised. Premedication with antihistamines or corticosteroids to avoid or minimize possible allergic reactions in such patients should be considered. Reports indicate that such pretreatment does not prevent serious life-threatening reactions, but may reduce both their incidence and severity.
General anesthesia may be indicated in the performance of some procedures in selected patients; however, a higher incidence of adverse reactions has been reported in these patients, and may be attributable to the inability of the patient to identify untoward symptoms or to the hypotensive effect of anesthesia which can prolong the circulation time and increase the duration of exposure to the contrast agent.
In angiographic procedures, the possibility of dislodging plaques or damaging or perforating the vessel wall should be considered during catheter manipulations and contrast medium injection. Test injections to insure proper catheter placement are suggested.
Angiography should be avoided whenever possible in patients with homocystinuria because of the risk of inducing thrombosis and embolism.
Patients with congestive heart failure should be observed for several hours following the procedure to detect delayed hemodynamic disturbances which may be associated with a transitory increase in the circulating osmotic load.
Selective coronary arteriography should be performed only in selected patients and those in whom the expected benefits outweigh the procedural risk. The inherent risks of angiocardiography in patients with chronic pulmonary emphysema must be weighed against the necessity for performing this procedure.
Extreme caution during injection of a contrast medium is necessary to avoid extravasation. This is especially important in patients with severe arterial or venous disease.
Information for Patients
Patients receiving iodinated intravascular contrast agents should be instructed to:
- Inform your physician if you are pregnant.
- Inform your physician if you are diabetic or if you have multiple myeloma, pheochromocytoma, homozygous sickle cell disease or known thyroid disorder. (See WARNINGS).
- Inform your physician if you are allergic to any drugs or food, or if you had any reactions to previous injections of dyes used for x-ray procedures. (See PRECAUTIONS, General).
- Inform your physician about any other medications you are currently taking including non-prescription drugs.
Drug Interactions
Renal toxicity has been reported in a few patients with liver dysfunction who were given oral cholecystographic agents followed by intravascular contrast agents. Administration of any intravascular contrast agent should therefore be postponed in patients who have recently received a cholecystographic contrast agent.
Other drugs should not be mixed with ioversol injection.
Drug / Laboratory Test Interactions
The results of PBI and radioactive iodine uptake studies, which depend on iodine estimation, will not accurately reflect thyroid function for up to 16 days following administration of iodinated contrast media. However, thyroid function tests not depending on iodine estimations, e.g., T3 resin uptake and total or free thyroxine (T4) assays are not affected.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long term animal studies have been performed to evaluate carcinogenic potential. However, animal studies suggest that this drug is not mutagenic and does not affect fertility.
Pregnancy Category B
No teratogenic effects attributable to ioversol have been observed in teratology studies performed in animals. There are, however, no adequate and well controlled studies in pregnant women. It is not known whether ioversol crosses the placental barrier or reaches fetal tissues. However, many injectable contrast agents cross the placental barrier in humans and appear to enter fetal tissue passively. Because animal teratology studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. X-ray procedures involve a certain risk related to the exposure of the fetus.
Nursing Mothers
It is not known whether ioversol is excreted in human milk. However, many injectable contrast agents are excreted unchanged in human milk. Although it has not been established that serious adverse reactions occur in nursing infants, caution should be exercised when intravascular contrast media are administered to nursing women because of potential adverse reactions, and consideration should be given to temporarily discontinuing nursing.
Pediatric Use
Safety and effectiveness in children have been established for the use of OPTIRAY 350 and OPTIRAY 320 in angiocardiography, and for OPTIRAY 320 in contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography.
Safety and effectiveness in newborns have not been established.
|