Optiray Injection

DRUG DESCRIPTION

OPTIRAY (ioversol injection) formulations are sterile, nonpyrogenic, aqueous solutions intended for intravascular administration as diagnostic radiopaque media. 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:

Optiray 350 [IOVERSOL] Structural Formula Illustration

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 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 350 provides 35% (350 mg/mL) organically bound iodine.

Each milliliter of OPTIRAY 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 320 provides 32% (320 mg/mL) organically bound iodine.

Each milliliter of OPTIRAY 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 300 provides 30% (300 mg/mL) organically bound iodine.

Each milliliter of OPTIRAY 240 (ioversol injection 51%) contains 509 mg of ioversol with 3.6 mg of tromethamine as a buffer and 0.2 mg of edetate calcium disodium as a stabilizer. OPTIRAY 240 provides 24% (240 mg/mL) organically bound iodine.

Each milliliter of OPTIRAY 160 (ioversol injection 34%) contains 339 mg of ioversol with 3.6 mg of tromethamine as a buffer and 0.2 mg of edetate calcium disodium as a stabilizer. OPTIRAY 160 provides 16% (160 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
160
OPTIRAY
240
OPTIRAY
300
OPTIRAY
320
OPTIRAY
350
Ioversol content (mg/mL) 339 509 636 678 741
Iodine content (mg I/mL) 160 240 300 320 350
Osmolality (mOsm/kg water) 355 502 651 702 792
Viscosity (cps)
at 25C 2.7 4.6 8.2 9.9 14.3
at 37C 1.9 3.0 5.5 5.8 9.0
Specific Gravity at 37C 1.188 1.281 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 1.2 to 2.8 times that of plasma (285 mOsm/kg water) as shown in the above table and are hypertonic under conditions of use.

What are the possible side effects of ioversol (Optiray 160, Optiray 240, Optiray 300, Optiray 320, Optiray 350)?

Some of the side effects of ioversol can occur up to 24 hours after you have received the medication.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • urinating less than usual or not at all;
  • severe muscle pain or weakness;
  • seizure (convulsions);
  • chest...

Read All Potential Side Effects and See Pictures of Optiray Injection


Optiray Injection Patient Information Including Side Effects

Brand Names: Optiray 160, Optiray 240, Optiray 300, Optiray 320, Optiray 350

Generic Name: ioversol (Pronunciation: eye oh VERS ol)

  • What is ioversol (Optiray Injection)?
  • What are the possible side effects of ioversol (Optiray Injection)?
  • What is the most important information I should know about ioversol (Optiray Injection)?
  • What should I discuss with my health care provider before receiving ioversol (Optiray Injection)?
  • How is ioversol used (Optiray Injection)?
  • What happens if I miss a dose (Optiray Injection)?
  • What happens if I overdose (Optiray Injection)?
  • What should I avoid while receiving ioversol (Optiray Injection)?
  • What other drugs will affect ioversol (Optiray Injection)?
  • Where can I get more information?

What is ioversol (Optiray Injection)?

Ioversol is in a group of drugs called radiopaque (RAY dee oh payk) contrast agents. Ioversol contains iodine, a substance that absorbs x-rays. Radiopaque contrast agents are used to allow blood vessels, organs, and other non-bony tissues to be seen more clearly on a CT scan or other radiologic (x-ray) examination.

Ioversol is used to help diagnose certain disorders of the heart, brain, and blood vessels.

Ioversol may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of ioversol (Optiray Injection)?

Some of the side effects of ioversol can occur up to 24 hours after you have received the medication.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • urinating less than usual or not at all;
  • severe muscle pain or weakness;
  • seizure (convulsions);
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • feeling light-headed, fainting;
  • wheezing, trouble breathing;
  • fast or slow heartbeat;
  • easy bruising, unusual bleeding, or skin changes; or
  • swelling of your hands, ankles, or feet.

Other less serious side effects are more likely to occur, such as:

  • fever, warmth, or pain;
  • skin rash or redness;
  • headache; or
  • nausea.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ioversol (Optiray Injection)?

You should not receive ioversol if you have any type of active infection.

Tell your doctor if you have asthma, hay fever, or history of food or drug allergies, especially if you have had any type of reaction to another contrast agent.

Drink extra fluids before and after you receive ioversol. This medication can cause you to get dehydrated, which can lead to dangerous effects on your kidneys. Follow your doctor's instructions about the types and amount of fluids you should drink before and after your test.

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