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Uses
Optiray 350 is indicated in adults for peripheral and coronary arteriography and left ventriculography. Optiray 350 is also indicated for contrast enhanced computed tomographic imaging of the head and body, intravenous excretory urography, intravenous digital subtraction angiography and venography. Optiray 350 is indicated in children for angiocardiography.
Optiray 320 is indicated in adults for angiography throughout the cardiovascular system. The uses include cerebral, coronary, peripheral, visceral and renal arteriography, venography, aortography, and left ventriculography. Optiray 320 is also indicated for contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography.
Optiray 320 is indicated in children for angiocardiography, contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography.
Optiray 300 is indicated for cerebral angiography and peripheral arteriography. Optiray 300 is also indicated for contrast enhanced computed tomographic imaging of the head and body, venography, and intravenous excretory urography.
History
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Other Information
Optiray (ioversol injection) formulations are sterile, nonpyrogenic, aqueous solutions intended for intravascular administration as diagnostic radiopaque media. Each bottle is to be used as a Pharmacy Bulk Package for dispensing multiple single dose preparations utilizing a suitable transfer device.
Ioversol is designated chemically as N,N'-Bis (2,3-dihydroxypropyl)-5-[N-(2-hydroxyethyl) -glycolamido] -2,4,6-triiodoisophthalamide and has the following structural formula:
The molecular weight of ioversol is 807.11 and the organically bound iodine content is 47.2%. Ioversol is nonionic and does not dissociate in solution.
Each milliliter of Optiray Pharmacy Bulk Package - 350 (ioversol injection 74%) contains 741 mg of ioversol with 3.6 mg of tromethamine as a buffer and 0.2 mg of edetate calcium disodium as a stabilizer. Optiray Pharmacy Bulk Package - 350 provides 35% (350 mg/mL) organically bound iodine.
Each milliliter of Optiray Pharmacy Bulk Package - 320 (ioversol injection 68%) contains 678 mg of ioversol with 3.6 mg of tromethamine as a buffer and 0.2 mg of edetate calcium disodium as a stabilizer. Optiray Pharmacy Bulk Package - 320 provides 32% (320 mg/mL) organically bound iodine.
Each milliliter of Optiray Pharmacy Bulk Package - 300 (ioversol injection 64%) contains 636 mg of ioversol with 3.6 mg of tromethamine as a buffer and 0.2 mg of edetate calcium disodium as a stabilizer. Optiray Pharmacy Bulk Package - 300 provides 30% (300 mg/mL) organically bound iodine.
The pH of the Optiray formulations has been adjusted to 6.0 to 7.4 with hydrochloric acid or sodium hydroxide. All solutions are sterilized by autoclaving and contain no preservatives. Unused portions should be discarded. Optiray solutions are sensitive to light and therefore should be protected from exposure.
Some physical and chemical properties of these formulations are listed below:
Optiray 300 |
Optiray 320 |
Optiray 350 |
||
Ioversol content | 636 | 678 | 741 | |
(mg/mL) | ||||
Iodine content | 300 | 320 | 350 | |
(mg I/mL) | ||||
Osmolality | 651 | 702 | 792 | |
(mOsm/kg water) | ||||
Viscosity (cps) | ||||
at 25°C | 8.2 | 9.9 | 14.3 | |
at 37°C | 5.5 | 5.8 | 9.0 | |
Specific Gravity | ||||
at 37°C | 1.352 | 1.371 | 1.405 |
The Optiray formulations are clear, colorless to pale yellow solutions containing no undissolved solids. Crystallization does not occur at room temperature. The products are supplied in containers from which the air has been displaced by nitrogen. Optiray solutions have osmolalities 2.3 to 2.8 times that of plasma (285 mOsm/kg water) as shown in the above table and are hypertonic under conditions of use.
Sources
Optiray Manufacturers
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Mallinckrodt Inc.
Optiray | Mallinckrodt Inc.
GeneralAs with all radiopaque contrast agents, only the lowest dose necessary to obtain adequate visualization should be used. A lower dose may reduce the possibility of an adverse reaction. Most procedures do not require use of either the maximum volume or the highest concentration of Optiray. The combination of volume and concentration of Optiray to be used should be carefully individualized accounting for factors such as age, body weight, size of the vessel and the rate of blood flow within the vessel. Other factors such as anticipated pathology, degree and extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed should be considered.
It is desirable that intravascularly administered iodinated contrast agents be at or close to body temperature when injected.
If during administration a reaction occurs, the injection should be stopped until the reaction has subsided.
Patients should be well hydrated prior to and following Optiray (ioversol injection) administration.
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