Optiray

Optiray

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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

There is currently no drug history available for this drug.

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:

chemical structure

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.

Optiray Manufacturers


  • Mallinckrodt Inc.
    Optiray (Ioversol) Injection Optiray (Ioversol) Injection Optiray (Ioversol) Injection [Mallinckrodt Inc.]

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